ພະຈິກ 2023: Pembrolizumab (Keytruda, Merck) ໄດ້ຮັບການອະນຸມັດຈາກອົງການອາຫານແລະຢາ (FDA) ເປັນການປິ່ນປົວ neoadjuvant ປະສົມປະສານກັບການປິ່ນປົວດ້ວຍທາງເຄມີທີ່ມີ platinum ແລະເປັນການປິ່ນປົວເສີມຫຼັງການຜ່າຕັດສໍາລັບການວັດແທກມະເຮັງປອດທີ່ບໍ່ແມ່ນຈຸລັງຂະຫນາດນ້ອຍ (NSCLC) tumors. ເສັ້ນຜ່າສູນກາງ 4 ຊຕມຫຼືຫຼາຍກວ່ານັ້ນ, ເມື່ອປະສົມປະສານກັບການປິ່ນປົວດ້ວຍທາງເຄມີທີ່ມີ 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.
ມາດຕະການປະສິດທິພາບຕົ້ນຕໍແມ່ນການຢູ່ລອດທີ່ບໍ່ມີເຫດການ (EFS) ແລະການຢູ່ລອດໂດຍລວມ (OS). OS ປານກາງສໍາລັບຜູ້ທີ່ໄດ້ຮັບ placebo ແມ່ນ 52.4 ເດືອນ (95% CI: 45.7, NE) ແລະບໍ່ໄດ້ບັນລຸຢູ່ໃນແຂນ pembrolizumab (95% CI: ຄາດຄະເນບໍ່ໄດ້ [NE], NE]; p-value=0.0103). ອັດຕາສ່ວນຄວາມສ່ຽງ [HR] ແມ່ນ 0.72 [95% CI: 0.56, 0.93]; p-value=0.0103]. EFS ປານກາງໃນແຂນ placebo ແມ່ນ 17 ເດືອນ (95% CI: 14.3, 22.0) ເມື່ອທຽບກັບ 17 ເດືອນໃນແຂນ pembrolizumab (95% CI: 34.1 ເດືອນ, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-value=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.
Pembrolizumab ແມ່ນຖືກກໍານົດໄວ້ໃນປະລິມານຂອງ 200 mg ທຸກໆ 3 ອາທິດຫຼື 400 mg ທຸກໆ 6 ອາທິດ. ເມື່ອປະຕິບັດໃນມື້ດຽວກັນກັບການປິ່ນປົວດ້ວຍທາງເຄມີ, pembrolizumab ຄວນໄດ້ຮັບການປະຕິບັດກ່ອນ.
