Ukuguqulwa kwe-BRAF kwenzeka ku-15% weziguli ezinombala. Azikho izidakamizwa ezihlosiwe ezigunyazwe yi-FDA kuze kube manje, futhi ukubikezela kubi. Phakathi kwazo, i-BRAF V600E iwushintsho oluvame kakhulu.
Recently, the results of the Phase III BEACON CRC trial study announced: three-drug combination therapy of patients with metastatic colorectal cancer (CRC) who had previously received second-line treatment of BRAF V600E mutation-encorafenib (Bratovi) + ibinimetinib (Mektovi) + cetuxima Monoclonal antibody (erbital), compared with the combination of irinotecan and cetuximab, can reduce the risk of death by 48%.
Imiphumela yocwaningo lwesigaba III ikhombise ukuthi ukusinda okuphakathi (OS) kokwelashwa okuphindwe kathathu kwakuyizinyanga eziyi-9.0, uma kuqhathaniswa nezinyanga eziyi-5.4 zeziguli ezithola i-cetuximab kanye ne-irinotecan.
Array BioPharma, the manufacturer of I-Encorafenib and binimetinib, said in a press release that it intends to submit these data for marketing approval in the second half of 2019.
Umphenyi omkhulu we-MD Anderson Cancer Center uDkt. Scott Kopetz uthe ukuhlolwa kwe-BEACON CRC kuyisivivinyo sokuqala somtholampilo sesigaba III ezigulini ezineziguli ezimhlophe ezinohlobo lwe-BRAF V600E-mutant. Kunokuthuthuka okuphawulekayo kunhlanganisela ejwayelekile yemithi emithathu futhi kulindeleke ukuthi iguqule uhlelo olukhona lwamanje lokwelashwa koMtholampilo.
Okunye ukukhonjwa okutholwe ukwelashwa okuphindwe kathathu
The US FDA previously granted the three-drug combination plan as a breakthrough treatment designation for the treatment of patients with BRAF V600E mutant metastatic umdlavuza colorectal, which was used after failure of first-line or second-line treatment. This decision is based on the results of the safety introduction phase of the BEACON CRC trial (a trial to assess the safety of drugs).
NgoMashi 2019, iNational Comprehensive Cancer Network (NCCN) yabuyekeza imihlahlandlela yokwelashwa komdlavuza we-colorectal oncology, ehlanganisa i-encorafenib + binimetinib + EGFR monoclonal antibody (cetuximab) njengesiguli se-BRAF V600E esiguquguqukayo somdlavuza we-metastatic colorectal. Thayipha ukwelashwa kwe-2A kuyatuswa futhi kufanele kusetshenziswe ngemuva kokuthi imigqa yokwelashwa engu-1 noma emi-2 yehlulekile.
Ngesikhathi sesingeniso esiphephile, iziguli ezingama-30 zithole ukwelashwa okuphindwe kathathu, ama-300 mg encorafenib kanye ngosuku; 45 mg binimetinib kabili ngosuku; bese ihlanganiswa nomthamo ojwayelekile we-cetuximab.
Iziguli ezingama-29 zinezinguquko ze-BRAF V600 kanti i-1% yeziguli zinesimo esiphakeme sokungazinzi kwemicrosatellite. Imiphumela ikhombisa ukuthi uhlelo olukathathu phambilini lukhombise ukubekezelelana okuhle. Ngokuya ngemininingwane ehlinzekwe kwi-2019 Gastrointestinal Cancer Symposium, isikhathi sokulandelela esiphakathi kwaba yizinyanga eziyi-18.2, futhi imiphumela ikhombise ukusinda okungenamkhawulo kokuqhubeka kwezinyanga eziyi-8.0 nokusinda okuphakathi kwezinyanga eziyi-15.3 (unyaka owodwa okuningi). Ngokuhlolwa kwendawo kwezinga lokuphendula lama-48%, iziguli ezi-3 zithole impendulo ephelele.
Mayelana nokuphepha, womabili ama-triplet nezinhlelo eziphindwe kabili zibekezelelwa kahle futhi abukho ubuthi obuyingozi. Izici ezimbili zokuphepha nazo ziyahambisana nalezo ezibonwe esifundweni ngasinye sangaphambilini.
Le datha yocwaningo esindayo ingase ibe uhlelo lokuqala lokwelapha oluqondiswe ezigulini ezinomdlavuza we-metastatic colorectal ongaqukethe imithi yokwelapha ngamakhemikhali. Akungabazeki ukuthi lezi yizindaba ezinhle ezibalulekile kubantu beziguli ezinomdlavuza we-BRAF V600E oguquguqukayo we-colorectal onesidingo esikhulu kakhulu sokwelashwa okusebenzayo.
