Urine-DNA testing for bladder cancer may decrease the number of patients with gross hematuria who would need to undergo flexible cystoscopy, researchers concluded based on the findings of a prospective, blinded study. Flexible cystoscopy, the current standard for detecting bladder tumors, is costly, invasive, and imperfect, the investigators, led by Per Guldberg, PhD, of the Danish Cancer Society Research Center in Copenhagen, noted. The study included 475 patients who underwent standard urologic examination, including flexible cystoscopy and computed tomography urography, and provided urine samples immediately before (461 patients, 97.1%) and after (444 patients, 93.5%) cystoscopy. Researchers collected urine cells from full bladder voids using a filtration device containing an 8 µm pore size membrane filter and tested the cells for 8 DNA mutation and methylation biomarkers. Clinical evaluation identified 99 patients (20.8%) with urothelial bladder tumors. Using this result as a reference and based on the analysis of all urine samples, the DNA test had a sensitivity of 97%, a specificity of 76.9%, a positive predictive value of 52.5%, and a negative predictive value of 99%, Dr Guldberg and colleagues reported online ahead of print in European Urology. In 3 patients with a positive urine-DNA test without clinical evidence of cancer, a tumor was detected at repeat cystoscopy within 16 months, according to the researchers. “In conclusion, with a negative predictive value of 99%, urine-DNA testing may be used to identify a large subgroup of patients with gross hematuria in whom the cystoscopic component of the work-up is not required,” the investigators wrote. A positive DNA-test result was obtained for 1 or both urine samples in 96 of 99 patients with bladder tumors and 87 of 376 patients without clinical evidence of cancer. The specificity of the urine-DNA test was significantly greater for pre-cystoscopy compared with post-cystoscopy urine specimens (87.5% vs. 81.7%); the sensitivity did not differ significantly. The filtration device used in the study was designed and patented by Dr Guldberg and a colleague, Kenneth E. Steven, MD. As described in a 2015 report in PLoS One, the device has a removable cartridge housing a membrane filter. After urinary cells are collected, the filter can be transferred to a storage unit containing an appropriate preserving solution. “The practical use of urinary cell-based tests is often hampered by difficulties in handling and analyzing large sample volumes, the need for rapid sample processing to avoid degradation of cellular content, and low sensitivity due to a high background of normal cells,” the authors wrote.
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Drug regulators in the United States have granted the immunotherapy drug Tecentriq (atezolizumab) accelerated approval to treat the most common type of bladder cancer - urothelial carcinoma. The drug is the first PD-1/PD-L1 inhibitor approved to treat this type of cancer. It works by helping to stop cancer cells evade the immune system. Urothelial carcinoma accounts for approximately 90 percent of bladder cancer cases and can also be found in the renal pelvis, ureter and urethra. In their announcement on May 18th, the Food and Drug Administration (FDA) say the drug is approved for the treatment of patients whose cancer is locally advanced or metastatic, who have disease progression during or following platinum-based chemotherapy, or whose cancer has advanced within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). Tecentriq is the first new drug approved in the U.S. for 30 years for treating patients with the most common form of bladder cancer. The FDA have given Tecentriq accelerated approval based on tumor response rate and duration of response. This type of approval can be given to a medicine that fills an unmet medical need for a serious condition, based on early evidence suggesting clinical benefit. However, it is conditional on the evidence being confirmed in later trials. Dr. Richard Pazdur - of the FDA's Center for Drug Evaluation and Research - says, "Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway." Tecentriq targets a cellular pathway called PD-1/PD-L1. PD-1 is a receptor (a protein that sits on the surface of the cell membrane) and PD-L1 is one of the molecules that binds to it. The pathway is an example of what is called an immune checkpoint - molecules or immune cells that need to be activated or stopped to start an immune response. By blocking the pathway, Tecentriq may help the body's immune system fight cancer cells. FDA also approve PD-L1 expression testThe FDA's approval is based on evidence from a clinical trial involving 310 patients with locally advanced or metastatic urothelial carcinoma. Nearly 15 percent of patients experienced at least a partial shrinkage of tumors, which lasted from about 2 months to nearly 14 months at the time the results were analyzed. In patients whose cancer cells tested "positive" for PD-L1 expression, 26 percent showed a tumor response. In contrast, of patients who were classed as "negative" for PD-L1 expression, only 9.5 percent showed a tumor response. The FDA also note in their announcement that: "While patients who received Tecentriq experienced a tumor response across the study, the greater effect in those who were classified as "positive" for PD-L1 expression suggests that the level of PD-L1 expression in tumor-infiltrating immune cells may help identify patients who are more likely to respond to treatment with Tecentriq." Therefore, the FDA have also approved a test for detecting PD-L1 protein expression levels in patients' tumor cells. The test - called the "Ventana PD-L1 (SP142) assay" - should help doctors decide which patients are most likely to benefit from treatment with Tecentriq. The most common side effects from treatment with Tecentriq include reduced appetite, fatigue, nausea, urinary tract infection, fever (pyrexia) and constipation. The drug may also give rise to infection and serious side effects - known as "immune-mediated side effects" - due to interaction with the immune system. These can affect healthy organs, including the lungs, colon and endocrine system. Tecentriq is marketed by Genentech of San Francisco, CA, who provide prescribing information. The drug is the first FDA-approved PD-L1 inhibitor and the latest in the broader class of PD-1/PD-L1 targeting products approved by the FDA in the last 2 years. |
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