A Antón1, A Ruiz2, A Plazaola3, L Calvo4, M A Seguí5, A Santaballa6, M Muñoz7, P Sánchez8, A Miguel9, E Carrasco10, J Lao11, J Camps2, J Alfaro3, S Antolín4, M C Cámara10. 1. Oncology Department, Hospital Universitario Miguel Servet, Zaragoza. Electronic address: aantont@gmail.com. 2. Oncology Department, Instituto Valenciano de Oncología, Valencia. 3. Oncology Department, Onkologikoa, San Sebastián. 4. Oncology Department, Complejo Hospitalario Universitario de A Coruña, A Coruña. 5. Oncology Department, Consorci Sanitari Parc Taulí, Sabadell. 6. Oncology Department, Hospital Universitario La Fe, Valencia. 7. Oncology Department, Hospital Clínic i Provincial, Barcelona. 8. Oncology Department, Complejo Hospitalario de Jaén, Jaén. 9. Oncology Department, Althaia-Xarxa Assistencial de Manresa, Manresa. 10. Staff members of GEICAM, Madrid, Spain. 11. Oncology Department, Hospital Universitario Miguel Servet, Zaragoza.
Abstract
BACKGROUND: we previously reported a phase I trial of liposome-encapsulated doxorubicin citrate (LD), docetaxel and trastuzumab as neoadjuvant in stages II and IIIA human epidermal growth factor receptor 2-overexpressing breast cancer patients. This study evaluates the efficacy of this regimen in a phase II trial. PATIENTS AND METHODS: patients were treated with LD 50 mg/m(2) and docetaxel 60 mg/m(2) every 21days associated with standard trastuzumab dose and pegfilgrastim support. RESULTS: fifty-nine patients were enrolled; median age: 48 years (range 24-71 years); premenopausal patients: 36 (61%); 19 patients (32%) presented stage IIIA disease and 40 patients (67%) stage II; histological grades 2-3 tumors: 50 patients (84%) and estrogen receptor-progesterone receptor negative: 28 patients (47%). In all, 27% achieved a pathological complete response in breast and axilla (grade 5-Miller and Payne classification); 15% of patients achieved grade 4. Clinical and radiological response rates were 86% and 81%, respectively. Forty-two patients (71%) underwent breast-conserving surgery. The main grades 3-4 toxic effects were non-febrile neutropenia (29%) and fatigue (8%). Grade 2 left ventricular ejection fraction decline was observed in nine patients. No congestive heart failure was observed. CONCLUSIONS: LD plus docetaxel combination associated with trastuzumab as neoadjuvant is active in breast cancer and entails a favorable cardiotoxicity profile. This regimen is a new treatment option in these patients.
BACKGROUND: we previously reported a phase I trial of liposome-encapsulated doxorubicin citrate (LD), docetaxel and trastuzumab as neoadjuvant in stages II and IIIA humanepidermal growth factor receptor 2-overexpressing breast cancerpatients. This study evaluates the efficacy of this regimen in a phase II trial. PATIENTS AND METHODS: patients were treated with LD 50 mg/m(2) and docetaxel 60 mg/m(2) every 21days associated with standard trastuzumab dose and pegfilgrastim support. RESULTS: fifty-nine patients were enrolled; median age: 48 years (range 24-71 years); premenopausal patients: 36 (61%); 19 patients (32%) presented stage IIIA disease and 40 patients (67%) stage II; histological grades 2-3 tumors: 50 patients (84%) and estrogen receptor-progesterone receptor negative: 28 patients (47%). In all, 27% achieved a pathological complete response in breast and axilla (grade 5-Miller and Payne classification); 15% of patients achieved grade 4. Clinical and radiological response rates were 86% and 81%, respectively. Forty-two patients (71%) underwent breast-conserving surgery. The main grades 3-4 toxic effects were non-febrile neutropenia (29%) and fatigue (8%). Grade 2 left ventricular ejection fraction decline was observed in nine patients. No congestive heart failure was observed. CONCLUSIONS: LD plus docetaxel combination associated with trastuzumab as neoadjuvant is active in breast cancer and entails a favorable cardiotoxicity profile. This regimen is a new treatment option in these patients.
Authors: Emilio Alba; Ana Lluch; Nuria Ribelles; Antonio Anton-Torres; Pedro Sanchez-Rovira; Joan Albanell; Lourdes Calvo; Jose Antonio Lopez García-Asenjo; Jose Palacios; Jose Ignacio Chacon; Amparo Ruiz; Juan De la Haba-Rodriguez; Miguel A Segui-Palmer; Beatriz Cirauqui; Mireia Margeli; Arrate Plazaola; Agusti Barnadas; Maribel Casas; Rosalia Caballero; Eva Carrasco; Federico Rojo Journal: Oncologist Date: 2016-01-19
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