2018-yilgi oshqozon-ichak saratoni simpoziumida III bosqich SELESTIAL sinovi natijalari shuni ko'rsatdiki, platsebo bilan solishtirganda, karbotinib ilgari davolangan jigar saratoni (HCC) bilan og'rigan bemorlarning umumiy omon qolishini (OS) 2.2 oyga yaxshilashi mumkin.
Ikki tomonlama ko'r-ko'rona sinovda karbotinibning o'rtacha omon qolish muddati platsebo uchun 10.2 oyga nisbatan 8.0 oyni tashkil etdi, bu esa rivojlanish yoki o'lim xavfini 24% ga kamaytirishni anglatadi. Katinitinib bilan rivojlanishsiz omon qolish (PFS) 5.2 oyni, platsebo esa 1.9 oyni tashkil etdi va maqsadli terapiyaning rivojlanishi yoki o'lim xavfi 56% ga kamaydi.
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.
CELESTIAL tadqiqotida 707 bemor kuniga 60 mg karbatinib (n = 470) yoki platsebo (n = 237) ga tasodifiy ravishda tayinlangan. Barcha bemorlar ECOG ko'rsatkichlari holati 0 yoki 1 edi. Kamida bitta tizimli davolash amalga oshirildi va bemorlarning 70% sorafenib (Nexavar) dan foydalangan.
Sorafeniya guruhini tahlil qilishda karbotinib guruhidagi o'rtacha OS platsebo guruhidagi 11.3 oyga nisbatan 7.2 oyni tashkil etdi; o'rtacha PFS platsebo guruhida 5.5 oy va 1.9 oy edi.
Davolash bilan bog'liq AE (16%) platsebo (3%) bilan solishtirganda, ko'proq bemorlar davolanishni to'xtatdilar. Platseboga qarshi eng ko'p uchraydigan 3-4 darajali nojo'ya ta'sirlar (AE) va kasatinib kaftning anormal qizarishi (17% ga nisbatan 0%), gipertenziya (16% ga qarshi 2%) va aspartat aminotransferaza (12% ga nisbatan 7%), charchoq. (10% ga qarshi 4%) va diareya (10% ga qarshi 2%). Platsebo bilan solishtirganda, karbotinib guruhida 5-darajali AE bilan kasallanish ko'proq edi. Umuman olganda, 6 bemorda jigar etishmovchiligi, qizilo'ngach bronxial oqma, portal vena trombozi, yuqori oshqozon-ichakdan qon ketish, o'pka emboliyasi va jigar venasi sindromi rivojlandi. Platsebo guruhidagi bir bemor jigar etishmovchiligidan vafot etdi.
