Food and Drug Administration yakabvumira pembrolizumab (Keytruda, Merck) pamwe chete nefluoropyrimidine- uye platinum-ine chemotherapy musi waNovember 16, 2023. Mvumo iyi ndeyekutanga kurapwa kwevanhu vakuru vane nzvimbo yepamusoro isingagadziriswi kana metastatic HER2-negative gastric kana gastroesophageal (GEJ) adenocarcinoma.
Kubudirira kwakaongororwa mune yakawanda-kati, randomized, kaviri-mapofu, placebo-inodzorwa kuedza inonzi KEYNOTE-859 (NCT03675737). Muedzo uyu waisanganisira varwere 1579 vane HER2-negative advanced gastric kana GEJ adenocarcinoma anga asati aita systemic kurapwa kwechirwere che metastatic. Vatori vechikamu vakapihwa zvisina tsarukano kuti vagamuchire pembrolizumab 200 mg kana placebo pamwe nesarudzo yemuongorori yemusanganiswa wechemotherapy, iyo yaisanganisira cisplatin 80 mg/m2 pamwe ne5-FU 800 mg/m2/zuva kwemazuva mashanu (FP) kana oxaliplatin 5 mg. / m130 paZuva 2 pamwe necapecitabine 1 mg / m1000 kaviri pazuva kwemazuva gumi nemana (CAPOX) mune imwe neimwe yemazuva 2.
Chiyero chekutanga chekushanda kwaive kupona kwese (OS). Chidzidzo ichi chakaongororawo kufambira mberi kwemahara kupona (PFS), chiyero chekupindura kwese (ORR), uye nguva yekupindura (DOR) kuburikidza neyakapofumadzwa yakazvimirira yepakati wongororo (BICR) yakavakirwa paRECIST v1.1 maitiro, ane muganhu wegumi chinangwa maronda uye 10 maronda anonangwa panhengo imwe neimwe.
Pembrolizumab yakasanganiswa nechemotherapy yakatungamira kukuwedzera kwakakosha mukupona kwese (OS), kufambira mberi-kusina kupona (PFS), uye mwero wekupindura (ORR). Kurarama kwepakati pese kwaive mwedzi gumi nemaviri (12.9% CI: 95, 11.9) nepembrolizumab uye mwedzi 14.0 (11.5% CI: 95, 10.6) ne placebo. The hazard ratio (HR) yaive 12.1 (0.78% CI: 95, 0.70) ine p-value ye <0.87. Kupona kwepakati-pasina kurarama (PFS) kwaive nemwedzi 0.0001 (6.9% CI: 95, 6.3) uye mwedzi 7.2 (5.6% CI: 95, 5.5) mumapoka maviri, ine hazard ratio (HR) ye5.7 [0.76% CI: 95, 0.67] uye p-kukosha kwe <0.85. Chinangwa chekupindura (ORR) chaiva 0.0001% (51% CI: 95, 48) uye 55% (42% CI: 95, 38) ine nhamba inokosha p-value isingasviki 45 mumapoka maviri ekurapa. Nguva yepakati yekupindura (DOR) yaive mwedzi misere (0.0001% CI: 8, 95) yepembrolizumab uye 7.0 mwedzi (9.7% CI: 5.7, 95) ye placebo.
Imwezve ongororo yakaratidza kuti varwere vakapihwa pembrolizumab uye vaive nemamota airatidza PD-L1 CPS> 1 uye CPS ≥ 10 vaive nenhamba yepamusoro yehupenyu hwese (OS), kufambira mberi-kusina kupona (PFS), uye chinangwa chekupindura mwero (ORR).
15% yevarwere vakawana kupera zvachose kwekurapa kwepembrolizumab nekuda kwemhedzisiro yakaipa. Zvakaipa zvinokonzeresa kupera zvachose mune inokwana 1% yezviitiko zvaisanganisira kutapukira uye manyoka.
Chiyero chinokurudzirwa chepembrolizumab ndeye 200 mg mavhiki matatu ega ega kana 3 mg masvondo matanhatu ega ega kusvika kukura kwechirwere kana kutyisa kusingagoneki. Ipa pembrolizumab pamberi pekemotherapy kana ikapihwa pazuva rimwe chete.
