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First Mutation-Targeted Bladder Cancer Drug May Be Under-Used

Dr. Kamal Kant KohliWritten by Dr. Kamal Kant Kohli Published On 2022-05-19T20:00:46+05:30  |  Updated On 2022-05-19T20:00:50+05:30
First Mutation-Targeted Bladder Cancer Drug May Be Under-Used
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PHILADELPHIA: The first bladder cancer drug targeting a cancer-driving gene mutation has been used relatively little despite its clear efficacy in a clinical trial, suggests a study from researchers at the Perelman School of Medicine at the University of Pennsylvania. The researchers, whose findings appear today in JAMA Oncology, analyzed a large, nationwide database of cancer cases...

 PHILADELPHIA: The first bladder cancer drug targeting a cancer-driving gene mutation has been used relatively little despite its clear efficacy in a clinical trial, suggests a study from researchers at the Perelman School of Medicine at the University of Pennsylvania.

The researchers, whose findings appear today in JAMA Oncology, analyzed a large, nationwide database of cancer cases and found that between 2019 and 2021, in a sample of nearly 800 bladder cancer patients potentially eligible for erdafitinib (Balversa) treatment, fewer than half had a record of being tested for the relevant gene mutation. Of those who were tested and found to have the mutation, fewer than half received the treatment.

The co-senior authors of the study were Ronac Mamtani, MD and Erica Carpenter, MBA, PhD, both of whom are assistant professors of Hematology/Oncology at Penn. Dr. Carpenter is also director of the Liquid Biopsy Laboratory.

According to the American Cancer Society, approximately 81,000 Americans are diagnosed with bladder cancer each year-about 70 percent of those in men -- and about 17,000 people die from the disease annually. The five-year survival rate is about 77 percent, and bladder tumors are considered very treatable when caught at early stages. Later stages are far less treatable. Standard treatments include surgery, radiation, chemotherapies, and immunotherapies.

The vast majority of bladder cancers arise from so-called urothelial cells lining the bladder and ureters, and are termed "urothelial carcinomas." About 20 percent of advanced urothelial carcinomas are driven by mutations that cause growth-related receptors called FGFRs (Fibroblast Growth Factor Receptors) to be overactive.

Erdafitinib works as an inhibitor of FGFR activity. Based on promising results from a phase 2 clinical trial, which showed much higher rates of tumor response to the drug than is normally seen in advanced urothelial cancer patients, the drug was provisionally approved-subject to further studies-by the U.S. Food and Drug Administration (FDA) in early 2019. It is meant to be used in patients who have susceptible FGFR mutations and are no longer responding to standard chemotherapy.

"Genetic testing needs to be more widely available for patients to learn about and access, and education for treating physicians is a must so they can gain knowledge on the benefits and value in use for eligible patients," Dr. Mamtani said.

The new analysis covered a total of 761 patients who were eligible for FGFR-mutation testing from April 1, 2019, to September 1, 2021. Of the 761, only 343 (45.1 percent) had a record of FGFR testing. Of these, 71 (20.7 percent) had evidence of an FGFR mutation that would render their cancer susceptible to erdafitinib. But just 30 (42.3 percent) of those 71 patients received erdafitinib.

The results also showed that, among patients expected to harbor susceptible FGFR alterations, the effective uptake rate for erdafitinib, in its first six months post-approval, was far lower than the initial uptake rate for the first immunotherapy for bladder cancer-which in published trials has had a lower response rate than erdafitinib's.

The analysis indicated that the median survival time (about nine months) for erdafitinib-treated patients was in line with results from the prior clinical trial.

The study wasn't designed to discover why the uptake of erdafitinib was so low. However, the researchers suggest that the drug's high cost-over $20,000 per month-and potential side effects, including mouth sores and the loss of fingernails, may have accounted in part for the low rate of uptake even among patients whose tests showed susceptible FGFR mutations.

The low rate of FGFR testing, the researchers added, may have been due in part to the novelty of genetic testing in bladder cancer oncology. Moreover, tumor genetic testing in general has traditionally been done on biopsied tumor samples, which may often have been unavailable when patients became eligible for testing.

Only about 22 percent of patients with FGFR testing in the study had the newer, blood-based liquid biopsy testing, which detects circulating tumor DNA and is much easier for patients but not yet standard in this area of oncology.

"We see tremendous opportunity to increase the proportion of eligible patients who get FGFR-mutation tests by encouraging more use of liquid biopsies," Dr. Carpenter said.

JAMA Oncology cancer bladder cancer cancer patients cancer treatment mutation tumors urothelial cancer bladder tumors Bladder Cancer Drug 
Source : JAMA Oncology
Dr. Kamal Kant Kohli
Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as an Editor-in-Chief for the Speciality Medical Dialogues section. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Before Joining Medical Dialogues, he has served at important positions in the medical industry in India including as the Hony. Secretary of the Delhi Medical Association as well as the chairman of Anti-Quackery Committee in Delhi and worked with other Medical Councils in India. Email: editorial@medicaldialogues.in. Contact no. 011-43720751

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