6 Mashi 2024: Inotuzumab ozogamicin (Besponsa, Pfizer) inikezwe imvume yi-Food and Drug Administration yokwelashwa kwe-CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL) ezigulini zezingane ezinonyaka owodwa nangaphezulu.
Ukuphumelela kokwelashwa kwahlolwa ocwaningweni olwenziwa ezikhungweni eziningi, olubandakanya iziguli zezingane ezingama-53 ezinonyaka ongu-1 nangaphezulu ezazibuyelwe kabusha noma ezazine-CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). Ucwaningo luhlole amazinga ethamo amabili ahlukene: umthamo wokuqala we-1.4 mg/m2/umjikelezo kubantu abayi-12 kanye nomthamo we-1.8 mg/m2/umjikelezo kubahlanganyeli abangama-41. Imithi eyasetshenziswa ngaphambili kwakuyi-methylprednisolone esikalini se-1 mg ngekhilogremu (nomkhawulo omkhulu we-50 mg), i-antipyretic, ne-antihistamine. Iziguli zithole imijikelezo emi-2 yokwelashwa, enobubanzi obuyimijikelezo engu-1 kuye kwemi-4.
Iziphetho eziyinhloko zokusebenza kwaba ukukhululwa okuphelele (CR), ubude besikhathi i-CR eyahlala ngaso, kanye nephesenti leziguli ezithole ukukhululwa okuphelele ngaphandle kwesifo esincane esitholakalayo esisalayo (MRD) esikhona. Ukukhululwa okuphelele (CR) kubonakala ngokuba khona kokuqhuma okungaphansi kuka-5% emnkantsheni kanye nokungabikho kokuqhuma kwe-leukemia egazini le-peripheral. Ukwengeza, i-CR idinga ukubuyiselwa kwezibalo zegazi ezivamile (ama-platelet alingana noma angaphezu kuka-100 × 109 kanye nenani eliphelele le-neutrophil elilingana noma elingaphezu kuka-1 × 109/L), kanye nokuxazululwa kwanoma yisiphi isifo se-extramedullary. Isifo esincane esisalayo (MRD) sibonakala ngokuba khona kwamaseli e-leukemic okubalwa ngaphansi kwe-1 x 10-4 (ngaphansi kuka-0.01%) wengqikithi yamaseli e-nucleated yomnkantsha wamathambo, njengoba kunqunywa i-cytometry yokugeleza noma i-PCR.
Kuzo zonke iziguli, i-22 kwezingu-53 (42%, 95% CI: 28.1, 55.9%) izuze ukukhululwa okuphelele (CR), nesikhathi esimaphakathi sezinyanga ezingu-8.2 (95% CI: 2.6, NE). Isigameko sokungabi nalutho kwe-MRD ezigulini ezinokuxolelwa okuphelele (CR) kwakuyi-21 ngaphandle kwe-22, ehambisana ne-95.5% (isikhathi sokuzethemba esingu-95%: 77.2, 99.9) ngokusho kwe-cytometry yokugeleza. Ngokusekelwe ku-RQ-PCR, izinga lokungabi nalutho kwe-MRD lalingu-19 kokungu-22, okulingana no-86.4% (isikhawu sokuzethemba esingu-95%: 65.1, 97.1).
Imiphumela emibi evelele (≥20%), ehlanganisa ukungahambi kahle kokuhlolwa, kwakuyi-thrombocytopenia, i-pyrexia, i-anemia, ukuhlanza, ukutheleleka, ukopha, i-neutropenia, isicanucanu, i-leukopenia, i-febrile neutropenia, ama-transaminase aphezulu, ukungakhululeki kwesisu, kanye nekhanda elibuhlungu.
Umthamo wokuqala we inotuzumab ozogamicin for the first cycle is 1.8 mg/m2 per cycle. This dose should be given in three separate doses on Day 1 (0.8 mg/m2), Day 8 (0.5 mg/m2), and Day 15 (0.5 mg/m2). Cycle 1 has a period of 3 weeks, although it can be prolonged to 4 weeks if the patient achieves complete remission or complete remission with incomplete hematologic recovery, and/or to allow for recovery from toxicity. Refer to the prescribed directions for the recommended dosage following the initial cycle.
