Association between diarrhea and survival in patients with HER2-positive advanced breast cancer treated with pyrotinib-based therapy: A landmark analysis from the real-world PRETTY study
Year: 2026
Type: article
Abstract: BACKGROUND: Diarrhea is the most common adverse event of pyrotinib. This study analyzed the association between diarrhea and survival in patients with HER2-positive advanced breast cancer treated with pyrotinib-based therapy. METHODS: A secondary analysis was performed using the individual patient data from the nationwide, prospective real-world PRETTY study. Baseline and treatment characteristics were summarized in groups by severity of diarrhea. Multivariable Cox regression analysis was used to analyze the association of diarrhea with real-world progression-free survival (rwPFS) and overall survival (OS), respectively. Immortal-time bias was adjusted using the landmark analysis and time-dependent Cox model. Multiple imputation was performed for missing data, and pooling ln(hazard ratio [HR]) estimations on the association between diarrhea and survival were reported. RESULTS: Of 1129 patients, 826 (73.2%) had any-grade treatment-related diarrhea (including 174 [15.4%] with grade ≥3 diarrhea). After multiple imputation, the multivariable Cox regression analysis showed that diarrhea was independently associated with longer OS (grade 1-2 diarrhea vs. none: HR = 0.57 [95% CI, 0.38-0.86], P = 0.007; grade ≥3 diarrhea vs. none: HR = 0.56 [95% CI, 0.31-0.99], P = 0.047) but was not associated with rwPFS. Significant association between diarrhea and OS was also observed in the 1-month landmark analysis (grade 1-2 diarrhea vs. none: HR = 0.59 [95% CI, 0.39-0.89], P = 0.012; grade ≥3 diarrhea vs. none: HR = 0.54 [95% CI, 0.30-0.98], P = 0.043). Time-dependent Cox model indicated the trend on better OS when diarrhea occurred, but without statistical significance. CONCLUSION: For patients with HER2-positive advanced breast cancer, diarrhea that occurs during pyrotinib-based therapy maybe a prognostic marker of longer OS.
Source: The Breast
Institutions: Chinese Academy of Medical Sciences & Peking Union Medical College, Cancer Hospital of Chinese Academy of Medical Sciences, Tianjin Medical University Cancer Institute and Hospital, Tianjin Medical University, Hubei Cancer Hospital, Harbin Medical University, Third Affiliated Hospital of Harbin Medical University, Central South University, Hunan Cancer Hospital, First Hospital of Jilin University, Shandong Tumor Hospital, Shandong First Medical University, Affiliated Hospital of Xuzhou Medical College, Zhejiang Cancer Hospital, University of Chinese Academy of Sciences, Dalian Medical University, Second Affiliated Hospital of Dalian Medical University, Affiliated Hospital of Qingdao University, Shandong University, Qilu Hospital of Shandong University, First Affiliated Hospital of Xi'an Jiaotong University
Language: English
Topic: HER2/EGFR in Cancer Research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,200
Funder: Jiangsu Hengrui Medicine
OpenAlex ID: W7148497244