අගෝස්තු 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).
ඔක්කාරය, මලබද්ධය, පාචනය, වමනය, ස්ටෝමැටිටිස්, තෙහෙට්ටුව / ඇස්ටේනියාව, ආහාර රුචිය අඩුවීම සහ බර අඩු වීම KEYNOTE-20 හි පෙම්බ්රොලිසුමාබ් සංයෝගය ලබා ගත් රෝගීන්ගෙන් ආසන්න වශයෙන් 590% ක් තුළ දක්නට ලැබෙන වඩාත්ම ප්රචලිත අතුරු ආබාධ වේ.
esophageal පිළිකා සඳහා, සෑම සති තුනකට වරක් 200 mg හෝ සෑම සති හයකට වරක් 400 mg මාත්රාවක් දක්වා ඇත.
යොමුව: https://www.fda.gov/
විස්තර පරීක්ෂා කරන්න මෙහි.
