April 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.
I-DESTINY-Breast03 (NCT03529110) kwakuyisivivinyo esigxile ezintweni eziningi, esivulekile, esingahleliwe esabhalisa iziguli ezingama-524 ezinomdlavuza webele we-HER2, ongahoxiki, kanye/noma we-metastatic owake wathola ukwelashwa kwe-trastuzumab kanye ne-taxane yesifo se-metastatic noma eziphinde zavela izifo ngesikhathi noma phakathi nezinyanga eziyisi-6 zokuqeda i-neoadjuvant noma i-adjuvant therapy. Iziguli zazinikezwa i-Enhertu noma i-ado-trastuzumab emtansine ngomthambo njalo ngemva kwamasonto amathathu kuze kube yilapho ubuthi obungabekezeleleki noma ukukhula kwesifo. Isimo se-hormone receptor, ukwelashwa kwangaphambili kwe-pertuzumab, nomlando wokugula kwe-visceral kwasetshenziselwa ukuhlela inqubo ye-randomization.
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).
Isicanucanu, ukukhathala, ukuhlanza, impandla, ukuqunjelwa, i-anemia, nokungakhululeki kwemisipha namathambo kwakuyizehlakalo ezimbi ezivame kakhulu (izigameko> amaphesenti angu-30) ezigulini ezithatha i-Enhertu. Ukuhlanza, isifo samaphaphu aphakathi nendawo, inyumoniya, i-pyrexia, kanye nokutheleleka ngomgudu womchamo kwaba yimiphumela emibi kakhulu ezigulini ezingaphezu kuka-1% ezithole i-Enhertu. Isexwayiso Esinebhokisi emibhalweni yemiyalelo ixwayisa odokotela mayelana nokwenzeka kwesifo se-interstitial wamaphaphu kanye nokulimala kwe-embryo-fetal.
I-Enhertu inikezwa njengomjovo kanye njalo emavikini amathathu (umjikelezo wezinsuku ezingama-21) kuze kube yilapho isifo siqhubeka noma ubuthi obungamukeleki.
Buka imininingwane egcwele ye-Enhertu.
