Avgust 2022: For adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH) breast cancer who have received prior chemotherapy in the metastatic setting or experienced a disease recurrence during or within six months of finishing adjuvant chemotherapy, the Food and Drug Administration has approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.).
DESTINY-Breast04 (NCT03734029), a randomised, multicenter, open-label clinical study that enrolled 557 patients with metastatic or unresectable HER2-low breast cancer, served as the foundation for the effectiveness analysis. In the study, there were two cohorts: 494 individuals with hormone receptor positivity (HR+) and 63 patients with hormone receptor negativity (HR-negative). In a centralised laboratory, IHC 1+ or IHC 2+/ISH- was used to characterise HER2-low expression. Enhertu 5.4 mg/kg was administered intravenously every three weeks to patients who were randomly assigned (2:1) to receive it or the physician’s choice of chemotherapy (N=184, including eribulin, capecitabine, gemcitabine, nab-paclitaxel, or paclitaxel).
The progression-free survival (PFS) rate in patients with HR+ ko'krak saratoni, 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.
Bemorlarning yoshi 28 dan 81 gacha bo'lgan, o'rtacha 57 yosh, 24% esa 65 va undan katta. Tanlangan demografik ma'lumotlarning quyidagi ro'yxati keltirilgan: aholining 99.6 foizi ayollar, 48 foizi oq tanlilar, 40 foizi osiyoliklar, 2 foizi qora tanlilar yoki afro-amerikaliklar, 3.8 foizi esa ispan/latinolar.
HR + kohortidagi o'rtacha PFS kimyoterapiya guruhida 5.4 oy va Enhertu guruhida 10.1 oy edi (xavf darajasi [HR] 0.51; 95% CI: 0.40, 0.64; p0.0001). Enhertu qo'lida o'rtacha PFS 9.9 oy (95% CI: 9.0, 11.3), kimyoterapiya olganlar uchun esa 5.1 oy (95% CI: 4.2, 6.8) (HR 0.50; 95% CI: 0.40, 0.63; p0.0001).
HR+ kohortida kimyoterapiya va Enhertu qo'llari uchun o'rtacha operatsion tizim mos ravishda 17.5 oyni (95% CI: 15.2, 22.4) va 23.9 oyni (95% CI: 20.8, 24.8) (HR 0.64: 95) tashkil etdi. , 0.48; p=0.86). Umumiy populyatsiyada Enhertu guruhi uchun o'rtacha operatsion tizim 0.0028 oyni (23.4% CI: 95, 20.0) va kimyoterapiya guruhi uchun 24.8 oyni (16.8% CI: 95, 14.5) (HR 20.0; 0.64% CI) tashkil etdi. : 95, 0.49; p=0.84).
Ushbu sinovda Enhertuni ko'pincha qabul qilgan odamlarda ko'ngil aynish, charchoq, alopesiya, qusish, anemiya, ich qotishi, ishtahaning pasayishi, diareya va mushak-skelet tizimining og'rig'i bor edi. Tibbiy mutaxassislarni embrion-homila zarari va interstitsial o'pka kasalligi ehtimoli haqida ogohlantiruvchi qutidagi ogohlantirish retseptlash ma'lumotlariga kiritilgan.
Ko'krak bezi saratoni bilan og'rigan bemorlar kasallik rivojlanmaguncha yoki yo'l qo'yib bo'lmaydigan toksiklik paydo bo'lgunga qadar har uch haftada bir marta (5.4 kunlik tsiklda) tomir ichiga 21 mg / kg Enhertu infuzionini olishlari kerak.
Enhertu uchun to'liq retsept ma'lumotlarini ko'ring.
