A phase II study of capecitabine plus oxaliplatin (XELOX) |
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Authors: | Thomas Makatsoris MD Haralabos P. Kalofonos Gerasimos Aravantinos Christos Papadimitriou Efstathios Kastritis Sotirios K. Rigatos Nikolaos Xiros Theodore Petsas Theofanis Economopoulos Athanassios K. Sakadamis George Fountzilas |
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Affiliation: | 1. Hellenic Cooperative Oncology Group (HECOG), Data Office, Athens, Greece
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Abstract: | Background: Capecitabine and oxaliplatin are both effective and well-tolerated monotherapies for the treatment of advanced colorectal cancer (CRC). Oxaliplatin has also been shown to be very effective when combined with 5-FU/LV in the first-line setting. Aim of the Study: Assess the efficacy and safety of capecitabine plus oxaliplatin (XELOX) in patients with previously untreated advanced CRC. Methods: Fifty-three patients with measurable disease received capecitabine 1,000 mg/m2 twice daily on d 1–14 and oxaliplatin 130 mg/m2 on d 1, every 3 wk. Of these, 52 were evaluable for safety and 49 for antitumor response. Results: There was a low rate of grade 1/2 adverse events; grade 3/4 events included leukopenia (10%), neutropenia (6%), thrombocytopenia (2%), nausea/vomiting (4%), and diarrhea (4%). The overall response rate was 39% (95% CI, 25–54%) and median time to disease progression was 7.8 mo. Conclusions: XELOX is an active and well-tolerated first-line treatment for advanced CRC. Randomized phase III studies are ongoing to compare XELOX with FOLFOX in view of the comparable efficacy and safety but superior convenience of XELOX therapy. |
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