Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial
Por:
Alba, E, Albanell, J, de la Haba, J, Barnadas, A, Calvo, L, Sanchez-Rovira, P, Ramos, M, Rojo, F, Burgues, O, Carrasco, E, Caballero, R, Porras, I, Tibau, A, Camara, MC, Lluch, A
Publicada:
4 mar 2014
Resumen:
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) x 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.
Filiaciones:
Alba, E:
Hosp Univ Virgen de la Victoria, Dept Med Oncol, Malaga 29010, Spain
Albanell, J:
Hosp Parc Salut Mar, Barcelona 8003, Spain
de la Haba, J:
Hosp Univ Reina Sofia, Cordoba 14004, Spain
Barnadas, A:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona 8041, Spain
Calvo, L:
Complejo Hosp Univ A Coruna, La Coruna 15006, Spain
Sanchez-Rovira, P:
Hosp Gen Jaen, Jaen 23007, Spain
Ramos, M:
Ctr Oncol Galicia, La Coruna 15009, Spain
Rojo, F:
Hosp Parc Salut Mar, Barcelona 8003, Spain
Fdn Jimenez Diaz, Dept Pathol, E-28040 Madrid, Spain
Burgues, O:
Hosp Clin Univ Valencia, Dept Pathol & Oncol, Valencia 46010, Spain
Carrasco, E:
GEICAM Spanish Breast Canc Res Grp, Madrid 28703, Spain
Caballero, R:
GEICAM Spanish Breast Canc Res Grp, Madrid 28703, Spain
Porras, I:
Hosp Univ Reina Sofia, Cordoba 14004, Spain
Tibau, A:
Univ Autonoma Barcelona, Hosp Santa Creu & St Pau, Barcelona 8041, Spain
Camara, MC:
GEICAM Spanish Breast Canc Res Grp, Madrid 28703, Spain
Lluch, A:
Hosp Clin Univ Valencia, Dept Pathol & Oncol, Valencia 46010, Spain
Hybrid Gold, Green Published
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