I. Isifinyezo se-I-ESMOIsiqondiso sika-2025
Ngo-Agasti 2025, i-ESMO yakhipha ngokusemthethweni umdlavuza wamaphaphu ongeyona iseli encane othuthukisiwe kanye nowendawo: Umhlahlandlela Wokuzijwayeza Wezokwelapha we-ESMO wokuxilongwa, ukwelashwa kanye nokulandelela, owashicilelwa ephephabhukwini eliphezulu le-oncology i-Annals of Oncology. Lesi yisibuyekezo sokuqala esiphelele kusukela enguqulweni ka-2017 futhi sinikeza ireferensi enegunya elikhulu kodokotela be-oncologists emhlabeni jikelele.
Umdlavuza wamaphaphu unezinga eliphezulu kakhulu lokufa kanye nokwanda kwazo zonke izifo zomdlavuza emhlabeni jikelele. Unyaka ngamunye, kunamacala amasha angaphezu kwezigidi ezingu-2.2 kanye nokufa okungaphezu kwezigidi ezingu-1.8, okwenza umdlavuza wamaphaphu ube yimbangela ehamba phambili yokufa okuhlobene nomdlavuza kokubili kwabesilisa nabesifazane. Umdlavuza wamaphaphu ongewona amaseli amancane (i-NSCLC) ubanga cishe ama-80-85% azo zonke iziguli zomdlavuza wamaphaphu. Ngokuphikisana nalesi simo esibucayi, ukukhishwa kwesiqondiso sika-2025 kufaka umfutho omusha wesayensi emisebenzini yezokwelapha, kanye nokubuyekezwa kwamasu okuhlola ama-biomarker kubaluleke kakhulu.
II. Ukuhunyushwa Kwezibuyekezo Zeziqondiso Eziyinhloko
2.1 Ukuhlolwa kwe-Biomarker: Kusukela “Kokuzikhethela” kuya “Okubalulekile”
Isiqondiso sika-2025 senza ushintsho olukhulu lwecebo mayelana nokuhlolwa kwe-biomarker. Isiqondiso sisho ngokusobala ukuthi ukuhlolwa kwe-biomarker kubalulekile ekunqumeni ukwelashwa ezigulini ezine-NSCLC yesigaba se-IB-III.
Lesi sincomo sandisa ukuhlolwa kwama-molecule kusukela ekugxileni kwawo kwangaphambilini ezigulini ezinesifo esithuthukile kuya ezimweni ezisesigabeni sokuqala, ezingasuswa. Inhloso eyinhloko ukuhlonza ukuguquka kwezakhi zofuzo ezishayelayo nokuhlinzeka ngesisekelo sesayensi sokwelashwa okunembile komuntu siqu. Lesi siqondiso sigcizelela nokuthi kungenzeka ukuthi i-biopsy kanye nendlela yokuxilonga kufanele kunqunywe yithimba elihlanganisa imikhakha eminingi ngokusekelwe ezicini zesiguli kanye nomdlavuza.
Ngokuphathelene nesu lokuhlola elithile, lesi siqondiso sincoma ngokusobala ukuthi ukuhlolwa kofuzo kwenziwe ngaphambi kokwenza izinqumo zokuhlinzwa, nokuthi okungenani kufanele kufake i-EGFR ne-ALK. Lo mqondo "wokuhlola kusengaphambili" unokubaluleka okukhulu kwezokwelapha kokuhlukaniswa okunembile kanye nokwelashwa komuntu siqu kwe-NSCLC yesigaba sokuqala - ukufika ngesikhathi kanye nokunemba kwemiphumela yokuhlolwa kunquma ngqo ukukhethwa kokwelashwa okulandelayo kwe-adjuvant.
2.2 Ukuphumelela Kokwelapha ku-Driver-Oncogene Positive Early-Stage NSCLC
Isiqondiso sika-2025 sihlanganisa ubufakazi obuvela ezifundweni eziningi ezinkulu zezokwelapha ukuze kusungulwe indlela yokwelapha ecacile nenembile yeziguli ezine-NSCLC yesigaba sokuqala ene-driver-oncogene.
Iziguli ezine-EGFR eziguqukile:Ngokusekelwe esivivinyweni esibalulekile se-ADAURA, i-adjuvant osimertinib ngemuva kokuhlinzwa iminyaka emithathu isibe yindinganiso yomhlaba wonke yokunakekelwa kweziguli ezine-EGFR exon 19 deletions noma i-exon 21 L858R mutations. Isivivinyo se-ADAURA siyisifundo samazwe ngamazwe, esinezikhungo eziningi, esingahleliwe, esilawulwayo sesigaba III esihlola ukusebenza kahle nokuphepha kwe-adjuvant osimertinib ezigulini ezine-NSCLC eguquliwe ngokuphelele yesigaba se-IB-IIIA EGFR. Ucwaningo lukhombisile ukuthi i-osimertinib ithuthukise kakhulu kokubili ukusinda okungenazifo kanye nokusinda okuphelele uma kuqhathaniswa ne-placebo, yasungula i-osimertinib njengendinganiso entsha yokunakekelwa kwaleli qembu labantu. Kodwa-ke, ukuhlaziywa kokuhlola kwesivivinyo se-ADAURA kubonise ukuthi cishe ama-36% okuyekiswa kokwelashwa kwasekuqaleni kwakubangelwa izehlakalo ezimbi, kanti amanye ama-31% ayebangelwa yisinqumo sesiguli. Lokhu okutholakele kugcizelela isidingo sokuhlolwa okuyisisekelo okunembile ngaphambi kokwelashwa ukuqinisekisa ukuthi ukwelashwa okuqondiwe kunikezwa iziguli ezingathola inzuzo eqhubekayo.
Iziguli ezine-ALK:Ngokusekelwe esivivinyweni se-ALINA, i-adjuvant alectinib ngemuva kokuhlinzwa iminyaka emibili manje iyindinganiso yokunakekelwa. Ekuhlaziyweni okuyinhloko kwesivivinyo se-ALINA esivulekile sesigaba sesi-3, i-alectinib ibonise inzuzo ephawulekayo yokusinda engenazifo kubantu besigaba sesi-II-IIIA, ngesilinganiso sengozi esingu-0.24. Idatha ebuyekeziwe evela esivivinyweni se-ALINA esethulwe engqungqutheleni ye-ESMO ka-2025 ibonise ukuthi ngemva kweminyaka engu-≥3 yokulandelela, inzuzo ye-DFS ye-alectinib yahlala "iqhubeka futhi inencazelo ngokwezokwelapha," ngesilinganiso sengozi esingu-0.36 kubantu besigaba sesi-II-IIIA. Izinga lokusinda elibikiwe lakamuva leminyaka emi-4 lifinyelele ku-98.4%, izinga le-DFS leminyaka emi-4 lalingu-75.5%, kanti i-DFS yesistimu yezinzwa ephakathi nayo yathuthukiswa, ngaphandle kwezimpawu ezintsha zokuphepha. Le datha eqinile iqhubeka nokusungula i-adjuvant alectinib njengendinganiso yokunakekelwa ngemva kokususwa kwe-ALK-positive NSCLC futhi igcizelela ukubaluleka kokuhlolwa okunembile ukuhlonza iziguli ezinjalo.
Ukukhetha indlela yokuhlola:Isiqondiso se-ESMO sika-2025 sichaza ngokucacileUkuhlolwa kwephaneli ye-RT-PCR eningikanye ne-NGS, i-IHC, kanye ne-FISH esekelwe kwi-RNA njengenye yezindlela zobuchwepheshe ezinconywayo zokuthola i-ALK fusion. Lokhu kubonisa ukuthi imfuneko eyinhloko yomhlahlandlela ukwenza ukuhlolwa ukuze kuqondiswe izinqumo zezokwelapha, kunokuba kuphoqelelwe ipulatifomu ethile yokuhlola. Ngemikhiqizo ye-RT-PCR egxile ekutholakaleni kwe-EGFR kanye ne-ALK, leli su lokuhlola eliguquguqukayo linikeza isizathu esinamandla esisekelwe kumhlahlandlela sokusetshenziswa kwayo emisebenzini yezokwelapha.
III. Izixazululo Zobuchwepheshe Zokuhlola Ngokunembile
Isiqondiso sika-2025 siqhubekela phambili ekuhlolweni kuze kufike esigabeni sokwenza izinqumo ngaphambi kokuhlinzwa, okuphakamisa izinga lokunemba kokuhlolwa, ukuzwela, kanye nokufinyeleleka. Imikhiqizo emibili yokuthola esekwe ku-RT-PCR echazwe ngezansi ihambisana ngqo nezidingo zesiqondiso ngokombono wobuchwepheshe.
3.1 Ikhithi Yokuthola Ukuguquka Kwe-EGFR – Ipulatifomu Yobuchwepheshe Ye-ARMS Ethuthukisiwe
Ubuchwepheshe obuyinhlokoUbuchwepheshe be-ARMS obuthuthukisiwe buvumela ukukhuliswa okukhethekile kochungechunge lwe-mutant olunezandi ezincane ngokumelene nesizinda se-wild-type esiphezulu
Izivikelo ezintathu zobuchwepheshe:
-I-ARMS Ethuthukisiwe → ithuthukisa ukuqashelwa kokuguquka kwezakhi zofuzo
-Ukucebisa nge-enzyme → kugaya isizinda se-wild-type futhi kucebisa ukulandelana kwe-mutant
-Ukuvimba izinga lokushisa → kunciphisa ukukhulisa okungaqondile
Ukusebenza: Ukuzwela kweimvamisa ye-allele engu-1% eguquliwe
Ukulawula ukungcola: Ukulawula kwangaphakathi okwakhelwe ngaphakathi + i-enzyme ye-UNG ivimbela ukungcola
Isikhathi sokuguquka: Ukusebenza kwepayipi elivaliwe, cisheImizuzu eyi-120
Ukuhambisana kwesampula:Izicubu/i-biopsy yoketsheziamasampula → ikhuluma ngesidingo "sokuhlola kusengaphambili"
Ukumbozwa:Izinguquko ezingu-45ku-EGFR exons 18-21, izifunda eziqokonyiswe ngokunembile (ukususwa kwe-exon 19 kanye ne-exon 21 L858R)
Ukusetshenziswa kwezokwelapha: Iqondisa ngokuqondile ukwelashwa kwe-EGFR-TKI
Ikhithi Yokuthola I-Fusion ye-MMT EML4-ALK engu-3.2 – Isixazululo Sokuthola I-Fusion Esisekelwe ku-RNA
-Ipulatifomu yobuchwepheshe: I-RT-PCR esekelwe kwi-RNA – inikeza izinzuzo ezingokwemvelo kunezindlela ezisekelwe kwi-DNA zokuthola i-fusion
-Inzuzo esekelwe ku-RNA: Ithola ngokuqondile imibhalo ehlanganisiwe evezwe, igwema ngempumelelo amaphutha angamanga
-Ubufakazi bokutadisha: Ekuhlanganiseni kwe-ALK okunenqwaba encane, i-RT-PCR ithembeke kakhulu kunokuhlolwa okusekelwe ku-DNA
-Ukuzwela: Ithola ukuhlangana kuze kufike kuAmakhophi angu-20 ngokusabela ngakunye
-Ukumbozwa kwezinhlobo ezahlukene: IzimbozoIzinhlobo ezingu-12 ezivamile ze-fusion ye-EML4-ALK(kufaka phakathi uhlobo 1 ~33%; izinhlobo 3a/3b ndawonye ~29%)
-Ukusebenza nokulawula ukungcola: Ipayipi elivaliwe, ~imizuzu eyi-120; izilawuli zenqubo ezakhelwe ngaphakathi + i-enzyme ye-UNG zivimbela imiphumela engamanga
-Ukuhambisana kwezinsimbi: Iyahambisana nezinsimbi ezahlukahlukene ze-PCR zesikhathi sangempela
-Ukuqondanisa isiqondiso: Kuhambisana kakhulu nesiqondiso se-ESMO
IV. Ukuvumelana Phakathi Kwezivivinyo Nezincomo Zesiqondiso
Imikhiqizo emibili yokuthola ihambisana kakhulu nesiqondiso se-ESMO 2025 somdlavuza wamaphaphu ongeyona iseli elincane kanye nesethulwe endaweni kulezi zigaba ezilandelayo ezibalulekile:
V. Isiphetho
Isiqondiso se-NSCLC sesigaba sokuqala se-ESMO 2025 siletha inkathi entsha yokuxilonga nokwelapha ngokunemba, okugxile ku-“ukuhlola kusenesikhathi, ukuqondiswa okuqondile, kanye nokwenza ngcono ukwelashwa."I-EGFR Mutation Detection Kit kanye ne-MMT EML4-ALK Fusion Detection Kit zihlangabezana nezidingo zesiqondiso sezinhloso, isikhathi, kanye nokunemba ngezindlela zobuchwepheshe ezihlukile."
Ikhithi ye-EGFR isebenzisa ubuchwepheshe be-ARMS obuthuthukisiwe bokuthola ukuzwela okuphezulu kokuguqulwa kwezakhi zofuzo okuqondiwe kumasampula alinganiselwe, okusekela kokubili izicubu kanye ne-biopsy yoketshezi ukuze kuvunyelwe "ukuhlolwa kusengaphambili."
Ikhithi ye-ALK isekelwe ku-RT-PCR esekelwe ku-RNA, inikeza izinzuzo kunezindlela ze-DNA zokuthola i-fusion, okuhambisana nesincomo se-ESMO samaphaneli e-multiplex RT-PCR okuhlolwa kwe-ALK.
Ndawonye, le mikhiqizo emibili yakha isisombululo sokuhlola ngokunemba esihambisana nesiqondiso se-ESMO 2025, esisekela ukwelashwa kwe-adjuvant okwenzelwe wena kwe-NSCLC esesigabeni sokuqala.
Izinkomba:
- UZer A, u-Ahn MJ, uBarlesi F, nabanye. Umdlavuza wamaphaphu ongeyona iseli elincane osuqalile futhi othuthuke endaweni: Umhlahlandlela Wokusebenza Kwezokwelapha we-ESMO wokuxilongwa, ukwelashwa kanye nokulandelela. Ann Oncol. 2025;36(11):1245-1262. doi:10.1016/j.annonc.2025.08.003
Isikhathi sokuthunyelwe: Meyi-06-2026