Jan 2022: Pembrolizumab (Keytruda, Merck) has been approved by the Food and Drug Administration for the adjuvant treatment of patients with renal cell carcinoma (RCC) who are at intermediate-high or high risk of recurrence after nephrectomy, or after nephrectomy plus resection of metastatic lesions.
Kubudirira kwakaongororwa muvarwere ve994 vane pakati-yakakwirira-yakakwirira kana pangozi yepamusoro yekudzoka kweRCC, kana M1 pasina uchapupu hwehurwere, muKEYNOTE-564 (NCT03142334), yakawanda, randomized (1: 1), kaviri-mapofu, placebo-inodzorwa. kutongwa. Varwere vaipihwa pembrolizumab 200 mg intravenously mavhiki ega e3 kana placebo kweanosvika gore, kana kusvika hurwere hwadzoka kana huturu husingagoneki, chero hupi hwakatanga.
Kupona-pasina chirwere (DFS), inotsanangurwa senguva pakati pekudzoka, metastasis, kana kufa, ndiyo yaive yekutanga kushanda kwemhedzisiro. Kupona kwese kwaive imwe mhedzisiro metric (OS). Ongororo yenguva pfupi yakatsanangurwa yakaratidza kuvandudzwa kwakakosha muDFS, ne109 (22%) zviitiko muruwoko rwepembrolizumab uye 151 (30%) zviitiko muruoko rwe placebo (HR 0.68; 95 muzana CI: 0.53, 0.87; p=0.0010). . Muruoko, yepakati DFS yakasvikwa. Data yeOS yakanga isati yakwana panguva yekuongorora kweDFS, ne5% yevanhu vaifa.
Musculoskeletal kusagadzikana, kuneta, kuputika, manyoka, pruritus, uye hypothyroidism ndiyo yainyanya kuipa yakaipisisa mukuedza uku (20 muzana).
Pembrolizumab inopiwa mumiyero ye200 mg mavhiki matatu ega ega kana 400 mg mavhiki matanhatu ega ega kusvika hurwere hwadzoka, huturu husingagoneki, kana kusvika kumwedzi gumi nemiviri.
Click here for full prescribing information for Keytruda.
