November 2022: Iko kusanganiswa kwe doxorubicin, vincristine, etoposide, prednisone, uye cyclophosphamide ine brentuximab vedotin (Adcetris, Seagen, Inc.) yakagamuchirwa neChikafu neDrug Administration kuti ishandiswe muvana nevakuru vechidiki vane njodzi yakakura yeHodgkin lymphoma vasina akawana kurapwa munguva yakapfuura (cHL). Iyi ndiyo brentuximab vedotin yekutanga mvumo yevana.
A randomised, open-label, kushingaira kudzorwa kuedza kwakashandiswa kuongorora kushanda. Nhanho IIB ine chirwere chakawanda muAnn Arbor, Stage IIIB, Stage IVA, uye Stage IVB zvese zvakaiswa munjodzi huru. Brentuximab vedotin plus doxorubicin (A), vincristine (V), etoposide (E), prednisone (P), uye cyclophosphamide (C) [brentuximab vedotin + AVEPC] yakapiwa kuvarwere ve300, nepo A + bleomycin (B) + V+ E+P+C [ABVE-PC] yakapihwa kuvarwere mazana matatu. Varwere vemaoko ega ega ekurapa vaigona kunge vaine mitsetse ye300 yeanotevera:
Prednisone 20 mg/m2 BID (mazuva 1-7), cyclophosphamide 600 mg/m2 (mazuva 1 ne2), doxorubicin 25 mg/m2 (mazuva 1 ne2), vincristine 1.4 mg/m2 (mazuva 1 ne8), etoposide 125 mg / m2 (mazuva 1-3), uye brentuximab vedotin 1.8 mg / kg pamusoro pemaminitsi makumi matatu (zuva (mazuva 30 uye 1).
Chiitiko-isina kupona (EFS), inova nguva kubva pakusarudzika kusvika kune yekutanga kufambira mberi kwechirwere kana kudzokazve, hutsinye hwechipiri, kana kufa kubva kune chero chikonzero, yakashanda seyekutanga kubudirira kwemhedzisiro chiyero. Hapana ruoko rwakanga rwuri mukati meEFS yakawanikwa. Nekuenzaniswa kwengozi ye0.41 (95% CI: 0.25, 0.67; p = 0.0002), pane zviitiko zve52 (17%) muABVE-PC ruoko uye 23 zviitiko (8%) mu brentuximab vedotin + AVEPC ruoko.
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%).
Kune vana vane makore 2 uye kupfuura, iyo inonzi brentuximab vedotin dose ndeye 1.8 mg / kg kusvika ku 180 mg pamwe chete ne AVEPC masvondo ose e3 nokuda kwehuwandu hwe5 doses.
Wona ruzivo rwakazara rwekurayira kweAdcetris.
