1. 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.
- Author
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Ganz, Patricia, Bandos, Hanna, Španić, Tanja, Friedman, Sue, Müller, Volkmar, Kuemmel, Sherko, Delaloge, Suzette, Brain, Etienne, Toi, Masakazu, Yamauchi, Hideko, de Dueñas, Eduardo-M, Armstrong, Anne, Im, Seock-Ah, Song, Chuan-Gui, Zheng, Hong, Sarosiek, Tomasz, Sharma, Priyanka, Geng, Cuizhi, Fu, Peifen, Rhiem, Kerstin, Frauchiger-Heuer, Heike, Wimberger, Pauline, tKint de Roodenbeke, Daphné, Liao, Ning, Goodwin, Annabel, Chakiba-Brugère, Camille, Friedlander, Michael, Lee, Keun, Giacchetti, Sylvie, Takano, Toshimi, Henao-Carrasco, Fernando, Virani, Shamsuddin, Valdes-Albini, Frances, Domchek, Susan, Bane, Charles, McCarron, Edward, Mita, Monica, Rossi, Giovanna, Rastogi, Priya, Fielding, Anitra, Gelber, Richard, Scheepers, Elsemieke, Cameron, David, Garber, Judy, Geyer, Charles, and Tutt, Andrew
- Subjects
Female ,Humans ,BRCA1 Protein ,BRCA2 Protein ,Breast Neoplasms ,Fatigue ,Mutation ,Nausea ,Patient Reported Outcome Measures ,Phthalazines ,Piperazines ,Quality of Life ,Receptor ,ErbB-2 ,Vomiting - 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
- Published
- 2024