Discussion
mCRC, tumor, DLTs, myelosuppression
METASTATIC COLORECTAL CANCER, DISEASE, METASTATIC GASTRIC CANCER, TUMOR
Refractory metastatic metastatic colorectal cancer (mCRC) treatment with trifluridine/tipiracil (FTD/TPI) combined with bevacizumab (BEV) or irinotecan (IRI) showed enhanced therapeutic effects in preclinical models.In 18 patients of the dose escalation part, 5 DLTs occurred. We determined that the recommended phase II dose (RP2D) could be defined as FTD/TPI 35 mg/mIn the entire population, at a median follow-up time of 417 (range, 346-611) days, the overall response rate (ORR) was 21%; 6 patients achieved partial response in 28 patients. The disease control rate (DCR) was 79% (Waterfall plot: maximum tumor shrinkage from baseline.Kaplan-Meier plots: progression-free survival (left) and overall survival (right).Even with biweekly administration of FTD/TPI, the combination of FTD/TPI, IRI plus BEV produced a high rate of myelosuppression. The preliminary efficacy results showed comparable antitumor activity compared to the standard FOLFIRI regimen. Continued investigation of this regimen may be possible in other patient populations such as metastatic gastric cancer.