ʻO ka maʻi maʻi maʻi endocrine therapy kahi mea nui o ka mālama ʻana i ka maʻi maʻi umauma maikaʻi.ʻO ke kumu nui o ka pale ʻana i ka lāʻau lapaʻau i nā maʻi HR+ ma hope o ka loaʻa ʻana o ka lāʻau lapaʻau mua (tamoxifen TAM a i ʻole aromatase inhibitor AI) ʻo ia ka hoʻololi ʻana i ka estrogen receptor gene α (ESR1).Ua pōmaikaʻi nā poʻe maʻi e loaʻa ana i ka estrogen receptor degraders (SERDs) me ka nānā ʻole i ke kūlana mutation ESR1.
Ma Ianuali 27, 2023, ua ʻae ka FDA i ka elacestrant (Orserdu) no nā wahine postmenopausal a i ʻole nā kāne makua me ka maʻi maʻi umauma kiʻekiʻe a i ʻole metastatic me ER +, HER2-, ESR1 mutations a me ka holomua o ka maʻi ma hope o hoʻokahi laina o ka lāʻau endocrine.nā maʻi maʻi maʻi maʻi.Ua ʻae pū ka FDA i ka Guardant360 CDx assay ma ke ʻano he mea hana diagnostic adjunct no ka nānā ʻana i nā maʻi maʻi maʻi umauma e loaʻa ana i ka elastran.
Hoʻokumu ʻia kēia ʻae ʻia ma ka hoʻokolokolo EMERALD (NCT03778931), ʻo nā ʻike nui i paʻi ʻia ma ka JCO.
ʻO ka EMERALD study (NCT03778931) he multi-center, randomized, open-label, active-controlled phase III clinical trial i hoʻopaʻa inoa i ka huina o 478 postmenopausal wahine a me nā kāne me ER +, HER2- holomua a metastatic maʻi, 228 o lākou i loaʻa iā ESR1 hoʻololi ʻana .Pono ka ho'āʻoʻana i nā maʻi me ka holomua o ka maʻi ma hope o ka lālani mua a iʻole ka laina lua o ka endocrine therapy, me ka CDK4 / 6 inhibitors.Ua loaʻa i nā poʻe maʻi kūpono i ka nui o ka chemotherapy laina mua.Ua hoʻokaʻawale ʻia nā maʻi (1: 1) e loaʻa i ka erastrol 345 mg i hoʻokahi manawa i ka lā (n=239) a i ʻole ke koho ʻana o ka endocrine therapy (n=239), me ka fulvestrant (n=239).166) a i ʻole nā mea hoʻopaneʻe aromatase (n=73).Ua hoʻopaʻa ʻia nā hoʻokolohua e like me ke kūlana mutation ESR1 (ʻike ʻia vs. ʻaʻole i ʻike ʻia), mua fulvestrant therapy (ʻae vs. ʻaʻole), a me nā metastases visceral (ʻae vs. ʻaʻole).Ua hoʻoholo ʻia ke kūlana mutation ESR1 e ctDNA me ka hoʻohana ʻana i ka Guardant360 CDx assay a ua kaupalena ʻia i nā mutations missense ESR1 i ka domain-binding domain.
ʻO ka hopena hope loa o ka holomua-free survival (PFS).Ua ʻike ʻia nā ʻokoʻa koʻikoʻi ma ka PFS i ka heluna kanaka i manaʻo e mālama (ITT) a me nā pūʻulu o nā maʻi me nā hoʻololi ESR1.
Ma waena o 228 mau mea maʻi (48%) me ka hoʻololi ESR1, ʻo ka median PFS he 3.8 mau mahina i ka hui elacestrant me 1.9 mau mahina i ka hui fulvestrant a i ʻole aromatase inhibitor (HR=0.55, 95% CI: 0.39-0.77, ʻelua ʻaoʻao p-value. = 0.0005).
Ua hōʻike ʻia kahi ʻimi noiʻi o PFS ma 250 (52%) mau mea maʻi me ka ʻole o ka hoʻololi ʻana o ESR1 i kahi HR o 0.86 (95% CI: 0.63-1.19), e hōʻike ana i ka hoʻomaikaʻi ʻana i ka heluna ITT ma muli o nā hopena i ka heluna mutation ESR1.
ʻO ka hapa nui o nā hanana ʻino (≥10%) i komo i nā mea ʻino o ka lab me ka ʻeha musculoskeletal, nausea, hoʻonui i ka cholesterol, piʻi ka AST, piʻi ka triglycerides, luhi, hoʻemi i ka hemoglobin, luaʻi, hoʻonui ʻia ka ALT, hoʻemi ʻia ka sodium, hoʻonui creatinine, hoʻemi i ka ʻai, ka maʻi maʻi, headache, constipation, ʻeha ʻōpū, ʻeha wela, a me ka ʻai ʻana.
ʻO ka nui o ka elastrol i ʻōlelo ʻia he 345 mg i ka waha i hoʻokahi lā i kēlā me kēia lā me ka meaʻai a hiki i ka piʻi ʻana o ka maʻi a i ʻole ka ʻona ʻae ʻole.
ʻO kēia ka lāʻau SERD waha mua loa e hoʻokō i nā hopena hopena maikaʻi ma kahi hoʻokolohua lapaʻau pivotal i nā maʻi me ka maʻi maʻi ER+/HER2- holomua a metastatic paha.A me ka nānā 'ole o ka heluna kanaka a i 'ole ka ESR1 mutation heluna kanaka, Erasetran lawe mai i ka helu helu ho'emi nui i ka PFS a me ka make pilikia, a hōʻike i ka palekana a me ka hoʻomanawanui.
Ka manawa hoʻouna: Apr-23-2023
