Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial

Liang Huang, Da Pang, Hongjian Yang, Wei Li, Shusen Wang, Shude Cui, Ning Liao, Yongsheng Wang, Chuan Wang, Yuan-Ching Chang, Hwei-Chung Wang, Seok Yun Kang, Jae Hong Seo, Kunwei Shen, Suphawat Laohawiriyakamol, Zefei Jiang, Haiyan Wang, François Lamour, Grace Song, Michelle Curran, Chunzhe Duan, Sanne Lysbet de Haas, Eleonora Restuccia and Zhimin Shao ()
Additional contact information
Liang Huang: Fudan University Shanghai Cancer Center
Da Pang: Harbin Medical University Cancer Hospital
Hongjian Yang: Cancer Hospital of The University of Chinese Academy of Sciences
Wei Li: The First Hospital of Jilin University
Shusen Wang: Sun Yat-sen University Cancer Center
Shude Cui: Henan Cancer Hospital
Ning Liao: Guangdong General Hospital
Yongsheng Wang: Shandong Cancer Hospital
Chuan Wang: Fujian Medical University Union Hospital
Yuan-Ching Chang: Department of General Surgery, Mackay Memorial Hospital
Hwei-Chung Wang: China Medical University Hospital
Seok Yun Kang: Ajou University School of Medicine
Jae Hong Seo: Korea University Guro Hospital
Kunwei Shen: Shanghai Jiao Tong University School of Medicine
Suphawat Laohawiriyakamol: Prince of Songkla University
Zefei Jiang: The Affiliated Hospital of Military Medical Sciences (The 307th Hospital of Chinese. People’s Liberation Army)
Haiyan Wang: Roche Product Development
François Lamour: F. Hoffmann-La Roche Ltd
Grace Song: Hangzhou Tigermed Consulting Co., Ltd
Michelle Curran: F. Hoffmann-La Roche Ltd
Chunzhe Duan: Department of Translational Medicine Oncology, Roche (China) Holding Ltd
Sanne Lysbet de Haas: F. Hoffmann-La Roche Ltd
Eleonora Restuccia: F. Hoffmann-La Roche Ltd
Zhimin Shao: Fudan University Shanghai Cancer Center

Nature Communications, 2024, vol. 15, issue 1, 1-11

Abstract: Abstract The randomized, multicenter, double-blind, placebo-controlled, phase III PEONY trial (NCT02586025) demonstrated significantly improved total pathologic complete response (primary endpoint) with dual HER2 blockade in HER2-positive early/locally advanced breast cancer, as previously reported. Here, we present the final, long-term efficacy (secondary endpoints: event-free survival, disease-free survival, overall survival) and safety analysis (62.9 months’ median follow-up). Patients (female; n = 329; randomized 2:1) received neoadjuvant pertuzumab/placebo with trastuzumab and docetaxel, followed by adjuvant 5-fluorouracil, epirubicin, and cyclophosphamide, then pertuzumab/placebo with trastuzumab until disease recurrence or unacceptable toxicity, for up to 1 year. Five-year event-free survival estimates are 84.8% with pertuzumab and 73.7% with placebo (hazard ratio 0.53; 95% confidence interval 0.32–0.89); 5-year disease-free survival rates are 86.0% and 75.0%, respectively (hazard ratio 0.52; 95% confidence interval 0.30–0.88). Safety data are consistent with the known pertuzumab safety profile and generally comparable between arms, except for diarrhea. Limitations include the lack of ado-trastuzumab emtansine as an option for patients with residual disease and the descriptive nature of the secondary, long-term efficacy endpoints. PEONY confirms the positive benefit:risk ratio of neoadjuvant/adjuvant pertuzumab, trastuzumab, and docetaxel treatment in this patient population.

Date: 2024
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DOI: 10.1038/s41467-024-45591-7

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