August 2023: For metastatic colorectal cancer (mCRC) that has already been treated with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy, the Food and Drug Administration has approved trifluridine and tipiracil (LONSURF, Taiho Oncology, Inc.). LONSURF, a single-agent medication, has already received FDA approval for this use in September 2015.
În SUNLIGHT (NCT04737187), un studiu randomizat, deschis, multicentric, internațional, care a comparat LONSURF cu bevacizumab cu LONSURF în monoterapie la 492 de pacienți cu cancer colorectal metastatic care au primit până la maximum două scheme de chimioterapie și au prezentat progresia bolii sau Au fost evaluate intoleranța la ultimul regim, siguranța și eficacitatea.
Overall survival (OS) and progression-free survival (PFS) were the key effectiveness outcome metrics. Patients assigned to the LONSURF plus bevacizumab arm of the trial showed a statistically significant OS improvement when compared to patients assigned to the LONSURF arm (Hazard ratio 0.61; 95% CI: 0.49, 0.77; 1-sided p0.001). The median OS for the LONSURF plus bevacizumab arm was 10.8 months (95% CI: 9.4, 11.8) and for the LONSURF arm was 7.5 months (95% CI: 6.3, 8.6). In the LONSURF plus bevacizumab arm, the median PFS was 5.6 months (95% CI: 4.5, 5.9), while in the LONSURF arm, it was 2.4 months (95% CI: 2.1, 3.2) (Hazard ratio: 0.44; 95% CI: 0.36, 0.54; 1-sided p0.001).
Neutropenia, anaemia, thrombocytopenia, fatigue, nausea, increased AST, increased ALT, increased alkaline phosphatase, decreased sodium, diarrhoea, stomach discomfort, and decreased appetite are the most frequent side events or laboratory abnormalities for LONSURF with bevacizumab (20%).
În zilele 1 până la 5 și zilele 8 până la 12 ale fiecărui ciclu de 28 de zile, doza recomandată de LONSURF este de 35 mg/m2 administrată oral de două ori pe zi cu alimente. Pentru detalii despre doza de bevacizumab, consultați informațiile de prescriere.
Vizualizați informații complete de prescriere pentru LONSURF.
