Eduardo Díaz‐Rubio1, Josep Tabernero1,2,3,4,5, Auxiliadora Gómez‐España1,2,3,4,5, Bartomeu Massutí1,2,3,4,5, Javier Sastre1,2,3,4,5, Manuel Chaves-Conde1,2,3,4,5, A. Abad1,2,3,4,5, Alfredo Carrato1,2,3,4,5, Bernardo Queralt1,2,3,4,5, Juan José Reina1,2,3,4,5, Joan Maurel1,2,3,4,5, E. González1,2,3,4,5, Jorge Aparicio1,2,3,4,5, Fernando Rivera1,2,3,4,5, Ferrán Losa1,2,3,4,5, Enrique Aranda1,2,3,4,5
1From the Department of Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid; Hospital Vall d’Hebrón, University Barcelona; Hospital Clinic; Hospital Hospitalet, Barcelona; Hospital Reina Sofia, Córdoba; Hospital General, Alicante; Hospital Virgen Rocio, Sevilla; Hospital Germans Trias i Pujol, Badalona; Hospital Universitario Elche, Alicante; ICO, Girona; Hospital J. Ramón Jimenez, Huelva; Hospital Virgen de las Nieves, Granada; Hospital la Fe, Valencia; and the Hospital Marqués Valdecilla...
2Hospital General, Alicante; Hospital Virgen Rocio, Sevilla;
3Hospital Germans
4Hospital Virgen de las Nieves. Granada
5Hospital la Fe, Valencia; and the
Tóm tắt
Purpose The aim of this phase III trial was to compare the efficacy and safety of capecitabine plus oxaliplatin (XELOX) versus Spanish-based continuous-infusion high-dose fluorouracil (FU) plus oxaliplatin (FUOX) regimens as first-line therapy for metastatic colorectal cancer (MCRC). Patients and Methods A total of 348 patients were randomly assigned to receive XELOX (oral capecitabine 1,000 mg/m2 bid for 14 days plus oxaliplatin 130 mg/m2 on day 1 every 3 weeks) or FUOX (continuous-infusion FU 2,250 mg/m2 during 48 hours on days 1, 8, 15, 22, 29, and 36 plus oxaliplatin 85 mg/m2 on days 1, 15, and 29 every 6 weeks). Results There were no significant differences in efficacy between XELOX and FUOX arms, which showed, respectively, median time to tumor progression (TTP; 8.9 v 9.5 months; P = .153); median overall survival (18.1 v 20.8 months; P = .145); and confirmed response rate (RR; 37% v 46%; P = .539). The safety profile of the two regimens was similar, although there were lower rates of grade 3/4 diarrhea (14% v 24%) and grade 1/2 stomatitis (28% v 43%), and higher rates of grade 1/2 hyperbilirubinemia (37% v 21%) and grade 1/2 hand-foot syndrome (14% v 5%) with XELOX versus FUOX, respectively. Conclusion This randomized study shows a similar TTP of XELOX compared with FUOX in the first-line treatment of MCRC, although there was a trend for slightly lower RR and survival. XELOX can be considered as an alternative to FUOX.
