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Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study

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机构： [1]Department of Medical Oncology National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China. [2]The Cancer Center, The First Hospital of Jilin University, Changchun, Jilin, China. [3]Harbin Medical University, Harbin, China. [4]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China. [5]Zhejiang Cancer Hospital, Hangzhou City, China. [6]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Breast Oncology, Peking University Cancer Hospital and Institute, Beijing, China. [7]Breast Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital and Institute, Liaoning, China. [8]Jiangsu Province Hospital, Nanjing, China. [9]West China Hospital, Sichuan University, Chengdu, China. [10]Jiangsu Cancer Hospital, Nanjing, China. [11]Roche Pharma Product Development China, Shanghai, China. [12]Product Development Clinical Oncology, Roche Products Limited, Welwyn Garden City, UK. [13]Oncology Biostatistics, F. Hoffmann-La Roche Ltd, Basel, Switzerland. [14]Product Development Oncology, Roche Products Limited, Welwyn Garden City, UK.

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关键词： Pertuzumab Metastatic breast cancer Locally recurrent breast cancer HER2 Chinese

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PUFFIN (NCT02896855), a Chinese bridging study in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer, assessed consistency of efficacy and safety of pertuzumab plus trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel, with CLEOPATRA (NCT00567190).Eligible patients, n = 243, were randomized 1:1, stratified by visceral disease and hormone receptor status, to pertuzumab, trastuzumab, and docetaxel or placebo, trastuzumab, and docetaxel.investigator-assessed progression-free survival (PFS). Secondary endpoints: safety and overall survival (OS). After primary analysis, patients could cross over to the pertuzumab arm.Updated median PFS: 16.5 months (pertuzumab arm) and 12.5 months (placebo arm), with a hazard ratio (HR) of 0.60 [95% confidence interval (CI) 0.45, 0.81; p = 0.0008]. Median OS was not reached in either arm; the OS HR was 0.68 (95% CI 0.45, 1.03; p = 0.0658). Safety was similar in both arms with no new safety signals: 73.8% (pertuzumab arm) and 69.2% (placebo arm) experienced grade ≥ 3 adverse events. No heart failure, symptomatic left ventricular systolic dysfunction, or left ventricular ejection fraction decline of < 40% were reported.The PUFFIN final analysis showed, per the primary analysis, that overall efficacy of pertuzumab plus trastuzumab and docetaxel was consistent with CLEOPATRA. Safety remained consistent with the known pertuzumab profile. Overall, PUFFIN contributes to the totality of data with pertuzumab in previously untreated HER2-positive locally recurrent or metastatic breast cancer and supports the favorable benefit-risk profile of pertuzumab in Chinese patients.ClinicalTrials.gov, NCT02896855, registered 7 September 2016.© 2022. The Author(s).

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出版当年[2022]版：

大类 | 2 区医学

小类 | 3 区肿瘤学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区肿瘤学

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第一作者机构： [1]Department of Medical Oncology National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China.

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Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study

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