Purpose:

To compare effectiveness and safety of regorafenib and trifluridine/tipiracil in patients with metastatic colorectal cancer in real clinical practice.

Methods:

A retrospective observational study including all patients with metastatic colorectal cancer who started treatment with regorafenib or trifluridine/ tipiracil (February 2013-May 2017) was carried out.

Demographic, diagnostic and therapeutic variables were collected. Adverse effects and dose reductions were recorded to measure safety.

Median progression free survival (PFS) and overall survival (OS) were recorded. Differences in survival were evaluated using the Cox's proportional hazard models to determine the hazard ratio.

Results:

Throughout the period of the study 39 patients were included (61.54% women, median age 62.69±11.51 years, 76.92% ECOG1, median previous lines 3.28±1.02, 58.97% mutant RAS, 61.54% had metastasis in the diagnosis): 10 patients started treatment with regorafenib and 29 with trifluridine/tipiracil.

The median PFS with regorafenib was 1.77 months and with trifluridine/tipiracil 2.46 months (HR 1.35 (0.64-2.85), p=0.428), and the median OS was 7.00 months with both drugs (HR 1.45 (0.68-3.09), p=0.335). Differences in survival were not statistically significant.

The median number of adverse effects per patient was 3.70±2.35 vs. 2.55±2. 16 with regorafenib and trifluridine/tipiracil, respectively. The most frequent adverse effects related to regorafenib were asthenia, diarrhea, hand-foot syndrome, hyporexia and mucositis, whereas with trifluridine/tipiracil asthenia, neutropenia and nausea. Dose reductions were necessary in 30.00% of the patients treated with regorafenib and in 27.58% of those with trifluridine/tipiracil.

Conclusions:

In our study, regorafenib and trifluridine/tipiracil have similar, modest effectiveness. Differences in toxicity may be decisive in the choice of either treatment.

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