ArticleBreast (Edinburgh, Scotland)2026
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.
Article in Breast (Edinburgh, Scotland), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundDiarrhea 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.
methodsA 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.
resultsOf 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.
conclusionFor patients with HER2-positive advanced breast cancer, diarrhea that occurs during pyrotinib-based therapy maybe a prognostic marker of longer OS.
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