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.
DESTINY-Breast03 (NCT03529110) erat multicenter, apertus titulus, randomizatus iudicii qui ascriptis 524 patientibus HER2-positivis, irresectabilis, et/vel cancer metastaticae pectoris, qui antea trastuzumab et taxane therapia pro metastatica morbo acceperat vel in recursu morbum habuit vel habuit. intra 6 menses perficiendi neoadjuvant vel therapia adjuvant. Aegroti Enhertu vel ado-trastuzumab emtansine intravenously dati sunt in tres septimanas usque ad progressionem toxicitatis vel morborum intolerabilem. Hormone receptor status, curationis pertuzumab prior, et historia morborum viscerum adhibita ad processum randomization stratandum.
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).
Nausea, lassitudo, vomitus, calvitium, constipatio, anaemia, et molestiae musculoskeletae erant frequentissima eventa adversa (incidentiam >30 percent) in aegris Enhertu capientes. Vomitus, morbus pulmonis interstitialis, pneumonia, pyrexia, et infectio tractus urinarii erant graves effectus latus effectus in plus quam 1% aegrorum qui Enhertu obtinuit. Admonitio cohibenti de praescriptionibus praeceptis monet doctores de possibilitate pulmonis interstitialis morbi et damni embryo-foetalis.
Enhertu ut infusio intravenosa semel in tribus septimanis (21-die cyclo) datur) usque ad progressionem morbi vel toxicitatem acceptam.
View plenam praescribens de Enhertu.
