I. Isishwankathelo seI-ESMOIsikhokelo sika-2025
Ngo-Agasti 2025, i-ESMO yakhupha ngokusesikweni umhlaza wamaphaphu ongengoweseli encinci ophuhlileyo nowasekhaya: Isikhokelo se-ESMO Clinical Practice for diagnosis, treatment and follow up, esapapashwa kwijenali ye-oncology ephezulu i-Annals of Oncology. Olu luhlaziyo lokuqala olupheleleyo ukusukela kwinguqulelo ka-2017 kwaye lubonelela ngereferensi enegunya kakhulu kwiingcali zomhlaza kwihlabathi liphela.
Umhlaza wemiphunga unenani eliphezulu lokufa kunye nokwanda kwezifo ezinobungozi kwihlabathi liphela. Unyaka ngamnye, kukho amatyala amatsha angaphezu kwezigidi ezi-2.2 kunye nokufa okungaphezulu kwezigidi ezi-1.8, nto leyo eyenza umhlaza wemiphunga ube yeyona nto iphambili yokufa okunxulumene nomhlaza kumadoda nabasetyhini. Umhlaza wemiphunga ongengoweeseli ezincinci (i-NSCLC) ubandakanya malunga ne-80-85% yazo zonke izigulana ezinomhlaza wemiphunga. Kwimeko enjalo, ukukhutshwa kwesikhokelo sika-2025 kufaka amandla amatsha esayensi kwindlela yokusebenza kwezonyango, kunye nohlaziyo lwezicwangciso zovavanyo lwe-biomarker lubaluleke kakhulu.
II. Ukutolikwa koHlaziyo lweZikhokelo eziPhambili
2.1 Uvavanyo lweBiomarker: Ukusuka "kokuzikhethela" ukuya "kokubalulekileyo"
Isikhokelo sika-2025 senza uhlengahlengiso olubalulekileyo malunga novavanyo lwe-biomarker. Esi sikhokelo sichaza ngokucacileyo ukuba uvavanyo lwe-biomarker lubalulekile kwisigqibo sonyango kwizigulane ezine-IB-III NSCLC yesigaba.
Esi sindululo sikwandisa uvavanyo lwemolekyuli ukusuka ekugxileni kwayo kwangaphambili kwizigulana ezinesifo esiphucukileyo ukuya kwiziganeko zokuqala, ezinokususwa. Injongo ephambili kukuchonga utshintsho lwezakhi zofuzo oluqhubayo kunye nokubonelela ngesiseko sesayensi sonyango oluchanekileyo lomntu ngamnye. Esi sikhokelo sikwagxininisa ukuba ukuba nokwenzeka kwe-biopsy kunye nendlela yokuxilonga kufuneka kumiselwe liqela elinamacandelo amaninzi ngokusekelwe kwiimpawu zesigulana kunye nethumba.
Ngokuphathelele icebo elithile lovavanyo, esi sikhokelo sicebisa ngokucacileyo ukuba uvavanyo lwemfuza lwenziwe ngaphambi kokwenziwa kwezigqibo ngotyando, kwaye kufuneka ubuncinane lugubungele i-EGFR kunye ne-ALK. Le ngcamango "yokuvavanya kwangaphambili" inentsingiselo enkulu yeklinikhi yokwahlulahlula ngokuchanekileyo kunye nonyango olulungiselelwe umntu ngamnye lwe-NSCLC yesigaba sokuqala - ukufaneleka kwexesha kunye nokuchaneka kweziphumo zovavanyo kumisela ngokuthe ngqo ukhetho lonyango oluncedisayo olulandelayo.
2.2 Uphuhliso Lonyango kwi-Driver-Oncogene Positive Early-Stage NSCLC
Isikhokelo sika-2025 sidibanisa ubungqina obuvela kwizifundo ezininzi eziphambili zeklinikhi ukuze kusekwe indlela ecacileyo yonyango oluchanekileyo kwizigulane ezine-NSCLC yesigaba sokuqala ene-driver-oncogene.
Izigulane ezine-EGFR-mutation positive:Ngokusekelwe kuvavanyo olubalulekileyo lwe-ADAURA, i-osimertinib emva kotyando kangangeminyaka emithathu iye yaba ngumgangatho wehlabathi wokhathalelo lwezigulane ezine-EGFR exon 19 deletions okanye i-exon 21 L858R mutations. Uvavanyo lwe-ADAURA luphononongo lwamazwe ngamazwe, oluneendawo ezininzi, olucwangcisiweyo, nolulawulwayo lwesigaba sesi-3 oluvavanya ukusebenza kakuhle kunye nokhuseleko lwe-osimertinib ye-adjuvant kwizigulane ezine-NSCLC eguqulwe ngokupheleleyo ye-IB-IIIA EGFR. Olu phononongo lubonise ukuba i-osimertinib iphucule kakhulu ukusinda okungenazifo kunye nokusinda ngokubanzi xa kuthelekiswa ne-placebo, nto leyo eseka i-osimertinib njengomgangatho omtsha wokhathalelo lwale qela. Nangona kunjalo, uhlalutyo lophando lovavanyo lwe-ADAURA lubonise ukuba malunga ne-36% yokuyekiswa konyango kwangoko kuqhutywa ziziganeko ezimbi, kwaye enye i-31% yayibangelwa sisigqibo sesigulana. Olu phando lubonisa imfuneko yovavanyo oluchanekileyo ngaphambi konyango ukuqinisekisa ukuba unyango olujoliswe kulo lunikwa izigulane ezinokufumana inzuzo eqhubekayo.
Izigulana ezine-ALK:Ngokusekelwe kuvavanyo lwe-ALINA, i-adjuvant alectinib emva kotyando iminyaka emibini ngoku yindlela yokunyamekela. Kuhlalutyo oluphambili lovavanyo lwe-ALINA oluvulelekileyo lwesigaba sesi-3, i-alectinib ibonise inzuzo ephawulekayo yokusinda engenasifo kuluntu lwesigaba sesi-II-IIIA, kunye nomlinganiselo wengozi we-0.24. Idatha ehlaziyiweyo evela kuvavanyo lwe-ALINA oluvezwe kwingqungquthela ye-ESMO ka-2025 ibonise ukuba emva kweminyaka eyi-≥3 yokulandelela, inzuzo ye-DFS ye-alectinib yahlala "izinzile kwaye inentsingiselo ngokwezonyango," kunye nomlinganiselo wengozi we-0.36 kuluntu lwesigaba sesi-II-IIIA. Izinga lokusinda leminyaka emi-4 elixeliweyo lamva nje lifikelele kwi-98.4%, izinga le-DFS leminyaka emi-4 laliyi-75.5%, kwaye i-DFS yenkqubo yemithambo-luvo ephakathi nayo iphuculwe, kungekho zimpawu zintsha zokhuseleko. Ezi datha ziqinileyo ziseka i-adjuvant alectinib njengomgangatho wokhathalelo emva kokususwa kwe-ALK-positive NSCLC kwaye zigxininisa ixabiso lovavanyo oluchanekileyo lokuchonga izigulane ezinjalo.
Ukukhetha indlela yokuvavanya:Isikhokelo se-ESMO sika-2025 sichaza ngokucacileyoUvavanyo lwephaneli ye-RT-PCR ye-multiplexkunye ne-RNA-based NGS, IHC, kunye ne-FISH njengenye yeendlela zobugcisa ezicetyiswayo zokufumanisa i-ALK fusion. Oku kubonisa ukuba imfuneko ephambili yesikhokelo kukwenza uvavanyo ukuze kukhokelwe izigqibo zeklinikhi, endaweni yokuyalela iqonga elithile lovavanyo. Kwiimveliso ze-RT-PCR ezigxile ekufumaneni i-EGFR kunye ne-ALK, esi sicwangciso sovavanyo esiguquguqukayo sibonelela ngesizathu esinamandla esisekelwe kwisikhokelo sokusetyenziswa kwazo kwizenzo zeklinikhi.
III. Izisombululo zoBugcisa zoVavanyo oluchanekileyo
Isikhokelo sika-2025 siqhubela phambili uvavanyo ukuya kwinqanaba lokwenza izigqibo ngaphambi kotyando, nto leyo ephakamisa umda wokuchaneka kovavanyo, uvakalelo, kunye nokufikeleleka. Iimveliso ezimbini zokufumanisa ezisekelwe kwi-RT-PCR ezichazwe ngezantsi zihambelana ngokuchanekileyo neemfuno zesikhokelo ngokwembono yobugcisa.
3.1 Ikhithi yokuFumanisa uTshintsho lwe-EGFR – Iqonga leTekhnoloji ye-ARMS ephuculweyo
Itekhnoloji engundoqo: Itekhnoloji ye-ARMS ephuculweyo ivumela ukwandiswa okukhethekileyo kweendlela eziguquguqukayo ezincinci ngokuchasene nemvelaphi ephezulu yohlobo lwasendle.
Izikhuselo zobugcisa ezintathu:
-Ii-ARMS eziphuculweyo → ziphucula ukuqondwa kokuguquka kwezakhi zofuzo
-Ukuphucula i-enzyme → isusa imvelaphi yohlobo lwasendle kwaye ityebise ulandelelwano lwe-mutant
-Ukuthintela ubushushu → kuthintela ukwanda okungachazwanga
Ukusebenza: Uvakalelo lweI-frequency ye-allele ye-mutant eyi-1%
Ulawulo longcoliseko: Ulawulo lwangaphakathi olwakhelwe ngaphakathi + i-enzyme ye-UNG ithintela ungcoliseko
Ixesha lokutshintsha: Ukusebenza kwetyhubhu evaliweyo, malungaimizuzu eli-120
Ukuhambelana kwesampulu:Izicubu/i-biopsy yolweloiisampulu → ijongana neemfuno "zovavanyo kwangaphambili"
Ugutyungelwe:Iinguqu ezingama-45kwi-EGFR exons 18-21, ihambelana ngokuchanekileyo nemimandla ekhankanyiweyo ngesikhokelo (ukususwa kwe-exon 19 kunye ne-exon 21 L858R)
Ukusetyenziswa kweklinikhi: Ikhokela ngokuthe ngqo unyango lwe-EGFR-TKI
I-3.2 MMT EML4-ALK Fusion Detection Kit – Isisombululo sokuFunxwa kwe-RNA esisekelwe kwi-RNA
-Iqonga lobuchwepheshe: I-RT-PCR esekwe kwi-RNA – inika iingenelo ezisisiseko kuneendlela ezisekwe kwi-DNA zokufumanisa i-fusion
-Inzuzo esekelwe kwi-RNA: Ibona ngokuthe ngqo ii-transcripts ze-fusion eziveziweyo, ithintela ngempumelelo iimpazamo ezingezizo
-Ubungqina bokufunda: Kwi-ALK fusions ezingabizi kakhulu, i-RT-PCR ithembeke ngakumbi kuneemvavanyo ezisekelwe kwi-DNA.
-Uvelwano: Ifumanisa ukudibana ukuya kuthi gaIikopi ezingama-20 ngempendulo nganye
-Ukugutyungelwa kweendidi ezahlukeneyoIzigqubutheloIindidi ezili-12 eziqhelekileyo ze-EML4-ALK fusion(kubandakanya uhlobo 1 ~33%; uhlobo 3a/3b xa zizonke ~29%)
-Ukusebenza kunye nolawulo longcoliseko: Ityhubhu evaliweyo, ~imizuzu eli-120; ulawulo lwenkqubo eyakhelwe ngaphakathi + i-enzyme ye-UNG ithintela iziphumo ezingezizo
-Ukuhambelana kwezixhobo: Iyahambelana nezixhobo ezahlukeneyo ze-PCR zexesha langempela
-Ulungelelwaniso lwesikhokelo: Ihambelana kakhulu nesikhokelo se-ESMO
IV. Ukungaguquguquki Phakathi koVavanyo kunye neeNgcebiso zeSikhokelo
Ezi mveliso zimbini zokufumanisa zihambelana kakhulu nesikhokelo somhlaza wemiphunga esingengoweeseli ezincinci se-ESMO 2025 sasekuqaleni nesasesiphuhlisiweyo apha ekhaya kwezi nkalo zilandelayo ziphambili:
V. Isiphelo
Isikhokelo se-ESMO 2025 se-NSCLC singenisa ixesha elitsha lokuxilongwa ngokuchanekileyo kunye nonyango, olugxile "ukuvavanya kwangaphambili, ukujolisa ngokuchanekileyo, kunye nokwenza ngcono unyango."I-EGFR Mutation Detection Kit kunye ne-MMT EML4-ALK Fusion Detection Kit ziyahlangabezana neemfuno zesikhokelo zeenjongo, ixesha, kunye nokuchaneka ngeendlela ezahlukeneyo zobugcisa.
Ikhithi ye-EGFR isebenzisa iteknoloji ye-ARMS ephuculweyo yokufumanisa utshintsho olujolise kulo kwiisampuli ezilinganiselweyo, ixhasa zombini i-tissue kunye ne-liquid biopsy ukuze kuvunyelwe "uvavanyo kwangaphambili."
Ikhithi ye-ALK isekelwe kwi-RNA-based RT-PCR, inika iingenelo ngaphezu kweendlela ze-DNA zokufumanisa i-fusion, ihambelana nengcebiso ye-ESMO yeephaneli ze-multiplex RT-PCR zovavanyo lwe-ALK.
Xa zizonke, ezi mveliso zimbini zenza isisombululo sovavanyo oluchanekileyo esihambelana nesikhokelo se-ESMO 2025, esixhasa unyango oluncedisayo olulungiselelwe wena kwi-NSCLC yesigaba sokuqala.
Iireferensi:
- Zer A, Ahn MJ, Barlesi F, et al. Umhlaza wemiphunga ongengoweeseli ezincinci oqhubele phambili ekuqaleni nasekuhlaleni: Isikhokelo se-ESMO Clinical Practice sokuxilonga, unyango kunye nokulandelela. Ann Oncol. 2025;36(11):1245-1262. doi:10.1016/j.annonc.2025.08.003
Ixesha leposi: Meyi-06-2026