Agasti 2022: Ezigulini ezikhulile ezinomdlavuza webele onganqandeki noma one-metastatic HER2-low (IHC 1+ noma IHC 2+/ISH) eziye zathola ukwelashwa ngamakhemikhali ngaphambilini esimweni se-metastatic noma ezihlangabezane nokuvela kwesifo phakathi noma phakathi nezinyanga eziyisithupha zokuqeda ukwelashwa kwe-adjuvant chemotherapy, Ukudla kanye Ukuphathwa Kwezidakamizwa kugunyaze i-fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).
I-DESTINY-Breast04 (NCT03734029), ucwaningo lomtholampilo olungahleliwe, olumaphakathi, olunelebula evulekile olubhalise iziguli ezingama-557 ezinomdlavuza webele we-metastatic noma onganqandeki we-HER2-low, lusebenze njengesisekelo sokuhlaziya ukusebenza kahle. Ocwaningweni, bekunamaqoqo amabili: abantu abangama-494 abane-hormone receptor positivity (HR+) kanye neziguli ezingama-63 ezine-hormone receptor negativity (HR-negative). Kulabhorethri emaphakathi, i-IHC 1+ noma i-IHC 2+/ISH- isetshenziselwe ukuveza izinkulumo eziphansi ze-HER2. I-Enhertu 5.4 mg/kg yafakwa emthanjeni njalo emavikini amathathu ezigulini ezazinikezwe ngokungahleliwe (2:1) ukuthi ziyithole noma ukukhetha kukadokotela ukwelashwa ngamakhemikhali (N=184, okuhlanganisa i-eribulin, i-capecitabine, i-gemcitabine, i-nab-paclitaxel, noma i-paclitaxel) .
The progression-free survival (PFS) rate in patients with HR+ umdlavuza webele, 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.
Iminyaka yeziguli ibisukela ku-28 kuya ku-81, kuthi ezingama-57 kube yizo ezimaphakathi, kanti u-24% ubengama-65 noma ngaphezulu. Uhlu olulandelayo lwezibalo zabantu ezikhethiwe lwanikezwa: 99.6% wabantu besifazane, 48% ngabaMhlophe, 40% ngabase-Asia, 2% ngabaNsundu noma base-Afrika baseMelika, futhi 3.8% ngabaseHispanic/Latino.
I-PFS emaphakathi eqenjini le-HR+ kwakuyizinyanga ezingu-5.4 eqenjini le-chemotherapy kanye nezinyanga ezingu-10.1 eqenjini le-Enhertu (isilinganiso sengozi [HR] 0.51; 95% CI: 0.40, 0.64; p0.0001). Engalweni ye-Enhertu, i-PFS emaphakathi yayiyizinyanga ezingu-9.9 (95% CI: 9.0, 11.3), kanti kulabo abathatha i-chemotherapy, kwakuyizinyanga ezingu-5.1 (95% CI: 4.2, 6.8) (HR 0.50; 95% CI: 0.40, 0.63; p0.0001).
Eqenjini le-HR+, i-median OS yokwelashwa ngamakhemikhali nezingalo ze-Enhertu, ngokulandelana, kwakuyizinyanga ezingu-17.5 (95% CI: 15.2, 22.4) kanye nezinyanga ezingu-23.9 (95% CI: 20.8, 24.8) (HR 0.64; 95% CI: 0.48. , 0.86; p=0.0028). Ngomphakathi jikelele, i-median OS yeqembu le-Enhertu yayiyizinyanga ezingu-23.4 (95% CI: 20.0, 24.8) futhi eqenjini le-chemotherapy, kwakuyizinyanga ezingu-16.8 (95% CI: 14.5, 20.0) (HR 0.64; 95% CI : 0.49, 0.84; p=0.001).
Kulolu cwaningo, abantu abathola i-Enhertu ngokuvamile babeba nesicanucanu, ukukhathala, i-alopecia, ukuhlanza, i-anemia, ukuqunjelwa, ukuncipha kwesifiso sokudla, isifo sohudo, nobuhlungu bemisipha namathambo. Isexwayiso Esinebhokisi esazisa ochwepheshe bezokwelapha mayelana nokwenzeka kokulimala kwe-embryo-fetal kanye nesifo samaphaphu aphakathi nendawo sifakiwe olwazini oluchazayo.
Iziguli ezinomdlavuza webele kufanele zithole u-5.4 mg/kg we-Enhertu njengokufakwa emthanjeni kanye njalo emavikini amathathu (ngomjikelezo wezinsuku ezingama-21) kuze kube yilapho isifo siqhubeka noma kuba nobuthi obungamukeleki.
Buka imininingwane egcwele ye-Enhertu.
