Nov 2023: Nivolumab (Opdivo, Bristol-Myers Squibb Kambani) yakapihwa mvumo neFood and Drug Administration senzira yekurapa yeStage IIB/C melanoma muvarwere vane makore gumi nemaviri zvichikwira vaive vaitwa resection yakakwana.
Mune randomized, double-blind trial CHECKMATE-76K (NCT04099251), iyo yaisanganisira varwere ve790 vane Stage IIB / C melanoma, kushanda kwakaongororwa. A placebo kana 480 mg nivolumab yaishandiswa intravenously kuvarwere nenzira isina kujairika (2: 1) vhiki imwe neimwe kwemavhiki mana kwepamusoro kwegore rimwe, kana kusvika kudzoka kwechirwere kana chepfu isingagamuchirwi yakaitika.
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).
Chiyero chekutanga chekubudirira kwemhedzisiro yaive yekudzokorora-isina kupona (RFS), iyo vaongorori vakatsanangura senguva pakati pe randomisation uye yekutanga yezviitiko zvinotevera-yemunharaunda, yedunhu, kana kure kure metastasis kudzokorora, nyowani yekutanga melanoma, kana kufa (kubva kune chero chikonzero. ) Ongororo dzakaitwa panguva dze26-vhiki kubva pagore rekutanga kusvika kumatatu, uyezve mavhiki makumi mashanu neshanu ega ega kwemakore mashanu anotevera. Mune ese ari maviri nivolumab uye placebo maoko, iyo yepakati RFS haina kuwanikwa (52% CI: 95, isina kusvika; p-kukosha <28.5). Chiyero chengozi chaive 0.0001 [0.42% CI: 95, 0.30]; p-value yaive isingasviki 0.59.
Kuchinja-chinja kwemafungiro, marwadzo emusculoskeletal, pruritis, rash, uye manyoka ndiyo yaiwanzotaurwa yakashata (> 20% yevarwere).
Varwere vanoyera 40 kg kana kupfuura vanorayirwa kuti vatore 240 mg ye nivolumab masvondo ose e2 kana 480 mg masvondo ose e4 kusvikira kufambira mberi kwechirwere kana chepfu isingagamuchirwi, kwepamusoro pegore rimwe. Kwegore rimwe chete, varwere vevana vanorema zvishoma kudarika 40 kg vanorayirwa chiyero che 3 mg / kg mavhiki maviri oga oga kana 6 mg / kg mavhiki mana oga oga, kusvikira kufambira mberi kwechirwere kana huturu husingagamuchirwi huchiitika.
