Rituximab plus chemotherapy waxaa u ogolaatay FDA ee tilmaamayaasha kansarka carruurta

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Maarso 2022: Maamulka Cuntada iyo Dawooyinka ayaa ansixiyay rituximab (Rituxan, Genentech, Inc.) iyada oo lala kaashanayo kiimoterabiga loogu talagalay CD20-positive diffuse big B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), ama qaan gaar ah. B-cell leukemia ba'an ee carruurta da'doodu tahay 6 bilood ilaa 18 sano (B-AL).

Inter-B-NHL Ritux 2010 (NCT01516580) waxay ahayd xarun caalami ah, calaamad furan, randomized (1: 1) tijaabada bukaanada da'doodu tahay 6 bilood iyo ka weyn oo aan hore loo daweyn, heer sare ah, CD20-positive DLBCL/BL/BLL/B -AL, oo ​​leh marxalad horumarsan oo lagu qeexay heerka III oo leh heerka lactose dehydrogenase (LDH) oo sarreeya (LDH oo ka weyn laba jeer xadka sare ee hay'adaha ee qiyamka caadiga ah) ama marxaladda IV B-cell NHL ama Lymphome Malin B (LMB) kiimoterabi (corticosteroids, vincristine) , cyclophosphamide, qiyaasta sare ee methotrexate, cytarabine, doxorubicin, etoposide, iyo daawo saddexle ah [methotrexate/cytarabine/corticosteroid] intrathecal therapy) ayaa la siiyay bukaanada kaligiis ama marka lagu daro rituximab ama non-US Sida ku cad qorshaha LMB, rituximab shati leh. waxaa loo maamulay sida lix faleebo oo rituximab IV ah oo ah qiyaasta 375 mg / m2 (2 qiyaasood inta lagu jiro mid kasta oo ka mid ah labada kalfadhi ee soo-saarka iyo hal dose inta lagu jiro mid kasta oo ka mid ah labada koorso ee xoojinta).

EFS waxaa lagu qeexay sida cudur ka sii dara, soo noqoshada, malignant labaad, dhimasho sabab kasta, ama jawaab la'aan sida lagu muujiyay ogaanshaha unugyada nool ee hadhaaga ka dib CYVE labaad (Cytarabine [Aracytine, Ara-C], Veposide [VP16]) daaweynta , kii soo hor maray. 328 bukaan oo la kala soocay oo leh dabagal dhexdhexaad ah oo ah sanadaha 3.1, daraasad ku meel gaar ah oo waxtarka leh ee 53 boqolkiiba macluumaadka ayaa la sameeyay. Kooxda LMB waxay lahaayeen 28 qaybood oo EFS ah, halka kooxda rituximab-LMB ay lahaayeen 10 (HR 0.32; 90 boqolkiiba CI: 0.17, 0.58; p=0.0012). Waxaa jiray 20 dhimasho oo ah cududda kiimoterabiga LMB wakhtiga falanqaynta ku-meel-gaadhka ah, marka la barbar dhigo 8 dhimashada rituximab iyo cududda kemotherabi LMB, guud ahaan badbaadada HR ee 0.36. (95 boqolkiiba CI: 0.16, 0.81). Badbaadada guud (OS) laguma marin imtixaan xisaabeed adag, natiijaduna waxa loo arkaa mid sifayn leh. Falanqaynta ku-meel-gaadhka ah ka dib, kala-soocidda ayaa la joojiyay, 122 bukaan oo dheeraad ah ayaa la siiyay rituximab oo lagu daray daawaynta LMB waxayna ka qayb qaadatay falanqaynta badbaadada.

qandho neutropenia, stomatitis, enteritis, sepsis, alanine aminotransferase sare, iyo hypokalemia ahaayeen dhacdooyinka xun ee ugu badan (fasalka 3 ama ka sareeya,> 15 boqolkiiba) ee bukaanada carruurta lagu daaweeyay rituximab iyo kiimoterabi. Sebsis, stomatitis, iyo enteritis waxay ka mid ahaayeen fasalka 3 ama jawaabaha xun xun ee ka sarreeya ee si joogto ah uga dhacay rituximab iyo cududda daawaynta LMB marka la barbar dhigo kiimoterabiga LMB. Labada nooc ee rituximab iyo LMB chemotherapy iyo LMB chemotherapy, dhacdooyinka xun xun ayaa ku dhacay 2% bukaanada.

Rituximab waxaa loo bixiyaa faleebo xididka ah oo lagu daray daawaynta nidaamka LMB ee qiyaasta 375 mg/m2. Lix faleebo oo rituximab ah ayaa la bixiyaa wadar ahaan, laba qiyaasood inta lagu jiro mid kasta oo ka mid ah koorasyada kicinta, COPDAM1 [cyclophosphamide, Oncovin (vincristine), prednisolone, Adriamycin (doxorubicin), methotrexate] iyo COPDAM2, iyo hal qiyaas midkiiba labada koorso ee xoojinta, CYM (Cytarabine [Aracytine, Ara-C], methotrexate

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