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Breast Cancer
Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA Trial
Kyung-Hun Lee, Joohyuk Sohn, Annabel Goodwin, Tiziana Usari, Silvana Lanzalone, Seock-Ah Im, Sung-Bae Kim
Cancer Res Treat. 2021;53(4):1084-1095.   Published online March 24, 2021
DOI: https://doi.org/10.4143/crt.2020.1381
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
We evaluated study outcomes in patients enrolled in Asian regions in the phase III EMBRACA trial of talazoparib vs. chemotherapy.
Materials and Methods
Patients with human epidermal growth factor receptor 2–negative germline BRCA1/2-mutated advanced breast cancer who received prior chemotherapy were randomized 2:1 to talazoparib 1 mg/day or chemotherapy (physician’s choice). Primary endpoint was progression-free survival (PFS) per independent central review in the intent-to-treat (ITT) population. This post-hoc analysis evaluated efficacy/safety endpoints in the ITT population of patients enrolled in Asian regions.
Results
Thirty-three patients were enrolled at Asian sites (talazoparib, n=23; chemotherapy, n=10). Baseline characteristics were generally comparable with the overall EMBRACA population. In Asian patients, median PFS was 9.0 months (95% confidence interval [CI] 3.0, 15.2) for talazoparib and 7.1 months (95% CI, 1.2, not reached) for chemotherapy (hazard ratio [HR] 0.74 [95% CI, 0.22, 2.44]). Objective response rate was numerically higher for talazoparib vs. chemotherapy (62.5% [95% CI, 35.4, 84.8] vs. 25.0% [95% CI, 3.2, 65.1]). Median overall survival was 20.7 months (95% CI, 9.4, 40.1) versus 21.2 months (95% CI, 2.7, 35.0) months (HR, 1.41 [95% CI, 0.49, 4.05]). In Asian patients, fewer grade 3/4 adverse events (AEs), serious AEs (SAEs), grade 3/4 SAEs, and AEs resulting in dose reduction/discontinuation occurred with talazoparib than chemotherapy; for talazoparib, the frequency of these events was lower in Asian patients versus overall EMBRACA population.
Conclusion
In this subgroup analysis, talazoparib numerically improved efficacy versus chemotherapy and was generally well tolerated in Asian patients, with fewer grade 3/4 TEAEs, SAEs, and TEAEs leading to dose modification vs. the overall EMBRACA population.

Citations

Citations to this article as recorded by  
  • HR-positive/HER2-negative breast cancer arising in patients with or without BRCA2 mutation: different biological phenotype and similar prognosis
    Pu-Chun Li, Yi-Fan Zhu, Jia-Ni Pan, Qiao-Yan Zhu, Yu-Yang Liao, Xiao-Wen Ding, Lin-Feng Zheng, Wen-Ming Cao
    Therapeutic Advances in Medical Oncology.2024;[Epub]     CrossRef
  • Detection and analysis of the safety profile of talazoparib based on FAERS database
    Mufei Tang, Peiyan Liu, Linzhe Du, Yuanyuan Li, Jinjin Chen, Yang Li
    Expert Opinion on Drug Safety.2024; : 1.     CrossRef
  • Facing inevitable PARPis resistance: Mechanisms and therapeutic strategies for breast cancer treatment
    Haixia Liu, Xiaohui Chen, Yimin Jia, Hengyi Chen, Xiaohui Wang, Guoxiang Liu, Yang Luo
    Interdisciplinary Medicine.2023;[Epub]     CrossRef
  • Sustained delivery of PARP inhibitor Talazoparib for the treatment of BRCA-deficient ovarian cancer
    Shicheng Yang, Allen Green, Needa Brown, Alexis Robinson, Merline Senat, Bryanna Testino, Daniela M. Dinulescu, Srinivas Sridhar
    Frontiers in Oncology.2023;[Epub]     CrossRef
  • Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, staging and treatment of patients with metastatic breast cancer
    S.-A. Im, A. Gennari, Y.H. Park, J.H. Kim, Z.-F. Jiang, S. Gupta, T.H. Fadjari, K. Tamura, M.Y. Mastura, M.L.T. Abesamis-Tiambeng, E.H. Lim, C.-H. Lin, A. Sookprasert, N. Parinyanitikul, L.-M. Tseng, S.-C. Lee, P. Caguioa, M. Singh, Y. Naito, R.A. Hukom,
    ESMO Open.2023; 8(3): 101541.     CrossRef
  • Molecular Biology Mechanisms and Emerging Therapeutics of Triple-Negative Breast Cancer
    Zhiying Zhang, Rui Zhang, Donghai Li
    Biologics: Targets and Therapy.2023; Volume 17: 113.     CrossRef
  • Development of the PARP inhibitor talazoparib for the treatment of advanced BRCA1 and BRCA2 mutated breast cancer
    Evthokia A. Hobbs, Jennifer K. Litton, Timothy A. Yap
    Expert Opinion on Pharmacotherapy.2021; : 1.     CrossRef
  • 8,406 View
  • 270 Download
  • 6 Web of Science
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Randomized Phase III Trial of Cisplatin, Epirubicin, Leucovorin, 5-Fluorouracil (PELF) Combination versus 5-fluorouracil Alone as Adjuvant Chemotherapy in Curative Resected Stage III Gastric Cancer
Jae Jin Lee, Si-Young Kim, Im sik Shin, Kyung Sam Cho, Hoong-Zae Joo, Choong Yoon, Yoon Wha Kim, Hwi Joong Yoon
Cancer Res Treat. 2004;36(2):140-145.   Published online April 30, 2004
DOI: https://doi.org/10.4143/crt.2004.36.2.140
AbstractAbstract PDFPubReaderePub
Purpose

The combination of cisplatin, epirubicin, leucovorin and 5-fluorouracil (PELF) administration, as adjuvant chemotherapy after curative resection for gastirc cancer, was compared with 5-fluorouracil (5-FU) administration alone. This paper reports the results of a prospective randomized comparison of the two regimens, PELF and 5-FU.

Methods

From August 1996 to July 1999, 54 patients were selected subsequent to being diagnosed with stage III cancer after a curative resection for gastric cancer. The patients were stratified according to stage IIIA/IIIB and subtotal/total gastrectomy, and then they were randomized into each treatment group, i.e. the PELF or 5-FU alone groups.

Results

54 assessable patients were enrolled in this study: 28 received PELF and 26 received 5-FU alone. 12 patients relapsed in each group and the median follow-up duration was 42 months (range: 10~77 months). The overall survival rate and disease-free survival rate (DFS) were not significantly different between two groups, (5-year survival of PELF vs. 5-FU: 57% vs. 64%, 5-year DFS: 54% vs. 51%). The PELF combination was more toxic in terms of anemia, anorexia, nausea and diarrhea than the 5-FU.

Conclusions

This study showed that the PELF combination, as an adjuvant therapy for gastric cancer after a curative resection, was a less effective treatment, and it had more toxic effects than the 5-FU.

Citations

Citations to this article as recorded by  
  • Multidisciplinary treatment strategy for locally advanced gastric cancer: A systematic review
    Kotaro Sugawara, Yoshikuni Kawaguchi, Yasuyuki Seto, Jean-Nicolas Vauthey
    Surgical Oncology.2021; 38: 101599.     CrossRef
  • The Efficacy and Safety of (Neo)Adjuvant Therapy for Gastric Cancer: A Network Meta-analysis
    Tom van den Ende, Emil ter Veer, Mélanie Machiels, Rosa M. A. Mali, Frank A. Abe Nijenhuis, Laura de Waal, Marety Laarman, Suzanne S. Gisbertz, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Cancers.2019; 11(1): 80.     CrossRef
  • Prognostic and Predictive Factors for the Curative Treatment of Esophageal and Gastric Cancer in Randomized Controlled Trials: A Systematic Review and Meta-Analysis
    Tom van den Ende, Emil ter Veer, Rosa M. A. Mali, Mark I. van Berge Henegouwen, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Cancers.2019; 11(4): 530.     CrossRef
  • COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis
    Tom van den Ende, Frank A. Abe Nijenhuis, Héctor G. van den Boorn, Emil ter Veer, Maarten C. C. M. Hulshof, Suzanne S. Gisbertz, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven
    Frontiers in Oncology.2019;[Epub]     CrossRef
  • Comparative effectiveness of adjuvant treatments for resected gastric cancer: a network meta-analysis
    Zhaolun Cai, Yiqiong Yin, Yuan Yin, Chaoyong Shen, Jian Wang, Xiaonan Yin, Zhixin Chen, Ye Zhou, Bo Zhang
    Gastric Cancer.2018; 21(6): 1031.     CrossRef
  • Current challenges of metastatic breast cancer
    Bora Lim, Gabriel N. Hortobagyi
    Cancer and Metastasis Reviews.2016; 35(4): 495.     CrossRef
  • Management of Gastroesophageal Junction Tumors
    Matthew P. Fox, Victor van Berkel
    Surgical Clinics of North America.2012; 92(5): 1199.     CrossRef
  • 9,705 View
  • 61 Download
  • 7 Crossref
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