Nov 2023: Ezigulini zezingane ezinonyaka owodwa nangaphezulu ezinesigaba esingapheli (CP) Ph+ chronic myelogenous leukemia (CML), esanda kutholakala (ND) noma engazweli noma engabekezeleli (R/I) ekwelashweni kwangaphambilini, iFood and Drug Administration igunyaze i-bosutinib ( Bosulif, Pfizer). Ukwengeza, ifomu lethamo le-capsule elinoveli elino-50 mg kanye ne-100 mg lokugxila lavunywa yi-FDA.
Uhlolo lwe-BCHILD (NCT04258943) luhlole ukusebenza kahle kwe-bosutinib ezigulini zezingane ezine-ND CP Ph+ CML kanye ne-R/I CP Ph+ CML. Ukuhlolwa bekugxile ezintweni eziningi, okungahleliwe, futhi kunelebula elivulekile, elinemigomo yokunquma umthamo onconywayo, ukulinganisa ukuphepha nokubekezeleleka, ukuhlola ukusebenza kahle, nokuhlola. bosutinib i-pharmacokinetics kulesi sibalo sesiguli. Ukuhlolwa kwakuhlanganisa iziguli ezingu-21 ezine-ND CP Ph+ CML eziphathwa ku-300 mg/m2 kanye ngosuku kanye neziguli ezingu-28 ezine-R/I CP Ph+ CML eziphathwe nge-bosutinib ku-300 mg/m2 kuya ku-400 mg/m2 ngomlomo kanye ngosuku.
Impendulo enkulu ye-cytogenetic (MCyR), impendulo ephelele ye-cytogenetic (CCyR), kanye nempendulo enkulu yamangqamuzana (MMR) bekungamamethrikhi womphumela wokusebenza kahle oyinhloko. Izimpendulo ezinkulu (MCyR) neziphelele (CCyR) ze-cytogenetic zeziguli zezingane ezine-ND CP Ph+ CML zazingu-76.2% (95% CI: 52.8, 91.8) kanye no-71.4% (95% CI: 47.8, 88.7), ngokulandelana. I-28.6% (95% CI: 11.3, 52.3) yayiyi-MMR, futhi izinyanga ezingu-14.2 kwakuyinkathi yokulandelela emaphakathi (ububanzi: 1.1, 26.3 izinyanga).
Izimpendulo ezinkulu (MCyR) neziphelele (CCyR) ze-cytogenetic zeziguli zezingane ezine-R/I CP Ph+ CML zazingu-82.1% (95% CI: 63.1, 93.9) kanye no-78.6% (95% CI: 59, 91.7), ngokulandelana. I-50% (95% CI: 30.6, 69.4) yayiyi-MMR. Iziguli ezimbili kweziyi-14 ezafinyelela ku-MMR zalahlekelwa yi-MMR ngemva kokuthola ukwelashwa izinyanga eziyi-13.6 nezingu-24.7, ngokulandelana. Ukulandelela kwezinyanga ezingu-23.2 kwakuyi-median (ububanzi: 1, 61.5 izinyanga).
Phakathi kweziguli zezingane, isifo sohudo, ubuhlungu besisu, ukuhlanza, isicanucanu, ukuqubuka, ukukhathala, ukungasebenzi kahle kwesibindi, ikhanda elibuhlungu, i-pyrexia, ukuncipha kwesifiso sokudla, nokuqunjelwa kwakuyimiphumela emibi ebikwa kaningi (≥20%). Ezigulini zezingane, ukwanda kwe-creatinine, ukwanda kwe-alanine aminotransferase noma i-aspartate aminotransferase, ukwehla kwenani lamangqamuzana egazi amhlophe, nokuncipha kwenani leplatelet kwakuyizinto ezingavamile zaselabhorethri ezivame kakhulu eziye zaba zimbi kakhulu kusukela kwesisekelo (≥45%).
Ezigulini zezingane ezine-ND CP Ph+ CML, umthamo onconyiwe we-bosutinib ngu-300 mg/m2 ngomlomo kanye ngosuku ngokudla; ezigulini zezingane ezine-R/I CP Ph+ CML, umthamo onconyiwe ngu-400 mg/m2 ngomlomo kanye ngosuku ngokudla. Okuqukethwe ama-capsules kungahlanganiswa ne-yoghurt noma i-apulauce kubantu abangakwazi ukuwagwinya.
