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Clinical Trial
. 2024 Apr 10;42(11):1288-1300.
doi: 10.1200/JCO.23.01214. Epub 2024 Feb 1.

Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in g BRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer

Patricia A Ganz  1   2 , Hanna Bandos  3 , Tanja Španić  4   5 , Sue Friedman  6 , Volkmar Müller  7 , Sherko Kuemmel  8   9 , Suzette Delaloge  10 , Etienne Brain  11 , Masakazu Toi  12   13 , Hideko Yamauchi  14 , Eduardo-M de Dueñas  15   16 , Anne Armstrong  17 , Seock-Ah Im  18 , Chuan-Gui Song  19 , Hong Zheng  20 , Tomasz Sarosiek  21 , Priyanka Sharma  22 , Cuizhi Geng  23 , Peifen Fu  24 , Kerstin Rhiem  25 , Heike Frauchiger-Heuer  26 , Pauline Wimberger  27   28   29   30   31   32 , Daphné t'Kint de Roodenbeke  33 , Ning Liao  34 , Annabel Goodwin  35 , Camille Chakiba-Brugère  36 , Michael Friedlander  37 , Keun Seok Lee  38 , Sylvie Giacchetti  39 , Toshimi Takano  40 , Fernando Henao-Carrasco  41 , Shamsuddin Virani  42 , Frances Valdes-Albini  43 , Susan M Domchek  44 , Charles Bane  45 , Edward C McCarron  46 , Monica Mita  47 , Giovanna Rossi  48 , Priya Rastogi  49   50 , Anitra Fielding  51 , Richard D Gelber  52   53 , Elsemieke D Scheepers  54 , David Cameron  55 , Judy Garber  56 , Charles E Geyer  49 , Andrew N J Tutt  57   58
Affiliations
Clinical Trial

Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in g BRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer

Patricia A Ganz et al. J Clin Oncol. .

Abstract

Purpose: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment.

Methods: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values <.05 were statistically significant for the primary end point. All secondary end points were descriptive.

Results: One thousand five hundred and thirty-eight patients (NACT: 746, ACT: 792) contributed to the analysis. Fatigue severity was statistically significantly greater for OL versus PL, but not clinically meaningfully different by prespecified criteria (≥3 points) at 6 months (diff OL v PL: NACT: -1.3 [95% CI, -2.4 to -0.2]; P = .022; ACT: -1.3 [95% CI, -2.3 to -0.2]; P = .017) and 12 months (NACT: -1.6 [95% CI, -2.8 to -0.3]; P = .017; ACT: -1.3 [95% CI, -2.4 to -0.2]; P = .025). There were no significant differences in fatigue severity between treatment groups at 18 and 24 months. NV severity was worse in patients treated with OL compared with PL at 6 months (NACT: 6.0 [95% CI, 4.1 to 8.0]; ACT: 5.3 [95% CI, 3.4 to 7.2]) and 12 months (NACT: 6.4 [95% CI, 4.4 to 8.3]; ACT: 4.5 [95% CI, 2.8 to 6.1]). During treatment, there were some clinically meaningful differences between groups for other symptoms but not for function subscales or global health status.

Conclusion: Treatment-emergent symptoms from OL were limited, generally resolving after treatment ended. OL- and PL-treated patients had similar functional scores, slowly improving during the 24 months after (N)ACT and there was no clinically meaningful persistence of fatigue severity in OL-treated patients.

Trial registration: ClinicalTrials.gov NCT02032823.

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Conflict of interest statement

The following represents disclosure information provided by authors of this manuscript. All relationships are considered compensated unless otherwise noted. Relationships are self-held unless noted. I = Immediate Family Member, Inst = My Institution. Relationships may not relate to the subject matter of this manuscript. For more information about ASCO's conflict of interest policy, please refer to www.asco.org/rwc or ascopubs.org/jco/authors/author-center.

Open Payments is a public database containing information reported by companies about payments made to US-licensed physicians (Open Payments).

No other potential conflicts of interest were reported.

Figures

FIG 1.
FIG 1.
CONSORT diagram: OlympiA PRO Study. PRO, patient-reported outcomes.
FIG 2.
FIG 2.
FACIT-Fatigue score change from baseline over time by treatment group for patients (A) who have completed neoadjuvant chemotherapy and (B) who have completed adjuvant chemotherapy: OlympiA PRO Study. FACIT-Fatigue score ranges from 0-52 with higher score indicating less fatigue. FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue; PRO, patient-reported outcomes.
FIG 3.
FIG 3.
EORTC QLQ-C30 scores over time by treatment and chemotherapy subgroup for Global Health Status ((A) neoadjuvant chemotherapy, (B) adjuvant chemotherapy), Physical scale ((C) neoadjuvant chemotherapy, (D) adjuvant chemotherapy), and Emotional scale ((E) neoadjuvant chemotherapy, (F) adjuvant chemotherapy): OlympiA PRO Study. EORTC QLQ-C30 Global Health Status/QOL Score, Physical and Emotional subscale scores range from 0-100, higher score indicates better quality of life, or functioning. EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item; PRO, patient-reported outcomes; QOL, quality of life.
FIG 4.
FIG 4.
EORTC QLQ-C30 scores change from baseline over time by treatment and chemotherapy subgroup for nausea and vomiting symptom ((A) neoadjuvant chemotherapy, (B) adjuvant chemotherapy) and diarrhea symptom ((C) neoadjuvant chemotherapy, (D) adjuvant chemotherapy): OlympiA PRO Study. EORTC QLQ-C30 Nausea and vomiting and Diarrhea symptoms scale scores range from 0-100, higher score indicate worse symptom. EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item; PRO, patient-reported outcomes.
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References

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