Phase III Study of Capecitabine Plus Oxaliplatin Compared With 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
| Autor: | Jose Tabernero, Juan José Reina, Jorge Aparicio, Encarnación González-Flores, Alfredo Carrato, Eduardo Díaz-Rubio, M. Chaves, Enrique Aranda, Auxiliadora Gómez-España, Ferran Losa, Bartomeu Massuti, Fernando Rivera, Alberto Abad, Joan Maurel, Javier Sastre, Bernardo Queralt |
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| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Cancer Research medicine.medical_specialty Organoplatinum Compounds Colorectal cancer medicine.drug_class Deoxycytidine Gastroenterology Antimetabolite Metastasis law.invention Capecitabine Randomized controlled trial law Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Aged Aged 80 and over business.industry Middle Aged medicine.disease Surgery Oxaliplatin Clinical trial Treatment Outcome Oncology Spain Fluorouracil Female Colorectal Neoplasms business medicine.drug |
| Zdroj: | Journal of Clinical Oncology. 25:4224-4230 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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