A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO)

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Details zur Publikation

Autorinnen und Autoren: Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmana J, Fasching P, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME
Zeitschrift: Clinical Cancer Research
Jahr der Veröffentlichung: 2019
Band: 25
Heftnummer: 9
Seitenbereich: 2717-2724
ISSN: 1078-0432


Abstract

PURPOSE: To assess talazoparib activity in germline BRCA1/2 mutation carriers with advanced breast cancer. PATIENTS AND METHODS: ABRAZO (NCT02034916) was a two-cohort, two-stage, phase II study of talazoparib (1 mg/day) in germline BRCA mutation carriers with a response to prior platinum with no progression on or within 8 weeks of the last platinum dose (cohort 1) or ≥3 platinum-free cytotoxic regimens (cohort 2) for advanced breast cancer. Primary endpoint was confirmed objective response rate (ORR) by independent radiological assessment. RESULTS: We enrolled 84 patients (cohort 1, n = 49; cohort 2, n = 35) from May 2014 to February 2016. Median age was 50 (range, 31-75) years. Triple-negative breast cancer (TNBC) incidence was 59% (cohort 1) and 17% (cohort 2). Median number of prior cytotoxic regimens for advanced breast cancer was two and four, respectively. Confirmed ORR was 21% [95% confidence interval (CI), 10-35; cohort 1] and 37% [95% CI, 22-55; cohort 2]. Median duration of response was 5.8 and 3.8 months, respectively. Confirmed ORR was 23% (BRCA1), 33% (BRCA2), 26% (TNBC), and 29% (hormone receptor-positive). The most common all-grade adverse events (AE) included anemia (52%), fatigue (45%), and nausea (42%). Talazoparib-related AEs led to drug discontinuation in 3 (4%) patients. In an exploratory analysis, longer platinum-free interval was associated with higher response rate in cohort 1 (0% ORR with interval <8 weeks; 47% ORR with interval >6 months). CONCLUSIONS: Talazoparib exhibited promising antitumor activity in patients with advanced breast cancer and germline BRCA mutation.


FAU-Autorinnen und Autoren / FAU-Herausgeberinnen und Herausgeber

Fasching, Peter PD Dr.
Professur für Translationale Frauenheilkunde und Geburtshilfe


Einrichtungen weiterer Autorinnen und Autoren

Autonomous University of Barcelona (UAB) / Universitat Autònoma de Barcelona
Banner MD Anderson Cancer Center
Centre Oscar Lambret (UNICANCER)
Eberhard Karls Universität Tübingen
Medieval LLC
Memorial Sloan Kettering Cancer Center
Stanford University
Technische Universität München (TUM)
The Institute of Cancer Research (ICR)
University of California Los Angeles (UCLA)
University of California San Francisco (UCSF)
University of Manchester


Zitierweisen

APA:
Turner, N.C., Telli, M.L., Rugo, H.S., Mailliez, A., Ettl, J., Grischke, E.-M.,... Robson, M.E. (2019). A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clinical Cancer Research, 25(9), 2717-2724. https://dx.doi.org/10.1158/1078-0432.CCR-18-1891

MLA:
Turner, Nicholas C., et al. "A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO)." Clinical Cancer Research 25.9 (2019): 2717-2724.

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Zuletzt aktualisiert 2019-23-05 um 10:23