Isbeddellada BRAF waxay ku dhacaan 15% bukaannada mindhicirka. Ma jiraan dawooyin la beegsaday oo ay ogolaatay FDA ilaa hadda, saadaashana waa liidataa. Waxaa ka mid ah, BRAF V600E waa isbeddelka ugu caansan.
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) + binimetinib (Mektovi) + cetuxima Monoclonal antibody (erbital), compared with the combination of irinotecan and cetuximab, can reduce the risk of death by 48%.
Natiijooyinka daraasadda wejiga III waxay muujisay in dhexdhexaadka guud ee badbaadada (OS) ee daaweynta seddexaad ay ahayd 9.0 bilood, marka la barbardhigo 5.4 bilood bukaannada qaata cetuximab oo lagu daray irinotecan.
Array BioPharma, the manufacturer of Encorafenib and binimetinib, said in a press release that it intends to submit these data for marketing approval in the second half of 2019.
Baadhaha guud ee MD Anderson Cancer Center Dr. Scott Kopetz ayaa sheegay in tijaabada BEACON CRC ay tahay wajiga koowaad ee tijaabada bukaan socodka III ee bukaanada leh bukaanjiifka malawadka qaba nooca BRAF V600E-mutant. Waxay leedahay horumar weyn oo ku saabsan isku darka caadiga ah ee seddex daroogo waxaana la rajeynayaa inay bedesho qorshaha daaweynta ee hadda jira.
Aqoonsiyada kale ee laga helo daaweynta seddex geesoodka ah
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 kansarka mindhicirka, 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).
Bishii Maarso 2019, Shabakadda Kansarka Guud ee Qaranka (NCCN) waxay cusboonaysiisay tilmaamaha ku dhaqanka bukaan-socodka ee kansarka mindhicirka, isku darka encorafenib + binimetinib + EGFR monoclonal antibody (cetuximab) sida BRAF V600E mutant metastatic kansarka mindhicirka bukaanka. Nooca 2A daawaynta ayaa lagula talinayaa waana in la isticmaalo ka dib marka 1 ama 2 xariiq oo daawadu ay fashilanto.
Intii lagu gudajiray wajiga hordhaca ee aaminka ah, 30 bukaan ah ayaa lasiiyay daaweyn seddex jeer ah, 300 mg dhiirigelinib hal jeer maalintii; 45 mg binimetinib laba jeer maalintii; ka dibna lagu daro qiyaasta caadiga ah ee cetuximab.
29 bukaan ah ayaa leh BRAF V600 mutation iyo 1% bukaannada ayaa leh xasillooni darro microsatelite-heer sare ah. Natiijooyinka waxay muujinayaan in qorshaha seddex geesoodka ah uu horay u muujiyay dulqaad wanaagsan. Marka loo eego xogta lagu bixiyay 2019 Symposium Kansarka Gastrointestinal, waqtiga la socoshada dhexdhexaadku wuxuu ahaa 18.2 bilood, natiijooyinkuna waxay muujiyeen badbaadin dhexdhexaad la'aan-dhexdhexaad ah oo 8.0 bilood ah iyo guud ahaan badbaado dhexdhexaad ah oo ah 15.3 bilood (hal sano badan). Qiimaynta maxalliga ah ee heerka jawaabta ee 48%, 3 bukaan ah ayaa ku gaadhay jawaab dhammaystiran.
Marka laga hadlayo nabadgelyada, qorshooyinka seddex-geesoodka iyo dabaqyada labadaba si wanaagsan ayaa loo dulqaatay mana jiraan wax sun ah oo shil ah. Labada astaamood ee amniga sidoo kale waxay la jaan qaadayaan kuwa lagu arkay mid kasta oo ka mid ah daraasadihii hore.
Xogtan culculus waxay noqon kartaa qorshaha daawaynta ugu horraysa ee loogu talagalay bukaanada qaba kansarka mindhicirka dheef-shiid kiimikaadka oo aan ku jirin dawooyinka kiimoterabiga. Tani shaki la'aan waa war wanaagsan oo muhiim u ah dadka bukaanka ah ee qaba kansarka mindhicirka ee BRAF V600E kuwaas oo leh baahi aad u sareysa oo daaweyn waxtar leh.