Mutation-targeting bladder cancer drug found underutilized

“, said lead author of the study, Vivek Nimgaonkar, a student at the Perelman School of Medicine and a graduate associate at the Penn Center for Precision Medicine.

Our study has implications for patients who begin treatment lines later after receiving platinum-based chemotherapy, and it is important that patients receive the necessary testing for full coverage. enough treatment options to ensure the best possible chance for a good outcome.. “

Study co-authors are Ronac Mamtani, MD, and Erica Carpenter, MBA, PhD, both assistant professors of Hematology/Oncology at Penn. Dr. Carpenter is also the director of the Laboratory of Fluid Biopsy.

According to the American Cancer Society, about 81,000 Americans are diagnosed with bladder cancer each year — about 70 percent of them in men — and about 17,000 die from the disease annually.

The five-year survival rate is about 77%, and bladder tumors are considered very treatable when detected at an early stage. The later stages are very less treatable. Standard treatments include surgery, radiation, chemotherapy, and immunotherapy.

The majority of bladder cancers arise from the so-called urothelial cells that line the bladder and ureters and are called “epithelial cancer“About 20 percent of advanced carcinomas are caused by mutations that cause growth-related receptors called FGFRs (Fibroblast Growth Factor Receptors) to become overactive.

Erdafitinib acts as an inhibitor of FGFR activity. Based on promising results from a phase 2 clinical trial, which showed a much higher-than-normal tumor response rate in patients with advanced carcinoma, the drug was approved. provisional approval – subject to further studies – by the US Food and Drug Administration (FDA) in early 2019.

It is used for patients who have sensitive FGFR mutations and are no longer responding to standard chemotherapy.

Genetic testing needs to be made more widely available to patients to learn and access, and education for treating physicians is essential so that they can gain knowledge of the benefits and value of its use. for eligible patients.“Dr. Mamtani said.

The new analysis included a total of 761 patients eligible for FGFR mutation testing between April 1, 2019 and September 1, 2021.

Out of 761, only 343 (45.1%) had an FGFR test record. Of these, 71 (20.7%) had evidence of an FGFR mutation that could make their cancer sensitive to erdafitinib. But only 30 (42.3%) of those 71 patients received erdafitinib.

The results also showed that, among patients expected to have sensitive FGFR changes, the rate of effective absorption for erdafitinib, during the first six months after approval, was much lower than that for erdafitinib. with initial absorption rates for first-line immunotherapy for bladder cancer – published trials had lower response rates than erdafitinib’s trial.

The analysis indicated that the median survival (approximately nine months) for patients treated with erdafitinib was consistent with results from the previous clinical trial.

The study was not designed to explore why absorption of erdafitinib was so low. However, the researchers suggest that the drug’s high cost – more than $20,000 per month – and potential side effects, including mouth sores and nail loss, may partly explain the rate. Drug absorption rates are low even in patients whose tests show sensitive FGFR mutations. .

The low rates of FGFR testing may be partly due to the novelty of genetic testing in bladder cancer oncology, the researchers added. Furthermore, tumor genetic testing, generally, traditionally performed on biopsied tumor samples, is often unavailable when patients are eligible for testing.

Only about 22% of the FGFR patients in the study had the newer blood-based liquid biopsy test, which detects circulating tumor DNA and is much easier for patients but has not yet met the standards in the field of oncology. this study.

We see a great opportunity to increase the proportion of patients eligible for FGFR mutation testing by promoting greater use of liquid biopsies.‘ said Dr. Carpenter.

Source: Medindia

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