Abstract

ObjectiveThis study aimed to evaluate the efficacy and safety of regorafenib plus drug-eluting beads-transarterial chemoembolization (DEB-TACE) versus regorafenib monotherapy in colorectal cancer liver metastases (CRLM) patients who failed standard treatment regimens.MethodsTotally, 76 eligible CRLM patients were analyzed, among which 42 patients received regorafenib monotherapy (as regorafenib group) and 34 patients received regorafenib plus DEB-TACE (as regorafenib plus DEB-TACE group).ResultsObjective response rate (35.3% versus 7.1%, P = 0.002) and disease control rate (76.5% versus 47.6%, P = 0.011) were both increased in regorafenib plus DEB-TACE group compared with regorafenib group; meanwhile, negative conversion rate of carcinoembryonic antigen (66.7% versus 28.6%, P = 0.008) after treatment was elevated in regorafenib plus DEB-TACE group compared with regorafenib group. Notably, progression-free survival (PFS) (median value: 7.6 versus 4.1 months, P < 0.001) and overall survival (OS) (median value: 15.7 versus 9.2 months, P < 0.001) were both higher in regorafenib plus DEB-TACE group compared with regorafenib group. Furthermore, liver function indexes (alanine transaminase, aspartate aminotransferase, and cholinesterase levels) after treatment were all similar between the two groups (all P > 0.05). In addition, the occurrences of upper abdominal distending pain (P < 0.001), nausea and vomiting (P = 0.002) and fever (P = 0.002) were higher in regorafenib plus DEB-TACE group compared with regorafenib group, while the majority of these adverse events were mild and tolerable.ConclusionsRegorafenib plus DEB-TACE is superior to regorafenib monotherapy regarding treatment response, PFS and OS, while induces tolerable post-embolization syndrome in CRLM patients who fail standard treatment regimens.

Highlights

  • Colorectal cancer (CRC) is the third most common cancer that annually causes more than 14 million new CRC cases and over 8 million deaths worldwide (Ferlay 2015)

  • Patients who met all of the following criteria were eligible for inclusion: (1) the primary lesion was confirmed as colorectal cancer by histology or cytology examination; (2) the intrahepatic lesion was proved to be a metastasis from colorectal cancer by histology, cytology, or imaging examination; (3) no other metastasis was found except liver metastasis; (4) disease was progressed after previous first- and second-line standard treatment regimens; (5) there was at least one evaluable lesion in the liver; (6) age ≥ 18 years; (7) no severe basic diseases such as heart failure, renal failure, respiratory failure, and severe coagulation dysfunction; (8) Eastern Cooperative Oncology Group (ECOG) score ≤ 2 points; (9) life expectancy ≥ 3 months

  • Comparison analyses showed that liver function indexes including alanine transaminase (ALT), AST, and cholinesterase were all increased in regorafenib group compared with regorafenib plus DEBTACE group, these indexes of the two groups were all within normal range

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Summary

Introduction

Colorectal cancer (CRC) is the third most common cancer that annually causes more than 14 million new CRC cases and over 8 million deaths worldwide (Ferlay 2015). Journal of Cancer Research and Clinical Oncology (2021) 147:2993–3002 first- and second-line treatment, which has improved their prognosis to some extent; while there are still a proportion of unresectable CRLM patients fail standard treatment regimens (Kow 2019; Van Cutsem et al 2010). Regorafenib is recommended as the third-line or above therapy for unresectable CRLM patients (Van Cutsem et al 2010). Previous clinical trials show that compared with placebo, regorafenib could only limitedly prolong the OS of CRLM patients who fail standard treatment regimens (Grothey 2013; Juan et al 2017; Li 2015). Further pursuing treatment strategies with better efficacy might improve the outcome of CRLM patients who fail standard treatment regimens

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