2021 avgust: 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.
Splošno preživetje (OS) in preživetje brez napredovanja bolezni (PFS) sta bila primarna končna merila učinkovitosti, kar je raziskovalec določil z uporabo RECIST 1.1. (spremenjeno tako, da sledi največ 10 ciljnim lezijam in največ 5 ciljnim lezijam na organ). Bolniki, ki so bili s kemoterapijo randomizirani na pembrolizumab, so imeli statistično značilno izboljšanje OS in PFS. Mediana OS v skupini s pembrolizumabom je bila 12.4 meseca (95 -odstotni interval zaupanja: 10.5, 14.0), v primerjavi s 9.8 meseca (95 -odstotni interval zaupanja: 8.8, 10.8) v skupini s kemoterapijo (HR 0.73; 95 -odstotni interval zaupanja: 0.62, 0.86; p0.0001). PFS je bil 6.3 meseca (95 -odstotni interval zaupanja: 6.2, 6.9) oziroma 5.8 meseca (95 -odstotni interval zaupanja: 5.0, 6.0) (HR 0.65; 95 -odstotni interval zaupanja: 0.55, 0.76; p0.0001).
Slabost, zaprtje, driska, bruhanje, stomatitis, utrujenost/astenija, zmanjšan apetit in izguba telesne mase so bili najpogostejši neželeni učinki, opaženi pri približno 20% bolnikov, ki so prejemali kombinacijo pembrolizumaba v zdravilu KEYNOTE-590.
Pri raku požiralnika je indiciran odmerek 200 mg vsake tri tedne ali 400 mg vsakih šest tednov.
Referenca: https://www.fda.gov/
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