Dina Symposium Kanker Gastrointestinal 2018, hasil uji coba CELESTIAL Fase III nunjukkeun yén dibandingkeun sareng plasebo, carbotinib tiasa ningkatkeun kasalametan umum (OS) pasien anu dirawat saacanna kanker ati (HCC) ku 2.2 bulan.
Dina sidang buta ganda, waktu survival median pikeun carbotinib éta 10.2 bulan dibandingkeun 8.0 bulan pikeun placebo, nu hartina 24% ngurangan résiko progression atawa maot. Progression-free survival (PFS) kalawan catinitinib éta 5.2 bulan, sarta placebo éta 1.9 bulan, sarta résiko progression atawa maot terapi sasaran diréduksi ku 56%.
Based on the results of this study, pharmaceutical companies are preparing to submit an application for approval to the FDA, which was approved for the treatment of kidney cancer and tiroid cancer. The prognosis of patients with advanced hepatocellular carcinoma is poor, and previous systemic treatments are limited. Principal Investigator Ghassan K, MD, MD, Memorial Sloan Kettering Cancer Center, said that in clinical trials, the significant benefits for patients ’overall survival and progression-free survival indicate that if approved, carbatinib can become an important treatment for these patients Complementary therapy.
Dina percobaan CELESTIAL, 707 pasien sacara acak ditugaskeun ka 60 mg carbatinib (n = 470) atanapi plasebo (n = 237) per dinten. Sadaya pasien ngagaduhan status kinerja ECOG 0 atanapi 1. Sahenteuna hiji perlakuan sistemik dilaksanakeun, sareng 70% pasien parantos nganggo sorafenib (Nexavar).
Dina analisa grup sorafenia, OS median dina grup carbotinib nyaéta 11.3 bulan, dibandingkeun sareng 7.2 bulan dina grup plasebo; PFS median nyaéta 5.5 bulan sareng 1.9 bulan dina grup plasebo.
AEs anu patali jeung perlakuan (16%) dibandingkeun sareng plasebo (3%), langkung seueur pasien ngeureunkeun perawatan. Kajadian ngarugikeun kelas 3-4 anu paling umum (AEs) sareng kasatinib ngalawan plasebo nyaéta redness palmar abnormal (17% vs 0%), hipertensi (16% vs 2%), sareng aspartate aminotransferase elevated (12% vs 7%), kacapean. (10% vs 4%) jeung diare (10% vs 2%). Dibandingkeun sareng plasebo, insiden kelas 5 AE dina grup carbotinib langkung luhur. Gemblengna, 6 pasien ngembangkeun gagal ati, fistula bronkial esophageal, trombosis vena portal, perdarahan saluran cerna luhur, embolisme pulmonal, sareng sindrom urat hépatik. Hiji pasien dina grup plasebo maot kusabab gagal ati.
