2023-р сарын XNUMX: The Food and Drug Administration (FDA) has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for people with hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer that has spread to other parts of the body and can not be removed. These people have also had at least two other systemic therapies in a metastatic setting.
TROPiCS-02 (NCT03901339) was a multicenter, open label, randomized study that looked at how well a CDK 4/6 inhibitor, endocrine therapy, and a taxane worked in 543 women with HR-positive, HER2-negative breast cancer that had spread or could not be removed. The patients’ disease got worse after receiving any of these treatments. At least two previous chemotherapies were administered to patients with metastatic disease (one of which could be in the neoadjuvant or adjuvant setting if recurrence occurred within 12 months).
Өвчтөнүүдийг 1 хоногийн мөчлөгийн 1 ба 271 дахь өдрүүдэд дан химийн эмчилгээ (n = 10) эсвэл сацизумаб говитекан-хзий, 1 мг/кг судсаар дусаах хэлбэрээр авахаар (8:21) санамсаргүй байдлаар хуваарилав. Санамсаргүй хуваарилалт хийхээс өмнө судлаач капецитабин (n=22), винорелбин (n=63), гемцитабин (n=56) эсвэл эрибулин (n=130) гэсэн сонголтуудын аль нэгээс нэг эмтэй химийн эмчилгээний горимыг сонгосон. Үсэрхийлсэн өвчний өмнөх хими эмчилгээний дэглэм (2-ын эсрэг 3-4), дотоод эрхтнүүдийн үсэрхийлэл (Тийм эсвэл Үгүй), мөн үсэрхийлсэн нөхцөлд дор хаяж 6 сарын турш дотоод шүүрлийн эмчилгээг санамсаргүй байдлаар ангилах (Тийм эсвэл Үгүй) ашигласан. Өвчтөнүүд хүлээн зөвшөөрөгдөөгүй гаж нөлөө үүсэх хүртэл эмчилгээ хийлгэсэн.
Progression-free survival (PFS), as defined by a blinded independent central review in accordance with RECIST v1.1, served as the primary efficacy outcome measure. Overall survival was a crucial secondary efficacy outcome metric (OS). The median PFS for the sacituzumab govitecan-hziy arm was 5.5 months (95% CI: 4.2, 7.0) and for the single agent chemotherapy arm was 4 months (95% CI: 3.1, 4.4) (hazard ratio [HR] of 0.661 [95% CI: 0.529, 0.826]; p-value=0.0003). For those getting sacituzumab govitecan-hziy, the median OS was 14.4 months (95% CI: 13.0, 15.7), whereas for those receiving single agent chemotherapy, it was 11.2 months (95% CI: 10.1, 12.7) (HR of 0.789 [95% CI: 0.646, 0.964]; p-value=0.0200).
Лейкоцитийн тоо (88%), нейтрофилын хэмжээ (83%), гемоглобины бууралт (73%), лимфоцитын тоо буурах (65%), суулгалт (62%), ядрах (60%), дотор муухайрах (59%), халцрах (48%), глюкозын хэмжээ ихсэх (37%), өтгөн хатах (34%), альбумин буурах (32%) зэрэг нь TROPiCS-25-д sacituzumab govitecan-hziy-ийг эмчилсэн өвчтөнүүдэд хамгийн их тохиолддог гаж нөлөө (02%) байв.
On Days 1 and 8 of a 21-day therapy cycle, 10 mg/kg of sacituzumab govitecan-hziy should be infused intravenously once a week until the disease gets worse or the side effects become too much to handle, whichever comes first.
Project Orbis, an initiative of the FDA Oncology Center of Excellence, was used to carry out this review. Using the infrastructure that Project Orbis provides, international partners can submit and review oncology medications simultaneously. FDA worked together on this review with the Therapeutic Goods Administration (TGA) of Australia, Health Canada, and Swissmedic. At the other regulatory organizations, the application reviews are still proceeding.
Trodelvy-ийн жорын талаархи бүрэн мэдээллийг үзнэ үү
