Nov 2023: Pembrolizumab (Keytruda, Merck) yakapihwa mvumo neFood and Drug Administration (FDA) semushonga weneoadjuvant wakasanganiswa neplatinum-ine chemotherapy uye seyepashure-kuvhiya adjuvant kurapa kwerectable isiri-diki cell kenza yemapapu (NSCLC) inoyera bundu. 4 cm kana kupfuura muhupamhi, kana yasanganiswa neplatinum-ine chemotherapy.
KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled controlled trial inosanganisira 797 varwere vane AJCC 8th edition rectable Stage II, IIIA, kana IIIB NSCLC vakanga vasati vamborapwa, vakaongorora kushanda kwemushonga. Varwere vari kurapwa neplatinum-based chemotherapy vakangoitwa (1: 1) kuti vagamuchire pembrolizumab kana placebo mavhiki matatu ega ega kwemaitiro mana (neoadjuvant kurapwa).
Mushure mezvo, kwehuwandu hwegumi nematatu (adjuvant treatment), varwere vaipiwa kana kuenderera mberi-mumiririri pembrolizumab kana placebo mavhiki matatu oga oga. Iro hwindo rekuvhiya uye chemotherapy chaiyo inowanikwa pane chinongedzo kune chinodhaka label pamusoro.
Iwo ekutanga mhedzisiro matanho ekubudirira aive muongorori-akaongororwa chiitiko-isina kupona (EFS) uye kupona kwese (OS). Iyo yepakati OS yeavo vaigamuchira placebo yaive mwedzi 52.4 (95% CI: 45.7, NE) uye haina kuwanikwa muruwoko rwepembrolizumab (95% CI: isingafungidzike [NE], NE]; p-value=0.0103). Nhamba yengozi [HR] yaiva 0.72 [95% CI: 0.56, 0.93]; p-kukosha=0.0103]. EFS yepakati muruoko rwe placebo yaiva mwedzi 17 (95% CI: 14.3, 22.0) yakaenzaniswa nemwedzi ye17 mu pembrolizumab ruoko (95% CI: 34.1 mwedzi, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-kukosha=0.0001).
Maitiro asina kunaka anowanzo kutaurwa ne20% kana kupfuura evarwere muKEYNOTE-671 aive anotevera: kusvotwa, kuneta, neutropenia, anemia, kuvimbiswa, kuderera kwechido, kuderera kwemasero machena eropa, kurwadziwa kwemusculoskeletal, kuputika, kusangana, kurutsa, manyoka, uye dyspnea.
Muyero wakaderera wakaderera wemaitiro akaipa wakadzivirira kuvhiyiwa kwe6% yevarwere vari muruwoko rwepembrolizumab vakagamuchira kurapwa neoadjuvant, kusiyana ne4.3% muruwoko rwe placebo. Uye zvakare, 3.1% yevarwere vakagamuchira neoadjuvant kurapwa uye kuvhiyiwa muruwoko rwepembrolizumab vakawana kunonoka kwekuvhiya kana zvichienzaniswa ne2.5% muruwoko rwe placebo. Iyo ruzivo rwekuchengetedza ine chekuita neoadjuvant uye adjuvant nhanho inogona kuwanikwa mune yezvinodhaka label link yakapihwa pamusoro.
Pembrolizumab inorayirwa pachiyero che 200 mg mavhiki matatu ega ega kana 3 mg mavhiki matanhatu. Kana ichishandiswa pazuva rimwechete sechemotherapy, pembrolizumab inofanira kupiwa kare.
