Agusta 2022: Ga manya marasa lafiya waɗanda ba su da tushe ko metastatic HER2-low (IHC 1+ ko IHC 2+/ISH) ciwon nono waɗanda suka karɓi chemotherapy kafin a cikin yanayin metastatic ko kuma sun sami sake dawowar cuta a cikin ko cikin watanni shida na gama adjuvant chemotherapy, Abinci da Hukumar Kula da Magunguna ta amince da fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).
KADDARA-Breast04 (NCT03734029), bazuwar, cibiyar da yawa, binciken asibiti na buɗaɗɗen lakabi wanda ya shigar da marasa lafiya 557 tare da ciwon daji na HER2-ƙananan nono, wanda ba a iya gyara shi ba, ya zama tushen tushen ingantaccen bincike. A cikin binciken, akwai ƙungiyoyi guda biyu: 494 mutane tare da halayen mai karɓa na hormone (HR +) da marasa lafiya na 63 tare da rashin lafiyar mai karɓa na hormone (HR-negative). A cikin dakin gwaje-gwaje na tsakiya, an yi amfani da IHC 1+ ko IHC 2+/ISH- don siffanta magana-ƙananan HER2. An yi amfani da Enhertu 5.4 mg / kg a cikin jini a kowane mako uku ga marasa lafiya waɗanda aka ba da izini (2: 1) don karɓar shi ko zaɓin maganin chemotherapy (N = 184, ciki har da eribulin, capecitabine, gemcitabine, nab-paclitaxel, ko paclitaxel) .
The progression-free survival (PFS) rate in patients with HR+ ciwon nono, as determined by a blinded independent central review using RECIST 1.1, served as the key effectiveness measure. PFS in the total population (all randomised HR+ and HR-negative patients), overall survival (OS) in HR+ patients, and OS in the total population were secondary effectiveness endpoints.
Shekarun marasa lafiya sun kasance daga 28 zuwa 81, tare da 57 kasancewa matsakaici, yayin da 24% sun kasance 65 ko fiye. An bayar da jerin abubuwan da aka zaɓa masu zuwa: 99.6% na yawan jama'a mata ne, 48% farare ne, 40% Asiya ne, 2% Baƙar fata ne ko Ba'amurke, kuma 3.8% 'yan Hispanic/Latino ne.
Matsakaicin PFS a cikin ƙungiyar HR + shine watanni 5.4 a cikin ƙungiyar chemotherapy da watanni 10.1 a cikin ƙungiyar Enhertu (haɗarin haɗari [HR] 0.51; 95% CI: 0.40, 0.64; p0.0001). A cikin hannun Enhertu, matsakaicin PFS shine watanni 9.9 (95% CI: 9.0, 11.3), yayin da waɗanda ke shan chemotherapy, watanni 5.1 ne (95% CI: 4.2, 6.8) (HR 0.50; 95% CI: 0.40, 0.63; p0.0001).
A cikin ƙungiyar HR +, matsakaicin OS na chemotherapy da makamai na Enhertu, bi da bi, shine watanni 17.5 (95% CI: 15.2, 22.4) da watanni 23.9 (95% CI: 20.8, 24.8) (HR 0.64; 95% CI: 0.48; , 0.86; p=0.0028). A cikin yawan jama'a, matsakaicin OS na ƙungiyar Enhertu shine watanni 23.4 (95% CI: 20.0, 24.8) kuma ga ƙungiyar chemotherapy, watanni 16.8 ne (95% CI: 14.5, 20.0) (HR 0.64; 95% CI). : 0.49, 0.84; p=0.001).
A cikin wannan gwaji, mutanen da suka karbi Enhertu akai-akai suna da tashin zuciya, gajiya, alopecia, amai, anemia, maƙarƙashiya, rage cin abinci, zawo, da ciwon tsoka. Gargadin Akwati yana faɗakar da ƙwararrun likitoci game da yuwuwar cutarwar tayi- tayi da cutar huhun tsaka-tsaki an haɗa cikin bayanan da aka tsara.
Masu ciwon daji na nono ya kamata su karbi 5.4 MG / kg na Enhertu a matsayin jiko na jini sau ɗaya a kowane mako uku (a kan zagayowar kwanaki 21) har sai cutar ta ci gaba ko kuma akwai guba mara yarda.
Duba cikakken bayanin rubutawa don Enhertu.
