Maris 2022: Cibiyar Abinci da Magunguna ta amince da rituximab (Rituxan, Genentech, Inc.) tare da haɗin gwiwar chemotherapy don CD20-positive diffuse babban B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), ko girma B-cell m cutar sankarar bargo a cikin yara masu shekaru 6 zuwa shekaru 18 (B-AL).
Inter-B-NHL Ritux 2010 (NCT01516580) ya kasance cibiyar sadarwa ta duniya da yawa, alamar buɗewa, bazuwar (1: 1) gwaji na marasa lafiya masu shekaru 6 watanni da mazan tare da a baya ba a kula da su ba, matakin ci gaba, CD20-tabbatacce DLBCL/BL/BLL/B -AL, tare da ci gaba mataki da aka ayyana a matsayin Stage III tare da haɓakar lactose dehydrogenase (LDH) matakin (LDH mafi girma fiye da sau biyu na babban ma'auni na ƙimar al'ada) ko mataki IV B-cell NHL ko Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine). , cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, da sau uku magani [methotrexate/cytarabine/corticosteroid] intrathecal far) an bai wa marasa lafiya ko dai shi kadai ko a hade tare da rituximab ko wadanda ba Amurka ba bisa ga tsarin LMB, lasisin rituximab. an gudanar da shi azaman infusions shida na rituximab IV a kashi na 375 mg / m2 (2 allurai a yayin kowane zaman gabatarwa guda biyu da kashi ɗaya yayin kowane ɗayan darussan haɗin gwiwa guda biyu).
An bayyana EFS a matsayin cutar da ta fi muni, sake dawowa, rashin lafiya na biyu, mutuwa daga kowane dalili, ko rashin amsawa kamar yadda aka nuna ta hanyar gano kwayoyin halitta a cikin saura bayan CYVE na biyu (Cytarabine [Aracytine, Ara-C], Veposide [VP16]). , duk wanda ya zo na farko. A cikin marasa lafiya na 328 da aka bazu tare da matsakaicin matsakaici na shekaru 3.1, an yi nazarin tasiri na wucin gadi a kashi 53 cikin 28 na bayanan bayanan. Ƙungiyar LMB tana da sassan 10 EFS, yayin da ƙungiyar rituximab-LMB ke da 0.32 (HR 90; 0.17 bisa dari CI: 0.58, 0.0012; p=20). An sami mutuwar mutane 8 a hannun LMB chemotherapy a lokacin bincike na wucin gadi, idan aka kwatanta da mutuwar 0.36 a cikin rituximab da LMB hannun chemotherapy, don jimlar HR na rayuwa na 95. (0.16 bisa dari CI: 0.81, 122). Gabaɗaya rayuwa (OS) ba a yi gwajin ƙididdiga mai tsauri ba, kuma ana ɗaukar sakamakon siffantawa. Bayan binciken wucin gadi, an dakatar da bazuwar, kuma an ba da ƙarin marasa lafiya XNUMX rituximab tare da jiyya na LMB kuma sun ba da gudummawa ga nazarin aminci.
febrile neutropenia, stomatitis, enteritis, sepsis, haɓakar alanine aminotransferase, da hypokalemia sune abubuwan da suka fi dacewa (sa 3 ko mafi girma,> 15 bisa dari) a cikin marasa lafiya na yara da aka bi da su tare da rituximab tare da chemotherapy. Sepsis, stomatitis, da enteritis sun kasance a cikin aji na 3 ko mafi girma na martani mara kyau wanda ya faru akai-akai a cikin rituximab tare da hannun jiyya na LMB idan aka kwatanta da LMB chemotherapy. A cikin duka rituximab da LMB chemotherapy da LMB chemotherapy makamai, munanan abubuwa sun faru a cikin 2% na marasa lafiya.
Ana ba da Rituximab azaman jiko na jijiya a hade tare da tsarin tsarin LMB a kashi na 375 mg/m2. Ana ba da infusions shida na rituximab gabaɗaya, allurai biyu yayin kowane darussan ƙaddamarwa, COPDAM1 [cyclophosphamide, Oncovin (vincristine), prednisolone, Adriamycin (doxorubicin), methotrexate] da COPDAM2, da kashi ɗaya kowane ɗayan kwasa-kwasan ƙarfafawa guda biyu, CYM (Cytarabine [Aracytine, Ara-C], methotrexate
