Sauye-sauye na BRAF yana faruwa a cikin 15% na marasa lafiya na launi. Babu magungunan da aka yi niyya da FDA ta amince da shi ya zuwa yanzu, kuma hasashen ba shi da kyau. Daga cikin su, BRAF V600E shine maye gurbi na yau da kullun.
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%.
Sakamakon binciken lokaci na III ya nuna cewa tsaka-tsakin rayuwa (OS) na maganin sau uku shine watanni 9.0, idan aka kwatanta da watanni 5.4 ga marasa lafiya masu karɓar cetuximab da 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.
Babban mai binciken MD Anderson Cancer Center Dr. Scott Kopetz ya bayyana cewa gwajin na BEACON CRC shi ne karo na farko na gwaji na uku a cikin marasa lafiya masu dauke da cutar da ke dauke da nau'in BRAF V600E. Yana da ci gaba mai mahimmanci akan daidaitattun haɗin magunguna uku kuma ana tsammanin zai canza tsarin kulawa na asibiti na yanzu.
Sauran bayanan da aka samo ta hanyar maganin sau uku
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 maganin ciwon daji, 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).
A cikin Maris 2019, National Comprehensive Cancer Network (NCCN) ta sabunta ƙa'idodin aikin asibiti don ciwon daji na ciwon daji, haɗa encorafenib + binimetinib + EGFR monoclonal antibody (cetuximab) azaman BRAF V600E mutant metastatic cancer colorectal haƙuri. Ana ba da shawarar nau'in magani na 2A kuma yakamata a yi amfani da shi bayan layin 1 ko 2 na jiyya sun gaza.
A lokacin gabatarwa mai aminci, marasa lafiya 30 sun sami maganin sau uku, 300 MG naɗaɗa sau ɗaya sau ɗaya kowace rana; 45 mg binimetinib sau biyu a rana; sannan a hade tare da daidaiton kashi na cetuximab.
29 marasa lafiya suna da BRAF V600 maye gurbi kuma 1% na marasa lafiya suna da rashin daidaiton microsatelite-babban matsayi. Sakamakon ya nuna cewa makircin sau uku ya nuna kyakkyawan haƙuri. Dangane da bayanan da aka bayar a taron Symposium na Gastrointestinal 2019, lokacin biyan masu matsakaici ya kasance watanni 18.2, kuma sakamakon ya nuna kimanin rashin samun ci gaban tsakiyan watanni 8.0 da kuma tsaka-tsakin tsaka-tsakin watanni 15.3 (shekara daya da yawa). Tare da ƙimar gida na ƙimar amsawa na 48%, marasa lafiya 3 sun sami cikakken amsa.
Dangane da aminci, duka makircin sau uku da duplex ana jurewa sosai kuma babu wata haɗari mai haɗari. Abubuwan tsaro guda biyu suma sunyi daidai da waɗanda aka gani a cikin kowane binciken da ya gabata.
Wannan bayanan bincike mai nauyi na iya zama shirin jiyya na farko da aka yi niyya ga majiyyata da ke fama da ciwon daji na kasusuwa wanda ba ya ƙunshi magungunan chemotherapy. Babu shakka wannan muhimmin labari ne mai kyau ga yawan marasa lafiya da ke fama da ciwon daji na BRAF V600E wanda ke da babban buƙatu don ingantaccen magani.
