Avgust 2021: Pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy has been approved by the Food and Drug Administration for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) carcinoma (tumours with epicentre 1 to 5 centimetres above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or definitive chlamy
Efficacy was assessed in the multicenter, randomised, placebo-controlled trial KEYNOTE-590 (NCT03189719), which involved 749 patients with metastatic or locally advanced esophageal or gastroesophageal junction cancer who were not candidates for surgical resection or final chemoradiation. The PD-L1 IHC 22C3 pharmDx kit was used to assess PD-L1 status in tumour specimens from all patients. Until intolerable toxicity or disease progression, patients were randomised (1:1) to pembrolizumab in combination with cisplatin and fluorouracil or placebo with cisplatin and fluorouracil.
Overall survival (OS) and progression-free survival (PFS) were the primary efficacy end measures, as determined by the investigator using RECIST 1.1. (modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ). Patients who were randomised to pembrolizumab with chemotherapy had a statistically significant improvement in OS and PFS. The median OS for the pembrolizumab group was 12.4 months (95 percent confidence interval: 10.5, 14.0), compared to 9.8 months (95 percent confidence interval: 8.8, 10.8) for the chemotherapy arm (HR 0.73; 95 percent confidence interval: 0.62, 0.86; p0.0001). PFS was 6.3 months (95 percent confidence interval: 6.2, 6.9) and 5.8 months (95 percent confidence interval: 5.0, 6.0), respectively (HR 0.65; 95 percent confidence interval: 0.55, 0.76; p0.0001).
Ko'ngil aynishi, ich qotishi, diareya, qusish, stomatit, charchoq/asteniya, ishtahaning pasayishi va vazn yo'qotish KEYNOTE-20 da pembrolizumab kombinatsiyasini olgan bemorlarning taxminan 590 foizida kuzatilgan eng keng tarqalgan nojo'ya ta'sirlar bo'lgan.
Qizilo'ngach saratoni uchun har uch haftada 200 mg yoki har olti haftada 400 mg dozasi ko'rsatiladi.
Malumot: https://www.fda.gov/
Tafsilotlarni tekshiring Bu yerga.
