Ubuvuzi bwa Brexu-cel CAR-T bwagaragaje ibisubizo byiza ku barwayi bakuru ba R/R B-ALL
Brexucabtagene autoleucel (brexu-cel), uburyo bwo kuvura selile za CD19 CAR-T, bwabaye uburyo bukomeye bwo kuvura leukemia ya B-cell acute lymphoblastic leukemia (B-ALL) yasubiwemo/isubirwamo (R/R) ku bantu bakuru. Dushingiye ku byavuye mu igerageza rya ZUMA-3, brexu-cel yemerewe muri Leta Zunze Ubumwe za Amerika ku barwayi bakuru barwaye R/R B-ALL. Ariko, ubushakashatsi bufatika ni ingenzi kugira ngo dusobanukirwe neza akamaro kayo n'umutekano wayo mu buvuzi. Ubushakashatsi buherutse gukorwa ku rwego runini bwasohotse mu kinyamakuru Ikinyamakuru cy'ubuvuzi bwa kanseri itanga ibitekerezo by'ingenzi ku mikorere ya brexu-cel mu itsinda rinini ry'abarwayi, igaragaza ibisubizo bishimishije ku gipimo cyo koroherwa no kubaho.
Incamake y'inyigo
Ubu bushakashatsi bwakorewe mu bigo byinshi bwakorewe ku barwayi 204 bakuru bafite R/R B-ALL bavuwe hanze y’igeragezwa ry’ubuvuzi mu bigo 31 by’ubuvuzi muri Leta Zunze Ubumwe za Amerika. Abarwayi 189 bose hamwe bahawe brexu-cel neza, hamwe n’imibare ine y’ubuvuzi bwabanje. Hafi kimwe cya kabiri cy’abarwayi bari barakorewe iterwa ry’uturemangingo tw’amaraso (HSCT), 59% bari barahawe blinatumomab, naho 48% bari baravuwe na inotuzumab ozogamicin. Mu gihe cy’indwara ya leukapheresis, 42% by’abarwayi bari mu kigero cyo kugabanuka kw’imiterere y’umubiri, ibi bikaba byari kubatandukanya n’igerageza rya mbere rya ZUMA-3.
Ibyavumbuwe by'ingenzi
Nyuma y'ikurikirana ry'igihe kingana n'amezi 11.4, ibyavuye mu bushakashatsi byagaragaje ko brexu-cel ifite akamaro gakomeye mu kuvura R/R B-ALL:
- Igisubizo cyuzuye (CR): 90% by'abarwayi bavuwe basubije neza, aho 79% bagaragaje ko indwara yasigaye ari nke cyane (MRD) idakira.
- Kurokoka Kudatera Imbere (PFS): Igipimo cya PFS cyari amezi 9.5.
- Kurokoka Muri Rusange (OS): Ntabwo ubuvuzi bw’ibanze bwagezweho, bigaragaza ko bishobora kugira ingaruka zirambye mu kongera igihe umurwayi akiriho.
- Ububi bwa MRD: Ku barwayi bapimwe MRD hakoreshejwe uburyo bwa clonoSEQ next-generation sequencing, MRD negativity ku munsi wa 28 yahujwe no kuba PFS na OS byari byiza, bishimangira agaciro ka MRD nk'ikimenyetso cy'uko hazabaho ubuhanuzi.
Ingaruka zo Gukoresha Uburyo Buhuriweho
Ubushakashatsi bwagaragaje ko abarwayi bahawe HSCT itera imbere nyuma yo kuvurwa na brexu-cel bari bafite PFS nziza cyane ugereranije n'abataragize ubuvuzi bwo gutera inkunga cyangwa bwo kubungabunga. Mu isesengura ryakozwe mu buryo bwinshi, HSCT (yakorewe abarwayi 30) nyuma ya CAR-T yagaragaye ko igabanya cyane ibyago byo kwiyongera kw'indwara (HR = 0.34).
Umwirondoro w'umutekano
Nubwo ubuvuzi bwa brexu-cel bufite akamaro, bwagaragaje ingaruka mbi zikomeye, ari nabyo by'ingenzi mu micungire y'ubuvuzi:
- Indwara yo Kurekura Cytokine (CRS) n'Uburozi bw'Imitsi (ICANS): CRS yagaragaye ku barwayi 84%, bafite ibibazo bikomeye (icyiciro cya 3-4) muri 11%. ICANS yagaragaye ku barwayi 56%, naho ibibazo bikomeye muri 31%.
- Impfu n'impfu zitagaruka: Mirongo itatu na bine ku ijana by'abarwayi bapfuye mu gihe cy'ubushakashatsi, 13% by'impfu zidafite aho zihuriye n'izamuka rya kanseri y'amaraso. Abarwayi icumi bapfuye mu minsi 28 ya mbere nyuma yo kuvurwa bazize uburozi cyangwa indwara zandura, cyane cyane mu bafite ikibazo gikomeye cy'indwara. Kwandura indwara za fungane ni byo byakunze gutera impfu ziterwa n'ubwandu, bigaragaza ko hakenewe uburyo bwo gucunga neza ubwandu.
Umwanzuro
Ibyavuye muri ubu bushakashatsi bw’ukuri bihuye n’ibyavuye mu igerageza rya ZUMA-3, byemeza igipimo cyo hejuru cya brexu-cel cy’indwara ya MRD-negative CR n’ingaruka nziza zo kubaho ku barwayi bakuru ba R/R B-ALL. Ariko, uburozi bukomeye, cyane cyane ICANS ikomeye n’impfu z’incuke, bigaragaza akamaro k’ingamba zo kugabanya ibyago, harimo no gukumira ubwandu no gukurikiranira hafi. Byongeye kandi, gukoresha uburyo bwo gutera umuti bwa HSCT nyuma ya CAR-T byagaragaye ko binoza ubuzima buzira umuze, bitanga inzira ishobora gutuma umurwayi arokoka neza.
Ubu bushakashatsi bugaragaza uruhare rwa brexu-cel nk'uburyo busanzwe bwo kuvura abantu bakuru barwaye R/R B-ALL, mu gihe bushimangira imbogamizi zikomeje kubaho mu gucunga ingaruka mbi zayo.