Fluorouracil, Doxorubicin, and Cyclophosphamide (FAC) Versus FAC Followed by Weekly Paclitaxel As Adjuvant Therapy for High-Risk, Node-Negative Breast Cancer: Results From the GEICAM/2003-02 Study

Martín, Miguel ; Ruiz, Amparo ; Borrego, Manuel Ruiz ; Barnadas, Agustí ; González, Sonia ; Calvo, Lourdes ; Vila, Mireia Margelí ; Antón, Antonio (Universidad de Zaragoza) ; Rodríguez-Lescure, Alvaro ; Seguí-Palmer, Miguel Angel ; Muñoz-Mateu, Montserrat ; Ribugent, Joan Dorca ; López-Vega, José Manuel ; Jara, Carlos ; Espinosa, Enrique ; Fernández, César Mendiola ; Andrés, Raquel (Universidad de Zaragoza) ; Ribelles, Nuria ; Plazaola, Arrate ; Sánchez-Rovira, Pedro ; Bofill, Javier Salvador ; Crespo, Carmen ; Carabantes, Francisco J. ; Servitja, Sonia ; Chacón, José Ignacio ; Rodríguez, César A. ; Hernando, Blanca ; Álvarez, Isabel ; Carrasco, Eva ; Lluch, Ana

Resumen: Purpose Adding taxanes to anthracycline-based adjuvant therapy improves survival outcomes of patients with node-positive breast cancer (BC). Currently, however, most patients with BC are node negative at diagnosis. The only pure node-negative study (Spanish Breast Cancer Research Group 9805) reported so far showed a docetaxel benefit but significant toxicity. Here we tested the efficacy and safety of weekly paclitaxel (wP) in node-negative patients, which is yet to be established. Patients and Methods Patients with BC having T1-T3/N0 tumors and at least one high-risk factor for recurrence (according to St. Gallen 1998 criteria) were eligible. After primary surgery, 1,925 patients were randomly assigned to receive fluorouracil, doxorubicin, and cyclophosphamide (FAC) × 6 or FAC × 4 followed by wP × 8 (FAC-wP). The primary end point was disease-free survival (DFS) after a median follow-up of 5 years. Secondary end points included toxicity and overall survival. Results After a median follow-up of 63.3 months, 93% and 90.3% of patients receiving FAC-wP or FAC regimens, respectively, remained disease free (hazard ratio [HR], 0.73; 95% CI, 0.54 to 0.99; log-rank P = .04). Thirty-one patients receiving FAC-wP versus 40 patients receiving FAC died (one and seven from cardiovascular diseases, respectively; HR, 0.79; 95% CI, 0.49 to 1.26; log-rank P = .31). The most relevant grade 3 and 4 adverse events in the FAC-wP versus the FAC arm were febrile neutropenia (2.7% v 3.6%), fatigue (7.9% v 3.4%), and sensory neuropathy (5.5% v 0%). Conclusion For patients with high-risk node-negative BC, the adjuvant FAC-wP regimen was associated with a small but significant improvement in DFS compared with FAC therapy, in addition to manageable toxicity, especially regarding long-term cardiac effects.

Idioma: Inglés

DOI: 10.1200/JCO.2012.46.9841

Año: 2013

Publicado en: JOURNAL OF CLINICAL ONCOLOGY 31, 20 (2013), 2593-2599
ISSN: 0732-183X

Factor impacto JCR: 17.96 (2013)

Categ. JCR: ONCOLOGY rank: 5 / 203 = 0.025 (2013) - Q1 - T1

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)