Agasti 2021: Sacituzumab govitecan (Trodelvy, Immunomedics Inc.) bathole imvume ye-FDA evamile ezigulini ezinomdlavuza webele webele osezingeni eliphezulu ongalawuleki noma one-metastatic triple-negative (mTNBC) ezithole ukwelashwa okuhleliwe okubili noma ngaphezulu kwangaphambilini, okungenani okukodwa kwakho obekungokokugula kwe-metastatic.
ISacituzumab govitecan yanikezwa imvume esheshayo ngo-Ephreli 2020 yeziguli ezine-mTNBC ezazike zathola okungenani ukwelashwa okubili kokugula kwemetastatic. Isivivinyo sokuqinisekisa semvume esisheshayo kwaba yisinyathelo esilandelayo.
Efficacy and safety were assessed in 529 patients with unresectable locally advanced or mTNBC who had relapsed after at least two prior chemotherapies, one of which could have been in the neoadjuvant or adjuvant setting, if progression occurred within 12 months, in a multicenter, open-label, randomised trial (ASCENT; NCT02574455). On days 1 and 8 of a 21-day (n=267) cycle, patients were randomised (1:1) to receive sacituzumab govitecan, 10 mg/kg as an intravenous infusion, or a physician’s choice of single agent chemotherapy (n=262).
The primary effectiveness outcome was progression-free survival (PFS) in patients who did not have brain metastases at the start of the study, as determined by a blinded, independent, centralised review using RECIST 1.1 criteria. PFS for the entire cohort (with and without brain metastases) and overall survival were also included as effectiveness objectives (OS).
Iziguli ezithola i-sacituzumab govitecan zine-PFS ephakathi yezinyanga ezingu-4.8 (isikhawu sokuzithemba esingamaphesenti angama-95: 4.1, 5.8) uma kuqhathaniswa nezinyanga eziyi-1.7 (isikhawu sokuzithemba samaphesenti angama-95: 1.5, 2.5) kulabo abathola i-chemotherapy (HR 0.43; 95% isikhawu sokuzithemba: 0.35, 0.54; p0.0001). I-median OS kwakuyizinyanga eziyi-11.8 (95% interval confidence: 10.5, 13.8) yabesilisa nezinyanga eziyi-6.9 (95% interval confidence: 5.9, 7.6) kwabesifazane (HR 0.51; 95% interval confidence: 0.41, 0.62; p0.0001) .
I-nausea, i-neutropenia, isifo sohudo, ukucobeka, i-alopecia, i-anemia, ukuhlanza, ukuqunjelwa, ukuqubuka, ukuncipha kwesifiso, nokungahambi kahle kwesisu yimicimbi eseceleni kakhulu (izehlakalo> 25%) ezigulini ezithatha i-sacituzumab govitecan.
Kuze kube ukukhula kwesifo noma ubuthi obungabekezeleleki, umthamo we-sacituzumab govitecan onconywayo ungu-10 mg / kg kanye ngesonto ngezinsuku 1 no-8 zemijikelezo yokwelashwa yezinsuku ezingama-21.
Inkomba: https://www.fda.gov/
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