TY - JOUR
T1 - Phase I/II study of bi-weekly XELIRI plus bevacizumab treatment in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy
AU - Mizushima, Tsunekazu
AU - Fukunaga, Mutsumi
AU - Sueda, Toshinori
AU - Ikeda, Masataka
AU - Kato, Takeshi
AU - Kim, Ho Min
AU - Kudo, Toshihiro
AU - Murata, Kohei
AU - Nishimura, Junichi
AU - Hata, Taishi
AU - Matsuda, Chu
AU - Yamamoto, Hirofumi
AU - Doki, Yuichiro
AU - Mori, Masaki
PY - 2017/7/1
Y1 - 2017/7/1
N2 - Purpose: We aimed to determine the recommended dose for bi-weekly XELIRI plus bevacizumab for second-line chemotherapy and examined its safety and efficacy in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy. Methods: Irinotecan and bevacizumab were administered as a continuous intravenous infusion on Day 1 at 150 mg/mm2 and 5 mg/kg, respectively. Capecitabine was orally administered in two divided doses on Days 2–8. Each 2-week treatment cycle was defined as a single course of treatment. During Phase I, we determined the recommended dose for capecitabine. In Phase II trials, efficacy and treatment safety was verified (UMIN000003934). Results: The recommended dose of capecitabine was determined to be 2000 mg/m2. Median progression-free survival was 7.8 months [95% confidence interval (CI) 6.1–10.9 months], and median overall survival was 18.9 months (95% CI 11.6–28.4 months). Response rate was 17.4% (95% CI 6.4–28.3%). The most common Grade ≥3 hematotoxic adverse events were anemia (10.9%), neutropenia (10.9%), and leukopenia (8.7%), while the occurrence rate of Grade ≥3 non-hematotoxic adverse events was relatively low (<10%). Conclusion: Bi-weekly XELIRI plus bevacizumab was found to be a safe and effective second-line treatment in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy.
AB - Purpose: We aimed to determine the recommended dose for bi-weekly XELIRI plus bevacizumab for second-line chemotherapy and examined its safety and efficacy in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy. Methods: Irinotecan and bevacizumab were administered as a continuous intravenous infusion on Day 1 at 150 mg/mm2 and 5 mg/kg, respectively. Capecitabine was orally administered in two divided doses on Days 2–8. Each 2-week treatment cycle was defined as a single course of treatment. During Phase I, we determined the recommended dose for capecitabine. In Phase II trials, efficacy and treatment safety was verified (UMIN000003934). Results: The recommended dose of capecitabine was determined to be 2000 mg/m2. Median progression-free survival was 7.8 months [95% confidence interval (CI) 6.1–10.9 months], and median overall survival was 18.9 months (95% CI 11.6–28.4 months). Response rate was 17.4% (95% CI 6.4–28.3%). The most common Grade ≥3 hematotoxic adverse events were anemia (10.9%), neutropenia (10.9%), and leukopenia (8.7%), while the occurrence rate of Grade ≥3 non-hematotoxic adverse events was relatively low (<10%). Conclusion: Bi-weekly XELIRI plus bevacizumab was found to be a safe and effective second-line treatment in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy.
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U2 - 10.1007/s00280-017-3336-3
DO - 10.1007/s00280-017-3336-3
M3 - Article
C2 - 28510802
AN - SCOPUS:85019207805
VL - 80
SP - 81
EP - 90
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
SN - 0344-5704
IS - 1
ER -