Cancer Research and Treatment

Original Articles

Pyrotinib Plus Trastuzumab and Docetaxel with Different Antidiarrheal Strategies in Patients with HER2-Positive Recurrent or Metastatic Breast Cancer (PHAENNA): A Multicenter, Phase 1 Trial: Wei Ren, Xiuping Lai, Guiying Bai, Yanqiong Liu, Hongtao Li, Huan Zhou, Shouman Wang, Qun Qin, Wei Li, Cuizhi Geng, Mingxia Wang, Xinshuai Wang, Yu Cao, Zhuang Yu, Caiwen Du, Wei Zhao, Shikai Wu, Yimin Cui, Pan Liu, Kaijing Zhao, Jiaman Lin, Xiaoyu Zhu, Yandan Yao, Yehui Shi, Herui Yao; Received April 12, 2026 Accepted July 14, 2026 Published online July 28, 2026; DOI: https://doi.org/10.4143/crt.2026.0400 [Accepted]

Abstract PDF: Purpose
The outcomes of different antidiarrheal strategies in HER2-positive breast cancer patients treated with pyrotinib plus trastuzumab and docetaxel are unknown.
Materials and Methods
97 eligible patients received pyrotinib once daily from Cycle 1 Day 7 onwards, combined with intravenous trastuzumab and docetaxel on Day 1 of each 21-day cycle. In the 400PYR cohort, patients were treated with 400 mg pyrotinib, without mandatory antidiarrheal prophylaxis. In the 320PYR+Pro-L and 400PYR+Pro-L cohorts, patients were given 320 or 400 mg pyrotinib and loperamide prophylaxis. In the 320PYR cohort, patients were treated with 320 mg pyrotinib, without mandatory antidiarrheal prophylaxis. In the PYR-DE+Pro-L cohort, patients were treated with escalating pyrotinib doses and loperamide prophylaxis.
Results
The incidence of grade 3 diarrhea in cohorts with loperamide prophylaxis was lower than in the 400PYR cohort. In the 3 cohorts with loperamide prophylaxis, the dose escalation cohort had the lowest incidence of grade 3 diarrhea. The incidence of grade 3 diarrhea in 320PYR cohort was similar to the 3 cohorts with prophylactic antidiarrheal loperamide. No event of grade 4 or 5 diarrhea was reported.
Conclusion
Loperamide prophylaxis and pyrotinib dose escalation were associated with lower observed rates of grade 3 diarrhea in patients receiving pyrotinib plus trastuzumab and docetaxel. The lower rate observed in the 320PYR cohort should be interpreted cautiously and may reflect improved clinical management rather than a reproducible protocolized intervention.

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Breast cancer

Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study: Wei Ren, Yunfang Yu, Huangming Hong, Ying Wang, Quanlong Gao, Yongjian Chen, Peixian Chen, Jianli Zhao, Qiyun Ou, Dagui Lin, Tuping Fu, Yujie Tan, Chenchen Li, Xinxin Xie, Guolin Ye, Jun Tang, Herui Yao; Cancer Res Treat. 2022;54(4):1038-1052. Published online February 4, 2022; DOI: https://doi.org/10.4143/crt.2021.698

Abstract PDF Supplementary Material PubReader ePub

Purpose
This study aims to comprehensively evaluate the clinical efficacy of chemotherapy or endocrine therapy maintenance in metastatic breast cancer (MBC) patients.
Materials and Methods
The meta-analysis of randomized clinical trials (RCTs) and propensity score matching of multicenter cohort study evaluated MBC patients who underwent first-line chemotherapy or endocrine therapy maintenance. This study is registered with PROSPERO: CRD42017071858 and ClinicalTrials.gov: NCT04258163.
Results
A total of 2,867 patients from 15 RCTs and 760 patients from multicenter cohort were included. The results from meta-analysis showed that chemotherapy maintenance improved progression-free survival (PFS) (hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.54 to 0.73; p < 0.001; moderate-quality evidence) and overall survival (OS) (HR, 0.87; 95% CI 0.78 to 0.97; p=0.016; high-quality evidence) than observation. In the cohort study, for hormone receptor–positive MBC patients, chemotherapy maintenance improved PFS (HR, 0.67; 95% CI, 0.52 to 0.85; p < 0.001) and OS (HR, 0.55; 95% CI 0.42 to 0.73; p < 0.001) compared with observation, and endocrine therapy maintenance also improved PFS (HR, 0.65; 95% CI, 0.53 to 0.80; p < 0.001) and OS (HR, 0.55; 95% CI, 0.44 to 0.69; p < 0.001). There were no differences between chemotherapy and endocrine therapy maintenance in PFS and OS (all p > 0.05). Regardless of the continuum or switch maintenance therapy, showed prolonged survival in MBC patients who were response to first-line treatment.
Conclusion
This study provided evidences for survival benefits of chemotherapy and endocrine therapy maintenance in MBC patients, and there was no difference efficacy between chemotherapy and endocrine therapy maintenance for hormone receptor–positive patients.

Citations

Citations to this article as recorded by

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