Efficacy, Safety, and Tolerability of Pertuzumab, Trastuzumab, and Docetaxel for Patients With Early or Locally Advanced ERBB2-Positive Breast Cancer in Asia: The PEONY Phase 3 Randomized Clinical Trial.
Abstract | Importance: Prospective assessment of treatments known to benefit patients in global clinical trials in specific racial groups is essential. Objective: Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled phase 3 trial enrolled 329 women with ERBB2-positive early (T2-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) and primary tumor larger than 2 cm from March 14, 2016, to March 13, 2017. Analysis of the primary end point was performed on an intention-to-treat basis. Interventions: Main Outcomes and Measures: The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by disease category and hormone receptor status, was used to compare rates between treatment groups. Results: In total, 329 female patients were randomized ( pertuzumab, 219; and placebo, 110; mean [SD] age, 48.8 [9.5] years). In the intention-to-treat population, total pathologic complete response rates were 39.3% (86 of 219) in the pertuzumab group and 21.8% (24 of 110) in the placebo group (difference, 17.5% [95% CI, 6.9%-28.0%]; P = .001). Of the most common grade 3 or higher adverse events, there was a higher incidence of neutropenia in the pertuzumab group (83 of 218 [38.1%] vs 36 of 110 [32.7%]). Serious adverse events were reported in 10.1% of patients (22 of 218) in the pertuzumab group and 8.2% of patients (9 of 110) in the placebo group. Conclusions and Relevance: Trial Registration: ClinicalTrials.gov identifier: NCT02586025.
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Authors | Zhimin Shao, Da Pang, Hongjian Yang, Wei Li, Shusen Wang, Shude Cui, Ning Liao, Yongsheng Wang, Chuan Wang, Yuan-Ching Chang, Hweichung Wang, Seok Yun Kang, Jae Hong Seo, Kunwei Shen, Suphawat Laohawiriyakamol, Zefei Jiang, Junjie Li, Julian Zhou, Betsy Althaus, Yixiang Mao, Jennifer Eng-Wong |
Journal | JAMA oncology
(JAMA Oncol)
Vol. 6
Issue 3
Pg. e193692
(03 01 2020)
ISSN: 2374-2445 [Electronic] United States |
PMID | 31647503
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal, Humanized
- Docetaxel
- ERBB2 protein, human
- Receptor, ErbB-2
- pertuzumab
- Trastuzumab
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Topics |
- Adult
- Antibodies, Monoclonal, Humanized
(adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Asia
- Breast Neoplasms
(drug therapy)
- Docetaxel
(adverse effects, therapeutic use)
- Double-Blind Method
- Female
- Humans
- Middle Aged
- Receptor, ErbB-2
- Trastuzumab
(adverse effects, therapeutic use)
- Treatment Outcome
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