2023 kolovoz: 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.
U SUNLIGHT-u (NCT04737187), randomiziranom, otvorenom, multicentričnom, međunarodnom ispitivanju koje uspoređuje LONSURF s bevacizumabom i LONSURF-om u monoterapiji u 492 bolesnika s metastatskim kolorektalnim karcinomom koji su primili najviše dva prethodna režima kemoterapije i pokazali su progresiju svoje bolesti ili netolerancija na posljednji režim, procijenjena je sigurnost i učinkovitost.
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%).
U danima od 1. do 5. i danima od 8. do 12. svakog ciklusa od 28 dana, preporučena doza lijeka LONSURF je 35 mg/m2 uzeta oralno dva puta dnevno s hranom. Pojedinosti o doziranju bevacizumaba potražite u informacijama o propisivanju.
Pogledajte sve informacije o propisivanju lijeka LONSURF.
