Zvita 2022: Atezolizumab (Tecentriq, Genentech, Inc.) yakabvumidzwa neFood and Drug Administration (FDA) yevakuru nevana varwere vane unresectable kana metastatic alveolar soft part sarcoma vane makore maviri ezera kana kupfuura (ASPS).
MuChidzidzo ML39345 (NCT03141684), chidzidzo chakazaruka, chidzidzo cheruoko chimwechete chinosanganisira 49 vanhu vakuru nevana vane metastatic kana kusagadziriswa ASPS, kushanda kwakaongororwa. A ECOG performance status ye2 uye histologically or cytologically proven ASPS isingarapike nekuvhiyiwa ndizvo zvaidiwa kuti ukwanise. Varwere vakarambidzwa kana vaine kenza yepakati penheyo system (CNS) kana symptomatic CNS metastases, chirwere chakakosha chechiropa, nhoroondo yekuronga pneumonia, pneumonitis, kana inoshanda pneumonitis pakufungidzira. Varwere vevana vakawana 15 mg/kg (kusvika pakukwirira kwe1200 mg) intravenously kamwe chete mazuva e21 kusvika kufambira mberi kwechirwere kana kutyisa kusingagoneki. Varwere vakuru vakagamuchira 1200 mg intravenously.
Kuwanda kwekupindura (ORR) uye nguva yekupindura (DOR), iyo yakatemerwa nekomiti yakazvimirira yekuongorora inoshandisa RECIST v1.1, ndiyo yaive yekutanga efficacy mhedzisiro matanho. (95% CI: 13, 39), ORR yaiva 24%. Makumi matanhatu nemanomwe muzana yevarwere gumi nevaviri vaive nechinangwa chemhinduro vaive neDOR yemwedzi mitanhatu kana kupfuura, uye 12 muzana yaive neDOR yemwedzi gumi nembiri kana kupfuura.
Age yemurwere wepakati aive makore 31 (rudzi rwaive 12-70); pakanga paine 47 varwere vakuru (2% vavo vaiva nemakore anopfuura 65) uye 2 varwere vevana (vane makore gumi nemaviri); 12% yevarwere vaiva vakadzi; 51% vaiva Vachena; 55% vaive vatema kana vemuAfrica vekuAmerica; uye 29% vaiva vokuAsia.
Zvakanyanya kuipa (15%) zvaive musculoskeletal kurwadziwa (67%), kuneta (55%), kuputika, kukosora, kusvotwa, musoro, uye hypertension (43% imwe neimwe), kuvimbiswa, dyspnea, dzungu, uye kubuda ropa (29% imwe neimwe), yakaderera kudya uye arrhythmia (22 muzana imwe neimwe), chirwere chefuruwenza, kuora muviri, uye allergic rhinitis anaphylaxis (18% imwe neimwe).
Varwere vakura vanofanira kutora atezolizumab pachiyero che 840 mg mavhiki maviri ega ega, 1200 mg mavhiki matatu ega ega, kana 1680 mg mavhiki mana ega ega kusvikira chirwere chavo chakura kana mhedzisiro isingashivirike. Vana vane makore maviri ekuberekwa zvichikwira vanofanira kuwana 2 mg/kg (kusvika ku15 mg) masvondo matatu oga oga kusvikira mamiriro acho achikura kana kuti pane huturu husingaregi.
View full prescribing information for Tecentriq.
