Fabrairu 2023: Cibiyar Abinci da Magunguna (FDA) ta amince da sacituzumab govitecan-hziy (Trodelvy, Gileyad Sciences, Inc.) ga mutanen da ke da maganin hormone (HR) - tabbatacce, HER2-negative (IHC 0, IHC 1+, ko IHC 2+/ ISH-) ciwon nono wanda ya yadu zuwa wasu sassan jiki kuma ba za a iya cirewa ba. Waɗannan mutane kuma sun sami wasu aƙalla wasu hanyoyin kwantar da hankali guda biyu a cikin yanayin haɓaka.
TROPiCS-02 (NCT03901339) wani nau'i ne mai yawa, alamar budewa, nazarin bazuwar wanda ya dubi yadda mai hana CDK 4/6, maganin endocrin, da kuma haraji ya yi aiki a cikin mata 543 tare da HR-tabbatacce, HER2-negative ciwon nono wanda ya yada. ko kuma an kasa cirewa. Ciwon marassa lafiyar ya yi tsanani bayan sun sami ɗayan waɗannan jiyya. Aƙalla magungunan chemotherapies guda biyu da aka yi amfani da su a baya ga marasa lafiya da cututtukan ƙwayar cuta (ɗayan wanda zai iya kasancewa a cikin neoadjuvant ko adjuvant saitin idan sake dawowa ya faru a cikin watanni 12).
An ba da marasa lafiya bazuwar (1: 1) don karɓar ko dai wakili guda ɗaya na chemotherapy (n = 271) ko sacituzumab govitecan-hziy, 10 mg / kg a matsayin jiko na ciki, a kan Kwanaki 1 da 8 a cikin sake zagayowar 21-day. Kafin bazuwar, mai binciken ya zaɓi tsarin maganin chemotherapy guda ɗaya daga ɗayan zaɓuɓɓuka masu zuwa: capecitabine (n=22), vinorelbine (n=63), gemcitabine (n=56), ko eribulin (n=130). Maganin maganin chemotherapy na farko don cututtukan cututtuka (2 vs. 3-4), visceral metastasis (Ee ko A'a), da kuma maganin endocrin a cikin tsarin metastatic na akalla watanni 6 duk an yi amfani da su don ƙaddamar da bazuwar (Ee ko A'a). Marasa lafiya sun sami magani har zuwa farkon illolin da ba za a yarda da su ba.
Rayuwa marar ci gaba (PFS), kamar yadda aka ayyana ta hanyar nazari na tsakiya mai zaman kansa mai zaman kansa daidai da RECIST v1.1, ya zama ma'aunin sakamako na farko. Gabaɗaya rayuwa shine ma'aunin ingancin inganci na biyu (OS). Matsakaicin PFS na hannun sacituzumab govitecan-hziy ya kasance watanni 5.5 (95% CI: 4.2, 7.0) kuma ga hannun ƙwayar cuta guda ɗaya shine watanni 4 (95% CI: 3.1, 4.4) (haɗarin rabo [HR] na 0.661 [HR] 95% CI: 0.529, 0.826]; p-darajar = 0.0003). Ga waɗanda ke samun sacituzumab govitecan-hziy, matsakaicin OS ya kasance watanni 14.4 (95% CI: 13.0, 15.7), yayin da waɗanda ke karɓar maganin chemotherapy guda ɗaya, watanni 11.2 ne (95% CI: 10.1, 12.7) (HR na 0.789). 95% CI: 0.646, 0.964]; p-darajar = 0.0200).
Rage adadin leukocyte (88%), rage yawan neutrophils (83%), raguwar haemoglobin (73%), raguwar adadin lymphocyte (65%), gudawa (62%), gajiya (60%), tashin zuciya (59%), alopecia. (48%), karuwar glucose (37%), maƙarƙashiya (34%), da raguwar albumin (32%) sune mafi yawan abubuwan da suka faru (25%) a cikin marasa lafiya da aka yi wa sacituzumab govitecan-hziy a cikin TROPiCS-02.
A ranakun 1 da 8 na sake zagayowar kwanaki 21, 10 mg/kg na sacituzumab govitecan-hziy ya kamata a shayar da shi a cikin intravenously sau ɗaya a mako har sai cutar ta yi muni ko kuma illar da ke tattare da ita ta yi yawa don ɗaukar nauyi, duk wanda ya fara zuwa.
Project Orbis, wani yunƙuri na Cibiyar Inganta Oncology na FDA, an yi amfani da shi don aiwatar da wannan bita. Yin amfani da kayan aikin da Project Orbis ke bayarwa, abokan tarayya na duniya zasu iya ƙaddamarwa da sake duba magungunan oncology lokaci guda. FDA ta yi aiki tare akan wannan bita tare da Hukumar Kula da Kaya ta Therapeutic (TGA) na Ostiraliya, Lafiyar Kanada, da Swissmedic. A sauran ƙungiyoyin tsari, sake dubawar aikace-aikacen na ci gaba da gudana.
Duba cikakken bayanin rubutawa don Trodelvy
