| Autor: |
Tao Ouyang, Yang Yang, Yingjian He, Zhaoqing Fan, Xue Chen, Yiqiang Liu, Chao Zhang, Hongchuan Jiang, Xin Wang, Xiang Wang, Fei Xie, Shu Wang, Bin Luo, Hua Kang, Tao Wang, Zefei Jiang, Peng Yuan, Binhe Xu, Ling Xu, Yinhua Liu, Jinfeng Li, Yuntao Xie, Tianfeng Wang |
| Rok vydání: |
2022 |
| DOI: |
10.21203/rs.3.rs-1954245/v1 |
| Popis: |
A multi-center, open-label, randomized, controlled phase III trial was conducted to evaluate pathological response-guided non-cross-resistant adjuvant chemotherapy in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-)/lymph node-positive (LN+) breast cancer who were non-responsive to primary chemotherapy. Patients received four cycles of non-cross-resistant adjuvant chemotherapy plus endocrine therapy (ET), or ET alone. Forty patients responsive to neoadjuvant chemotherapy and with Miller and Payne G4 or G5 and LN − status were assigned to the observation group. Distant disease-free survival was the primary endpoint. The final intention-to-treat analysis comprised 379 patients. After a median follow-up period of 72.4 months, the 5-year distant disease-free survival was 92% and 90% in the chemotherapy plus ET and ET-alone groups, respectively. Comparatively, the observation group showed a trend towards better distant disease-free survival. For patients non-responsive to neoadjuvant chemotherapy, adjuvant non-cross-resistant chemotherapy did not significantly improve distant disease-free survival compared to ET alone. Trial registration: The trial was registered on November 25, 2009, at ClinicalTrials.gov, and the registration number was NCT01019616. https://clinicaltrials.gov/ct2/show/NCT01019616?term=alternative+non-cross-resistant&draw=2&rank=1 |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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