Nuwamba 2023: Pembrolizumab (Keytruda, Merck) Hukumar Abinci da Magunguna (FDA) ta ba da izini a matsayin maganin neoadjuvant a hade tare da chemotherapy mai ɗauke da platinum kuma azaman maganin adjuvant na bayan tiyata don auna ciwace-ciwacen ƙwayar cuta marasa kanana (NSCLC). 4 cm ko fiye a diamita, lokacin da aka haɗe shi da chemotherapy mai ɗauke da platinum.
KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled trial involving 797 patients with AJCC 8th edition resectable Stage II, IIIA, or IIIB NSCLC who had not been previously treated, assessed the drug’s efficacy. Patients undergoing platinum-based chemotherapy were randomized (1:1) to receive pembrolizumab or a placebo every three weeks for four cycles (neoadjuvant treatment).
Subsequently, for a maximum of thirteen cycles (adjuvant treatment), patients were administered either continued single-agent pembrolizumab or a placebo every three weeks. The surgical window and chemotherapy specifics are available at the link to the drug label above.
Ma'aunin sakamako na farko na inganci shine mai bincike-ƙimar rayuwa marar lalacewa (EFS) da rayuwa gabaɗaya (OS). Matsakaicin OS na waɗanda ke karɓar placebo shine watanni 52.4 (95% CI: 45.7, NE) kuma ba a samu ba a hannun pembrolizumab (95% CI: ba ƙididdigewa [NE], NE]; p-darajar = 0.0103). Halin haɗari [HR] shine 0.72 [95% CI: 0.56, 0.93]; p-darajar = 0.0103]. Matsakaicin EFS a cikin hannun placebo shine watanni 17 (95% CI: 14.3, 22.0) idan aka kwatanta da watanni 17 a cikin hannun pembrolizumab (95% CI: 34.1 months, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-darajar = 0.0001).
The adverse reactions most frequently reported by 20% or more of the patients in KEYNOTE-671 were as follows: nausea, fatigue, neutropenia, anaemia, constipation, decreased appetite, decreased white blood cell count, musculoskeletal pain, rash, congestion, vomiting, diarrhoea, and dyspnea.
A comparatively lower rate of adverse reactions prevented surgery for 6% of patients in the pembrolizumab arm who received neoadjuvant treatment, as opposed to 4.3% in the placebo arm. In addition, 3.1% of patients who received neoadjuvant treatment and surgery in the pembrolizumab arm experienced surgical delays as compared to 2.5% in the placebo arm. The safety information pertaining to the neoadjuvant and adjuvant phases can be found in the drug label link provided above.
An wajabta Pembrolizumab a kashi na 200 MG kowane mako 3 ko 400 MG kowane mako 6. Lokacin gudanar da magani a rana ɗaya da chemotherapy, yakamata a gudanar da pembrolizumab tukuna.
