Quality of life with talazoparib versus physician's choice of chemotherapy in patients wits advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA ease III trial

被引：108

作者：

Ettl, J. ^{[1
]}

Quek, R. G. W. ^{[2
]}

Lee, K. -H. ^{[3
]}

Rugo, H. S. ^{[4
]}

Hurvitz, S. ^{[5
]}

Goncalves, A. ^{[6
]}

Fehrenbacher, L. ^{[7
]}

Yerushalmi, R. ^{[8
]}

Mina, L. A. ^{[9
]}

Martin, M. ^{[10
]}

Roche, H. ^{[11
]}

Im, Y. -H. ^{[12
]}

Markova, D. ^{[2
]}

Bhattacharyya, H. ^{[13
]}

Hannah, A. L. ^{[2
]}

Eiermann, W. ^{[14
]}

Blum, J. L. ^{[15
]}

Litton, J. K. ^{[16
]}

机构：

[1] Tech Univ Munich, Klinikum Rechts Isar, Dept Obstet & Gynecol, Ismaningerstr 22, D-81675 Munich, Germany

[2] Pfizer Inc, San Francisco, CA USA

[3] Seoul Natl Univ Hosp, Seoul, South Korea

[4] UCSF Helen Diller Family Comprehens Canc Ctr, San Francisco, CA USA

[5] Univ Calif Los Angeles, Los Angeles, CA USA

[6] Inst Paoli Calmettes, Marseille, France

[7] Kaiser Permanente, Northern Calif, Vallejo, CA USA

[8] Beilinson Med Ctr, Rabin Med Ctr, Petah Tiqwa, Israel

[9] Banner Hlth, Phoenix, AZ USA

[10] Univ Complutense, Inst Invest Sanitaria Gregorio Maranon, CIBERONC, GEICAM, Madrid, Spain

[11] Inst Univ Canc Toulouse, Toulouse, France

[12] Samsung Med Ctr, Seoul, South Korea

[13] Pfizer Inc, New York, NY USA

[14] Interdisziplinares Onkol Zentrum Munchen, Munich, Germany

[15] US Oncol, Texas Oncol, Baylor Sammons Canc Ctr, Dallas, TX USA

[16] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

来源：

ANNALS OF ONCOLOGY | 2018年 / 29卷 / 09期

关键词：

poly(ADP-ribose) polymerase (PARP); talazoparib; breast cancer; patient-reported outcomes; quality of life; BRCA1; BRCA2; CLINICAL-TRIALS;

D O I：

10.1093/annonc/mdy257

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background: In the EMBRACA phase III trial, talazoparib (1 mg daily, orally) demonstrated a statistically significant improvement in PFS versus physician's choice of chemotherapy (PCT; capecitabine, eribulin, gemcitabine, or vinorelbine) in patients with HER2-negative advanced breast cancer carrying a germline BRCA1/2 mutation; we evaluated patient-reported outcomes (PROs). Patients and methods: Patients were randomized 2 :1 to receive talazoparib or PCT. PROs were assessed at day 1 (baseline), the start of each treatment cycle (every 3 weeks), and at the end of treatment, using the. European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-30) and its breast cancer module, QLQ-BR23. Prespecified exploratory analyses included a longitudinal mixed-effect model comparing treatment arms and a time to definitive clinically meaningful deterioration (TTD) analysis carried out in the global health status/quality of life (GHS/QoL), and all functional and symptom scales from the EORTC QLQ-C30 and -BR23 questionnaires. Between-arm TTD comparisons were made using a stratified log-rank test and a Cox proportional hazards model. Results: Baseline scores were similar between arms. Statistically significant estimated overall improvement from baseline in GHS/QoL was seen for talazoparib compared with statistically significant deterioration for PCT {3.0 [95% confidence interval (CI) 1.2,4.8] versus -5.4 [95% CI -8.8, -2.0]; between arms, P < 0.0001}. A statistically significant greater delay was observed in TTD in GHS/QoL, favoring talazoparib over PCI [hazard ratio, 0.38 (95% CI 0.26,0.5.5; median, 24.3 versus 6.3 months, respectively; P < 0.0001)]. A statistically significant overall change and a statistically significant delay in TTD, all favoring talazoparib, were also observed in multiple functions and symptoms. Conclusion: Patients who received talazoparib had significant overall improvements and significant delay in TTD in multiple -r related and breast cancer-specific symptoms, functions, and GHS/QoL.

引用

页码：1939 / 1947

页数：9

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