Agustus 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.
Dalam SUNLIGHT (NCT04737187), uji coba internasional acak, label terbuka, multisenter, membandingkan LONSURF dengan bevacizumab dengan agen tunggal LONSURF pada 492 pasien dengan kanker kolorektal metastatik yang telah menerima maksimal dua rejimen kemoterapi sebelumnya dan menunjukkan perkembangan penyakit mereka atau intoleransi terhadap rejimen terakhir, keamanan dan kemanjuran dinilai.
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%).
Pada hari 1 sampai 5 dan hari 8 sampai 12 dari setiap siklus 28 hari, dosis LONSURF yang dianjurkan adalah 35 mg/m2 diminum dua kali sehari dengan makanan. Untuk perincian tentang dosis bevacizumab, konsultasikan dengan informasi resep.
Lihat informasi resep lengkap untuk LONSURF.
