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.

Autor:	Ganz PA; University of California, Los Angeles, Los Angeles, CA.; Jonsson Comprehensive Cancer Center, Los Angeles, CA., Bandos H; NRG Oncology SDMC, The University of Pittsburgh, Pittsburgh, PA., Španić T; Europa Donna-The European Breast Cancer Coalition, Milan, Italy.; Europa Donna Slovenia, Ljubljana, Slovenia., Friedman S; Facing Our Risk of Cancer Empowered, Tampa, FL., Müller V; Depatment of Gynecology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Kuemmel S; Breast Unit, Kliniken Essen-Mitte, Essen, Germany.; Department of Gynecology with Breast Center, Charité-Universitätsmedizin Berlin, Berlin, Germany., Delaloge S; Gustave Roussy, Villejuif, France., Brain E; Department of Medical Oncology, Institut Curie, Saint-Cloud, France., Toi M; Kyoto University Hospital, Kyoto, Japan.; Tokyo Metropolitan Cancer and Infectious Disease Center, Komagome Hospital, Tokyo, Japan., Yamauchi H; St Luke's International Hospital, Tokyo, Japan., de Dueñas EM; Consorcio Hospitalario Provincial de Castellón, Castellón, Spain.; GEICAM Spanish Breast Cancer Group, Madrid, Spain., Armstrong A; Department of Medical Oncology, Division of Cancer Sciences, The University of Manchester, The Christie Hospital, Manchester, United Kingdom., Im SA; Cancer Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea., Song CG; Department of Breast Surgery, Fujian Medical University Union Hospital, Fuzhou, China., Zheng H; West China Hospital, Sichuan University, Chengdu, China., Sarosiek T; Luxmed Onkologia, Warsaw, Poland., Sharma P; University of Kansas Medical Center, Westwood, KS., Geng C; The Fourth Hospital of Hebei Medical University, Shiijazhuang, China., Fu P; Breast Surgery Department, First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China., Rhiem K; Center for Hereditary Breast and Ovarian Cancer, Center for Integrated Oncology (CIO), Cologne, Germany., Frauchiger-Heuer H; Breast Center Unit, UniversitätsSpital Zürich, Zürich, Switzerland., Wimberger P; Department of Gynecology and Obstetrics, Medical Faculty and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.; German Cancer Consortium (DKTK), Dresden and German Cancer Research Center (DKFZ), Heidelberg, Germany.; National Center for Tumor Diseases (NCT), Dresden, Germany.; German Cancer Research Center (DKFZ), Heidelberg, Germany.; Faculty of Medicine and University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.; Helmholtz-Zentrum Dresden-Rossendorf (HZDR), Dresden, Germany., t'Kint de Roodenbeke D; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium., Liao N; Guangdong People's Hospital, Guangzhou, China., Goodwin A; Concord Repatriation General Hospital, University of Sydney, Sydney, NSW, Australia., Chakiba-Brugère C; Département d'oncologie médicale, Institut Bergonié, Bordeaux, France., Friedlander M; Prince of Wales Clinical School, University of NSW and Nelune Comprehensive Cancer Centre, Prince of Wales Hospital, Sydney, NSW, Australia., Lee KS; Center for Breast Cancer, National Cancer Center, Goyang, Republic of Korea., Giacchetti S; Breast Disease Unit (Sénopole), AP-HP, Hôpital Saint-Louis, Paris, France., Takano T; Breast Medical Oncology Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan., Henao-Carrasco F; Hospital Universitario Virgen Macarena GEICAM Spanish Breast Cancer Group, Sevilla, Spain., Virani S; Advocate Aurora Health, Milwaukee, WI., Valdes-Albini F; University of Miami Sylvester Comprehensive Cancer Center, Miami, FL., Domchek SM; Basser Center for BRCA, University of Pennsylvania, Philadelphia, PA., Bane C; Dayton Physicians Network, Dayton, OH., McCarron EC; MedStar Franklin Square Medical Center-Harry and Jeanette Weinberg Cancer Institute, Baltimore, MD., Mita M; Cedars Sinai Medical Center, SOCCI, Los Angeles, CA., Rossi G; Breast International Group (BIG), Brussels, Belgium., Rastogi P; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA.; Magee Women's Hospital, Pittsburgh, PA., Fielding A; Oncology R&D, AstraZeneca, Gaithersburg, MD., Gelber RD; Dana-Farber Cancer Institute, Harvard Medical School, Harvard TH Chan School of Public Health, Boston, MA.; Frontier Science Foundation, Boston, MA., Scheepers ED; Frontier Science (Scotland), Kincraig, United Kingdom., Cameron D; University of Edinburgh, Edinburgh, United Kingdom., Garber J; Dana-Farber/Harvard Cancer Center, Boston, MA., Geyer CE; UPMC Hillman Cancer Center, University of Pittsburgh School of Medicine, Pittsburgh, PA., Tutt ANJ; The Institute of Cancer Research London, London, United Kingdom.; Kings College London, London, United Kingdom.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2024 Apr 10; Vol. 42 (11), pp. 1288-1300. Date of Electronic Publication: 2024 Feb 01.
DOI:	10.1200/JCO.23.01214
Abstrakt:	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.
Databáze:	MEDLINE
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