2022 April: 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) mangrupikeun uji coba multicenter, labél kabuka, uji acak anu ngadaptarkeun pasien 524 kalayan kanker payudara HER2-positip, teu tiasa diresectable, sareng / atanapi métastatik anu saacanna nampi trastuzumab sareng terapi taxane pikeun panyakit métastatik atanapi ngagaduhan kambuh panyakit nalika atanapi dina 6 bulan sanggeus terapi neoadjuvant atanapi adjuvant. Pasén dibéré Enhertu atanapi ado-trastuzumab emtansine intravenously unggal tilu minggu dugi karacunan teu kaampeuh atawa progression kasakit. Status reséptor hormon, perlakuan pertuzumab saméméhna, sarta sajarah kasakit visceral anu dipaké pikeun ngastratifikasi prosés 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).
Seueul, kacapean, utah, botak, kabebeng, anémia, sareng teu ngarareunah musculoskeletal mangrupikeun acara ngarugikeun anu paling umum (kajadian> 30 persén) dina pasien anu nyandak Enhertu. Muntah, panyakit paru interstitial, pneumonia, pyrexia, sareng inféksi saluran kemih mangrupikeun efek samping anu serius dina langkung ti 1% pasien anu ngagaduhan Enhertu. Perhatosan Boxed dina petunjuk resep ngingetkeun dokter ngeunaan kamungkinan panyakit paru-paru interstitial sareng karusakan émbrio-fétal.
Enhertu dirumuskeun salaku infus intravena sakali unggal tilu minggu (siklus 21 dinten) dugi ka kamajuan panyakit atanapi karacunan anu teu katampi.
Ningali inpormasi resep lengkep pikeun Enhertu.
