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
N1 - Funding Information:
We are indebted to Kenzo Shimazu, Department of Breast and Endocrine Surgery, and Shusaku Tsutsui, Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine, for serving on the safety and efficacy committee of this study. We would also like to thank Yuko Ohno and Makoto Fujii, Department of Mathematical Health Science, Osaka University Graduate School of Medicine, Division of Health Sciences, and Yuriko Takeda, Supporting Center for Clinical Research and Education (SCCRE) Data Center, for their work on data management. Finally, we would like to thank Minori Kageyama and Risa Nishikubo for their secretarial assistance. This work was supported by the SCCRE.
Publisher Copyright:
© 2017, Springer-Verlag Berlin Heidelberg.
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 -
