Noofambar 2023: Pembrolizumab (Keytruda, Merck) waxaa oggolaatay Maamulka Cuntada iyo Dawooyinka (FDA) sida daawaynta neoadjuvant oo ay weheliso kiimiko ku daawaynta platinum-ku-jirta iyo daawaynta qalliinka ka dib ee loogu talagalay burooyinka kansarka sambabada ee unugyada yaryar ee la soo saari karo 4 cm ama in ka badan oo dhexroor ah, marka lagu daro kiimiko-ku-daweynta platinum-ka.
KEYNOTE-671 (NCT03425643), xarun badan, randomized, laba-indho la'aan, placebo-koontarool tijaabo ah oo ku lug leh 797 bukaan oo leh daabacaadda 8-aad ee AJCC II, IIIA, ama IIIB NSCLC kuwaas oo aan horay loo daweyn, ayaa qiimeeyay waxtarka daawada. Bukaan-socodka lagu qaadanayo daaweynta kiimikaad ee platinum-ku-salaysan ayaa la kala soocay (1:1) si ay u helaan pembrolizumab ama placebo saddexdii toddobaadba mar afar wareeg (daawaynta neoadjuvant).
Ka dib, ugu badnaan saddex iyo toban wareeg (daawaynta adjuvant), bukaanada ayaa la maamulay mid ka mid ah wakiil-kaliya pembrolizumab ama placebo saddexdii toddobaadba mar. Daaqadda qalliinka iyo gaar ahaan kemotherabi ayaa laga heli karaa isku xirka calaamadda daawada ee sare.
Cabbiraadaha natiijada aasaasiga ah ee waxtarka leh waxay ahaayeen baaruhu-qiimeeyay badbaadada-free dhacdo (EFS) iyo guud ahaan badbaadada (OS). Dhexdhexaadinta OS ee kuwa helay placebo waxay ahayd 52.4 bilood (95% CI: 45.7, NE) oo laguma gaadhin cududda pembrolizumab (95% CI: lama qiyaasi karo [NE], NE]; p-value=0.0103). Saamiga khatarta ah [HR] wuxuu ahaa 0.72 [95% CI: 0.56, 0.93]; p-qiimaha=0.0103]. Dhexdhexaadinta EFS ee cududda placebo waxay ahayd 17 bilood (95% CI: 14.3, 22.0) marka la barbardhigo bilaha 17 ee cududda pembrolizumab (95% CI: 34.1 bilood, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-qiimaha=0.0001).
Dareen-celinta xun ee inta badan ay soo sheegaan 20% ama in ka badan bukaannada ku jira KEYNOTE-671 waxay ahaayeen sida soo socota: lallabbo, daal, neutropenia, dhiig-yaraan, calool-istaagga, rabitaanka cuntada oo yaraada, hoos u dhaca tirada unugyada dhiigga ee cad, muruq xanuun, finan, ciriiri, matag, shuban, iyo dyspnea.
Heer hoose oo is barbar dhig ah oo falcelin xun ayaa ka hortagay qalliin loogu talagalay 6% bukaannada ku jira gacanta pembrolizumab kuwaas oo helay daawaynta neoadjuvant, oo ka soo horjeeda 4.3% cududda placebo. Intaa waxaa dheer, 3.1% bukaannada helay daaweynta neoadjuvant iyo qalliinka cududda pembrolizumab waxay la kulmeen dib u dhac qalliin marka loo eego 2.5% cududda placebo. Macluumaadka badbaadada ee la xidhiidha wajiyada neoadjuvant iyo adjuvant waxa laga heli karaa isku xirka calaamadda daawada ee kor lagu sheegay.
Pembrolizumab waxaa lagu qoraa qiyaas dhan 200 mg 3 asbuuc kasta ama 400 mg 6 asbuuc kasta. Marka la qaato isla maalinta kiimoterabiga, pembrolizumab waa in la maamulaa ka hor.
