Abstract | PURPOSE: PATIENTS AND METHODS: The antitumor activity of XELOX was investigated in a colon cancer xenograft model. Patients with MCRC received first-line XELOX in 3-week treatment cycles: intravenous oxaliplatin 130 mg/m(2) (day 1) followed by oral capecitabine 1,000 mg/m(2) twice daily (day 1, evening, to day 15, morning). RESULTS: A preclinical study confirmed that capecitabine has supra-additive activity with oxaliplatin. In the clinical study, 53 of 96 patients (55%) achieved an objective response, and 30 (31%) experienced disease stabilization for >/= 3 months following treatment. After 24 months' minimum follow-up, median time to disease progression ( TTP) and median overall survival were 7.7 and 19.5 months, respectively. XELOX safety was predictable and similar to the FOLFOX4 regimen, except that myelosuppression was uncommon with XELOX (grade 3 or 4 neutropenia, 7%). Most adverse events were mild to moderate, the most common being acute sensory neuropathy (85%). Sixty-day, all-cause mortality was 2%. CONCLUSION:
XELOX is a highly effective first-line treatment for MCRC. Response rates, TTP, and overall survival are similar to those observed with FU/ leucovorin/ oxaliplatin combinations. XELOX provides a more convenient regimen, likely to be preferred by both patients and healthcare providers. Capecitabine has the potential to replace FU/LV in combination with oxaliplatin for MCRC.
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Authors | Jim Cassidy, Josep Tabernero, Chris Twelves, René Brunet, Charles Butts, Thierry Conroy, Filippo Debraud, Arie Figer, Johannes Grossmann, Noriaki Sawada, Patrick Schöffski, Alberto Sobrero, Eric Van Cutsem, Eduardo Díaz-Rubio |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 22
Issue 11
Pg. 2084-91
(Jun 01 2004)
ISSN: 0732-183X [Print] United States |
PMID | 15169795
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Organoplatinum Compounds
- Oxaliplatin
- Deoxycytidine
- Capecitabine
- Fluorouracil
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Topics |
- Adult
- Aged
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Capecitabine
- Colorectal Neoplasms
(drug therapy, mortality, pathology)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Drug Administration Schedule
- Female
- Fluorouracil
(analogs & derivatives)
- Humans
- Male
- Middle Aged
- Organoplatinum Compounds
(administration & dosage)
- Oxaliplatin
- Safety
- Survival Rate
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