• Toshiki Masuishi, Hiroya Taniguchi, Satoshi Hamauchi, Azusa Komori, Yosuke Kito, Yukiya Narita, Takahiro Tsushima, Makoto Ishihara, Akiko Todaka, Tsutomu Tanaka, Tomoya Yokota, Shigenori Kadowaki, Nozomu Machida, Takashi Ura, Akira Fukutomi, Masashi Ando, Yusuke Onozawa, Masahiro Tajika, Hirofumi Yasui, Kei Muro, Keita Mori, and Kentaro Yamazaki.
• Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
• Clin Colorectal Cancer. 2017 Jun 1; 16 (2): e15-e22.

BackgroundRegorafenib and trifluridine/tipiracil (TAS-102) both prolong survival for patients with refractory metastatic colorectal cancer. However, it is unclear which drug should be administered first.Materials And MethodsWe retrospectively evaluated the data from patients who had received regorafenib or TAS-102 at 2 institutions from May 2013 to March 2015. The inclusion criteria were disease refractory or intolerant to fluoropyrimidines, oxaliplatin, irinotecan, anti-vascular endothelial growth factor antibodies, and anti-epidermal growth factor receptor (EGFR) antibodies (if KRAS exon 2 wild-type), and no previous treatment with regorafenib or TAS-102.ResultsA total of 146 and 54 patients received regorafenib and TAS-102, respectively. The baseline characteristics were similar between the 2 groups, except for a history of irinotecan and anti-EGFR therapy and high alkaline phosphatase levels. The median progression-free survival and overall survival were 2.1 months and 6.7 months, respectively, with regorafenib and 2.1 months and 6.5 months, respectively, with TAS-102 (progression-free survival hazard ratio 1.20, P = .27; overall survival hazard ratio, 1.01, P = .97). The analysis of overall survival for patients after the approval of TAS-102 in Japan was similar to the overall survival for the entire population. The frequency of hand-foot syndrome and increased aspartate aminotransferase, alanine aminotransferase, and bilirubin levels was higher and the frequency of neutropenia, leukopenia, anemia, nausea, and febrile neutropenia was lower with regorafenib than with TAS-102. No remarkable differences were found in the efficacy and safety of TAS-102 between patients with and without previous regorafenib and vice versa.ConclusionRegorafenib and TAS-102 had similar efficacy but resulted in different toxicities, which could guide the agent choice.Copyright © 2016 Elsevier Inc. All rights reserved.

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