ARTÍCULO

Sequential administration of dose-dense epirubicin/cyclophosphamide followed by docetaxel/capecitabine for patients with HER2-negative and locally advanced or node-positive breast cancer

Autores: Nieto Regueira, Yago Luis; Aramendía Beitia, José Manuel; Espinos Jiménez, Jaime; de la Cruz Sánchez, Susana; Fernández Hidalgo, Óscar Aurelio; Santisteban Eslava, Marta; Arbea Moreno, Leire; Aristu Mendioroz, José Javier; Martínez Monge, Rafael; Moreno Jiménez, Marta; Pina Insausti, Luis Javier; Sola Gallego, Jesús Javier; Zornoza Celaya, Gerardo; Martínez Regueira, Fernando
Título de la revista: CANCER CHEMOTHERAPY AND PHARMACOLOGY
ISSN: 0344-5704
Volumen: 65
Número: 3
Páginas: 457 - 465
Fecha de publicación: 2010
Resumen:
Purpose Capecitabine is effective against metastatic breast cancer (MBC). We hypothesized that sequential treatment with dose-dense epirubicin/cyclophosphamide (EC) and docetaxel/capecitabine would be active and tolerable in the adjuvant/neoadjuvant setting. Methods In this prospective phase II clinical trial patients with HER2-negative and node-positive or locally advanced tumors were eligible to receive four cycles of EC (100/600 mg/m2) every 2 weeks with G-CSF on days 3¿10, followed by four cycles of docetaxel/capecitabine (75/1,000 mg/m2 b.i.d., days 1¿14) every 3 weeks. Results Fifty-five patients were enrolled with median age of 49, and 80% had hormone receptor-positive disease. The median tumor size was 2.5 cm, with a median of two axillary nodes involved. Seventy-five percent of the first 20 patients had grade 2/3 hand-foot syndrome (HFS). Dose reduction of capecitabine to 800 mg/m2 reduced the grade 2/3 HFS incidence to 31% in the remaining patients. No grade 4/5 toxicities were observed. All 20 patients treated preoperatively responded, with 5 (25%) pathologic complete responses and 3 additional pT0N1 tumors. At a median follow-up of 48 (range 28¿60) months, the event-free and overall survival rates are 91 and 98%, respectively. Conclusions Sequential treatment with dose-dense EC followed by docetaxel/capecitabine, using a lower capecitabine dose than that approved for MBC, has an acceptable toxicity profile and encouraging activity when used as neoadjuvant or adjuvant treatment of breast cancer.