Abstract
BackgroundCombination therapy comprised of fluoropyrimidine plus irinotecan with an angiogenesis inhibitor is widely used as a second-line treatment for metastatic colorectal cancer (mCRC). Patients and MethodsThis retrospective study evaluated the efficacy and safety of fluorouracil and irinotecan (FOLFIRI) plus ramucirumab (RAM); FOLFIRI plus aflibercept (AFL); irinotecan and S-1 (IRIS) plus bevacizumab (BEV); and capecitabine and irinotecan (CAPIRI) plus BEV, with FOLFIRI plus BEV serving as the control among mCRC patients who failed treatment with fluoropyrimidine and oxaliplatin plus BEV. Data were collected from a medical claim database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). The primary outcome was time to treatment failure (TTF). Secondary outcomes were time to first subsequent therapy (TFST), overall survival (OS), and safety. ResultsAmong 3,136 patients assessed, TTF was significantly shorter with FOLFIRI plus RAM (adjusted hazard ratio [HR], 1.40; 95% confidence interval [CI], 1.26-1.56; P < .001) and FOLFIRI plus AFL (HR, 1.34; 95% CI, 1.09-1.66; P = .002), and significantly longer with IRIS plus BEV (HR, 0.80; 95% CI, 0.70-0.92; P = .002). TFST was significantly shorter with FOLFIRI plus RAM (HR, 1.32; 95% CI, 1.17-1.49; P < .001); no significant difference in OS was observed. The incidences of neutropenia requiring granulocyte colony-stimulating factor were significantly lower with IRIS plus BEV and CAPIRI plus BEV. ConclusionRegarding TTF, BEV seemed to be a favorable option compared with RAM and AFL when combined with FOLFIRI, and IRIS might be preferable compared to FOLFIRI when combined with BEV for patients who failed to respond to fluoropyrimidine, oxaliplatin, and BEV.
Highlights
Colorectal cancer is currently the fourth most common cancer worldwide, with more than 550,000 associated deaths annually.[1]
In the analysis of a combination of irinotecan-based chemotherapies with BEV, approximately 90% of the patients who received irinotecan and S-1 (IRIS) or capecitabine and irinotecan (CAPIRI) plus BEV were treated with capecitabine and oxaliplatin (CAPOX) or S-1 and oxaliplatin (SOX) plus BEV as first-line chemotherapy (Table 1)
The proportion of patients treated with IRIS or CAPIRI plus BEV was higher than that of patients treated with FOLFIRI plus BEV in large hospitals (≥500 beds) or designated cancer hospitals, who had TNM stage I to III at diagnosis, who had longer first-line treatment failure (TTF) (≥6 months), and who were treated after 2016
Summary
Colorectal cancer is currently the fourth most common cancer worldwide, with more than 550,000 associated deaths annually.[1]. A randomized phase III study (RAISE) showed a prolongation of survival associated with the addition of ramucirumab (RAM), a fully human immunoglobulin G1 monoclonal antibody targeting VEGF-receptor 2, to FOLFIRI for mCRC patients who failed first-line treatment with fluoropyrimidines and oxaliplatin plus BEV.[15]. In a randomized phase III study (VELOUR), which compared FOLFIRI plus AFL to FOLFIRI, a survival benefit of FOLFIRI plus AFL was confirmed among mCRC patients who failed first-line treatment with fluoropyrimidines and oxaliplatin with or without BEV.[13] Based on these results, combination therapy with angiogenesis inhibitors, irinotecan-based chemotherapy plus angiogenesis inhibitors for patients who failed oxaliplatin-based chemotherapy plus BEV, has been established as a standard second-line treatment according to several guidelines.[23-26]
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