Van Cutsem, Eric and Twelves, Chris and Cassidy, Jim and Allman, David and Bajetta, Emilio and Boyer, Michael and Bugat, Roland and Findlay, Mike and Frings, Stefan and Jahn, Michaela and McKendrick, Joe and Osterwalder, Bruno and Perez-Manga, Gumersindo and Rosso, Riccardo and Rougier, Philippe and Schmiegel, Wolff H. and Seitz, Jean-Francois and Thompson, Paul and Vieitez, Jose M. and Weitzel, Christof and Harper, Peter (2001) Oral capecitabine compared with intravenous fluorouracil plus leucovorin in patients with metastatic colorectal cancer: Results of a large phase III study. JOURNAL OF CLINICAL ONCOLOGY, 19 (21). pp. 4097-4106. ISSN 0732-183X
Full text not available from this repository.Abstract
Purpose: To compare the efficacy and safety of orally administered capecitabine (Xeloda; Roche Laboratories, Inc, Nutley, NJ), a novel fluoropyrimidine carbamate designed to mimic continuous fluorouracil (5-FU) infusion but with preferential activation at the tumor site, with that of intravenous (IV) 5-FU plus leucovorin (5-FU/LV) as first-line treatment for metastatic colorectal cancer. Patients and Methods: We prospectively randomized 602 patients to treatment with capecitabine 1,250 mg/m(2) administered twice daily days I to 14 every 3 weeks, or to the 4-weekly Mayo Clinic regimen (5-FU/LV) until disease progression or unacceptable toxicity. Results: The primary objective, to demonstrate at least equivalent response rates in the two treatment groups, was met. The overall response rate was 18.9% for capecitabine and 15.0% for 5-FU/LV. In the capecitabine and 5-FU/LV groups, respectively, median time to disease progression was 5.2 and 4.7 months (log-rank P = .65), median time to treatment failure was 4.2 and 4.0 months (log-rank P = .89); and median overall survival was 13.2 and 12.1 months (log-rank P = .33). The toxicity profiles of both treatments were typical of fluoropyrimidines. However, capecitabine led to significantly lower incidences (P < .00001) of stomatitis and alopecia, but a higher incidence of cutaneous hand-foot syndrome (P < .00001). Capecitabine also resulted in lower incidences (P < .00001) of grade 3/4 stomatitis and neutropenia, leading to a lower incidence of grade 3/4 neutropenic fever and sepsis. Only grade 3 hand-foot syndrome (P < .00001) and uncomplicated grade 3/4 hyperbilirubinemia (P < .0001) were reported more frequently with capecitabine. Conclusion: Oral capecitabine achieved an at least equivalent efficacy compared with IV 5-FU/LV. Capecitabine demonstrated clinically meaningful safety advantages and the convenience of an oral agent. (C) 2001 by American Society of Clinical Oncology.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | FLUOROPYRIMIDINE CARBAMATE; PALLIATIVE CHEMOTHERAPY; CONTINUOUS-INFUSION; RANDOMIZED TRIAL; 5-FLUOROURACIL; IRINOTECAN; SURVIVAL; MODULATION; CARCINOMA; THERAPY; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 30 Nov 2021 10:37 |
| Last Modified: | 30 Nov 2021 10:37 |
| URI: | https://pred.uni-regensburg.de/id/eprint/40978 |
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