Trifluridine/tipiracil (TAS-102) is an oral combination therapy approved for the treatment of patients with metastatic colorectal cancer (mCRC). We reported a phase I/II C-TASK FORCE study of TAS-102 plus bevacizumab (Bev) for patients with refractory mCRC demonstrated a promising activity with an acceptable toxicity profile. More recently, promising results of TAS-102 plus Bev were reported in a randomized phase II TASCO1 study in chemo-naïve mCRC patients who were not eligible for intensive therapies. The retrospective study is aiming to investigate safety and efficacy of TAS-102 plus Bev for patients with refractory mCRC in clinical practice.
We retrospectively reviewed mCRC patients treated with TAS-102 (35 mg/m2, twice a daily on days 1-5 and 8-12 in a 28-day cycle) plus Bev (5 mg/kg, days 1 and 15) who were refractory to standard therapies in our institution since 2016. Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Median progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method.
A total of 60 patients received TAS-102 plus Bev. Median age was 60 years old (range, 23-79) and 35 patients (58%) were males. ECOG performance status was 0/1/2 in 35/24/1 patients. RAS/BRAF/MSI status were as follows; RAS wild-type/mutant (mt), 28/32: BRAF wild-type/V600E mt/non-V600E mt/unknown, 52/1/2/5: MSI-H/MSS/unknown, 0/53/7. With a median follow-up of 7.9 months, median PFS and OS were 3.9 months (95% CI, 1.9-5.9 months) and 8.5 months (95% CI, 7.4-9.6 months), respectively. Overall response rate and disease control rate were 5% and 53%, respectively. The most common grade 3 or 4 adverse events were neutropenia (50%), leucopenia (38%), anemia (13%), proteinuria (7%), febrile neutropenia (3%), and gastrointestinal perforation (3%). Ten patients (17%) received G-CSF. There was no treatment-related death.
Safety and efficacy of TAS-102 plus Bev in clinical practice were comparable to those in the clinical trials.
Clinical trial identification
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All authors have declared no conflicts of interest.