2023 Samhain: Thug an Riarachán Bia agus Drugaí (FDA) faomhadh do Pembrolizumab (Keytruda, Merck) mar chóireáil neoadjuvant i gcomhar le ceimiteiripe ina bhfuil platanam agus mar chóireáil aidiúvach iar-mháinliachta le haghaidh siadaí ailse scamhóg neamh-bheag inseolta (NSCLC) a thomhas. 4 cm nó níos mó ar trastomhas, nuair a chomhcheanglaítear é le ceimiteiripe ina bhfuil platanam.
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.
Ba iad na príomhthorthaí éifeachtúlachta ná marthanas saor ó imeacht (EFS) agus marthanas foriomlán (OS) a mheas imscrúdaitheoir. Ba é an OS airmheánach dóibh siúd a fuair phlaicéabó ná 52.4 mí (95% CI: 45.7, NE) agus níor baineadh amach é sa ghéag pembrolizumab (95% CI: neamh-inmheasta [NE], NE]; p-value=0.0103). Ba é an cóimheas riosca [HR] ná 0.72 [95% CI: 0.56, 0.93]; p-luach=0.0103]. Ba é an EFS airmheánach sa lámh phlaicéabó ná 17 mí (95% CI: 14.3, 22.0) i gcomparáid le 17 mí sa lámh pembrolizumab (95% CI: 34.1 mí, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-luach=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.
Tá Pembrolizumab forordaithe ag dáileog de 200 mg gach 3 seachtaine nó 400 mg gach 6 seachtaine. Nuair a dhéantar é a riaradh ar an lá céanna le ceimiteiripe, ba chóir pembrolizumab a thabhairt roimh ré.
