Cholangiocarcinoma (CCA) is a heterogeneous group of malignancies that can evolve from the canals of Hering to the main bile duct. CCA are rare tumors consisting of about 3% of gastrointestinal tumors and have an overall occurrence of less than 2/100,000. They are the second most common primary hepatic malignancies following hepatocellular carcinoma (HCC). It accounts for about 20% of the deaths from hepatobiliary cancers, which cause 13% of the total cancer mortality globally. CCA is one of the most fatal cancers: although it has been seen that 1-year mortality has improved over time, the 5-year survival is still as low as 10%. The only possible treatment option for patients with CCA is surgical resection. Despite the respectability rate having been reported to be as high as 65%, curative resection rates are less than 50%. Unfortunately, two-thirds of CCA remain clinically silent and are only diagnosed in more advanced stages. At advanced stage, CCA has a devastating prognosis with a median overall survival of only 12-15 months.
Cholangiocarcinoma is a type of cancer that forms in the slender tubes that carry the digestive fluid bile. Bile ducts connect your liver to your gallbladder and to your small intestine. Cholangiocarcinoma, also known as bile duct cancer, occurs mostly in people older than 50, though it can occur at any age.
The Various Signs and Symptoms of Cholangiocarcinoma Include:
Cause of Cholangiocarcinoma
The actual reason of cholangiocarcinoma. The risk factors suggest that health conditions that cause chronic (long-term) inflammation in the bile ducts may play a role in developing this cancer. Consistent damage such as inflammation can also cause DNA changes, which may change how certain cells grow, divide and behave. These changes probably aren't inherited, which means parents don't pass them to their children. Instead, the changes are likely happen during a person's lifetime.
Symptoms and Treatment:
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Several treatment methods include liver therapy, chemotherapy, radiation therapy, targeted drug therapy, immunotherapy. For many patients, a liver transplant can be a cure for hilar cholangiocarcinoma, but there is a high risk that the cancer will recur after a liver transplant. Radiation therapy uses high-powered energy beams from sources such as X-rays and protons to kill the cancer cells. Immunotherapy uses body's own immune system to fight cancer. Immunotherapy works by interfering with that process.
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Concerning the treatment of cholangiocarcinoma, the Food and Drug Administration (FDA) recently granted accelerated approval to futibatinib for adult patients with previously treated, unrespectable, locally advanced or metastatic intrahepatic cholangiocarcinoma having fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.
This trial involved 103 patients who were previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma. All these patients received 20 mg of futibatinib orally once daily continuously for 21-day cycles until disease progression or unacceptable toxicity.
The End-Points are Discussed Below:
Overall Response Rate(ORR)
Disease control rate (DCR)
Progression-free survival (PFS)
Overall survival (OS)
Duration of response (DOR)
It was observed that the ORR was 41.7%, and the DCR was 82.5%. A complete response was observed in 1 patient, 42 patients had a partial response, 42 patients had stable disease, and 16 had progressive disease. The median duration of response was 9.5 months and the median time to response was 2.6 months. In the pre-specified subgroup analysis, the ORR was consistent across patient all subgroups.
The median progression-free survival was 8.9 months. At 6 months the PFS rate was 65%, and at 12 months it was 35%. The median OS was 20.0 months. The PFS rate at 6 months was 88% and at 12 months it was 73%.
Although, the patients received adverse reactions as well. The most common treatment-related adverse events (TRAEs) of any grade included alopecia, hyperphosphatemia, dry mouth, and diarrhea. Most TRAEs were grade 3 or less, but there were 2 grade 4 events. Grade 3 AEs Included
Through this trial, there has been some safety and precautions noticed with this drug. It has been mentioned below:
The prevalence of cholangiocarcinoma is on the rise and thus effective treatment is necessary for the fast recovery of the patients. FDA recently approved a drug which received accelerated approval called futibatinib for adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma having fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Such developments are necessary for treating these patients.
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