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oai:recercat.cat:10230/463962026-01-23T20:04:51Zcom_2072_6col_2072_452952

urn:hdl:10230/46396 Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial Alba, Emilio Albanell Mestres, Joan Haba-Rodríguez, Juan de la Barnadas, Agustí Calvo, Lourdes Sánchez-Rovira, Pedro Ramos, Manuel Rojo, Federico Burgués, Octavio Carrasco, Eva María Caballero, Rosalía Porras, Ignacio Tibau, Ariadna Cámara, Maria del Carmen Lluch, Ana HER2-positive breast cancer Lapatinib Neoadjuvant Trastuzumab Biomarkers Background: The addition of trastuzumab (T) and lapatinib (L) to neoadjuvant chemotherapy increases the pathological complete response (pCR) rate in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer. We investigated the efficacy of T or L with neoadjuvant chemotherapy and specific efficacy biomarkers. Methods: Patients with stages I–III (including inflammatory) HER2-positive breast cancer were randomised to receive epirubicin (E) plus cyclophosphamide (C) × 4 cycles followed by docetaxel (D) plus either T (EC-DT) or L (EC-DL). End points included pCR (primary), clinical response, toxicity, and pCR-predictive biomarkers. Results: We randomised 102 patients to EC-DT (50) and EC-DL (52). Median age was 48, 56% were premenopausal and 58% had oestrogen receptor (ER)-positive tumours. Pathological complete response in breast was 52.1% (95% CI:38.0–66.2%) for EC-DT and 25.5% (95% CI:13.5–37.5%) for EC-DL (P=0.0065). Pathological complete response in breast and axilla was 47.9% for EC-DT and 23.5% for EC-DL (P=0.011). Grade 3–4 toxicity did not differ across treatments, except for diarrhoea (2% in EC-DT vs 13.5% in EC-DL, P=0.030). Multivariate analyses showed that treatment (P=0.036) and ER (P=0.014) were the only predictors of pCR in both groups. Conclusion: EC-DT exhibited higher efficacy and lower toxicity than EC-DL. Of the different biomarkers studied, only the absence of ER expression was associated with increased pCR. 2021-02-09T08:42:42Z 2021-02-09T08:42:42Z 2014 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion British Journal of Cancer. 2014 Mar 4;110(5):1139-47 This work is published under the standard license to publish agreement. After 12 months the work will become freely available and the license terms will switch to a Creative Commons AttributionNonCommercial-Share Alike 3.0 Unported License. https://creativecommons.org/licenses/by-nc-sa/3.0/ info:eu-repo/semantics/openAccess Nature Research