TROPION-Breast01 China cohort: datopotamab deruxtecan versus chemotherapy in previously treated HR-positive, HER2-negative breast cancer
Among the 83 patients enrolled in mainland China, datopotamab deruxtecan roughly doubled the time before the cancer grew compared with chemotherapy, with fewer severe side effects, in line with the global trial.
Overview
Prespecified analysis of the 83 patients enrolled in mainland China in TROPION-Breast01, the global phase 3 trial of datopotamab deruxtecan (6 mg/kg every three weeks) against investigator's choice of chemotherapy (eribulin, capecitabine, vinorelbine or gemcitabine) in inoperable or metastatic hormone receptor-positive, HER2-negative breast cancer after progression on endocrine therapy and one or two lines of chemotherapy. Dual primary endpoints were progression-free survival by blinded independent central review and overall survival.
In the China cohort (44 on datopotamab deruxtecan, 39 on chemotherapy) median progression-free survival was 8.1 against 4.2 months (hazard ratio 0.54, 95 percent CI 0.30 to 0.96, nominal p 0.0329). Overall survival numerically favoured datopotamab deruxtecan (hazard ratio 0.83, 95 percent CI 0.49 to 1.43, nominal p 0.5028). Grade 3 or worse treatment-related adverse events occurred in 29.5 percent against 58.3 percent; nausea (47.7 percent) and raised aspartate aminotransferase (40.9 percent) were the commonest with datopotamab deruxtecan, and oral mucositis or stomatitis and ocular surface events affected 43.2 and 47.7 percent.
- Median progression-free survival by blinded review 8.1 vs 4.2 months; hazard ratio 0.54 (95 percent CI 0.30 to 0.96, nominal p 0.0329).
- Overall survival hazard ratio 0.83 (95 percent CI 0.49 to 1.43, nominal p 0.5028), not significant.
- Grade 3 or worse treatment-related adverse events 29.5 percent vs 58.3 percent; oral mucositis or stomatitis in 43.2 percent and ocular surface events in 47.7 percent with datopotamab deruxtecan.
Chinese patients in the trial saw the same pattern as the global population: a clear progression-free survival gain, no proven survival gain, and a different rather than heavier side-effect burden, with mouth and eye toxicity in nearly half. It supports use of datopotamab deruxtecan in this setting in China but does not resolve the global trial's missing survival benefit.
- Small cohort of 83 patients; p-values are nominal and the trial was not powered for this subgroup.
- Overall survival was not significantly different, as in the global analysis.
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