Real-World Study Shows Trifluridine/Tipiracil Plus Bevacizumab Effective for mCRC

According to data being presented by Nieves Martínez Lago, MD, PhD, Complejo Hospitalario Universitario, A Coruña, Spain, and colleagues at the virtual ESMO 23rd World Congress on Gastrointestinal Cancer, real-world findings suggest trifluridine/tipiracil (TAS-102) plus bevacizumab was effective in patients with refractory metastatic colorectal cancer (mCRC).

“Trifluridine/tipiracil plus bevacizumab, compared with TAS-102 monotherapy, was associated with a statistically significant and clinically relevant improvement in progression-free survival (PFS) with tolerable toxicity in a randomized, open-label, phase 2 trial. However, the role of this combination in a real-world setting is unknown,” explained Dr Lago.

With this in mind, researchers conducted a retrospective, observational study of patients with mCRC who were refractory or intolerant to standard therapies; prior therapy with bevacizumab, aflibercept, or regorafenib was allowed. Patients recieved 35mg/m2 of TAS-102 twice daily on days 1-5 and 8-12 every 28 days plus bevacizumab 5mg/kg on days 1 and 15.

The clinical and pathological characteristics, as well as overall response rate (ORR), disease control rate (DCR), overall survival (OS), and progression-free survival (PFS) data, were collected and analyzed.

Researchers recorded 20 patients treated between July 2019 and January 2021. Of them, 75% had an ECOG score of PS0-1, 60% had mutated rat sarcoma virus (RASmt), 65% synchronous presentation, and 80% primary tumor resection. 

Of the 20 patients, 15 (75%) were evaluated for response. The average cycle received was 4 (range 2-14+), and the median follow-up was 7.7 months. The ORR was 5%, and the DCR was 40%. Furthermore, the median PFS and OS were 4.9 months (95% CI, 2.5-7.2 months) and 8.1 months (95% CI, 3.3-12.9 months), respectively.

The most common adverse events (AEs) of grade 3 or higher were asthenia (35%), neutropenia (30%; 0% febrile neutropenia), and vomiting (15%). Forty-five percent of patients required dose delays and 20% had dose reductions due to toxicity. However, no treatment-related deaths occurred.—Alexandra Graziano

N. Martinez Lago, B. Alonso de Castro, R. Varela Ponte, et al. Real-world efficacy and safety of trifluridine/tipiracil plus bevacizumab for patients with metastatic colorectal cancer refractory to standard therapies. Presented at: the ESMO 23rd World Congress on Gastrointestinal Cancer; June 30-July 3, 2021; virtual. Abstract P-31.