Patient-reported outcomes in OlympiA: a phase III, randomized, placebo-controlled trial of adjuvant olaparib in gBRCA1/2 mutations and high-risk human epidermal growth factor receptor 2-negative early breast cancer
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Authors
Ganz, P. A.Bandos, H.
Španić, T.
Friedman, S.
Müller, V.
Kuemmel, S.
Delaloge, S.
Brain, E.
Toi, M.
Yamauchi, H.
de Dueñas, E. M.
Armstrong, Anna
Im, S. A.
Song, C. G.
Zheng, H.
Sarosiek, T.
Sharma, P.
Geng, C.
Fu, P.
Rhiem, K.
Frauchiger-Heuer, H.
Wimberger, P.
t'Kint de Roodenbeke, D.
Liao, N.
Goodwin, A.
Chakiba-Brugère, C.
Friedlander, M.
Lee, K. S.
Giacchetti, S.
Takano, T.
Henao-Carrasco, F.
Virani, S.
Valdes-Albini, F.
Domchek, S. M.
Bane, C.
McCarron, E. C.
Mita, M.
Rossi, G.
Rastogi, P.
Fielding, A.
Gelber, R. D.
Scheepers, E. D.
Cameron, D.
Garber, J.
Geyer, C. E.
Tutt, A. N. J.
Affiliation
Department of Medical Oncology, Division of Cancer Sciences, The University of Manchester, The Christie Hospital, Manchester, United Kingdom.Issue Date
2024
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Show full item recordAbstract
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.Citation
Ganz PA, Bandos H, Španić T, Friedman S, Müller V, Kuemmel S, et al. Patient-Reported Outcomes in OlympiA: A Phase III, Randomized, Placebo-Controlled Trial of Adjuvant Olaparib in gBRCA1/2 Mutations and High-Risk Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2024 Apr 10;42(11):1288-300. PubMed PMID: 38301187. Pubmed Central PMCID: PMC11095886 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. Epub 2024/02/01. eng.Journal
Journal of clinical oncologyDOI
10.1200/jco.23.01214PubMed ID
38301187Additional Links
https://dx.doi.org/10.1200/jco.23.01214Type
ArticleLanguage
enae974a485f413a2113503eed53cd6c53
10.1200/jco.23.01214
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