Jan 2022: Ezigulini ezikhulile ezinamaqhubu amaseli e-perivascular epithelioid athuthukisiwe athuthukile endaweni yangakini, i-Food and Drug Administration inelayisensi izinhlayiya ze-sirolimus eziboshwe ngamaprotheni zokumiswa komjovo (i-albumin-bound) (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.
Isilinganiso sokuphendula sisonke (i-ORR) nobude besikhathi sokuphendula (DOR) bekuyizinyathelo ezibalulekile zemiphumela esebenza ngempumelelo, njengoba kunqunywe ukubuyekezwa okuzimele okuphuphuthekile kusetshenziswa i-RECIST v.1.1. I-ORR yayingamaphesenti angu-39 (amaphesenti angu-95 CI: amaphesenti angu-22, amaphesenti angu-58), neziguli ezimbili eziphendula ngokuphelele. I-DOR emaphakathi ayizange ihlangane (amaphesenti angu-95 CI: izinyanga ezingu-6.5, azinakulinganiswa). Amaphesenti angu-67 abaphendulile abe nempendulo eyathatha izinyanga ezingaphezu kwezingu-12, kanti amaphesenti angu-58 abe nempendulo eyathatha izinyanga ezingaphezu kwezingu-24.
I-stomatitis, ukukhathala, ukuqubuka, ukutheleleka, isicanucanu, i-edeema, isifo sohudo, ukungakhululeki kwemisipha namathambo, ukuncipha kwesisindo, ukuncipha kwesifiso sokudla, ukukhwehlela, ukuhlanza, kanye ne-dysgeusia kwakuyizehlakalo eziseceleni ezivame kakhulu (amaphesenti angama-30). Ukuncipha kwama-lymphocyte, ukukhuphuka kweglucose, ukwehla kwe-potassium, ukuncipha kwe-phosphate, ukuncipha kwe-hemoglobin, kanye ne-lipase ephakeme kwakuyizinto ezivame kakhulu ezingavamile zaselabhorethri zebanga lesi-3 ukuya kwelesi-4 (6%).
Kuze kube yilapho isifo siqhubeka noma ubuthi obungabekezeleleki, umthamo onconyiwe ngu-100 mg/m2 onikezwe njengomuthi we-IV ngaphezu kwemizuzu engama-30 ngosuku loku-1 no-8 lomjikelezo ngamunye wezinsuku ezingama-21.
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