March 2022: Chikafu neDrug Administration yakabvumidza rituximab (Rituxan, Genentech, Inc.) pamwe chete nechemotherapy yeCD20-positive diffuse hombe B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), kana yakakura. B-cell acute leukemia muvana vane mwedzi mitanhatu kusvika kumakore gumi nemasere (B-AL).
Inter-B-NHL Ritux 2010 (NCT01516580) yaive yepasirese yakawanda, yakavhurika-label, randomized (1: 1) muedzo wevarwere vane makore 6 mwedzi uye kupfuura vane kare vasina kurapwa, nhanho yepamusoro, CD20-positive DLBCL/BL/BLL/B -AL, ine danho repamusoro rinotsanangurwa seStage III ine yakakwira lactose dehydrogenase (LDH) nhanho (LDH inodarika kaviri chiyero chepamusoro chepamusoro chetsika) kana danho IV B-cell NHL kana Lymphome Malin B (LMB) chemotherapy (corticosteroids, vincristine , cyclophosphamide, high-dose methotrexate, cytarabine, doxorubicin, etoposide, uye katatu mushonga [methotrexate/cytarabine/corticosteroid] intrathecal therapy) yakapiwa kuvarwere vari voga kana kuti pamwe chete ne rituximab kana kuti isiri US Maererano nechirongwa cheLMB, chine rezinesi rituximab. yaishandiswa sezvitanhatu infusions ye rituximab IV pachiyero che 375 mg / m2 (2 doses panguva imwe neimwe yezvikamu zviviri zvekupinza uye imwe yero panguva imwe neimwe yezvidzidzo zviviri zvekusimbisa).
EFS yakatsanangurwa sechirwere chinowedzera, kudzokazve, chirwere chechipiri, kufa kubva kune chero chikonzero, kana kusapindura sezvakaratidzwa nekuonekwa kwemasero mhenyu mune zvakasara mushure mechipiri CYVE (Cytarabine [Aracytine, Ara-C], Veposide [VP16]) kurapwa. , chero ipi zvayo yakatanga. Mune 328 randomized varwere vane yepakati yekutevera yemakore 3.1, chidzidzo chenguva pfupi chekubudirira pa 53 muzana chikamu chemashoko chakaitwa. Boka reLMB raive nezvikamu makumi maviri nemasere zveEFS, nepo rituximab-LMB boka raive negumi (HR 28; 10 muzana CI: 0.32, 90; p=0.17). Pakave nerufu makumi maviri muLMB chemotherapy ruoko panguva yekuongororwa kwechinguvana, zvichienzaniswa nerufu makumi masere mu rituximab pamwe neLMB chemotherapy ruoko, yekurarama kwese kweHR kwe0.58. (0.0012 muzana CI: 20, 8). Kupona kwese (OS) hakuna kuiswa pasi pekuyedzwa kwenhamba, uye mhedzisiro yacho inoonekwa seinotsanangura. Mushure mekuongororwa kwechinguvana, kurongeka kwakamiswa, uye vamwe varwere ve0.36 vakapihwa rituximab pamwe neLMB kurapwa uye vakabatsira mukuwongorora kwekuchengetedza.
febrile neutropenia, stomatitis, enteritis, sepsis, yakakwira alanine aminotransferase, uye hypokalemia ndiyo yakajairika zviitiko zvakashata (giredhi 3 kana kupfuura,> 15 muzana) muvarwere vevana vaibatwa ne rituximab pamwe nekemotherapy. Sepsis, stomatitis, uye enteritis zvaive pakati pegiredhi 3 kana yepamusoro mhinduro dzakaipa dzakaitika kakawanda mu rituximab pamwe neLMB ruoko rwekurapa zvichienzaniswa neLMB chemotherapy. Mune ese ari maviri rituximab pamwe neLMB chemotherapy uye LMB chemotherapy maoko, zvinouraya zviitiko zvakashata zvakaitika mu2% yevarwere.
Rituximab inopiwa semutsinga wekupinda muropa pamwe chete nesystemic LMB kurapwa pachiyero che 375 mg/m2. Matanhatu infusions ye rituximab anopiwa akazara, miviri miviri panguva imwe neimwe yezvidzidzo zvekudzidzira, COPDAM1 [cyclophosphamide, Oncovin (vincristine), prednisolone, Adriamycin (doxorubicin), methotrexate] uye COPDAM2, uye imwe yero imwe neimwe yezvidzidzo zviviri zvekubatanidza, CYM. (Cytarabine [Aracytine, Ara-C], methotrexate