Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 Jan 17;30(1):oyae194.
doi: 10.1093/oncolo/oyae194.

Pegylated liposomal doxorubicin in partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer: a prospective study

Ying Zhang  1 , Zhen Yuan  1 , Guo-Nan Zhang  2 , Qing-Shui Li  3 , Man-Hua Cui  4 , Wen-Jun Cheng  5 , Yuan-Guang Meng  6 , Xiao-Hua Wu  7 , Ying Yue  8 , Li Wang  9 , Jian-Qing Hou  10 , Chang-Zhong Li  11 , Peng-Peng Qu  12 , Li-Xin Sun  13 , Guang-Shi Tao  14 , Gui-Ling Li  15 , Ya-Qing Chen  16 , Fang Ren  17 , Dong-Yan Cao  1 , Keng Shen  1
Affiliations
Multicenter Study

Pegylated liposomal doxorubicin in partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer: a prospective study

Ying Zhang et al. Oncologist. .

Abstract

Background: This study aimed to evaluate the efficacy and safety of pegylated liposomal doxorubicin (PLD) for patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer.

Methods: Patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer were recruited in this prospective, open-label, single-arm, multicenter study. Eligible patients were given 4-6 cycles of PLD (40 mg/m2 on day 1, every 4 weeks). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), disease control rate (DCR), quality of life, and safety. Exploratory endpoints included the change trend of CA125 and platinum-free interval.

Results: Between June 2017 and November 2020, 167 eligible patients were included in the full analysis set. The median PFS and OS were 6.8 months (95% CI, 4.4-9.3 months) and 19.1 months (95% CI, 15.0-23.3 months), respectively. The ORR and DCR were 32.3% and 60.5%, respectively. The ORR (62.3 vs 22.5%) and DCR (84.9 vs 60.7%) of patients with a CA125 decrease after the first cycle were significantly higher than those without a CA125 decrease (all P < .05). Grade ≥ 3 and serious adverse events were reported in 9.9% and 3.9% of patients, respectively. No treatment-related death was observed.

Conclusion: PLD showed promising efficacy and manageable tolerability in patients with partially platinum-sensitive, platinum-resistant, or platinum-refractory ovarian cancer.ClinicalTrials.gov Identifier: Chinese Clinical Trial Registry, ChiCTR1900022962.

Keywords: ovarian cancer; partially platinum-sensitive; pegylated liposomal doxorubicin; platinum-refractory; platinum-resistant.

PubMed Disclaimer

Conflict of interest statement

The authors have no relevant financial or nonfinancial interests to disclose.

Figures

Figure 1.
Figure 1.
Trial profile. Abbreviations: RECIST 1.1, the Response Evaluation Criteria in Solid Tumors version 1.1; NE, not evaluable; GCIG, Gynecologic Cancer InterGroup; C, cycle; D, day.
Figure 2.
Figure 2.
The PFS and OS of the overall and different subgroup populations in the FAS and PPS. (A) The PFS of the overall population in the FAS and PPS. (B) The PFS of partially platinum-sensitive, platinum-resistant, and platinum-refractory populations in the FAS and PPS. (C) The OS of the overall population in the FAS and PPS. (D) The OS of partially platinum-sensitive, platinum-resistant, and platinum-refractory populations in the FAS and PPS. Abbreviations: PFS, progression-free survival; OS, overall survival; FAS, full analysis set; PPS, per-protocol set.
Figure 3.
Figure 3.
Swimmer plot of patients with an objective response. Abbreviations: CR, complete response; PR, partial response; PD, progressive disease.
Figure 4.
Figure 4.
Quality of life questionnaire scores. Abbreviation: C, cycle.
Figure 5.
Figure 5.
The platinum-free interval. (A) The platinum-free interval of the overall population (n = 62). (B) The platinum-free interval of partially platinum-sensitive (n = 28), platinum-resistant (n = 16), and platinum-refractory (n = 18) populations.
See this image and copyright information in PMC

References

    1. Ledermann JA, Raja FA, Fotopoulou C, et al.Newly diagnosed and relapsed epithelial ovarian carcinoma: ESMO clinical practice guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013;24(Suppl 6):24-32. 10.1093/annonc/mdt333 - DOI - PubMed
    1. Herzog TJ, Monk BJ.. Bringing new medicines to women with epithelial ovarian cancer: what is the unmet medical need? Gynecol Oncol Res Pract. 2017;4:13. 10.1186/s40661-017-0050-0 - DOI - PMC - PubMed
    1. Gordon AN, Tonda M, Sun S, Rackoff W; Doxil Study 30-49 Investigators. Long-term survival advantage for women treated with pegylated liposomal doxorubicin compared with topotecan in a phase 3 randomized study of recurrent and refractory epithelial ovarian cancer. Gynecol Oncol. 2004;95(1):1-8. 10.1016/j.ygyno.2004.07.011 - DOI - PubMed
    1. Ferrandina G, Ludovisi M, Lorusso D, et al.Phase III trial of gemcitabine compared with pegylated liposomal doxorubicin in progressive or recurrent ovarian cancer. J Clin Oncol. 2008;26(6):890-896. 10.1200/JCO.2007.13.6606 - DOI - PubMed
    1. Cohn DE, Sill MW, Walker JL, et al.Randomized phase IIB evaluation of weekly paclitaxel versus weekly paclitaxel with oncolytic reovirus (Reolysin®) in recurrent ovarian, tubal, or peritoneal cancer: an NRG oncology/gynecologic oncology group study. Gynecol Oncol. 2017;146(3):477-483. 10.1016/j.ygyno.2017.07.135 - DOI - PMC - PubMed

Publication types