PACLITAXEL FOR HIGH RISK N0 BREAST CANCER 

J Clin Oncol. 2013 Jun 3. [Epub ahead of print]

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 M, Ruiz A, Borrego MR, Barnadas A, González S, Calvo L, Vila MM, Antón A, Rodríguez-Lescure A, Seguí-Palmer MA, Muñoz-Mateu M, Ribugent JD,López-Vega JM, Jara C, Espinosa E, Fernández CM, Andrés R, Ribelles N, Plazaola A, Sánchez-Rovira P, Bofill JS, Crespo C, Carabantes FJ, Servitja S,Chacón JI, Rodríguez CA, Hernando B, Alvarez I, Carrasco E, Lluch A.

Source

Miguel Martín, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense; Carlos Jara, Fundación Hospitalaria de Alcorcón; Enrique Espinosa, Hospital Universitario la Paz; César Mendiola Fernández, Hospital Universitario 12 de Octubre; Carmen Crespo, Hospital Universitario Ramón y Cajal; Eva Carrasco, Spanish Breast Cancer Research Group (GEICAM) Headquarters, Madrid; Amparo Ruiz, Instituto Valenciano de Oncología; Ana Lluch, Hospital Clinico Universitario, Valencia; Manuel Ruiz Borrego, Hospital Universitario Virgen del Rocío; Javier Salvador Bofill, Hospital de Valme, Sevilla; Agustí Barnadas, Hospital Santa Creu i Sant Pau, Universitat Autónoma de Barcelona; Sonia González, Hospital Mutua de Terrassa; Mireia Margelí Vila, Hospital Universitario Germans Trias i Pujol; Miguel Angel Seguí-Palmer, Corporacion Sanitaria Parc Tauli; Montserrat Muñoz-Mateu, Hospital Clinic i Provincial; Sonia Servitja, Hospital del Mar, Barcelona; Lourdes Calvo, Complejo Hospitalario Universitario A Coruña, A Coruña; Antonio Antón, Hospital Universitario Miguel Servet; Raquel Andrés, Hospital Universitario Lozano Blesa, Zaragoza; Alvaro Rodríguez-Lescure, Hospital General de Elche, Alicante; Joan Dorca Ribugent, Instituto Catalán de Oncología, Girona; José Manuel López-Vega, Hospital Universitario Marques de Valdecilla, Santander; Nuria Ribelles, Hospital Universitario Virgen de la Victoria; Francisco J. Carabantes, Hospital Regional Universitario Carlos Haya, Málaga; Arrate Plazaola, Onkologikoa; Isabel álvarez, Hospital Universitario Donostia, San Sebastian; Pedro Sánchez-Rovira, Complejo Hospitalario de Jáen, Jáen; José Ignacio Chacón, Hospital Universitario Virgen de la Salud, Toledo; César A. Rodríguez, Hospital Universitario de Salamanca, Salamanca; and Blanca Hernando, Hospital Universitario de Burgos, Burgos, Spain.

Abstract

PURPOSEAdding 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 methodsPatients 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.ResultsAfter 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%). CONCLUSIONFor 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.