March 2022: I-Food and Drug Administration igunyaze i-rituximab (Rituxan, Genentech, Inc.) ngokuhlanganyela nokwelashwa ngamakhemikhali kwe-CD20-positive diffuse B-cell lymphoma enkulu (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), noma evuthiwe. I-B-cell acute leukemia ezinganeni ezineminyaka engu-6 kuya kweyi-18 (B-AL).
I-Inter-B-NHL Ritux 2010 (NCT01516580) ibiyisivivinyo se-multicenter emhlabeni jikelele, esivulekile, esingahleliwe (1:1) seziguli ezinezinyanga ezingu-6 nangaphezulu ezinesigaba esingazange selashwe, esithuthukisiwe, i-CD20-positive DLBCL/BL/BLL/B -AL, enesiteji esithuthukisiwe esichazwa njengeSigaba III esinezinga eliphakeme le-lactose dehydrogenase (LDH) (i-LDH engaphezu kokuphindwe kabili kunomkhawulo ongaphezulu wesikhungo wamanani avamile) noma isigaba IV B-cell NHL noma i-Lymphome Malin B (LMB) ukwelashwa ngamakhemikhali (i-corticosteroids, i-vincristine , i-cyclophosphamide, umthamo ophezulu we-methotrexate, i-cytarabine, i-doxorubicin, i-etoposide, nesidakamizwa esiphindwe kathathu [i-methotrexate/cytarabine/corticosteroid] i-intrathecal therapy) yanikezwa iziguli zizodwa noma zihlanganiswe ne-rituximab noma okungezona ezase-US Ngokohlelo lwe-LMB, i-rituximab enelayisensi yasetshenziswa njengama-infusions ayisithupha e-rituximab IV ngethamo lama-375 mg/m2 (imithamo emi-2 phakathi neseshini ngayinye yokungeniswa kanye nomthamo owodwa ngesikhathi ngasinye sezifundo ezimbili zokuhlanganisa).
I-EFS yachazwa njengesifo esibi kakhulu, ukuphindaphinda, ukonakala kwesibili, ukufa kunoma yisiphi isizathu, noma ukungaphenduli njengoba kuboniswa ukutholwa kwamaseli aphilayo endaweni eyinsalela ngemva kokwelashwa kwe-CYVE yesibili (Cytarabine [Aracytine, Ara-C], Veposide [VP16]) , noma yimuphi ofike kuqala. Ezigulini ezingama-328 ezingahleliwe ezinokulandelela okuphakathi kweminyaka engu-3.1, isifundo sesikhashana sokuphumelela kumaphesenti angu-53 wengxenyana yolwazi lwenziwa. Iqembu le-LMB libe neziqephu ze-EFS ezingu-28, kuyilapho iqembu le-rituximab-LMB linezi-10 (HR 0.32; 90 amaphesenti CI: 0.17, 0.58; p=0.0012). Kube nokufa kwabantu abangu-20 engalweni yokwelapha ngamakhemikhali ye-LMB ngesikhathi sokuhlaziywa kwesikhashana, uma kuqhathaniswa nokufa kwabantu abayisi-8 ku-rituximab kanye nengalo yokwelapha ngamakhemikhali ye-LMB, ku-HR isiyonke engu-0.36. (95 amaphesenti CI: 0.16, 0.81). Ukusinda sekukonke (i-OS) akuzange kube ngaphansi kokuhlolwa kwezibalo okuqinile, futhi umphumela uthathwa njengokuchazayo. Ngemva kokuhlaziywa kwesikhashana, i-randomization yamiswa, futhi iziguli ezengeziwe ezingu-122 zanikezwa i-rituximab kanye nokwelashwa kwe-LMB futhi zaba nesandla ekuhlaziyeni ukuphepha.
i-febrile neutropenia, i-stomatitis, i-enteritis, i-sepsis, i-alanine aminotransferase ephakeme, kanye ne-hypokalemia kwakuyizehlakalo ezimbi ezivame kakhulu (ibanga lesi-3 noma ngaphezulu, > amaphesenti angu-15) ezigulini zezingane eziphathwa nge-rituximab kanye ne-chemotherapy. I-Sepsis, i-stomatitis, kanye ne-enteritis bekuphakathi kwezimpendulo ezimbi zebanga lesi-3 noma ngaphezulu ezenzeka kaningi ku-rituximab kanye nengalo yokwelapha ye-LMB uma kuqhathaniswa nokwelashwa ngamakhemikhali kwe-LMB. Kuzo zombili izingalo ze-rituximab plus LMB chemotherapy nezingalo ze-LMB chemotherapy, izehlakalo ezimbi ezibulalayo zenzeke ku-2% weziguli.
I-Rituximab inikezwa njengokufakwa emthanjeni kuhlanganiswe nokwelashwa kwe-LMB okuhleliwe ngethamo lika-375 mg/m2. Imithamo eyisithupha ye-rituximab inikezwa isiyonke, imithamo emibili ngesikhathi ngasinye sezifundo zokungeniswa, i-COPDAM1 [cyclophosphamide, Oncovin (vincristine), i-prednisolone, i-Adriamycin (doxorubicin), i-methotrexate] ne-COPDAM2, kanye nomthamo owodwa isifundo ngasinye kulezi zifundo ezimbili zokuhlanganisa, i-CYM. (Cytarabine [Aracytine, Ara-C], methotrexate
