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Review
. 2023 Jul 5;7(7):CD006910.
doi: 10.1002/14651858.CD006910.pub3.

Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer

Rebecca Newhouse #  1 , Ellen Nelissen #  2 , Karim Hussien El-Shakankery #  3 , Ewelina Rogozińska  4 , Esme Bain  5 , Susana Veiga  5 , Jo Morrison  1
Affiliations
Review

Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer

Rebecca Newhouse et al. Cochrane Database Syst Rev. .

Abstract
in English, Korean

Background: Cancer of ovarian, fallopian tube and peritoneal origin, referred to collectively as ovarian cancer, is the eighth most common cancer in women and is often diagnosed at an advanced stage. Women with relapsed epithelial ovarian cancer (EOC) are less well and have a limited life expectancy, therefore maintaining quality of life with effective symptom control is an important aim of treatment. However, the unwanted effects of chemotherapy agents may be severe, and optimal treatment regimens are unclear. Pegylated liposomal doxorubicin (PLD), which contains a cytotoxic drug called doxorubicin hydrochloride, is one of several treatment modalities that may be considered for treatment of relapsed EOCs. This is an update of the original Cochrane Review which was published in Issue 7, 2013.

Objectives: To evaluate the efficacy and safety of PLD, with or without other anti-cancer drugs, in women with relapsed high grade epithelial ovarian cancer (EOC).

Search methods: We searched CENTRAL, MEDLINE (via Ovid) and Embase (via Ovid) from 1990 to January 2022. We also searched online registers of clinical trials, abstracts of scientific meetings and reference lists of included studies.

Selection criteria: We included randomised controlled trials (RCTs) that evaluated PLD in women diagnosed with relapsed epithelial ovarian cancer.

Data collection and analysis: Two review authors independently extracted data to a pre-designed data collection form and assessed the risk of bias according to the Cochrane Handbook for Systematic Reviews of Interventions guidelines. Where possible, we pooled collected data in meta-analyses.

Main results: This is an update of a previous review with 12 additional studies, so this updated review includes a total of 26 RCTs with 8277 participants that evaluated the effects of PLD alone or in combination with other drugs in recurrent EOC: seven in platinum-sensitive disease (2872 participants); 11 in platinum-resistant disease (3246 participants); and eight that recruited individuals regardless of platinum sensitivity status (2079 participants). The certainty of the evidence was assessed for the three most clinically relevant comparisons out of eight comparisons identified in the included RCTs. Recurrent platinum-sensitive EOC PLD with conventional chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in overall survival (OS) (hazard ratio (HR) 0.93, 95% confidence interval (CI) 0.83 to 1.04; 5 studies, 2006 participants; moderate-certainty evidence) but likely increases progression-free survival (PFS) (HR 0.81, 95% CI 0.74 to 0.89; 5 studies, 2006 participants; moderate-certainty evidence). The combination may slightly improve quality of life at three months post-randomisation, measured using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (mean difference 4.80, 95% CI 0.92 to 8.68; 1 study, 608 participants; low-certainty evidence), but this may not represent a clinically meaningful difference. PLD in combination with another chemotherapy agent compared to alternative combination chemotherapy likely results in little to no difference in the rate of overall severe adverse events (grade ≥ 3) (risk ratio (RR) 1.11, 95% CI 0.95 to 1.30; 2 studies, 834 participants; moderate-certainty evidence). PLD with chemotherapy likely increases anaemia (grade ≥ 3) (RR 1.37, 95% CI 1.02 to 1.85; 5 studies, 1961 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD with conventional chemotherapy on hand-foot syndrome (HFS)(grade ≥ 3) (RR 4.01, 95% CI 1.00 to 16.01; 2 studies, 1028 participants; very low-certainty evidence) and neurological events (grade ≥ 3) (RR 0.38, 95% CI 0.20 to 0.74; 4 studies, 1900 participants; very low-certainty evidence). Recurrent platinum-resistant EOC PLD alone compared to another conventional chemotherapy likely results in little to no difference in OS (HR 0.96, 95% CI 0.77 to 1.19; 6 studies, 1995 participants; moderate-certainty evidence). The evidence is very uncertain about the effect of PLD on PFS (HR 0.94, 95% CI 0.85 to 1.04; 4 studies, 1803 participants; very low-certainty evidence), overall severe adverse events (grade ≥ 3) (RR ranged from 0.61 to 0.97; 2 studies, 964 participants; very low-certainty evidence), anaemia (grade ≥ 3) (RR ranged from 0.19 to 0.82; 5 studies, 1968 participants; very low-certainty evidence), HFS (grade ≥ 3) (RR ranged from 15.19 to 109.15; 6 studies, 2184 participants; very low-certainty evidence), and the rate of neurological events (grade ≥ 3)(RR ranged from 0.08 to 3.09; 3 studies, 1222 participants; very low-certainty evidence). PLD with conventional chemotherapy compared to PLD alone likely results in little to no difference in OS (HR 0.92, 95% CI 0.70 to 1.21; 1 study, 242 participants; moderate-certainty evidence) and it may result in little to no difference in PFS (HR 0.94, 95% CI 0.73 to 1.22; 2 studies, 353 participants; low-certainty evidence). The combination likely increases overall severe adverse events (grade ≥ 3) (RR 2.48, 95% CI 1.98 to 3.09; 1 study, 663 participants; moderate-certainty evidence) and anaemia (grade ≥ 3) (RR 2.38, 95% CI 1.46 to 3.87; 2 studies, 785 participants; moderate-certainty evidence), but likely results in a large reduction in HFS (grade ≥ 3) (RR 0.24, 95% CI 0.14 to 0.40; 2 studies, 785 participants; moderate-certainty evidence). It may result in little to no difference in neurological events (grade ≥ 3) (RR 1.40, 95% CI 0.85 to 2.31; 1 study, 663 participants; low-certainty evidence).

Authors' conclusions: In platinum-sensitive relapsed EOC, including PLD in a combination chemotherapy regimen probably makes little to no difference in OS compared to other combinations, but likely improves PFS. Choice of chemotherapy will therefore be guided by symptoms from previous chemotherapy and other patient considerations. Single-agent PLD remains a useful agent for platinum-resistant relapsed EOC and choice of agent at relapse will depend on patient factors, e.g. degree of bone marrow suppression or neurotoxicity from previous treatments. Adding another agent to PLD likely increases overall grade ≥ 3 adverse events with little to no improvement in survival outcomes. The limited evidence relating to PLD in combination with other agents in platinum-resistant relapsed EOC does not indicate a benefit, but there is some evidence of increased side effects.

배경: 난소암, 나팔관암, 복막암으로 통칭되는 난소암은 여성에서 8번째로 흔한 암이며 종종 진행된 단계에서 진단된다. 재발된 상피성 난소암(EOC) 여성은 건강 상태가 좋지 않고 기대 수명이 제한되어 있으므로 효과적인 증상 조절로 삶의 질을 유지하는 것이 치료의 중요한 목표이다. 그러나 화학요법제의 원치 않는 효과는 심각할 수 있으며 최적의 치료 요법은 불분명하다. doxorubicin hydrochloride라고 불리는 세포 독성 약물을 포함하는 Pegylated liposomal doxorubicin(PLD)은 재발된 EOC의 치료를 위해 고려할 수 있는 여러 치료 양식 중 하나이다. 이것은 2013년 7호에 게시된 원래 Cochrane Review의 업데이트이다. 목적: 재발한 고도 상피성 난소암(EOC)이 있는 여성에서 다른 항암제와 병용하거나 병용하지 않는 PLD의 효능과 안전성을 평가한다. 검색 전략: 1990년부터 2022년 1월까지 CENTRAL, MEDLINE(Ovid를 통해) 및 Embase(Ovid를 통해)를 검색했다. 또한 온라인 임상 시험 등록부, 과학 회의 초록 및 포함된 연구의 참조 목록을 검색했다. 선정 기준: 재발성 상피성 난소암으로 진단받은 여성에서 PLD를 평가한 무작위 대조 시험(RCT)을 포함했다. 자료 수집 및 분석: 2명의 검토 저자가 사전 설계된 데이터 수집 형식으로 독립적으로 데이터를 추출하고 Cochrane Handbook for Systematic Reviews of Interventions 가이드라인에 따라 비뚤림 위험을 평가했다. 가능한 경우 수집된 데이터를 메타 분석에 통합했다. 주요 결과: 이것은 12개의 추가 연구가 포함된 이전 검토의 업데이트이므로 이 업데이트된 검토에는 재발성 EOC에서 PLD 단독 또는 다른 약물과의 조합의 효과를 평가한 8277명의 참가자가 포함된 총 26개의 RCT가 포함된다: platinum에 민감한 질병에서 7개( 참가자 2872명); platinum 내성 질환 11위(참가자 3,246명); platinum 민감도 상태에 관계없이 개인을 모집한 8명(참가자 2079명). 포함된 RCT에서 확인된 8개의 비교 중 임상적으로 가장 관련성이 높은 3개의 비교에 대해 근거의 확실성을 평가했다. platinum에 민감한 EOC 재발 기존 화학요법제를 사용한 PLD는 대체 병용 화학요법과 비교하여 전체 생존(OS)에 거의 또는 전혀 차이가 없을 가능성이 높다(위험비(HR) 0.93, 95% 신뢰 구간(CI) 0.83~1.04, 5개 연구, 2006년 참가자, 중간‐ 근거 확실성) 그러나 무진행 생존(PFS)을 증가시킬 가능성이 있다(HR 0.81, 95% CI 0.74~0.89; 5개 연구, 2006년 참가자; 근거 확실성 중간). 조합은 무작위 배정 후 3개월에 삶의 질을 약간 향상시킬 수 있다. 유럽 암 연구 및 치료 기관 삶의 질 설문지 C30(평균 차이 4.80, 95% CI 0.92 ~ 8.68; 1건의 연구, 608명의 참가자; 낮은 확실성 근거), 그러나 이것은 임상적으로 의미 있는 차이를 나타내지 않을 수 있다. 대체 화학요법과 비교하여 다른 화학요법제와 PLD를 병용하면 전체 중증 이상반응(등급 ≥ 3)(위험비(RR) 1.11, 95% CI 0.95~1.30, 2건의 연구, 834명의 참가자, 중간 정도의 근거 확실성). 화학 요법을 사용한 PLD는 빈혈을 증가시킬 가능성이 높다(등급 ≥ 3)(RR 1.37, 95% CI 1.02 ~ 1.85, 5개 연구, 1961명의 참가자, 근거 확실성 중간). 기존 화학요법을 사용한 PLD가 수족증후군(HFS)(등급 ≥ 3)(RR 4.01, 95% CI 1.00~16.01; 2개 연구, 1028명 참가; 매우 낮은 불확실성 근거)과 신경학적 사건(등급 ≥ 3)(RR 0.38, 95% CI 0.20~0.74; 4, 1900명 참가; 매우 낮은 불확실성 근거)에 대한 영향에 대한 근거는 매우 불확실하다. platinum 내성 EOC 재발 다른 기존 화학 요법과 비교하여 PLD 단독은 OS의 차이가 거의 또는 전혀 없을 가능성이 높다(HR 0.96, 95% CI 0.77 ~ 1.19; 6건의 연구, 1995명의 참가자; 근거 확실성 중간). PFS에 대한 PLD의 효과(HR 0.94, 95% CI 0.85 ~ 1.04; 4건의 연구, 1803명의 참가자; 매우 낮은 근거 확실성), 전반적인 심각한 부작용(등급 ≥ 3)(RR 범위는 0.61 ~ 0.97; 2개의 연구, 964명의 참가자; 매우 낮은 근거 확실성), 빈혈(등급 ≥ 3)(RR 범위는 0.19에서 0.82까지; 5개의 연구, 1968명의 참가자; 매우 낮은 근거 확실성), HFS(등급 ≥ 3) ( RR 범위는 15.19~109.15, 6건의 연구, 2184명의 참여자, 매우 낮은 근거 확실성) 및 신경학적 사건의 비율(등급 ≥ 3)(RR의 범위는 0.08~3.09, 3건의 연구, 1222명의 참여자, 매우 낮은 근거 확실성)에 대한 근거는 매우 불확실하다. PLD 단독과 비교하여 기존 화학 요법을 사용한 PLD는 OS의 차이가 거의 또는 전혀 없을 가능성이 높으며(HR 0.92, 95% CI 0.70 ~ 1.21; 1건의 연구, 242명의 참가자, 근거 확실성 중간) PFS의 차이가 거의 또는 전혀 없을 수 있다. (HR 0.94, 95% CI 0.73 ~ 1.22, 2건의 연구, 353명의 참가자, 근거 확실성 낮음). 이 조합은 전반적인 심각한 부작용(등급 ≥ 3)(RR 2.48, 95% CI 1.98~3.09; 1건의 연구, 663명의 참가자, 근거 확실성 중간) 및 빈혈(등급 ≥ 3)(RR 2.38, 95% CI 1.46~3.87, 2개 연구, 785명 참가자, 근거 확실성 중간)을 증가시킬 가능성이 있지만, HFS(등급 ≥ 3)(RR 0.24, 95% CI 0.14 ~ 0.40, 2개 연구, 785명 참가자, 중간 확실성 근거)가 크게 감소할 가능성이 있다. 신경학적 사건(등급 ≥ 3)(RR 1.40, 95% CI 0.85~2.31; 1건의 연구, 663명의 참가자; 낮은 확실성 근거)의 결과 차이가 거의 또는 전혀 없을 수 있다. 연구진 결론: platinum 민감성 재발 EOC에서 병용 화학요법 요법에 PLD를 포함하는 것은 아마도 다른 병용과 비교하여 OS의 차이가 거의 또는 전혀 없지만 PFS를 개선할 가능성이 있다. 따라서 화학 요법의 선택은 이전 화학 요법의 증상 및 기타 환자 고려 사항에 따라 결정된다. 단일 제제 PLD는 platinum 내성 재발 EOC에 유용한 제제로 남아 있으며 재발 시 제제 선택은 이전 치료의 골수 억제 또는 신경 독성 정도와 같은 환자 요인에 따라 달라진다. PLD에 다른 제제를 추가하면 생존 결과가 거의 또는 전혀 개선되지 않고 전체 등급 ≥ 3 이상 반응이 증가할 가능성이 높다. platinum 내성 재발 EOC에서 다른 약제와 함께 PLD와 관련된 제한된 근거는 이점을 나타내지 않지만 증가된 부작용에 대한 일부 근거가 있다.

Trial registration: ClinicalTrials.gov NCT04348032 NCT00102973 NCT00350948 NCT01991210 NCT00538603 NCT00262990 NCT02421588 NCT02580058 NCT00628251 NCT00635193 NCT01666444 NCT01846611 NCT00191607 NCT01840943 NCT00113607 NCT00722592 NCT00043082 NCT01281254 NCT00976911 NCT01121406.

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Conflict of interest statement

RN ‐ attended GSK‐sponsored educational event but no direct funding received EN ‐ declares no conflict of interest KE‐S ‐ attended industry‐sponsored educational events but no direct funding received. Declares no other conflicts of interests and no funding received. ER ‐ declares no conflict of interest EB ‐ delares no conflict of interest SV ‐ declares no conflict of interest JM ‐ declares no conflict of interest

Figures

1
1
PRISMA flow chart of original version of review (Lawrie 2013) ‐ search to 15 October 2012
2
2
Flow diagram for search for review update from February 2013 to January 2022
3
3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 1: Overall survival
1.2
1.2. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 2: Progression‐free survival
1.3
1.3. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 3: Quality of life
1.4
1.4. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 4: Overall Severe Adverse Events (grade ≥ 3)
1.5
1.5. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 5: SevAE: Anaemia (grade ≥ 3)
1.6
1.6. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 6: SevAE: Hand‐foot syndrome (grade ≥ 3)
1.7
1.7. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 7: SevAE: Neurological (grade ≥ 3)
1.8
1.8. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 8: SevAE: Neutropenia (grade ≥ 3)
1.9
1.9. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 9: SevAE: Thrombocytopenia (grade ≥ 3)
1.10
1.10. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 10: SevAE: Stomatitis (grade ≥ 3)
1.11
1.11. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 11: SevAE: Vomiting (grade ≥ 3)
1.12
1.12. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 12: SevAE: Fatigue (grade ≥ 3)
1.13
1.13. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 13: SevAE: Arthralgia/myalgia (grade ≥ 3)
1.14
1.14. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 14: SevAE: Hypersensitivity reactions (grade ≥ 3)
1.15
1.15. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 15: Serious AE: Treatment‐related death
1.16
1.16. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 16: Discontinuation due to toxicity
1.17
1.17. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 17: Antibiotics required
1.18
1.18. Analysis
Comparison 1: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus alternative combination chemotherapy, Outcome 18: Granulocyte colony stimulating factor (G‐CSF) required
2.1
2.1. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 1: Overall survival
2.2
2.2. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 2: Progression‐free survival
2.3
2.3. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 3: Overall Severe Adverse Events (grade ≥3)
2.4
2.4. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 4: SevAE: Anaemia (grade ≥3)
2.5
2.5. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
2.6
2.6. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 6: SevAE: Neutropenia (grade ≥ 3)
2.7
2.7. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 7: SevAE: Thrombocytopenia (grade ≥ 3)
2.8
2.8. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 8: SevAE: Stomatitis (grade ≥ 3)
2.9
2.9. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 9: SevAE: Vomiting (grade ≥ 3)
2.10
2.10. Analysis
Comparison 2: Platinum‐sensitive recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 10: SevAE: Fatigue (grade ≥ 3)
3.1
3.1. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 1: Overall survival
3.2
3.2. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 2: Progression‐free survival
3.3
3.3. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 3: Overall Severe Adverse Events (grade ≥ 3)
3.4
3.4. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 4: SevAE: Anaemia (grade ≥ 3)
3.5
3.5. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
3.6
3.6. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 6: SevAE: Neurological (grade ≥ 3)
3.7
3.7. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 7: SevAE: Neutropenia (grade ≥ 3)
3.8
3.8. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 8: SevAE: Thrombocytopenia (grade ≥ 3)
3.9
3.9. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 9: SevAE: Stomatitis (grade ≥ 3)
3.10
3.10. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 10: SevAE: Vomiting (grade ≥ 3)
3.11
3.11. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 11: SevAE: Diarrhoea (grade ≥ 3)
3.12
3.12. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 12: SevAE: Fatigue (grade ≥ 3)
3.13
3.13. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 13: SevAE: Hypersensitivity reactions (grade ≥ 3)
3.14
3.14. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 14: Dose reductions
3.15
3.15. Analysis
Comparison 3: Platinum‐resistant recurrent EOC: PLD versus other chemotherapy, Outcome 15: Dose delays
4.1
4.1. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 1: Overall survival
4.2
4.2. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 2: Progression‐free survival
4.3
4.3. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 3: Overall Severe Adverse Events (grade ≥ 3)
4.4
4.4. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 4: SevAE: Anaemia (grade ≥ 3)
4.5
4.5. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
4.6
4.6. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 6: SevAE: Neurological (grade ≥ 3)
4.7
4.7. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 7: SevAE: Neutropenia (grade ≥ 3)
4.8
4.8. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 8: SevAE: Thrombocytopenia (grade ≥ 3)
4.9
4.9. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 9: SevAE: Stomatitis (grade ≥ 3)
4.10
4.10. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 10: SevAE: Vomiting (grade ≥ 3)
4.11
4.11. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 11: SevAE: Fatigue (grade ≥ 3)
4.12
4.12. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 12: Serious AE: Treatment‐related death
4.13
4.13. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 13: Dose delays
4.14
4.14. Analysis
Comparison 4: Platinum‐resistant recurrent EOC: PLD with chemotherapy versus PLD alone, Outcome 14: Dose reductions
5.1
5.1. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 1: Overall survival
5.2
5.2. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 2: Progression‐free survival
5.3
5.3. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 3: Overall Severe Adverse Events (grade ≥ 3)
5.4
5.4. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 4: SevAE: Anaemia (grade ≥ 3)
5.5
5.5. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
5.6
5.6. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 6: SevAE: Neurological (grade ≥ 3)
5.7
5.7. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 7: SevAE: Neutropenia (grade ≥ 3)
5.8
5.8. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 8: SevAE: Stomatitis (grade ≥ 3)
5.9
5.9. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 9: SevAE: Vomiting (grade ≥ 3)
5.10
5.10. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 10: SevAE: Diarrhoea (grade ≥ 3)
5.11
5.11. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 11: SevAE: Fatigue (grade ≥ 3)
5.12
5.12. Analysis
Comparison 5: Platinum‐resistant recurrent EOC: PLD versus targeted therapy, Outcome 12: Dose reductions
6.1
6.1. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 1: Overall survival
6.2
6.2. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 2: Progression‐free survival
6.3
6.3. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 3: Overall Severe Adverse Events (grade ≥3)
6.4
6.4. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 4: SevAE: Anaemia (grade ≥ 3)
6.5
6.5. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
6.6
6.6. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 6: SevAE: Neurological (grade ≥ 3)
6.7
6.7. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 7: SevAE: Neutropenia (grade ≥ 3)
6.8
6.8. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 8: SevAE: Thrombocytopenia (grade ≥ 3)
6.9
6.9. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 9: SevAE: Stomatitis (grade ≥ 3)
6.10
6.10. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 10: SevAE: Vomiting (grade ≥ 3)
6.11
6.11. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 11: SevAE: Diarrhoea (grade ≥ 3)
6.12
6.12. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 12: SevAE: Fatigue (grade ≥ 3)
6.13
6.13. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 13: Serious AE: Treatment‐related death
6.14
6.14. Analysis
Comparison 6: Platinum‐resistant recurrent EOC: PLD with targeted therapy versus PLD alone, Outcome 14: Dose reductions
7.1
7.1. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 1: Overall survival
7.2
7.2. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 2: Progression‐free survival
7.3
7.3. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 3: Overall Severe Adverse Events (grade ≥ 3)
7.4
7.4. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 4: SevAE: Anaemia (grade ≥ 3)
7.5
7.5. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
7.6
7.6. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 6: SevAE: Neutropenia (grade ≥ 3)
7.7
7.7. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 7: SevAE: Thrombocytopenia (grade ≥ 3)
7.8
7.8. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 8: SevAE: Stomatitis (grade ≥ 3)
7.9
7.9. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 9: SevAE: Vomiting (grade ≥ 3)
7.10
7.10. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 10: SevAE: Diarrhoea (grade ≥ 3)
7.11
7.11. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 11: SevAE: Fatigue (grade ≥ 3)
7.12
7.12. Analysis
Comparison 7: Platinum‐resistant recurrent EOC: PLD versus immunotherapy, Outcome 12: Dose reductions
8.1
8.1. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 1: Overall survival
8.2
8.2. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 2: Progression‐free survival
8.3
8.3. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 3: Overall Severe Adverse Events (grade ≥ 3)
8.4
8.4. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 4: SevAE: Anaemia (grade ≥ 3)
8.5
8.5. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 5: SevAE: Hand‐foot syndrome (grade ≥ 3)
8.6
8.6. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 6: SevAE: Neurological (grade ≥ 3)
8.7
8.7. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 7: SevAE: Neutropenia (grade ≥ 3)
8.8
8.8. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 8: SevAE: Thrombocytopenia (grade ≥ 3)
8.9
8.9. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 9: SevAE: Stomatitis (grade ≥ 3)
8.10
8.10. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 10: SevAE: Vomiting (grade ≥ 3)
8.11
8.11. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 11: SevAE: Diarrhoea (grade ≥ 3)
8.12
8.12. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 12: SevAE: Fatigue (grade ≥ 3)
8.13
8.13. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 13: Serious AE: Treatment‐related death
8.14
8.14. Analysis
Comparison 8: Platinum‐resistant recurrent EOC: PLD with immunotherapy versus PLD alone, Outcome 14: Dose reductions
See this image and copyright information in PMC

Update of

References

References to studies included in this review

APPROVE {published data only}
    1. Wang T, Li N, Tang J, Yang HY, Yin R, Jingru Zhang J, et al. Apatinib combined with pegylated liposomal doxorubicin (PLD) versus PLD for platinum-resistant recurrent ovarian cancer (APPROVE): a multicenter, randomized, controlled, open-label, phase II trial. Gynecologic Oncology August 2021;162:Suppl 1.
ASSIST‐3 {published data only}
    1. NCT00102973. TLK286 (telcyta) in combination with carboplatin (paraplatin) versus doxil in platinum refractory or resistant ovarian cancer. clinicalTrails.gov 2005.
    1. Rose P, Edwards R, Finkler N, Seiden M, Duska L, Krasner C, et al. Phase 3 Study: Canfosfamide (C, TLK286) plus carboplatin (P) vs liposomal doxorubicin (D) as 2nd line therapy of platinum (P) resistant ovarian cancer (OC). Journal of Clinical Oncology, 2007 ASCO Annual Meeting Proceedings Part I 2007;25 Suppl 18:5529.
ASSIST‐5 {published data only}
    1. Vergote I, Finkler N, Hall J, Melnyk O, Edwards R, Jones M, et al. Randomised phase III study of canfosfamide (TLK 286) plus pegylated liposomal doxorubicin (PLD) vs PLD as second-line therapy in platinum (P) refractory or resistant ovarian cancer (OC). Journal of Clinical Oncology 2009;27 Suppl 15:5552.
    1. Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, et al. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. International Journal of Gynecological Cancer 2010;20(5):772-80. - PubMed
Banerjee 2018 {published data only}
    1. Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, et al. A randomized, open-label, phase II study of anti-NaPi2b antibody-drug conjugate (ADC) lifastuzumab (Lifa) vedotin (DNIB0600A) compared to pegylated liposomal doxorubicin (PLD) in patients (pts) with platinum-resistant ovarian cancer (PROC). Journal of Clinical Oncology 2016;34(15 Suppl):5569.
    1. Banerjee S, Oza AM, Birrer MJ, Hamilton EP, Hasan J, Leary A, et al. Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. Annals of Oncology 2018;29(4):917-23. - PubMed
    1. NCT01991210. A Study of DNIB0600A in ocmparison with pegylated liposomal doxorubicin (PLD) in participants with platinum-resistant ovarian cancer (PROC). https://clinicaltrials.gov/ct2/show/NCT01991210 2013.
CALYPSO {published and unpublished data}
    1. Alexandre J, Brown C, Coeffic D, Raban N, Pfisterer J, Mäenpää J, et al. CA-125 can be part of the tumour evaluation criteria in ovarian cancer trials: experience of the GCIG CALYPSO trial. British Journal of Cancer 2012;106(4):633-637. - PMC - PubMed
    1. Alexandre J, Brown C, Priou F, De Rauglaudre G, Pfisterer J, Maenpaa J, et al. Should CA 125 still be part of tumour evaluation criteria in ovarian cancer trials? Experience of the GCIG calypso trial. Annals of Oncology 2010;21(Suppl 8):307-308.
    1. Baumann KH, Pujade-Lauraine E, Jackisch C, Lubbe D, du Bois A, Brown C, et al. Therapy expectations of patients with recurrent platinum-sensitive ovarian cancer-a German substudy of the calypso/ago-ovar 2.9 trial. In: International Journal of Gynecological Cancer, 17th International Meeting of ESGO. 2011.
    1. Baumann KH, Sehouli J, Du Bois A, Lubbe D, Wimberger P, Beckmann MW, et al. Quality of life and therapy expectations of patients with recurrent platinum-sensitive ovarian cancer. A German substudy of the Calypso/AGO-Ovar 2.9 trial. Cochrane Database of Systematic Reviews (Online) 2012, Issue 5. [DOI: 10.1002/central/CN-01065059/full] - DOI
    1. Brundage M, Gropp M, Mefti F, Mann K, Lund B, Gebski V, et al. Health-related quality of life in recurrent platinum-sensitive ovarian cancer - results from the CALYPSO trial. Annals of Oncology 2012;23(8):2020-2027. - PubMed
Colombo 2012 {published data only}
    1. Colombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, et al. Randomized, open-Label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. Journal of Clinical Oncology 2012;30(31):3841-7. - PubMed
CORAIL {published data only}
    1. Gaillard S, Ghamande S, Pardo B, Lorusso D, Vergote I, Papai Z, et al. CORAIL trial: Randomized phase III study of lurbinectedin (PM01183) versus pegylated liposomal doxorubicin (PLD) or topotecan (T) in patients with platinum-resistant ovarian cancer. Gynecologic Cancer 2016;34(15 Suppl):TPS5597.
Fujiwara 2019 {published data only}
    1. Fujiwara H, Ushijima K, Nagao S, Takei Y, Shimada M, Takano M, et al. A phase II randomized controlled study of pegylated liposomal doxorubicin and carboplatin vs. gemcitabine and carboplatin for platinum-sensitive recurrent ovarian cancer (GOTIC003/intergroup study). International Journal of Clinical Oncology 2019;24:1284-91. - PubMed
    1. Fujiwara H, Ushijima K, Nagao S, Takei Y, Shimada M, Takano M, et al. Phase 2, randomized controlled study of pegylated liposomal doxorubicin and carboplatin versus gemcitabine and carboplatin in platinum-sensitive recurrent ovarian cancer (gotic003/intergroup study). International Journal of Gynecological Cancer 2017;27:1493. - PubMed
    1. Fujiwara H, Ushijima K, Nagao S, Takei Y, Shimada M, Takano M, et al. Phase 2, randomized controlled study of pegylated liposomal doxorubicin and carboplatin versus gemcitabine and carboplatin in platinum-sensitive recurrent ovarian cancer (gotic003/intergroup study). International Journal of Gynecological Cancer 2018;28:48. - PubMed
Gordon 2001 {published data only}
    1. Capri S, Cattaneo G. Cost-minimization analysis of pegylated liposomal doxorubicin versus topotecan for the treatment of ovarian cancer in Italy. Clinical Therapeutics 2003;25(6):1826-45. - PubMed
    1. Coleman RL, Gordon A, Barter J, Sun S, Rackoff W, Herzog TJ. Early changes in CA125 after treatment with pegylated liposomal doxorubicin or topotecan do not always reflect best response in recurrent ovarian cancer patients. The Oncologist 2007;12(1):72. - PubMed
    1. Gordon A, Sun S, Rackoff W. Incidence of adverse events in women (</=65 or >65 years) with recurrent ovarian cancer receiving pegylated liposomal doxorubicin or topotecan [abstract]. Gynecologic Oncology 2006;101(Suppl 1):60.
    1. Gordon A, Teitelbaum A. Overall survival advantage for pegylated liposomal doxorubicin compared to topotecan in recurrent epithelial ovarian cancer [abstract]. European Journal of Cancer Supplements 2003;5(1):S51.
    1. Gordon AN, Fleagle JT, Guthrie D, Parkin DE, Gore ME, Lacave AJ, et al. Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan. Journal of Clinical Oncology 2001;19(14):3312-22. - PubMed
HeCOG 2010 {published and unpublished data}ACTRN12609000436279
    1. Bafaloukos D, Linardou H, Aravantinos G, Papadimitriou G, Bamias A, Fountzilas G, et al. A randomized phase II study of carboplatin plus pegylated liposomal doxorubicin versus carboplatin plus paclitaxel in platinum sensitive ovarian cancer patients: a Hellenic Cooperative Oncology Group study. BMC Medicine 2010;8(1):3. - PMC - PubMed
JAVELIN Ovarian 200 {published data only}
    1. NCT02580058 - A study of avelumab alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in patients with platinum resistant/refractory ovarian cancer (JAVELIN Ovarian 200) NCT02580058. https://clinicaltrials.gov/ct2/show/NCT02580058.
    1. Pujade-Lauraine E, Fujiwara K, Dychter SS, Devgan G, Monk BJ. Avelumab (anti-PD-L1) in platinum-resistant/refractory ovarian cancer: JAVELIN Ovarian 200 Phase III study design. Future Oncology 2018;14(21):2103-13. - PubMed
    1. Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit R, Ray-Coquard IL, et al. Avelumab alone or in combination with chemotherapy versus chemotherapy alone in platinum-resistant or platinum-refractory ovarian cancer (JAVELIN Ovarian 200): an open-label, three-arm, randomised, phase 3 study. Lancet Oncology 2021;22(7):1034-1046. [DOI: 10.1016/S1470-2045(21)00216-3] - DOI - PubMed
    1. Pujade-Lauraine E, Fujiwara K, Ledermann JA, Oza AM, Kristeleit RS, Ray-Coquard IL, et al. Avelumab alone or in combination with pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in platinum-resistant or refractory epithelial ovarian cancer: primary and biomarker analysis of the phase III JAVELIN Ovarian 200 trial. Gynecologic Oncology 2019;154(Supplement 1):21-2.
    1. Pujade-Lourraine E, Colombo N, Disis ML, Fujiwara K, Ledermann JA, Mirza MR, et al. Avelumab (MSB0010718C; anti-PD-LI) +/- pegylated liposomal doxorubicin vs pegylated liposomal doxorubicin alone in patients with platinum-resistant/refractory ovarian cancer: the phase III JAVELIN Ovarian 200 trial. Journal of Clinical Oncology 2016;34(15 Suppl):TPS5600.
Kaye 2012 {published data only}
    1. Kaye S, Kaufman B, Lubinski J, Matulonis U, Gourley C, Karlan B, et al. Phase II study of the oral PARP inhibitor olaparib (AZD2281) versus liposomal doxorubicin in ovarian cancer patients with BRCA1 and/or BRCA2 mutations. Annals of Oncology 2010;21:304.
    1. Kaye SB, Lubinski J, Matulonis U, Ang JE, Gourley C, Karlan BY, et al. Phase II, open-label, randomized, multicenter study comparing the efficacy and safety of olaparib, a poly (ADP-ribose) polymerase inhibitor, and pegylated liposomal doxorubicin in patients with BRCA1 or BRCA2 mutations and recurrent ovarian cancer. Journal of Clinical Oncology 2012;30(4):372-9. - PubMed
M200 {published data only}
    1. Vergote IB, Colombo N, Kutarska E, Del Campo J, Pippitt C, Casado A, et al. Phase II study comparing volociximab (an antiangiogenic antibody) and pegylated liposomal doxorubicin (PLD) with PLD alone in recurrent ovarian or primary peritoneal cancer. Journal of Clinical Oncology 2009;27(15 Suppl):5560.
McGuire 2018 {published data only}
    1. McGuire W, Penson R, Gore M, Herraez A, Peterson P, Shahir A and Ilaria Jr R, . Randomized phase II study of the PDGFRα antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer. BMC Cancer 2018;18:1292. - PMC - PubMed
    1. McGuire WP, Shah GD, Loizos N, Youssoufian H, Rowinsky EK, Gore ME. Randomized phase II trial of pegylated liposomal doxorubicin (PLD) with or without anti-platelet-derived growth factor receptor-alpha (PDGFR-alpha) monoclonal antibody IMC-3G3 in platinum-refractory/resistant advanced ovarian cancer. In: Journal of Clinical Oncology. Vol. 28. 2010:Suppl 15.
MITO‐3 {published and unpublished data}
    1. Ferrandina G, Ludovisi M, Lorusso D, Pignata S, Breda E, Savarese A, et al. Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. Journal of Clinical Oncology 2008;26(6):890-6. - PubMed
Monk 2017 {published data only}
    1. Coukos G, Brady M, Lankes H, Aghajanian C, Gottardo R, Swisher E, et al. GOG-3003: identifying biomarkers predictive of immune and clinical response in a phase 2 RCT of chemo-immunotherapy in recurrent ovarian cancer. International Journal of Gynecological Cancer 2016;26:26-7.
    1. Monk BJ, Brady MF, Aghajanian C, Lankes H, Rizack T, Leach JW, et al. A phase II, randomized, double-blind, placebo-controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a gynecologic oncology group partners study. Gynecologic Oncology 2017;145(Suppl 1):220-1. - PMC - PubMed
    1. Monk BJ, Brady MF, Aghajanian C, Lankes HA, Rizack T, Leach J, et al. A phase 2, randomized, double-blind, placebo- controlled study of chemo-immunotherapy combination using motolimod with pegylated liposomal doxorubicin in recurrent or persistent ovarian cancer: a Gynecologic Oncology Group partners study. Annals of Oncology 2017;28(5):996-1004. - PMC - PubMed
Monk 2020 {published data only}
    1. Bradley J Monk, Thomas J Herzog, George Wang, Spyros Triantos, Scott Maul, Roland Knoblauch, Tracy McGowan, Waleed S W Shalaby, Robert L Coleman. A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer. Gynecologic Oncology March 2020;156 (3):535-44. [DOI: 10.1016/j.ygyno.2019.12.043] [PMID: ] - DOI - PubMed
    1. Coleman R, Monk B, Knoblauch R, Parekh T, Triantos S, Maul R, et al. A phase III study of trabectedin (T) plus pegylated liposomal doxorubicin (PLD) versus PLD for treatment of advanced relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancer. Journal of Clinical Oncology 2015;33(15 Suppl):TPS5606.
    1. Jones RL, Herzog TJ, Patel SR, Mehren M, Schuetze SM, Tine BA, et al. Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer. Cancer Medician June 2021;10(11):3565-74. [DOI: 10.1002/cam4.3903] [PMID: ] - DOI - PMC - PubMed
    1. Monk BJ, Herzog TJ, Kaye SB, Krasner CN, Vermorken JB, Muggia F, et al. Final survival results of the randomized phase III study of trabectedin with pegylated liposomal doxorubicin (PLD) versus PLD in recurrent ovarian cancer. Journal of Clinical Oncology 2011;29(15 Suppl):5046.
    1. Monk BJ, Herzog TJ, Triantos S, Maul S, Wang G, Pontes Valero MJ, et al. Impact of prior pegylated liposomal doxorubicin (PLD) treatment in recurrent ovarian cancer (ROC): sub-group analysis from a randomized, open-label study comparing trabectedin (T) and PLD versus PLD alone in ROC (ET743-OVC-3006). Annals of Oncology 2019;Conference: 44th Congress of European Society for Medical Oncology, ESMO 2019. Spain. 30(Supplement 5):v420-1.
Mutch 2007 {published data only}
    1. Mutch DG, Orlando M, Goss T, Teneriello MG, Gordon AN, McMeekin SD, et al. Randomized phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer. Journal of Clinical Oncology 2007;25(19):2811-8. - PubMed
    1. Mutch DG, Orlando M, Goss T, Wang Y, Lilly E, Teneriello MG, et al. Randomized phase III trial of gemcitabine versus pegylated liposomal doxorubicin for patients with platinum-resistent taxane-pretreated ovarian cancer as second or third line therapy [abstract]. Gynecologic Oncology 2006;101(Suppl 1):S14.
    1. NCT00191607. A randomized trial for patients with platinum resistant ovarian, fallopian or primary peritoneal cancer. https://clinicaltrials.gov/ct2/show/NCT00191607 2005.
NCT00653952 {published and unpublished data}
    1. Doxil: Clinical Study Report. https://yoda.yale.edu/sites/default/files/nct00653952.pdf 15 March 2004. [CSR: https://yoda.yale.edu/sites/default/files/nct00653952.pdf]
    1. NCT00653952. CAELYX versus paclitaxel HCl in patients with epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. https://clinicaltrials.gov/ct2/show/NCT00653952 2008.
    1. O'Byrne KJ. A phase III study of Doxil/Caelyx versus paclitaxel in platinum-treated, taxane-naïve relapsed ovarian cancer. In: Proceedings of the American Society of Clinical Oncologists. Vol. 21. 2002:203a.
NCT01840943 {published data only}
    1. NCT01840943. A study to compare CAELYX with topotecan HCL in patients with recurrent epithelial ovarian carcinoma following failure of first-line, platinum-based chemotherapy. https://clinicaltrials.gov/ct2/show/NCT01840943 2013.
OVA‐301 {published data only}
    1. Bidzinski M, Poveda A, Vermorken J, Kaye S, Makhson A, Jagiello-Gruszfeld A, et al. Influence of an independent review on PFS and response assessments in a phase III clinical trial in relapsed ovarian cancer. European Journal of Cancer Supplements 2009;2(7):468.
    1. Boman K, Colombo N, Runnebaum IB, Vergote I, Gore M, Oaknin A, et al. Tolerability of trabectedin (TR) plus pegylated liposomal doxorubicin (PLD) in platinum sensitive (p-s) vs. platinum resistant (P-R) patients (PTS) with relapsed ovarian cancer. In: Annals of Oncology; 35th ESMO Congress, Milan, Italy. Vol. 21. Oxford: Oxford University Press, 2010:306.
    1. Brundage M, Gropp M, Mefti F, Mann K, Lund B, Gebski V, et al. Health-related quality of life in recurrent platinum-sensitive ovarian cancer--results from the CALYPSO trial. Annals of Oncology 2012;23(8):2020-7. - PubMed
    1. Colombo N, Casado A, Fernandez C, Vergote I. Trabectedin plus pegylated liposomal doxorubicin (PLD) prior to subsequent platinum chemotherapy in patients with platinum-resistant (PR) recurrent ovarian cancer (ROC): results from OVA-301 follow-up. Journal of Clinical Oncology 2014;32(15 Suppl):5551.
    1. Colombo N. Efficacy of trabectedin in platinum-sensitive-relapsed ovarian cancer: new data from the randomized OVA-301 study. International Journal of Gynecological Cancer 2011;21(Suppl 1):S12-6. - PubMed
Pfisterer 2020 {published data only}
    1. Pfisterer J, Dean AP, Baumann K, Rau J, Harter P, Joly F et al. Carboplatin/pegylated liposomal doxorubicin/bevacizumab (CD-BEV) vs. carboplatin/gemcitabine/bevacizumab (CG-BEV) in patients with recurrent ovarian cancer: a prospective randomized phase III ENGOT/ GCIG-Intergroup study (AGO study group, AGO-Austria, ANZGOG, GINECO, SGCTG). In: Oncology Research and Treatment. Vol. Conference: 43rd Congress of European Society for Medical Oncology, ESMO 2018. Germany. 29. 2018:viii332-3.
    1. Pfisterer J, Shannon CM, Baumann K, Rau J, Harter P, Joly F, et al. Bevacizumab and platinum-based combinations for recurrent ovarian cancer: a randomised, open-label, phase 3 trial. The Lancet Oncology 2020;21(5):699-709. - PubMed
PRECEDENT {published data only}
    1. Naumann RW, Coleman RL, Burger RA, Sausville EA, Kutarska E, Ghamande SA, et al. PRECEDENT: a randomized phase II trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD) in combination versus PLD alone in patients with platinum-resistant ovarian cancer. Journal of Clinical Oncology 2013 Dec 10;31(35):4400-6. [DOI: 10.1200/JCO.2013.49.7685] [PMID: ] - DOI - PubMed
PROCEED 2014 {published data only}
    1. Armour A. A randomised double-blind plase 3 trial comparing vintafolide (EC145) and pegylated liposomal doxorubicin (PLD/DOXIL/Caelyx) in combination versus PLD with platinum ressitant ovarian cancer [EC-FV-06 Clinical Study Report]. Clinical Trials Register 15 February 2017.
    1. NCT01170650. Study for Women With Platinum Resistant Ovarian Cancer Evaluating EC145 in Combination With Doxil® (PROCEED). clinicaltrials.gov 2010.
    1. Naumann RW Burger RA Sausville EA Kutarska E Ghamande SA DePasquale SE et al. Vintafolide therapy shows greater efficacy in patients with folate receptor positive tumors selected by 99mTc-etarfolatide. European Journal of Cancer 2013;49:S712.
    1. Naumann RW, Gilbert L, Habbe A, Ma H, Ghamande S, Vergote IB. Trial in progress: a randomized double-blind phase 3 trial comparing vintafolide + pegylated liposomal doxorubicin (PLD) versus PLD + placebo in patients with platinum-resistant ovarian cancer (PROCEED). Gynecologic Oncology 2014;133(Suppl 1):177.
    1. Naumann RW, Gilbert L, Miller AM, Ma H, Ghamande SA, Vergote I. A randomized double-blind phase III trial comparing vintafolide plus pegylated liposomal doxorubicin (PLD) versus PLD plus placebo in patients with platinum-resistant ovarian cancer (PROCEED). Journal of Clinical Oncology 2013;31(15 Suppl):TPS5613. - PubMed
SWOG S0200 {published and unpublished data}
    1. Alberts DS, Liu PY, Wilczynski S, Clouser M, Lopez A, Lange M, et al. Phase III randomized trial of pegylated liposomal doxorubicin plus carboplatin versus carboplatin in platinum-sensitive patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy: Southwest Oncology Group Protocol S0200. Journal of Clinical Oncology 2007;25(18 Suppl):5551. - PMC - PubMed
    1. Alberts DS, Liu PY, Wilczynski SP, Clouser MC, Lopez AM, Michelin DP, et al. Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200). Gynecologic Oncology 2008;108(1):90-94. - PMC - PubMed
    1. Markman M, Moon J, Wilczynski S, Lopez AM, Rowland KM, Michelin DP, et al. Single agent carboplatin versus carboplatin plus pegylated liposomal doxorubicin in recurrent ovarian cancer: final survival results of a SWOG (S0200) phase 3 randomized trial. Gynecologic Oncology 2010;116(3):323-5. - PMC - PubMed
TRINOVA‐2 {published data only}
    1. Marth C, Vergote I, Colombo N, Kurzeder C, Lorusso D, Clamp A, et al. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. International Journal of Gynecological Cancer 2015;9:97-9. - PubMed
    1. Marth C, Vergote I, Scambia G, Oberaigner W, Clamp A, Berger R, et al. ENGOT-ov-6/TRINOVA-2: Randomised, double-blind, phase 3 study of pegylated liposomal doxorubicin plus trebananib or placebo in women with recurrent partially platinum-sensitive or resistant ovarian cancer. European Journal of Cancer 2017;70:111-21. - PubMed

References to studies excluded from this review

A'hern 1995 {published data only}
    1. A'hern RP, Gore ME. Impact of doxorubicin on survival in advanced ovarian cancer. Journal of Clinical Oncology 1995;13(3):726-32. - PubMed
AGOG06‐001 {published data only}
    1. Lai C-H. Phase III randomised trial of maintenance pegylated liposomal doxorubicin/carboplatin versus without in patients with advanced ovarian cancer [Ongoing]. Australia and New Zealand Clinical Trials Registry; 2010;ACTRN12607000329460:Accessed on 20/11/12 at http://www.anzctr.org.au/ACTRN12607000329460.aspx.
Aracil 2013 {published data only}
    1. Aracil M, Nieto A, Tanovic A, Monk BJ, Kaye SB, Poveda A, et al. Low expression of nibrin predicts better prognosis in patients with ovarian cancer treated with trabectedin plus pegylated liposomal doxorubicin (PLD). International Journal of Gynecological Cancer 2013;23(8 SUPPL. 1):133.
Bakrin 2018 {published data only}
    1. Bakrin N, Tempfer C, Scambia G, De Simone M, Gabriel B, Grischke E-M, et al. PIPAC-OV3: a multicenter, open-label, randomized, two-arm phase III trial of the effect on progression-free survival of cisplatin and doxorubicin as pressurized intra-peritoneal aerosol chemotherapy (PIPAC) vs. chemotherapy alone in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Pleura and Peritoneum 2018;3:0114. - PMC - PubMed
Basu 2011 {published data only}
    1. Basu C. Second line chemotherapy in platinum potentially resistant recurrent epithelial ovarian cancer: Experience from Eastern India. In: International Journal of Gynecological Cancer. Vol. 21. 2011:99.
Basu 2013 {published data only}
    1. Basu C and Mukhopadhyay A. Second line chemotherapy in epithelial ovarian cancer - issues of quality of life and cost-effective ratio: experience from a cancer institute of eastern India. In: International Journal of Gynecological Cancer. Vol. 23. 2013:852.
Bhowmik 2018 {published data only}
    1. Bhowmik S, Bhowmik S, Maiiti K, Chakra A, Shahi P, Jain D, et al. Two multicenter Phase I randomized trials to compare the bioequivalence and safety of a generic doxorubicin hydrochloride liposome injection with Doxil® or Caelyx® in advanced ovarian cancer. Cancer Chemotherapy and Pharmacology 2018;82(3):521-32. - PubMed
Bookman 2002 {published data only}
    1. Bookman MA. Developmental chemotherapy in advanced ovarian cancer: incorporation of newer cytotoxic agents in a phase III randomized trial of the Gynecologic Oncology Group (GOG-0182). In: Seminars in Oncology. Vol. 29. 2002:20-31. - PubMed
Cherchi 2003 {published data only}
    1. Cherchi PL, Capobianco G, Fattorini F, Canetto AM, Milia L, Cosso M, et al. Second-line therapy with topotecan and pegylated liposomal doxorubicin vs. topotecan slone in patients with recurrent ovarian cancer. In: International Journal of Gynecological Cancer. Vol. 13(Suppl):53. 2003 IGCS Annual Meeting, 2003.
Colombo 2014 {published data only}
    1. Colombo N, Biagioli E, Copreni E, Floriani I, Fossati R. Trabectedin and pegylated liposomal doxorubicin (PLD) versus carboplatin and PLD in partially platinum-sensitive ovarian cancer patients: Inovatyon study. In: Annals of Oncology. Vol. 25. 2014:iv325.
Colombo 2014a {published data only}
    1. Colombo N, Tanovic A, Fernandez C, Casado Herraez A. Trabectedin plus pegylated liposomal doxorubicin (PLD) prior to subsequent platinum-based chemotherapy in recurrent ovarian cancer (ROC): results from ova-301 follow-up. In: International Journal of Gynecological Cancer. Vol. 24. 2014:452-3.
GOG0182/ICON 5 {published data only}
    1. Bookman MA, Brady MF, McGuire WP, Harper PG, Alberts DS, Friedlander M, et al. Evaluation of new platinum-based treatment regimens in advanced-stage ovarian cancer: a phase III trial of the Gynecologic Cancer Intergroup. Journal of Clinical Oncology 2009;27(9):1419-25. - PMC - PubMed
    1. Bookman MA, Greer BE, Ozols RF. Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel vs. cisplatin and paclitaxel (GOG 158) and an update on GOG0 182-ICON5. International Journal of Gynecological Cancer 2003;13(6):735-40. - PubMed
    1. Bookman MA, Gynecologic Cancer InterGroup (GCIG). GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. In: Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol. 24, 18S (June 20 Supplement). 2006:5002.
    1. Bookman MA. Erratum. Journal of Clinical Oncology 2009;27(13):2305.
    1. Bookman MA. GOG0182-ICON5: 5-arm phase III randomized trial of paclitaxel (P) and carboplatin (C) vs combinations with gemcitabine (G), PEG-lipososomal doxorubicin (D), or topotecan (T) in patients (pts) with advanced-stage epithelial ovarian (EOC) or primary peritoneal (PPC) carcinoma. [Abstract]. In: Journal of Clinical Oncology. Vol. 24 (Suppl 18): A-5002, 256s. 2006.
Graybill 2014 {published data only}
    1. Graybill WS, Coleman RL. Vintafolide: a novel targeted agent for epithelial ovarian cancer. In: Future Oncology. Vol. 10. 2014:541-8. - PubMed
Herzog 2014 {published data only}
    1. Herzog TJ, Anderson K, Wang J, Xu R. Model prediction of mean PFS and OS time from a phase II trial comparing vintafolide plus pegylated liposomal doxorubicin versus pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer patients with 100% folate receptor-positive target. In: Gynecologic Oncology. Vol. 133. 2014:178-9.
INOVATYON {published data only}
    1. Colombo N, Gadducci A, Sehouli J, Biagioli E, Nyvang GB, Riniker S, et al. LBA30 INOVATYON study: Randomized phase III international study comparing trabectedin/PLD followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line. Annals of Oncology 1 September 2020;31(Supplement 4):S1161. [DOI: ]
    1. Colombo N. INOVATYON STUDY -International, randomized study in patients with ovarian cancer. Accessed on 14/11/12 at http://www.clinicaltrials.gov/ct2/show/NCT01379989.
Kavanagh 2004 {published data only}
    1. Kavanagh JJ, Garcia A, Choi H, Gershenson DM, Lewis L, Mascavage J, et al. Efficacy of TLK286 (Telcyta) alone and Inparaplatin® or Doxil® (Caelyx®) in platinum resistant ovarian cancer - results from 3 phase 2 studies. In: International Journal of Gynaecological Cancer. Vol. 14 (suppl 1). 2004.
Khokhlova 2012 {published data only}
    1. Khokhlova SV, Cherkasova MV, Gorbounova VA, Orel NF, Limareva SV. Trabectedin-based combinations in treatment of platinum sensitive recurrence epithelial ovarian cancer (EOC). Pilot study. International Journal of Gynecological Cancer 2012;22(var.pagings):E381.
Lai 2018 {published data only}
    1. Lai CH, Vallikad E, Lin H, Yang LY, Ou YC, Chou HH, et al. Phase III randomized trial of maintenance pegylated liposomal doxorubicin (PLD) / carboplatin versus without in patients with advanced ovarian cancer: an Asian Gynecologic Oncology Group study. In: Journal of Clinical Oncology. Vol. 36. 2018:5584.
Lindemann 2017 {published data only}
    1. Lindemann K, Gibbs E, Avall-Lundqvist E, Depont Christensen R, Woie K, Kalling M, et al. Chemotherapy vs tamoxifen in platinum-resistant ovarian cancer: a phase III, randomised, multicentre trial (Ovaresist). British Journal of Cancer 2017;116(4):455-63. - PMC - PubMed
Lorusso 2014 {published data only (unpublished sought but not used)}
    1. Lorusso D, Scambia G, Colombo N, Reed N, Pisano C, Lord R, et al. Randomized phase II trial of NGR-hTNF with an anthracycline in platinum-refractory or -resistant ovarian cancer (OC). In: ASCO Meeting Abstracts. Vol. 32. 2014:5523.
Marme 2019 {published data only}
    1. Marme F, Pautier P, Van Nieuwenhuysen E, Reuss A, Redondo A, Lindemann K, et al. AGO-OVAR 2.29 (ENGOT-ov34): Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer (ROC). In: Journal of Clinical Oncology. Vol. 37. 2019. - PubMed
MILO ENGOT‐ov11 {published data only}
    1. Monk BJ, Grisham RN, Marth C, Banerjee SN, Hilpert F, Coleman RL, et al. The MEK Inhibitor in Low-Grade Serous Ovarian Cancer (MILO)/ENGOT-ov11 study: a multinational, randomized, open-label phase 3 study of binimetinib (MEK162) versus physician's choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube, or primary peritoneum. Journal of Clinical Oncology 2014;32(15 Suppl):TPS5618.
    1. Monk BJ, Grisham RN, Marth C, Banerjee SN, Hilpert F, Coleman RL, et al. The MILO (MEK inhibitor in low-grade serous ovarian cancer)/ENGOT-ov11 study: A multinational, randomized, open-label phase 3 study of binimetinib (MEK162) versus physician's choice chemotherapy in patients with recurrent or persistent low-grade serous carcinomas of the ovary, fallopian tube, or primary peritoneum. Journal of Clinical Oncology 2015;33(15 Suppl):TPS5610.
MITO‐2 2011 {published data only}
    1. Pignata S, Scambia G, Ferrandina G, Savarese A, Sorio R, Breda E, et al. Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial. Journal of Clinical Oncology 2011;29(27):3628-35. - PubMed
    1. Pignata S, Scambia G, Savarese A, Breda E, Scollo P, De Vivo R, et al. Safety of a 3-weekly schedule of carboplatin plus pegylatedliposomal doxorubicin as first line chemotherapy in patients withovarian cancer: preliminary results of the MITO-2 randomized trial. BMC Cancer 2006;6:202:This article is available from: http://www.biomedcentral.com/1471-2407/6/202. - PMC - PubMed
    1. Pignata S, Scambia G, Savarese A, Breda E, Sorio R, Pisano C, et al. Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer: preliminary activity results of the MITO-2 phase III trial. Oncology 2009;76(1):49-54. - PubMed
    1. Pignata S, Scambia G, Savarese A, Breda E, Sorio R, Vernaglia Lombardi A, et al. Carboplatin plus paclitaxel versus carboplatin plus Stealth liposomal doxorubicin in patients with advanced ovarian cancer: preliminary activity results of the MITO-2 randomized multicenter trial [Abstract]. In: Journal of Clinical Oncology; 2007 ASCO Annual meeting. Vol. 25:18S (abstr. 5532). 2007.
    1. Pignata S, Scambia G, Savarese A, Sorio R, Breda E, Ferrandina G, et al. Carboplatin plus paclitaxel (CP) versus carboplatin plus stealth liposomal doxorubicin (CLD) in patients with advanced ovarian cancer (AOC): activity and safety results of the MITO-2 randomized multicenter trial [abstract]. In: Journal of Clinical Oncology; 2009 ASCO Annual Meeting. Vol. 27:15S (suppl; abstr LBA5508). 2009.
Monk 2016 {published data only}
    1. Monk BJ, Herzog T, Alvarez R, Chan J, Chase D, Couchenour R, et al. Focus study: physician's choice chemotherapy (PCC) plus bevacizumab and CA4P versus PCC plus bevacizumab and placebo in platinum-resistant ovarian cancer. International Journal of Gynecological Cancer 2016;26:878-9.
Nagao 2016 {published data only}
    1. Nagao S, Iwasa N, Kurosaki A, Nishikawa T, Hanaoka T, Hasegawa K, et al. The efficacy of low-dose paclitaxel added to combination chemotherapy of carboplatin and gemcitabine or pegylated liposomal doxorubicin. International Journal of Gynaecological Cancer 2016;26(3):443-8. - PubMed
NCT02641639 2015 {published data only}
    1. NCT02641639. FOCUS: PCC + bevacizumab + CA4P versus PCC + bevacizumab + placebo for subjects with platinum resistant ovarian cancer. https://clinicaltrials.gov/ct2/show/NCT02641639 2015.
NCT02891824 2016 {published data only}
    1. NCT02891824. ATALANTE: atezolizumab vs placebo phase III study in late relapse ovarian cancer treated with chemotherapy + bevacizumab. Https://clinicaltrials.gov/show/NCT02891824 2016;():2016 2016.
NCT03632798 2018 {published data only}
    1. NCT03632798. Avastin plus chemotherapy vs. avastin plus chemotherapy guided by cancer stem cell test in recurrent ovarian cancer. Https://clinicaltrials.gov/show/nct03632798 2018.
NCT03639246 2018 {published data only}
    1. NCT03639246. Efficacy and safety study of AVB-S6-500 in patients with platinum-resistant recurrent ovarian cancer. Https://clinicaltrials.gov/show/nct03639246 2018.
NCT03699449 2018 {published data only}
    1. NCT03699449. An umbrella study of bioomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer(AMBITION). Https://clinicaltrials.gov/show/nct03699449 2018.
NCT03949283 2019 {published data only}
    1. NCT03949283. Cancer stem cell assay directed chemotherapy in recurrent platinum resistant ovarian cancer. Https://clinicaltrials.gov/show/nct03949283 2019.
Palaia 2006 {published data only}
    1. Palaia I, Angioli R, Calcagno M, Zullo MA, Plotti F, Basile S, et al. Liposome-encapsulated doxorubicin citrate in previously treated recurrent/metastatic gynecologic malignancies. International Journal of Gynecological Cancer 2007;17:88-93. - PubMed
PiSARRO 2016 {published data only}
    1. Basu B, Gourley C, Gabra H, Vergote IB, Brenton JD, Abrahmsen L, et al. PiSARRO: a EUTROC phase 1b study of APR-246 with carboplatin (C) and pegylated liposomal doxorubicin (PLD) in relapsed platinum-sensitive high-grade serous ovarian cancer (HGSOC). Annals of Oncology 2016;27:vi123.
Scarfone 2006 {published data only}
    1. Scarfone G, Presti M, Scarabelli C, Polverino GP, Polonio N, Bertoglio S, et al. Pegylated liposomal doxorubicin alone or in combination with platinum compounds in recurrent ovarian cancer after first line chemotherapy containing paclitaxel and carboplatin. In: International Journal of Gynecological Cancer. Vol. 16. 2006:668.
Shoji 2018 {published data only}
    1. Shoji T, Komiyama S, Kigawa J, Tanabe H, Kato K, Itamochi H, et al. An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without bevacizumab in platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer patients previously treated with bevacizumab for front-line or platinum-sensitive ovarian cancer: rationale, design, and methods of the Japanese Gynecologic Oncology Group study JGOG3023. BMC Cancer 2018;18(1):1-8. - PMC - PubMed
Trillsch 2016 {published data only}
    1. Trillsch F, Mahner S, Hilpert F, Davies L, Garcia-Martinez E, Kristensen G, et al. Prognostic and predictive effects of primary versus secondary platinum resistance for bevacizumab treatment for platinum-resistant ovarian cancer in the AURELIA trial. Annals of Oncology 2016;27(9):1733-9. - PubMed
Wydra 2014 {published data only}
    1. Wydra D, Ghamande S, Gabrail N, Nowara E, Bidzinski M, De Pasquale S, et al. Vintafolide and its companion imaging agent, etarfolatide-results from a PRECEDENT subanalysis. European Journal of Nuclear Medicine and Molecular Imaging 2014;41:S353-4.
Yabuno 2019 {published data only}
    1. Yabuno A, Tabata T, Michimae H, Oishi T, Nonaka M, Takano M, et al. Randomized phase III trial comparing pegylated liposomal doxorubicin (PLD) 50 mg/m2 and 40 mg/m2 in patients with platinum-resistant Mullerian carcinoma (JGOG3018). In: Journal of Clinical Oncology. Vol. 37. 2019:5550.

References to studies awaiting assessment

ASSIST‐1 2009 {published and unpublished data}
    1. Vergote I, Finkler N, Campo J, Lohr A, Hunter J, Matei D, et al. Phase 3 randomised study of canfosfamide (Telcyta®, TLK286) versus pegylated liposomal doxorubicin or topotecan as third-line therapy in patients with platinum-refractory or-resistant ovarian cancer. European Journal of Cancer 2009;45(13):2324-32. - PubMed
    1. Vergote I, Finkler N, Campo J, Lohr A, Hunter J, Matei D, et al. Single agent, canfosfamide (C, TLK286) vs pegylated liposomal doxorubicin or topotecan in 3rd-line treatment of platinum refractory or resistant ovarian cancer: phase III study results [Abstract]. In: Journal of Clinical Oncology; 2007 ASCO Annual Meeting. Vol. 25:18S (Suppl, abstr. LBA5528). 2007.
AURELIA 2012 {published data only}
    1. Hilpert F, Fabbro M, Jesus Rubio M, Reuss A, Rosenberg P, Benedettu Panici P, et al. Symptoms and adverse effects with chemotherapy +/- bevacizumab for platinum-resistant recurrent ovarian cancer: Analysis of the phase III AURELIA trial. Gynecologic Oncology 2013;130(1):e3.
    1. Hoffmann-La Roche. AURELIA: A study of Avastin (Bevacizumab) added to chemotherapy in patients with platinum-resistant ovarian cancer. Accessed on 14/11/12 at http://www.clinicaltrials.gov/ct2/show/NCT00976911.
    1. Husain A, Wany Y, Hanker L, Ojeda B, Anttila M, Breda E, et al. Independent radiologic review of AURELIA, a phase 3 trial of bevacizumab plus chemotherapy for platinum-resistant recurrent ovarian cancer. Gynecologic Oncology 2016;142(3):465-470. - PubMed
    1. Kristensen G Berton-Rigaud D Hilpert F Reuss A Bover I Raspagliesi F et al. Effect of bevacizumab (BEV) plus chemotherapy (CT) for platinum-resistant recurrent ovarian cancer (OC) with ascites: analysis of the aurelia trial. ASCO Annual Meeting II, Journal of Clinical Oncology 2012;22(Suppl 3):E103.
    1. Lesnock J, Hamilton C, Darcy K, Havrilesky L, Krivak T, Maxwell G, et al. A cost-effectiveness analysis of the AURELIA trial: bevacizumab and paclitaxel offer a promising clinical and economic combination for platinum-resistant ovarian cancer. Gynecologic Oncology 2016;141:36-37.
FORWARD I {published data only}
    1. Moore K, Oza A, Colombo N, Oaknin A, Scambia G, Lorusso D, et al. FORWARD I (GOG 3011): a phase III study of mirvetuximab soravtansine, a folate receptor alpha (FRalpha)-targeting antibody-drug conjugate (ADC), versus chemotherapy in patients (pts) with platinumresistant ovarian cancer (PROC). Annals of Oncology 2019;30(Suppl 5):v403.
    1. Moore KN, Vergote I, Oaknin A, Colombo N, Banerjee S, Oza A, et al. FORWARD I: a Phase III study of mirvetuximab soravtansine versus chemotherapy in platinum-resistant ovarian cancer. Future Oncology 2018;14(17):1669-78. - PubMed
    1. Moore KN, Vergote I, Oaknin A, Colombo N, Banerjee S, Oza AM, et al. FORWARD I: a phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRa)-positive, platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer. Annals of Oncology 2017;28(Supplement 5):353.
    1. Moore KN, Vergote I, Oaknin A, Colombo N, Banerjee SN, Oza AM, et al. FORWARD I (GOG 3011): a randomized phase 3 study to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) versus chemotherapy in adults with folate receptor alpha (FRalpha)-positive, platinum-resistant epithelial ovarian cancer (EOC), primary peritoneal cancer, or primary fallopian tube cancer. Journal of Clinical Oncology 2017;35(15 Suppl):TPS5607.
    1. NCT02631876. PH3 Study of Mirvetuximab Soravtansine vs Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer. Cochrane Database of Systematic Reviews 2015.
HECTOR {published data only}
    1. Mahner S, Chekerov R, Zeimet A, Garcia-Martinez E, Hanker L, Klare P, et al. Topotecan-carboplatin versus standard platinum combinations in patients with platinum-sensitive recurrent ovarian cancer-the gcig intergroup 'HECTOR' phase III trial. In: International Gynecologic Cancer Society. Vol. 22. 2012:E104.
    1. Meier W, Lichtenegger W, Marth C, Gonzalez-Martin AJ, Harter P, Tome O, et al. Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabin plus carboplatin (GC) or carboplatin plus pegylated doxorubicin (PLDC): A planed 200-pt interim safety analysis of the NOGGO-AGO-Germany-AGO Austria and GEICO-GCIG Intergroup Study (HECTOR). In: Journal of Clinical Oncology, 2010 ASCO Annual Meeting. Vol. 28:15s, (suppl; abstr 5071). 2010.
    1. Sehouli J, Chekerov R, Reinthaller A, Richter R, Gonzalez-Martin A, Harter P, et al. Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabine plus carboplatin (GC) or pegylated liposomal doxorubicin plus carboplatin (PLDC): a randomized phase III trial of the NOGGO-AGO-Study Group-AGO Austria and GEICO-ENGOT-GCIG intergroup study (HECTOR). Annals of Oncology 2016;27(12):2236-41. - PubMed
    1. Sehouli J, Meier W, Wimberger P, Chekerov R, Belau A, Mahner S, et al. Topotecan plus carboplatin versus standard therapy with paclitaxel plus carboplatin (PC) or gemcitabin plus carboplatin (GC) or carboplatin plus pegylated doxorubicin (PLDC): a randomized phase III trial of the NOGGO-AGO-Germany-AGO Austria and GEICO-GCIG intergroup study (HECTOR). Journal of Clinical Oncology 2012;30(15 Suppl):5031.
MITO‐16 MANGO OV2b {published data only}
    1. NCT01802749. Bevacizumab Beyond Progression in Platinum Sensitive Ovarian Cancer. https://clinicaltrials.gov/ct2/show/NCT01802749 2013.
    1. Pignata S, Lorusso D, Joly F, Gallo C, Colombo N, Sessa C, et al. MITO16b/MANGO–OV2/ENGOT–ov17 Investigators. Carboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial. The Lancet Oncology 2021;22(2):267-76. - PubMed
MITO‐23 {published data only}
    1. NCT02903004. Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients _MITO-23. clinicaltrials.gov 2016.
    1. Scambia G, Raspagliesi F, Valabrega G, Colombo N, Pisano C, Cassani C, et al. Randomized phase III trial on trabectedin (ET-743) single agent versus clinician’s choice chemotherapy in recurrent ovarian, primary peritoneal, or fallopian tube cancers of BRCA-mutated or BRCAness phenotype patients (MITO23). Abstract for ASCO 2022 meeting 2022.
MITO‐8 2017 {published data only (unpublished sought but not used)}
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MORAb‐003 {published data only}
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NCT03690739 {published data only}
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Oza 2019 {published data only}
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PROVE 2011 {published data only}
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SOLO3 {published data only}
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Volasertib Trial {published data only}
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References to ongoing studies

ABT‐888/NCT01113957 {published data only}
    1. Abbott. A trial of ABT-888 in combination with temozolomide versus pegylated liposomal doxorubicin alone in ovarian cancer [Ongoing]. Accessed on 12/11/12 at http://www.http://clinicaltrials.gov/show/NCT01113957.
ATI0918/NCT01715168 {published data only}
    1. Kuhn K. A Crossover bioequivalence study of intravenously administered ATI0918 and DOXIL/CAELYX in patients with ovarian cancer. Accessed on 14/11/12 at ttp://www.clinicaltrials.gov/ct2/show/record/NCT01715168.
EPIK‐O/ENGOT‐OV61 {published data only}
    1. P Konstantinopoulos, A González-Martín, F Cruz, M Friedlander, R Glasspool, D Lorusso, et al. EPIK-O/ENGOT-OV61: a phase 3, randomized study of alpelisib + olaparib in patients with no germline brca mutation detected, platinum-resistant or-refractory, high grade serous ovarian cancer. International Journal of Gynecological Cancer 1/11/2021;31 (Suppl 4):A139‐A140. [DOI: 10.1136/ijgc-2021-IGCS.350] - DOI
MIRASOL {published data only}
    1. Moore KN, Van Gorp T, Wang J, Esteves B, Zweidler-McKay PA. A study of mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression (MIRASOL) NCT04209855. Journal of Clinical Oncology 2020;38. [DOI: 10.1200/JCO.2020.38.15_suppl.TPS6103] [NCT: NCT04209855] - DOI
MIROVA {published data only}
    1. Mirvetuximab soravtansine (IMGN853), in folate receptor alpha (FRα) high recurrent ovarian cancer. clinicaltrials.gov. [NCT: 04274426]
MITO‐27 {published data only}
    1. NCT03539328. Study on MK-3475 plus chemotherapy versus chemotherapy alone in recurrent, platinum-resistant ovarian cancer. https://clinicaltrials.gov/ct2/show/NCT03539328 2018.
MITO‐29/NCT03467178 {published data only}
    1. NCT03467178. Study on decitabine plus carboplatin versus physician's choice chemotherapy in recurrent, platinum-resistant ovarian cancer. https://clinicaltrials.gov/ct2/show/NCT03467178 2018.
NCT01100372 {published data only}
    1. NCT01100372. Liposome-encapsulated doxorubicin citrate with or without gemcitabine hydrochloride in treating patients with ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. https://clinicaltrials.gov/ct2/show/NCT01100372 2010.
NCT03353831 {published data only}
    1. Harter P, Pautier P, Nieuwenhuysen EV, Reuss A, Redondo A, Lindemann K, et. Atezolizumab in combination with bevacizumab and chemotherapy versus bevacizumab and chemotherapy in recurrent ovarian cancer - a randomized phase III trial (AGO-OVAR 2.29/ENGOT-ov34). International Journal of Gynecological Cancer Dec 2020;30(12):1997-2001. - PubMed
    1. NCT03353831. Atezolizumab with bevacizumab and chemotherapy vs bevacizumab and chemotherapy in early relapse ovarian cancer. https://clinicaltrials.gov/ct2/show/NCT03353831 2017.
NCT04739800 {published data only}
    1. Comparison of standard of care treatment with a triplet combination of targeted immunotherapeutic agents. clinicaltrials.gov. [NCT: NCT04739800]
NCT05092360 {published data only}
    1. Phase 3 study of nemvaleukin alfa in combination with pembrolizumab (ARTISTRY-7). clinicaltrials.gov. [NCT: 05092360]
PROVE/NCT01388621 {published data only}
    1. Chekerov R, Klare P, Krabisch P, Potenberg J, Heinrich G, Mueller L. Panitumumab in platinum-sensitive epithelial ovarian cancer patients with KRAS wild-type: The PROVE-study, a phase II randomized multicenter study of the North-Eastern German Society of Gynaecologic Oncology. Journal of Clinical Oncology 2017;35:suppl, 5558-5558.
    1. Sehouli J. PROVE A randomized phase II trial of standard carboplatin-based chemotherapy with or without panitumumab in platinum-sensitive recurrent ovarian cancer. Accessed on 14/11/12 at http://clinicaltrials.gov/ct2/show/NCT01388621.

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References to other published versions of this review

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