ArticleBreast (Edinburgh, Scotland)2026
Effect of dose-dense adjuvant chemotherapy in patients with node-positive early breast cancer according to estrogen receptor levels: an exploratory analysis of the GIM2 trial.
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
backgroundEstrogen receptor (ER)-negative early breast cancer (eBC) generally derives greater benefit from adjuvant chemotherapy than ER-positive disease, but the predictive role of ER expression levels for dose-dense (DD) chemotherapy remains uncertain. This exploratory analysis of the GIM2 phase III trial evaluated whether ER expression influences the efficacy of DD chemotherapy in node-positive eBC.
methodsIn the GIM2 trial, patients with node-positive eBC were randomized to receive anthracycline-based chemotherapy followed by paclitaxel, administered either in a DD or standard-interval schedule. ER expression was categorized as ER 0, ER-low (1-10%), ER-intermediate (11-50%), and ER-high (>50%). Associations between ER levels and invasive disease-free survival (iDFS) and overall survival (OS) were evaluated using multivariable Cox models. Treatment effects across the continuum of ER expression were explored using STEPP.
resultsAmong 1709 eligible patients, 150 (9%) had ER 0, 78 (4%) ER-low, 283 (17%) ER-intermediate, and 1198 (70%) ER-high tumors. After a median follow-up of 15 years (IQR 8-16), 15-year iDFS rates were 48%, 59%, 56%, and 59%, respectively (p = 0.001). Corresponding 15-year OS rates were 72%, 71%, 68%, and 75% (p < 0.001). ER expression was independently associated with both iDFS and OS; however, no significant interaction was observed between ER levels and treatment effect for either endpoint. STEPP analyses demonstrated a consistent benefit of DD chemotherapy across the spectrum of ER expression.
conclusionsER expression levels were prognostic, but quantitative ER expression did not identify a subgroup with a clearly differential benefit from DD chemotherapy. Given the exploratory nature of this analysis and the small size of the ER-0 and ER-low subgroups, these hypothesis-generating findings are consistent with DD chemotherapy remaining an effective adjuvant treatment option for patients with node-positive eBC across the range of ER expression.
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