Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.
机构：[1]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China[2]The Cancer Center, The First Hospital of Jilin University, Jilin, China[3]Harbin Medical University, Harbin, China[4]Fudan University Shanghai Cancer Center, Shanghai, China[5]Zhejiang Cancer Hospital, Hangzhou City, China浙江省肿瘤医院[6]Beijing Cancer Hospital, Beijing, China[7]Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Liaoning, China[8]Jiangsu Province Hospital, Nanjing, China江苏省人民医院[9]West China Hospital, Sichuan University, Chengdu, China四川大学华西医院[10]Jiangsu Cancer Hospital, Nanjing, China[11]Roche (China) Holding Ltd, Shanghai, China[12]Roche Products Limited, Welwyn Garden City, UK[13]F. Hoffmann-La Roche Ltd, Basel, Switzerland[14]Present Address: Janssen China R&D, Beijing, China
The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer.
Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (in patients with measurable baseline disease), overall survival, and safety. The consistency threshold for PFS (hazard ratio [HR] < 0.81) (maintaining ≥ 50% of the risk reduction determined in CLEOPATRA [HR 0.62]) determined the target sample size (n = 240).
Two hundred forty-three patients were randomized. Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]). Objective responses were recorded in 83/105 (79.0%) and 67/97 (69.1%) patients, respectively. Grade ≥ 3 adverse events (70.5% and 69.2%, respectively) and serious adverse events (19.7% and 19.2%, respectively) were similar across both arms. No heart failure cases or symptomatic left ventricular ejection fraction declines were reported.
PUFFIN met its primary objective. Overall, efficacy data were consistent with CLEOPATRA. Safety was consistent with the known pertuzumab safety profile. PUFFIN adds 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 TRIAL REGISTRATION: ClinicalTrials.gov, NCT02896855, registered 7 September 2016.
基金：
This work was supported by F. Hoffmann-La Roche Ltd,
Basel, Switzerland (no grant number applicable). F. Hoffmann-La
Roche Ltd was involved in the study design, data interpretation, and
the decision to submit for publication in conjunction with the authors.
Support for third-party writing assistance for this manuscript, furnished
by Daniel Clyde, PhD, and Helen Singleton, PhD, of Health Interactions,
was provided by F. Hoffmann-La Roche Ltd.
第一作者机构：[1]National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Binghe Xu,Wei Li,Qingyuan Zhang,et al.Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.[J].BREAST CANCER RESEARCH AND TREATMENT.2020,182(3):689-697.doi:10.1007/s10549-020-05728-w.
APA：
Binghe Xu,Wei Li,Qingyuan Zhang,Zhimin Shao,Qiao Li...&Eleonora Restuccia.(2020).Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study..BREAST CANCER RESEARCH AND TREATMENT,182,(3)
MLA：
Binghe Xu,et al."Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.".BREAST CANCER RESEARCH AND TREATMENT 182..3(2020):689-697
