Abstract
Fluorouracil (5-FU) plus irinotecan combined with bevacizumab has significant activity in metastatic colorectal cancer (mCRC), but S-1 has become a substitute for continuous infusion of 5-FU and has a very low incidence of hand-foot syndrome. With the S-1 plus irinotecan regimen (SIR), the response rate was 62.5%, and the progression-free survival was 8.0 months. We report here on an update of efficacy and safety of the SIR plus bevacizumab (SIRB) regimen as first line treatment for mCRC patients. Fifty-one eligible patients with histologically confirmed advanced or recurrent colorectal cancer received this treatment. S-1 was administered orally on days 1-14 of a 21-day cycle. Patients were assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg, 50 mg, or 60 mg. Irinotecan (150 mg/m(2)) plus bevacizumab (7.5 mg/kg) were administered by intravenous infusion on day 1. Safety analysis identified a grade 3/4 neutropenia rate of 26%. Other grade 3/4 toxicities were diarrhea (8%), nausea (6%), vomiting (2%), and hypertension (8%). The response rate was 67% and the median progression-free survival time was 373 days. The SIRB regimen appears to be highly active and well tolerated as first-line treatment for mCRC.
Publication types
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Clinical Trial, Phase II
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Research Support, Non-U.S. Gov't
MeSH terms
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Administration, Oral
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Adult
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Aged
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Aged, 80 and over
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Antibodies, Monoclonal, Humanized / administration & dosage
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Antibodies, Monoclonal, Humanized / adverse effects
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Antibodies, Monoclonal, Humanized / therapeutic use*
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / administration & dosage
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
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Bevacizumab
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Camptothecin / administration & dosage
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Camptothecin / adverse effects
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Camptothecin / analogs & derivatives*
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Camptothecin / therapeutic use
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Colorectal Neoplasms / drug therapy*
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Colorectal Neoplasms / pathology
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Disease-Free Survival
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Drug Combinations
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Female
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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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Neoplasm Metastasis
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Oxonic Acid / administration & dosage*
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Oxonic Acid / adverse effects
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Oxonic Acid / therapeutic use*
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Tegafur / administration & dosage*
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Tegafur / adverse effects
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Tegafur / therapeutic use*
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Treatment Outcome
Substances
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Antibodies, Monoclonal, Humanized
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Antineoplastic Agents
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Drug Combinations
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S 1 (combination)
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Tegafur
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Bevacizumab
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Oxonic Acid
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Irinotecan
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Camptothecin