Maganin da aka yi niyya na ciwon daji na colorectal, BRAF V600E maye gurbi da aka yi niyya na maganin ciwon daji Braftovi + Erbitux a ƙarshe ya sami sakamako mai kyau.
Matsayin maganin cutar kansa
Colorectal cancer is one of the most common malignant tumors in the digestive system. In recent years, its morbidity ranks third in the world in terms of malignant tumors, and its mortality rate ranks second, which seriously threatens people’s lives and health. With the changes in the living habits and dietary structure of our nationals, the incidence of maganin ciwon daji has generally shown an upward trend, and has become the second highest incidence of digestive system, and the highest incidence of malignant tumors. According to relevant research statistics, the number of new cases of colorectal cancer in China is expected to exceed 521,000 in 2018, and the number of deaths is as high as 248,000.
Bincike ya nuna cewa kimanin kashi 15% na marasa lafiya masu fama da cutar sankara za su sami maye gurbin BRAF da mummunan hangen nesa. V600E maye gurbi shine mafi yawan maye gurbi na BRAF. Haɗarin mutuwar marasa lafiya tare da maye gurbin BRAF V600E shine ɗaukar nau'in kwayar cutar BRAF marasa lafiya sau biyu.
Faced with such a dangerous BRAF V600E mutation metastatic colorectal cancer, the editor shares a piece of exciting good news learned recently! On April 8, 2020, Pfizer announced that the US FDA has approved Braftovi® (encorafenib, connefenib) and Erbitux® (cetuximab, cetuximab) combination therapy (Braftovi two-drug protocol) is used to treat patients with metastatic colorectal cancer (mCRC) who carry the BRAF V600E mutation. These patients have already received one or two pre-treatments. This approval also makes the Braftova tsarin magani na biyu na farko da aka yi niyya wanda FDA ta amince da shi don marasa lafiya tare da mCRC dauke da maye gurbi na BRAF.
Braftovi ninki biyu da sau uku yana ba da ƙarin tsawon rai
Tun a watan Disambar 2019, FDA ta karɓi sabon aikace-aikacen magani na Pfizer Braftovi Second Drug Programme kuma ta ba da cancantar duba fifiko. Wannan yarda ya dogara da sakamakon gwajin gwaji na BEACON CRC Phase 3.
An gudanar da binciken a cikin marasa lafiya tare da BRAF V600E mutant mCRC na gaba wanda ya ci gaba a baya bayan karɓar magunguna ɗaya ko biyu. Inganci da amincin tsarin kulawa na al'ada tare da magani (kulawa).
Table 1: Tsarin magani na kowane rukuni
| Na biyu magani | Braftovi (ƙarfafarafenib, Connefini) |
| Na biyu magani | Erbitux (tsamiya, da sakewa) |
| Shirye-shiryen kwayoyi uku | Braftovi (ƙarfafarafenib, Connefini) |
| Shirye-shiryen kwayoyi uku | Erbitux (tsamiya, da sakewa) |
| Shirye-shiryen kwayoyi uku | Mektovi (binimetinib, bemetinib) |
| Ƙungiyar sarrafawa | Erbitux (tsamiya, da sakewa) |
| Ƙungiyar sarrafawa | Irinotecan ko FOLFIRI (folinic acid, fluorouracil da irinotecan) |
Babban sakamakon bincike
1. Rayuwa ta Mediya (OS): watanni 9.0 a cikin rukunin masu maganin sau uku
8.4 watanni a cikin rukunin farfadowa biyu
Controlungiyar kulawa ita ce watanni 5.4
2. Cigaba da rashin ci gaba: Watanni 4.3 a cikin rukunin masu maganin sau uku
Watanni 4.2 don rukunin maganin biyu
Controlungiyar kulawa ita ce watanni 1.5
3. Tsarin rayuwar watanni 6: 71% a cikin rukuni uku
65% a cikin ƙungiyar farfadowa biyu
Ungiyar kulawa ita ce 47%
4. issionimar Rarraba Maƙasudin (ORR): 26% a cikin rukuni uku
20% a cikin ƙungiyar farfadowa biyu
Ungiyar kulawa ita ce 2%
Hoto a hannun hagu yana kwatanta tsarin raftovi na miyagun ƙwayoyi uku da OS na rukunin sarrafawa, kuma hoton dama yana kwatanta tsarin maganin raftovi na miyagun ƙwayoyi biyu da OS na ƙungiyar kulawa
Gabaɗaya, idan aka kwatanta da Erbitux da nau'ikan maganin da ke ƙunshe da irinotecan, ingancin tsarin shan magani biyu da na magunguna uku ba shi da bambanci sosai, kuma akwai ƙananan sakamako masu illa na asibiti.
Babban mai binciken Dakta Scott Kopetz ya ce: “A matsayina na mai haƙuri da mai fama da cutar BRAF V600E wanda ya kamu da cutar kansa, Braftovi + Erbitux (conefinil + cetuximab) shi ne na farko kuma wanda aka yi niyya shi kadai Wannan shine sabon zaɓin magani wanda irin waɗannan marasa lafiya ke buƙata. "
Ka'idojin maganin Braftovi masu hadewa da alamomi
Braftovi’s active pharmaceutical ingredient binimetinib is an oral small molecule BRAF inhibitor, and Mektovi’s active pharmaceutical ingredient encorafenib is an oral small molecule MEK inhibitor. MEK and BRAF are two key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK).
Studies have shown that this pathway regulates many key cell activities including cell proliferation, differentiation, survival, and angiogenesis. In many cancers, such as melanoma, colorectal cancer, and thyroid cancer, proteins in this signaling pathway have been shown to be abnormally activated.
A cikin Amurka, an amince da haɗin Braftovi + Mektovi don melanoma wanda ba a iya gyarawa ko metastatic tare da maye gurbin BRAF V600E ko BRAF V600K. Braftovi bai dace da maganin BRAF melanoma na daji ba. A cikin Turai, an yarda da haɗin gwiwa ga manya tare da melanoma wanda ba a iya jurewa ko metastatic tare da maye gurbin BRAF V600. A cikin Japan, an yarda da haɗin don BRAF-mutated unresected melanoma.
| Sunan Turanci | Sunan kasar Sin | Target | manufacturer | alamomi | Medicare |
| Trametinib (Mekinist) | Trametinib | SOFT | Novartis (a waje) | Daidai kamar na sama | babu |
| Vemurafenib (Zelboraf) | Verofinil (Verofinil, Zuobofu) | Farashin BRAF | Roche Gold da Azurfa Tektronix (a waje) | Melanoma | Haka ne, an haɗa shi a cikin inshorar lafiya |
| Cobimetinib (Cotelic) | Cobitinib | SOFT | Roche Gold da Azurfa Tektronix (a waje) | Daidai kamar na sama | babu |
| Encorafenib (Braftovi) | Connefini | Farashin BRAF | Tsarin BioPharma | Melanoma | babu |
| Binimetinib (Mektovi) | Bemetinib | SOFT | Tsarin BioPharma | Daidai kamar na sama | babu |
Sharuɗɗan NCCN na 2019 don Ciwon Ciwon Lala yana ƙara sabbin hanyoyin haɗin gwiwar EGFR / BRAF / MEK sau uku don marasa lafiya tare da ci-gaba BRAF V600E maye gurbi-tabbatacciyar cuta mai ci gaba, wato:
[1] Dabrafenib + Trametinib + Cetuximab / Panitumumab (Cetuximab / Panitumumab)
[2] Encorafenib (conefinil) + Binimetinib (bimetinib) + Cetuximab / Panitumumab (cetuximab / panitumumab)
Xiaobian yana da abin faɗi
A cikin zamanin da aka yi niyya, kowane mai haƙuri da ciwon daji ya kamata ya wuce ganowar MSI, nazarin maye gurbi na RAS da BRAF, da yin haɓakawa na HER2, NTRK da sauran gano kwayoyin halitta gwargwadon yiwuwa. Za a haɗa gwajin kwayoyin halitta (NGS) a cikin babban Ma'aunin gwajin farko na yawancin marasa lafiya. Abokan ciwon daji da suka yi gwajin kwayoyin halitta na iya aika rahoton zuwa sashen kiwon lafiya don fassarawa don ganin ko akwai wani zaɓin magani mai dacewa.
Editan ya yi imanin cewa a nan gaba za a sami ci gaban bincike na baya-bayan nan da kuma mafi kyawun magunguna don ciwon daji na launin fata. Manyan ƙwararrun ƙwararrun ciwon daji ne kawai a gida da waje suna da ƙwarewar aikin asibiti. Masu fama da cutar sankara mai launi na iya neman izini ta hanyar shawarwarin ƙwararrun ƙwararrun likitocin Oncologist na Duniya, samun mafi kyawun ganewar asali da tsarin kulawa.
