engleski

Treatment outcomes of trifluridine/tipiracil therapy in refractory metastatic colorectal cancer: A single-centre observational study

Background Treatment options for patients (pts) with metastatic colorectal cancer (mCRC) after progression to standard therapy are limited. Trifluridine/tipiracil (TAS-102) is an orally administered cytotoxic agent approved for treatment of patients with refractory mCRC. Patients treated with TAS-102 derived a significant benefit in OS compared with placebo as was demonstrated in two phase III trials (RESOURCE and TERRA). However, real-world data on the effectiveness of TAS-102 are sparse. Methods The aim of this observational study was to investigate the efficacy and safety of TAS-102. We included 72 pts (47 men, 25 women) who began treatment with TAS-102 between May 1st 2018 and Dec 31st 2019 in the University Hospital Centre Zagreb. Eligible pts were had metastatic disease and were in good general condition (ECOG ≤1). Fourty-three started irinotecan- and 29 pts oxaliplatin-based chemotherapy (CT) with biological agent added according to RAS status in 53 pts. TAS-102 was introduced after progression to two standard treatment lines. Outcomes were measured as PFS in the 3rd line and overall duration of therapy (DoT). To further assess the potential influence of other variables, correlation with Spearman's rank test was used. Results PFS in the 3rd line was 2.4 months (95% CI 1.94- 2.80) and DoT was 25.2 months (95% CI 21.59- 34.64). DoT was signifantly correlated with PFS in the 3rd line (P=0.001) and no other significant correlation was found for age, performance status, RAS status, primary tumor sidedness, number of metastatic sites, liver metastases, CT, and biological agents received in the 2 previous treatment lines. The patients received a median of 3 cycles of TAS-102 and PFS rate at 12 weeks was 37.5%. One patient (1.4%) achieved partial response and 14 (19.4%) disease stabilization. Although a relatively high incidence of grade 1 and 2 neutropenia (38.9%), the incidence of grade 3 neutropenia (8.3%) was not high and only 1 case of febrile neutropenia was documented. Conclusion We aimed to investigate the outcomes and safety of TAS-102 treatment in real-world setting. Our results, being comparable with previously reported studies, further demonstrate the clinical benefit of TAS-102 for refractory mCRC patients with manageable toxicities. Furthermore, the benefit was derived regardless of tumour characteristics or previous treatment received.

trifluridine/tipiracil ; metastatic colorectal cancer ; observational study

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