Nov 2023: I-Nivolumab (i-Opdivo, i-Bristol-Myers Squibb Company) yagunyazwa yi-Food and Drug Administration njengokwelashwa kwe-adjuvant ye-Stage IIB/C melanoma ezigulini ezineminyaka engu-12 ubudala nangaphezulu ezazihlinzwe ngokuphelele.
Ocwaningweni olungahleliwe, oluyimpumputhe kabili i-CHECKMATE-76K (NCT04099251), ehlanganisa iziguli ze-790 ezine-Stage IIB/C melanoma, ukusebenza kahle kwahlolwa. I-placebo noma i-nivolumab engu-480 mg yafakwa emthanjeni ezigulini ngendlela engahleliwe (2:1) njalo emavikini amane isikhathi esingangonyaka owodwa, noma kuze kube yilapho kuphindeka isifo noma ubuthi obungamukeleki.
Ukukhishwa okuphelele kwe-primary melanoma enamamajini angalungile kanye ne-sentinel lymph node engalungile phakathi kwamaviki angu-12 ngaphambi kwe-randomization, kanye nesimo sokusebenza kwe-ECOG se-0 noma i-1, kwakuyizimfuneko zokubhalisa. Iziguli ezihlangabezane nenqubo yokufakwa kocwaningo zazingenayo i-ocular/uveal noma i-mucosal melanoma, isifo esizimele, noma yisiphi isimo esidinga ukwelashwa okuhleliwe nge-corticosteroids (okulingana noma okudlula i-10 mg ye-prednisone yansuku zonke) noma ezinye izidakamizwa ze-immunosuppressive, noma ukwelashwa kwangaphambili kwe-melanoma okunye. kunokuhlinzwa. I-AJCC 8th staging system edition stratification of randomization yaqashwa (T3b vs T4a vs T4b).
Isilinganiso esiyinhloko somphumela wokusebenza ngempumelelo kwaba ukusinda kokungaphindi (i-RFS), okuchazwe abaphenyi njengesikhathi esiphakathi kwe-randomization kanye nesehlakalo sokuqala sezehlakalo ezilandelayo—ukuvela kabusha kwe-metastasis yendawo, yesifunda, noma ekude, i-melanoma entsha eyinhloko, noma ukufa (kusuka kunoma iyiphi imbangela. ). Ukuhlola kwenziwa ngezikhathi zamasonto angama-26 kusukela onyakeni wokuqala kuya kwemithathu, bese kuthi njalo emavikini angama-52 eminyakeni emihlanu elandelayo. Kuzo zombili izingalo ze-nivolumab ne-placebo, i-RFS emaphakathi ayizange ifinyelelwe (95% CI: 28.5, ayifinyelelwanga; p-value<0.0001). Isilinganiso sengozi sasingu-0.42 [95% CI: 0.30, 0.59]; p-value ibingaphansi kuka-0.0001.
Ukuguquguquka kwemizwa, ubuhlungu bemisipha namathambo, i-pruritis, ukuqubuka, kanye nesifo sohudo kwakuyimiphumela emibi ebikwa kaningi (>20% yeziguli).
Iziguli ezinesisindo esingu-40 kg noma ngaphezulu ziyelulekwa ukuthi zithathe i-240 mg ye-nivolumab njalo emavikini ama-2 noma ama-480 mg njalo emavikini ama-4 kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki, isikhathi esingaphezu konyaka owodwa. Kuze kube unyaka owodwa, iziguli zezingane ezinesisindo esingaphansi kwama-40 kg zinqunywa umthamo we-3 mg/kg njalo emavikini amabili noma u-6 mg/kg njalo emavikini amane, kuze kube yilapho kwenzeka ukukhula kwesifo noma ubuthi obungamukeleki.
