Noofambar 2023: Nivolumab (Opdivo, Bristol-Myers Squibb Company) waxa oggolaaday Maamulka Cunnada iyo Dawooyinka sida daawaynta adjuvant ee Marxaladda IIB/C melanoma ee bukaanada 12 sano jir iyo ka weyn ee maray dib-u-eegis dhamaystiran.
Tijaabo aan kala sooc lahayn, laba-indho la'aan CHECKMATE-76K (NCT04099251), oo ay ku jiraan 790 bukaan oo qaba Stage IIB/C melanoma, waxtarka ayaa la qiimeeyay. A placebo ama 480 mg nivolumab ayaa xididka laga siiyay bukaanada qaab aan kala sooc lahayn (2:1) afartii toddobaadba mar ugu badnaan hal sano, ama ilaa uu cudurku soo noqnoqonayo ama sun aan la aqbali karin ayaa dhacay.
A complete resection of the primary melanoma with negative margins and a negative sentinel lymph node within 12 weeks prior to randomization, as well as an ECOG performance status of 0 or 1, were prerequisites for enrollment. Patients who met the inclusion criteria for the trial did not have ocular/uveal or mucosal melanoma, autoimmune disease, any condition necessitating systemic treatment with corticosteroids (equivalent to or exceeding 10 mg of daily prednisone) or other immunosuppressive drugs, or prior melanoma therapy other than surgery. AJCC 8th staging system edition stratification of randomization was employed (T3b versus T4a versus T4b).
Qiyaasta natiijada waxtarka aasaasiga ah waxay ahayd badbaadada xorta ah ee soo noqnoqda (RFS), taas oo baarayaashu ku qeexeen wakhtiga u dhexeeya randomization iyo ugu horrayn ee dhacdooyinka soo socda-maxali, gobol, ama soo noqnoqoshada metastasis fog, melanoma cusub, ama dhimasho ( sabab kasta ha ahaatee ). Qiimaynta waxaa la sameeyay 26-usbuuc u dhexeeya sannadaha koowaad ilaa saddex, ka dibna 52 toddobaad kasta shanta sano ee soo socota. Labada hubka nivolumab iyo placebo, dhexdhexaadiyaha RFS lama gaarin (95% CI: 28.5, lama gaarin; p-qiimaha <0.0001). Saamiga khatarta wuxuu ahaa 0.42 [95% CI: 0.30, 0.59]; p-qiimaha wuxuu ka yaraa 0.0001.
Isbeddelka dareenka, xanuunka murqaha, cuncunka, finan, iyo shuban ayaa ah kuwa ugu badan ee la soo sheego saameynta xun (> 20% bukaannada).
Bukaannada miisaankoodu yahay 40 kg ama ka badan waxaa lagula talinayaa inay qaataan 240 mg oo nivolumab ah 2 asbuuc kasta ama 480 mg 4 asbuuc kasta ilaa cudurku ka sii socdo ama sunta aan la aqbali karin, ugu badnaan hal sano. Ilaa hal sano, bukaannada carruurta ee miisaankoodu ka yar yahay 40 kg ayaa loo qoraa qiyaasta 3 mg / kg labadii toddobaadba mar ama 6 mg / kg afartii toddobaadba mar, ilaa uu cudurku ka sii socdo ama sunta aan la aqbali karin.
