Nov 2023: I-Pembrolizumab (Keytruda, Merck) yanikezwa imvume ngabakwaFood and Drug Administration (FDA) njengokwelashwa kwe-neoadjuvant okuhlanganiswe ne-chemotherapy equkethe i-platinum kanye nokwelashwa okungeziwe kwangemva kokuhlinzwa komdlavuza wamaphaphu ongewona omncane (NSCLC) okhishwayo. 4 cm noma ngaphezulu ububanzi, lapho kuhlanganiswa ne-chemotherapy equkethe i-platinum.
I-KEYNOTE-671 (NCT03425643), isilingo esilawulwa yi-multicenter, esingahleliwe, esingaboni kabili, esilawulwa yi-placebo esibandakanya iziguli ze-797 ezine-AJCC 8th edition rectable Stage II, IIIA, noma i-IIB NSCLC engazange yelashwe ngaphambilini, ihlole ukusebenza komuthi. Iziguli ezithola i-chemotherapy-based chemotherapy zahlelwa ngokungahleliwe (1:1) ukuze zithole i-pembrolizumab noma i-placebo njalo emavikini amathathu emijikelezweni emine (ukwelashwa kwe-neoadjuvant).
Kamuva, emijikelezweni eyishumi nantathu (ukwelashwa kwe-adjuvant), iziguli zanikezwa i-pembrolizumab ye-ejenti eyodwa eqhubekayo noma i-placebo njalo emavikini amathathu. Iwindi lokuhlinza kanye nemininingwane ye-chemotherapy iyatholakala kusixhumanisi selebula yomuthi engenhla.
Izinyathelo eziyinhloko zomphumela wokuphumelela kwaba ukusinda okungenamcimbi okuhlolwe umphenyi (EFS) kanye nokusinda okuphelele (OS). I-OS emaphakathi yalabo abathola i-placebo kwakuyizinyanga ezingama-52.4 (95% CI: 45.7, NE) futhi ayizange itholwe engalweni ye-pembrolizumab (95% CI: ayilinganiseki [NE], NE]; p-value=0.0103). Isilinganiso sengozi [HR] sasingu-0.72 [95% CI: 0.56, 0.93]; p-value=0.0103]. I-EFS ephakathi engalweni ye-placebo yayiyizinyanga ezingu-17 (95% CI: 14.3, 22.0) uma kuqhathaniswa nezinyanga ezingu-17 engalweni ye-pembrolizumab (95% CI: izinyanga ezingu-34.1, NE) (HR 0.58 [95% CI: 0.46, 0.72]; p-value=0.0001).
Ukusabela okubi okuvame ukubikwa yi-20% noma ngaphezulu kweziguli ku-KEYNOTE-671 kwakumi kanje: isicanucanu, ukukhathala, i-neutropenia, i-anemia, ukuqunjelwa, ukuncipha kwesifiso sokudla, ukuncipha kwenani lamangqamuzana egazi amhlophe, ubuhlungu be-musculoskeletal, ukuqubuka, ukuminyana, ukuhlanza, isifo sohudo kanye ne-dyspnea.
Izinga eliphansi ngokuqhathaniswa lokusabela okubi livimbele ukuhlinzwa ku-6% weziguli ezingalweni ze-pembrolizumab ezithole ukwelashwa kwe-neoadjuvant, ngokuqhathaniswa no-4.3% engalweni ye-placebo. Ngaphezu kwalokho, u-3.1% weziguli ezathola ukwelashwa nokuhlinzwa kwe-neoadjuvant engalweni ye-pembrolizumab zaba nokubambezeleka kokuhlinzwa uma kuqhathaniswa no-2.5% engalweni ye-placebo. Ulwazi lokuphepha oluphathelene nezigaba ze-neoadjuvant kanye ne-adjuvant lungatholakala kusixhumanisi ngelebula yomuthi enikezwe ngenhla.
I-Pembrolizumab inqunywa ngethamo lama-200 mg njalo emavikini ama-3 noma ama-400 mg njalo emavikini ayi-6. Lapho isetshenziswa ngosuku olufanayo njenge-chemotherapy, i-pembrolizumab kufanele inikezwe kusenesikhathi.
