학술논문

Phase I/II study of bi-weekly XELIRI plus bevacizumab treatment in patients with metastatic colorectal cancer resistant to oxaliplatin-based first-line chemotherapy.
Document Type
Journal Article
Source
Cancer Chemotherapy & Pharmacology. Jul2017, Vol. 80 Issue 1, p81-90. 10p.
Subject
*BEVACIZUMAB
*COLON cancer treatment
*OXALIPLATIN
*CANCER chemotherapy
*PROGRESSION-free survival
*THERAPEUTICS
*ANTINEOPLASTIC agents
*CAMPTOTHECIN
*CLINICAL trials
*COLON tumors
*COMPARATIVE studies
*DRUG resistance in cancer cells
*DOSE-effect relationship in pharmacology
*RESEARCH methodology
*MEDICAL cooperation
*METASTASIS
*ORGANOPLATINUM compounds
*PROGNOSIS
*RESEARCH
*SURVIVAL
*EVALUATION research
*TREATMENT effectiveness
RECTUM tumors
Language
ISSN
0344-5704
Abstract
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. [ABSTRACT FROM AUTHOR]