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I-Brentuximab vedotin ivunywe yi-FDA ngokuhlanganiswa ne-chemotherapy yeziguli zezingane ezine-classical Hodgkin lymphoma

I-Brentuximab vedotin

Yabelana ngalokhu okuthunyelwe

Novemba 2022: Inhlanganisela ye-doxorubicin, i-vincristine, i-etoposide, i-prednisone, ne-cyclophosphamide ene-brentuximab vedotin (i-Adcetris, Seagen, Inc.) ivunyelwe yi-Food and Drug Administration ukuze isetshenziswe ezinganeni nakubantu abadala abasebasha abane-Hodgkin lymphoma eyingozi kakhulu engazange uthole ukwelashwa esikhathini esidlule (cHL). Lokhu ukugunyazwa kokuqala kwezingane ze-brentuximab vedotin.

Isilingo esingahleliwe, esivulekile, esilawulwa ngokuqhubekayo sasetshenziswa ukuze kuhlolwe ukusebenza kahle. I-Stage IIB enesifo senqwaba e-Ann Arbor, Stage IIIB, Stage IVA, kanye ne-Stage IVB zonke zahlukaniswa njengengozi enkulu. I-Brentuximab vedotin plus doxorubicin (A), vincristine (V), etoposide (E), prednisone (P), ne-cyclophosphamide (C) [brentuximab vedotin + AVEPC] yanikezwa iziguli ezingu-300, kuyilapho i-A+bleomycin (B)+V+ I-E+P+C [ABVE-PC] inikezwe iziguli ezingama-300. Iziguli zengalo yokwelapha ngayinye bezingaba nemijikelezo emi-5 yalokhu okulandelayo:

I-Prednisone 20 mg/m2 BID (izinsuku 1-7), cyclophosphamide 600 mg/m2 (izinsuku 1 no-2), doxorubicin 25 mg/m2 (izinsuku 1 no-2), vincristine 1.4 mg/m2 (izinsuku 1 no-8), etoposide I-125 mg / m2 (izinsuku ezingu-1-3), kanye ne-brentuximab vedotin 1.8 mg / kg ngaphezu kwemizuzu ye-30 (usuku (izinsuku 1 no-2).
Ukusinda okungenamcimbi (EFS), okuyisikhathi esisuka ekwenziweni okungahleliwe kuya ekuqaleni kokuqhubekela phambili kwesifo noma ukuvela kabusha, ukonakala kwesibili, noma ukufa kunoma iyiphi imbangela, kusetshenziswe njengesilinganiso esiyinhloko somphumela wokusebenza ngempumelelo. Kuzo zombili izingalo akuzange kutholwe i-EFS emaphakathi. Ngenani elilinganayo lengozi ye-0.41 (95% CI: 0.25, 0.67; p = 0.0002), kwakukhona izenzakalo ze-52 (17%) engalweni ye-ABVE-PC kanye nemicimbi ye-23 (8%) engalweni ye-brentuximab vedotin + AVEPC.

In paediatric patients receiving brentuximab vedotin in combination with AVEPC, neutropenia, anaemia, thrombocytopenia, febrile neutropenia, stomatitis, and infection were the most frequent Grade 3 adverse events (5%).

Ezinganeni ezineminyaka engu-2 ubudala nangaphezulu, umthamo ophakanyisiwe we-brentuximab vedotin yi-1.8 mg / kg kuze kufike ku-180 mg ngokuhambisana ne-AVEPC njalo emavikini angu-3 ngenani eliphezulu le-5.

Buka imininingwane egcwele ye-Adcetris.

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