Retrospective Study of Regorafenib Versus TAS-102 Efficacy and Safety in Chemorefractory Metastatic Colorectal Cancer (mCRC) Patients: A Multi-institution Real Life Clinical Data

• Published in: Clinical colorectal cancer 2021-09, Vol.20 (3), p.227-235
• Main Authors: Vitale, Pasquale, Zanaletti, Nicoletta, Famiglietti, Vincenzo, De Falco, Vincenzo, Cervantes, Andres, Rosellò, Susanna, Fenocchio, Elisabetta, Milanesio, Michela, Lombardi, Pasquale, Ciardiello, Davide, Martini, Giulia, Martinelli, Erika, Ciardiello, Fortunato, Troiani, Teresa, Napolitano, Stefania
• Format: Article
• Language: English
• Subjects: chemorefractory; Colorectal Neoplasms - drug therapy; Drug Combinations; Humans; mCRC; Phenylurea Compounds - adverse effects; Pyridines; Pyrrolidines; Real Life Clinical data; regorafenib; Retrospective Studies; TAS-102; Thymine; Trifluridine; Uracil
• ISSN: 1533-0028; 1938-0674
• DOI: 10.1016/j.clcc.2021.06.002

There have been significant developments in colorectal cancer (CRC) research over the last few years, with the introduction of new agents that have been prolonged median overall survival of metastatic colorectal cancer (mCRC). These therapies have improved patient outcomes; however, despite significant progress in strategies for cancer treatment, their use is limited by development of resistant mechanism. Almost 30% of patients with refractory mCRC will remain good candidates for further treatment. Regorafenib and TAS-102 are novel antitumor agents for patients with refractory mCRC. However, it is unclear which patients may derive a survival benefit from these drugs in real-life clinical practice. We performed a retrospective analysis evaluating safety and efficacy of TAS-102 and regorafenib in a cohort of refractory mCRC patients, in 3 different centers between January 1 2018 and May 31 2020, with the aim of assessing the optimal sequence treatment for these 2 drugs. One hundred and forty mCRC patients were included in the analysis. Of these patients, 64 received regorafenib and 76 received TAS-102 as first treatment. After progression, in the regorafenib 24 (37%) patients switched to secondary treatment with TAS-102, instead, in the TAS-102 group, among 76 patients, 29 (45%) patients switched to secondary treatment with regorafenib. Disease control was achieved in 8 (12.5%) of 64 patients in the regorafenib group and 17 (22.4%) of 76 patients in the TAS-102 group. In terms of efficacy, the PFS and OS were similar in both treatment groups for primary and secondary treatments. AEs reported in this analysis were mostly consistent with the known safety profiles of regorafenib and TAS-102 in previous clinical trials. The present study is the first one to compare the activity of the two agents in a large cohort of chemo-refractory mCRC patients providing more details about the best sequence, to be incorporated in clinical practice. Regorafenib and TAS-102 are novel antitumor agents for patients with refractory metastatic colorectal cancer (mCRC). We performed a retrospective analysis evaluating safety and efficacy of TAS-102 and regorafenib in 140 refractory mCRC patients, in 3 different centers, with the aim of assessing the optimal sequence treatment for these 2 drugs. PFS, overall survival were similar in both treatment groups for primary and secondary treatments.