Abriil 2022: Adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within 6 months of completing therapy have been given fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) by the Food and Drug Administration.
DESTINY-Breast03 (NCT03529110) waxay ahayd xarun badan, calaamad furan, tijaabo randomized oo diiwaan gashaday 524 bukaan oo qaba HER2-positive, aan la sixi karin, iyo/ama kansarka naasaha metastatic kuwaas oo hore u helay trastuzumab iyo daawaynta canshuurta ee cudurada dheef-shiid kiimikaadka ama lahaa soo noqoshada cudur inta lagu jiro ama 6 bilood gudahood marka la dhammeeyo daaweynta neoadjuvant ama adjuvant. Bukaannada waxaa la siin jiray xididada Enhertu ama ado-trastuzumab emtansine saddexdii toddobaadba mar ilaa ay ka sii socdaan sunta ama cudurka aan loo dulqaadan karin. Xaaladda soo-dhoweynta hoormoonka, daawaynta hore ee pertuzumab, iyo taariikhda jirrada visceral-ka ayaa loo isticmaalay si loo caddeeyo habka kala-soocidda.
Progression-free survival (PFS) was the primary efficacy outcome measure, as determined by a blinded independent central review using the RECIST v.1.1 scoring system. The primary secondary outcome measures included overall survival (OS) and verified objective response rate (ORR). The Enhertu arm had a median PFS of not achieved (95 percent confidence interval: 18.5, not estimable) and the ado-trastuzumab emtansine arm had a median PFS of 6.8 months (95 percent confidence interval: 5.6, 8.2). The hazard ratio was 0.28 (95 percent confidence interval: 0.22 to 0.37; p=0.0001). 16 percent of patients had died at the time of the PFS study, while the OS was still in its infancy. The Enhertu arm had an ORR of 82.7 percent (95 percent CI: 77.4, 87.2) at baseline, while those receiving ado-trastuzumab emtansine had an ORR of 36.1 percent (95 percent CI: 30.0, 42.5).
Lalabbo, daal, matag, bidaar, calool-istaag, dhiig-yaraan, iyo raaxo la'aanta muruqyada ayaa ah dhacdooyinka ugu badan ee aan fiicnayn (dhacdooyinka>30 boqolkiiba) bukaannada qaadanaya Enhertu. Matagga, cudurada sambabada interstitial, oof-wareen, pyrexia, iyo caabuqa kaadi mareenka ayaa saameyn xun ku yeeshay in ka badan 1% bukaanada helay Enhertu. Digniin Sanduuqan oo ku saabsan tilmaamaha qorista ayaa uga digaya dhakhaatiirta suurtagalnimada cudur-sidaha sambabada ee interstitial iyo dhaawaca uurjiifka.
Enhertu waxaa la siiyaa faleebo faleebo ah hal mar saddexdii toddobaadba (wareeg 21 maalmood ah) ilaa cudurku ka sii socdo ama sunta aan la aqbali karin.
U fiirso macluumaadka dhamaystiran ee Enhertu.
