Abstract
Introduction: Regorafenib (REG) and TAS‐102 (TAS) have been approved as salvage treatment drugs for patients with metastatic colorectal cancer (mCRC) that progressed after standard chemotherapies. To date, however, no clinical comparison of these two drugs has been reported. The aim of this study was to compare the efficacy and safety of REG alone and TAS alone in patients with mCRC refractory to standard chemotherapies. Methods: From May 2014 to November 2015, 74 patients with mCRC were treated with REG or TAS as salvage‐line therapy. Long‐term survival, safety and clinical outcomes were retrospectively evaluated. Major inclusion criteria of this study were as follows; histologically proven colorectal adenocarcinoma; refractory to fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti‐EGFR antibody (limited KRAS or RAS wild type); measurable or evaluable lesion; age > 20 years; ECOG PS 0 to 2; and written informed consent. Results: Among 74 patients, 38 received REG and the other 36 received TAS. Patient background between the groups was the same.With a median follow‐up of 5.8 months, median progression‐free survival (TAS 2.1 vs REG 2.0 months; p = 0.145) and median overall survival (TAS 7.9 vs REG 7.7 months; p = 0.549) did not statistically differ. Furthermore, the objective response rate (TAS 0% vs REG 3%; p = 0.330) and the disease control rate (TAS 94% vs REG 95%; p = 0.956) did not statistically differ. The incidence of neutropenia were statistically more frequent with TAS, whereas thrombocytopenia, hyperbilirubinemia, skin disorder, hand‐foot syndrome, fever, hypertension, hoarseness were statistically more frequent with REG. Conclusion: REG and TAS showed equivalent efficacy in the treatment of mCRC which had progressed after standard therapies, although with different toxic profiles.
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CITATION STYLE
Kotaka, M., Satake, H., Okita, Y., Hatachi, Y., Kotake, T., Hashida, H., … Tsuji, A. (2016). P-159 Regorafenib vs TAS-102 as salvage-line treatment in patients with metastatic colorectal cancer refractory to standard chemotherapies: A multicenter retrospective comparison study. Annals of Oncology, 27, ii47. https://doi.org/10.1093/annonc/mdw199.153
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