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I-Neoadjuvant nivolumab kanye ne-platinum-doublet chemotherapy igunyazelwe umdlavuza wamaphaphu weselula ongewona omncane.

Yabelana ngalokhu okuthunyelwe

March 2022: Esimweni se-neoadjuvant, i-FDA igunyaze i-nivolumab (i-Opdivo, i-Bristol-Myers Squibb Company) ihlanganiswe ne-platinum-doublet chemotherapy yeziguli ezikhulile ezinomdlavuza wamaphaphu ongewona omncane (NSCLC).

Kungokokuqala ukuthi i-FDA igunyaze ukwelashwa kwe-neoadjuvant kwe-NSCLC yesigaba sangaphambi kwesikhathi.

Ukusebenza kahle kwahlolwa ku-CHECKMATE-816 (NCT02998528), ukuhlolwa kwelebula okungahleliwe, okuvulekile ezigulini ezinesifo esitholakalayo futhi esithathekayo, esifakazelwe nge-histologically Isigaba IB (4 cm), II, noma i-IIA NSCLC (inqubo yesiteji ye-AJCC/UICC) (RECIST v1.1 .1.). Iziguli zafakwa kungakhathaliseki isimo se-PD-L358 ku-tumor. Ingqikithi yeziguli ezingama-XNUMX zabelwa ngokungahleliwe ukuthi zithole i-nivolumab kanye ne-platinum-doublet chemotherapy njalo emasontweni amathathu kuze kube imijikelezo emithathu, noma i-platinum-chemotherapy kuphela ohlelweni olufanayo.

Ngokubuyekezwa okuzimele okuphuphuthekisiwe okuphuphuthekile, izinyathelo ezibalulekile zemiphumela yokusebenza kahle kwaba ukusinda ngaphandle kwemicimbi (EFS) kanye nokuphendula okuphelele kwe-pathologic (pCR). I-EFS emaphakathi yalabo abathola i-nivolumab + i-chemotherapy yayiyizinyanga ezingu-31.6 (isikhathi sokuzethemba samaphesenti angu-95: 30.2, asifinyelelwanga) uma kuqhathaniswa nezinyanga ezingu-20.8 (isikhawu sokuzethemba esingamaphesenti angu-95: 14.0, 26.7) kulabo abathola i-chemotherapy kuphela. Isilinganiso sengozi sasingu-0.63 (p=0.0052; 97.38 amaphesenti CI: 0.43, 0.91). Izinga le-pCR ku-nivolumab plus chemotherapy ingalo yayingamaphesenti angu-24 (amaphesenti angu-95 CI: 18.0, 31.0) namaphesenti angu-2.2 (amaphesenti angu-95 CI: 0.6, 5.6) engalweni ye-chemotherapy yodwa.

Isicanucanu, ukuqunjelwa, ukukhathala, ukuncipha kwesifiso sokudla, nokuqubuka kwakuyizehlakalo ezimbi kakhulu ezigulini (izigameko ezingama-20%). Ukwengezwa kwe-nivolumab ku-chemotherapy akuzange kubangele ukwanda kwenani lokulibaziseka kokuhlinzwa noma ukukhanselwa. Iziguli kuzo zombili izingalo zokuhlolwa zibe nobude obumaphakathi obufanayo bokuhlala esibhedlela kulandela ukuhlinzwa okuqinisekile kanye namazinga okuphendula okungekuhle abonwa njengezinkinga zokuhlinzwa.

Umthamo ophakanyisiwe we-nivolumab ngu-360 mg njalo emavikini amathathu nge-platinum-doublet chemotherapy ngosuku olufanayo.

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