Janaayo 2022: Bukaannada qaangaarka ah ee leh burooyinka unugga unugyada epithelioid ee xuubka xuubka xididdada dhiigga ee aan la sixin karin ama metastatic, Maamulka Cuntada iyo Dawooyinka ayaa shati u haysta Qaybaha borotiinka ku xidhan sirolimus ee ka joojinta la isku duro (albumin-ku xidhan) (Fyarro, Aadi Bioscience, Inc.) (PEComa).
Efficacy was tested in 31 patients with locally advanced unresectable or metastatic malignant PEComa in AMPECT (NCT02494570), a multicenter, single-arm clinical study. On days 1 and 8 of each 21-day cycle, patients received 100 mg/m2 sirolimus protein-bound particles until disease progression or intolerable toxicity.
Heerka jawaabta guud (ORR) iyo muddada jawaabta (DOR) waxay ahaayeen cabbirada natiijooyinka waxtarka ee muhiimka ah, sida lagu go'aamiyay dib-u-eegis madax-bannaan oo madax-bannaan oo indha la' iyadoo la adeegsanayo RECIST v.1.1. ORR wuxuu ahaa 39 boqolkiiba (95 boqolkiiba CI: 22 boqolkiiba, 58 boqolkiiba), iyadoo laba bukaan ay si buuxda uga jawaabeen. Dhexdhexaadka DOR lama buuxin (95 boqolkiiba CI: 6.5 bilood, lama qiyaasi karo). 67 boqolkiiba jawaab bixiyaasha ayaa helay jawaab socotay in ka badan 12 bilood, iyo 58 boqolkiiba waxay heleen jawaab socotay in ka badan 24 bilood.
Stomatitis, daal, finan, caabuq, lallabbo, edoema, shuban, raaxo la'aanta muruqyada, miisaanka oo yaraada, rabitaanka cuntada oo yaraada, qufaca, matagga, iyo dysgeusia ayaa ahaa dhacdooyinka ugu badan ee dhinaca (boqolkiiba 30). Limfosaytis hoos u dhaca, gulukoosta oo kordha, potassium hoos u dhaca, fosfooraska hoos u dhaca, hoos u dhaca haemoglobin, iyo lipase sare ayaa ah kuwa ugu badan ee aan caadiga ahayn ee shaybaadhka 3 ilaa 4 (6%).
Ilaa uu cudurku ka sii socdo ama sunta aan loo dulqaadan karin, qiyaasta lagu taliyey waa 100 mg/m2 la siiyay faleebo IV ah 30 daqiiqo maalmaha 1 iyo 8 ee wareeg kasta oo 21-maalmood ah.
Click this link for full prescribing information for Fyarro.
