Abstract
A phase II study was conducted to assess the efficacy and tolerability of capecitabine in combination with irinotecan (CAPIRI) in advanced colorectal cancer. Forty-seven patients with previously untreated metastatic or unresectable colorectal adenocarcinoma received capecitabine 1000 mg/m2 twice daily on days 2-15 and intravenous irinotecan 100 mg/m2 on days 1 and 8, every 21 days. A total of 268 cycles of chemotherapy (median 6: range 1-11) were administered. According to an intent-to-treat analysis, the overall response rate was 49% (95% CI, 35-63%). Median time to progression and overall survival were 7.5 months (95% CI, 4.8-10.2) and 19.5 months (95% CI, 15.7-23.8), respectively. The most common grade 3/4 adverse events were diarrhea (24%) and neutropenia (11%). There were no treatment-related deaths. These results indicate that CAPIRI has comparable activity and tolerability to FOLFIRI as first-line treatment for advanced colorectal cancer.
Publication types
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Clinical Trial
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Clinical Trial, Phase II
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Multicenter Study
MeSH terms
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Adenocarcinoma / drug therapy*
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Adenocarcinoma / secondary
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Adult
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Aged
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Antimetabolites, Antineoplastic / administration & dosage*
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Antineoplastic Agents, Phytogenic / administration & dosage*
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Camptothecin / administration & dosage
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Camptothecin / analogs & derivatives*
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Capecitabine
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Colonic Neoplasms / drug therapy*
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Deoxycytidine / administration & dosage
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Deoxycytidine / analogs & derivatives*
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Diarrhea / chemically induced
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Disease Progression
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Female
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Fluorouracil / analogs & derivatives
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Follow-Up Studies
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Humans
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Irinotecan
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Male
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Middle Aged
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Neutropenia / chemically induced
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Prodrugs / administration & dosage
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Rectal Neoplasms / drug therapy*
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Remission Induction
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Survival Rate
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Topoisomerase I Inhibitors
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Treatment Outcome
Substances
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Antimetabolites, Antineoplastic
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Antineoplastic Agents, Phytogenic
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Prodrugs
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Topoisomerase I Inhibitors
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Deoxycytidine
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Capecitabine
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Irinotecan
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Fluorouracil
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Camptothecin