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JCO Early Release, published online ahead of print Jun 4 2007
Journal of Clinical Oncology, 10.1200/JCO.2006.09.8467

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Received November 11, 2006
Accepted January 16, 2007

Phase III Study of Capecitabine Plus Oxaliplatin Versus Continuous-Infusion Fluorouracil Plus Oxaliplatin As First-Line Therapy in Metastatic Colorectal Cancer: Final Report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial

Eduardo Díaz-Rubio,* Jose Tabernero, Auxiliadora Gómez-España, Bartomeu Massutí, Javier Sastre, Manuel Chaves, Alberto Abad, Alfredo Carrato, Bernardo Queralt, Juan José Reina, Joan Maurel, Encarnación González-Flores, Jorge Aparicio, Fernando Rivera, Ferrán Losa, and Enrique Aranda

From 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, Santander, Spain.

* To whom correspondence should be addressed. E-mail: ediazrubio.hcsc{at}salud.madrid.org

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.


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Related Editorial

  • Should Capecitabine Replace Infusional Fluorouracil and Leucovorin When Combined With Oxaliplatin in Metastatic Colorectal Cancer?
    Robert J. Mayer
    JCO 2007 25: 4165-4167 [Full Text]

Related Correspondence

  • Capecitabine Plus Oxaliplatin in Metastatic Colorectal Cancer
    Jim Cassidy
    JCO 2007 25: 5043-5045 [Full Text]


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