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3 results on '"Fielding, Anitra"'

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

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

2. Efficacy and Safety of Trastuzumab Deruxtecan in Patients With HER2-Expressing Solid Tumors: Primary Results From the DESTINY-PanTumor02 Phase II Trial.

Author

Meric-Bernstam, Funda, Makker, Vicky, Oaknin, Ana, Oh, Do-Youn, Banerjee, Susana, González-Martín, Antonio, Jung, Kyung Hae, Ługowska, Iwona, Manso, Luis, Manzano, Aránzazu, Melichar, Bohuslav, Siena, Salvatore, Stroyakovskiy, Daniil, Fielding, Anitra, Ma, Yan, Puvvada, Soham, Shire, Norah, and Lee, Jung-Yun

Published
2024
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3. 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.

Author

Ganz PA, Bandos H, Španić T, Friedman S, Müller V, Kuemmel S, Delaloge S, Brain E, Toi M, Yamauchi H, de Dueñas EM, Armstrong A, Im SA, Song CG, 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 KS, Giacchetti S, Takano T, Henao-Carrasco F, Virani S, Valdes-Albini F, Domchek SM, Bane C, McCarron EC, Mita M, Rossi G, Rastogi P, Fielding A, Gelber RD, Scheepers ED, Cameron D, Garber J, Geyer CE, and Tutt ANJ

Subjects
Female, Humans, BRCA1 Protein genetics, BRCA2 Protein genetics, Fatigue chemically induced, Mutation, Nausea, Patient Reported Outcome Measures, Vomiting, Breast Neoplasms drug therapy, Breast Neoplasms genetics, Phthalazines, Piperazines, Quality of Life, Receptor, ErbB-2
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.

Published
2024
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