2026-04-14T06:12:15Zhttps://recercat.cat/oai/request
oai:recercat.cat:10230/463962026-01-23T20:04:51Zcom_2072_6col_2072_452952
RECERCAT author Alba, Emilio author Albanell Mestres, Joan author Haba-Rodríguez, Juan de la author Barnadas, Agustí author Calvo, Lourdes author Sánchez-Rovira, Pedro author Ramos, Manuel author Rojo, Federico author Burgués, Octavio author Carrasco, Eva María author Caballero, Rosalía author Porras, Ignacio author Tibau, Ariadna author Cámara, Maria del Carmen author Lluch, Ana 2021-02-09T08:42:42Z2021-02-09T08:42:42Z2014 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. 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 HER2-positive breast cancer Lapatinib Neoadjuvant Trastuzumab Biomarkers Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion