Pembrolizumab ine chemoradiotherapy inotenderwa neUSFDA yeFIGO 2014 Danho III-IVA gomarara remuchibereko.

Pembrolizumab ine chemoradiotherapy inotenderwa neUSFDA yeFIGO 2014 Danho III-IVA gomarara remuchibereko.

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Chikafu neDrug Administration yakabvumidza pembrolizumab (Keytruda, Merck) pamwe chete nechemoradiotherapy (CRT) yevarwere vane FIGO 2014 Stage III-IVA kenza yemuchibereko muna Ndira 12, 2024.

Chidzidzo chinodaidzwa kuti KEYNOTE-A18 (NCT04221945) chakatarisa kuti chakashanda sei. Yakanga iri muyedzo wakawanda, wakasarudzika, wakapetwa kaviri-mapofu, placebo-inodzorwa nevarwere vekenza yekervical 1060 vaive vasati vambovhiyiwa, radiation, kana systemic therapy. Paive nevanhu mazana mashanu nemakumi mapfumbamwe nevatanhatu mukutongwa neFIGO 596 Stage III-IVA chirwere uye 2014 vanhu vane FIGO 462 Stage IB-IIB chirwere vaive node-positive chirwere.

Vatori vechikamu vakagoverwa kuti vagamuchire pembrolizumab 200 mg kana placebo masvondo ega e3 emitambo ye5 pamwe neCRT. Masvondo matanhatu ega ega kwezvikamu gumi neshanu, pembrolizumab 15 mg kana placebo yakauya mushure meizvi. Iyo CRT regimen yaisanganisira cisplatin pachiyero che400 mg / m40 yakapihwa intravenously kamwe pavhiki kwe2 kutenderera, paine mukana wekuwedzera 5th kutenderera, pamwe nekunze beam radiation therapy (EBRT) uye brachytherapy. Randomization yakatemwa zvichibva pane yaitarisirwa mhando yekunze beam radiation therapy (EBRT), cancer nhanho, uye inofungidzirwa yakazara irradiation dose.

Iwo ekutanga efficacy zviratidzo aisanganisira kufambira mberi-kusina kupona (PFS) yakaongororwa nemuongorori zvichibva paRECIST v1.1 maitiro kana histopathological simbiso, uye kupona kwese (OS). Muedzo wakaratidza kuwedzera kwakakosha mukurarama-kusina kupona (PFS) muboka rese. Ongororo yeboka rekuongorora yakaitwa pavarwere ve596 vane FIGO 2014 Stage III-IVA chirwere. Iyo PFS hazard ratio fungidziro yaive 0.59 (95% CI: 0.43, 0.82). Muruoko rwepembrolizumab, 21% yevarwere vakawana chiitiko chePFS chichienzaniswa ne31% muruwoko rwe placebo. Ongororo yeboka rekuongorora rakaitwa pavarwere ve462 vane FIGO 2014 Stage IB2-IIB chirwere. Iyo PFS HR fungidziro yaive 0.91 (95% CI: 0.63, 1.31), zvichiratidza kuti kuvandudzwa kwePFS muhuwandu hwese kwainyanya kuonekwa kune varwere vane FIGO 2014 Stage III-IVA chirwere. Iyo OS data haina kugadzirwa zvakakwana pakaitwa ongororo yePFS.

Varwere vakapiwa pembrolizumab pamwe chete ne chemoradiotherapy vaiwanzosangana nemigumisiro yakadai sekusvotwa, manyoka, kurutsa, urinary tract infections, kuneta, hypothyroidism, kuvimbiswa, kurasikirwa kwechido, kuwedzera uremu, kurwadziwa kwepamuviri, pyrexia, hyperthyroidism, dysuria, rash, uye pelvic. kurwadziwa.

Chirongwa chedosi yepembrolizumab 200 mg inopihwa mutsinga mavhiki matatu ega ega kana 3 mg mutsinga mavhiki matanhatu ega ega, ichienderera kusvika pakukura kwechirwere, mhedzisiro isingashiviriki, kana kweinodarika mwedzi makumi maviri nemana. Ipa pembrolizumab pamberi pechemoradiotherapy kana ikapihwa pazuva rimwe chete.

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