Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial
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....
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2024-03-01
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| Series: | Nature Communications |
| Online Access: | https://doi.org/10.1038/s41467-024-45591-7 |
| _version_ | 1797266695552761856 |
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| author | 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 Zhimin Shao |
| author_facet | 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 Zhimin Shao |
| author_sort | Liang Huang |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-25T01:04:47Z |
| format | Article |
| id | doaj.art-483aaf8ea22445929229f4f4bb8b8966 |
| institution | Directory Open Access Journal |
| issn | 2041-1723 |
| language | English |
| last_indexed | 2024-04-25T01:04:47Z |
| publishDate | 2024-03-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | Nature Communications |
| spelling | doaj.art-483aaf8ea22445929229f4f4bb8b89662024-03-10T12:17:04ZengNature PortfolioNature Communications2041-17232024-03-0115111110.1038/s41467-024-45591-7Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trialLiang Huang0Da Pang1Hongjian Yang2Wei Li3Shusen Wang4Shude Cui5Ning Liao6Yongsheng Wang7Chuan Wang8Yuan-Ching Chang9Hwei-Chung Wang10Seok Yun Kang11Jae Hong Seo12Kunwei Shen13Suphawat Laohawiriyakamol14Zefei Jiang15Haiyan Wang16François Lamour17Grace Song18Michelle Curran19Chunzhe Duan20Sanne Lysbet de Haas21Eleonora Restuccia22Zhimin Shao23Fudan University Shanghai Cancer CenterHarbin Medical University Cancer HospitalCancer Hospital of The University of Chinese Academy of SciencesThe First Hospital of Jilin UniversitySun Yat-sen University Cancer CenterHenan Cancer HospitalGuangdong General HospitalShandong Cancer HospitalFujian Medical University Union HospitalDepartment of General Surgery, Mackay Memorial HospitalDepartment of Surgery, China Medical University HospitalAjou University School of MedicineKorea University Guro HospitalRuijin Hospital, Shanghai Jiao Tong University School of MedicinePrince of Songkla UniversityThe Affiliated Hospital of Military Medical Sciences (The 307th Hospital of Chinese. People’s Liberation Army)Roche Product DevelopmentF. Hoffmann-La Roche LtdHangzhou Tigermed Consulting Co., LtdF. Hoffmann-La Roche LtdDepartment of Translational Medicine Oncology, Roche (China) Holding LtdF. Hoffmann-La Roche LtdF. Hoffmann-La Roche LtdFudan University Shanghai Cancer CenterAbstract 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.https://doi.org/10.1038/s41467-024-45591-7 |
| spellingShingle | 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 Zhimin Shao Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial Nature Communications |
| title | Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial |
| title_full | Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial |
| title_fullStr | Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial |
| title_full_unstemmed | Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial |
| title_short | Neoadjuvant–adjuvant pertuzumab in HER2-positive early breast cancer: final analysis of the randomized phase III PEONY trial |
| title_sort | neoadjuvant adjuvant pertuzumab in her2 positive early breast cancer final analysis of the randomized phase iii peony trial |
| url | https://doi.org/10.1038/s41467-024-45591-7 |
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