Observational studyThe oncologist2026
Comparative safety of concurrent adjuvant trastuzumab emtansine vs trastuzumab with radiotherapy in HER2-positive early breast cancer.
Observational study in The oncologist, 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
backgroundReal-world comparative data on the safety of adjuvant trastuzumab emtansine (T-DM1) vs trastuzumab with concurrent radiotherapy (RT) in HER2-positive early breast cancer (BC) remain limited.
methodsIn this retrospective, multicenter study, we included 133 patients with HER2-positive early-stage BC treated with neoadjuvant therapy, surgery, and adjuvant systemic therapy administered concurrently with RT at 4 hospitals. Patients received adjuvant T-DM1 (n = 50) if residual disease was present, or trastuzumab (n = 83) if a pathologic complete response was achieved. Toxicities were graded according to CTCAE criteria. A post-hoc power analysis indicated 80% power to detect an absolute between-group difference in toxicity rates of ≥ 25%.
resultsThe T-DM1 group had poorer performance status, higher nodal stage, and more intensive neoadjuvant regimens. RT parameters were balanced between groups (median dose 50 Gy, 25 fractions; P > .05 for all comparisons). T-DM1 was associated with higher rates of thrombocytopenia (70% vs 36.1%, P < .001), ALT elevation (20% vs 4.8%, P = .008), AST elevation (24.5% vs 2.4%, P < .001), and early pulmonary toxicity (48.8% vs 24.1%, P = .017), with events predominantly grade 1. In sensitivity analyses adjusting for pertuzumab exposure, T-DM1 associations remained significant for thrombocytopenia (adjusted odds ratio [OR] = 3.85, P = .001), ALT elevation (adjusted OR = 4.12, P = .026), and early pulmonary toxicity (adjusted OR = 2.64, P = .034).
conclusionConcurrent adjuvant T-DM1 and RT demonstrated higher but manageable hematologic, hepatic, and pulmonary toxicity compared with trastuzumab. These hypothesis-generating findings require validation in prospective studies.
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