Newly released clinical practice guidelines for the diagnosis and management of non-muscle invasive bladder cancer (NMIBC) may enable clinicians to provide patients with more individualized treatment. The guidelines, developed by the American Urological Association (AUA) and the Society for Urologic Oncology (SUO), make 38 recommendations regarding diagnosis, risk stratification, surgical intervention, and intravesical therapy. “We've come a long way in understanding bladder cancer and how to treat and manage this disease and this guideline takes our knowledge one step further by refining our approach and allowing us to provide more individualized treatment to our patients,” said Sam S. Chang, MD, in an AUA press release. Dr Chang, of Vanderbilt University Medical Center in Nashville, TN, led the AUA/SUO panel that developed the guidelines. With respect to diagnosis, the guidelines state that at the time of transurethral resection (TUR) of suspected bladder cancer, a clinician should perform a thorough cystoscopic examination of a patient's entire urethra and bladder that evaluates and documents tumor size, location, configuration, number, and mucosal abnormalities. At initial diagnosis, when technically feasible, clinicians should perform complete visual resection of the tumor. As part of an initial evaluation of a bladder cancer patient, clinicians should perform upper urinary tract imaging. “In a patient with a history of NMIBC with normal cystoscopy and positive cytology, a clinician should consider prostatic urethral biopsies and upper tract imaging, as well as enhanced cystoscopic techniques (blue light cystoscopy, when available), ureteroscopy, or random bladder biopsies,” the guidelines state. At the time of each cancer occurrence or recurrence, clinicians should assign a clinical stage and classify a patient as low-, intermediate-, or high-risk. The guidelines also address the use of urinary biomarkers following a diagnosis of bladder cancer. In surveillance of NMIBC, the guidelines strongly recommend that clinicians not use urinary biomarkers in place of cystoscopic evaluation. Clinicians should not routinely use a urinary biomarker or cytology during surveillance in a patient with a history of low-risk cancer and normal cystoscopic findings. In a patient with NMIBC, a clinician may use biomarkers to assess response to intravesical bacillus Calmette-Guérin (BCG) and adjudicate equivocal cytology. For NMIBC patients who underwent an incomplete initial resection (not all visible tumor treated), clinician should perform repeat TUR or endoscopic treatment of all remaining tumor if technically feasible. For patients with known or suspected low- or intermediate-risk tumors, clinicians should consider administering a single postoperative instillation of intravesical chemotherapy, such as mitomycin C or epirubicin, within 24 hours of TUR. Clinicians should not use postoperative chemotherapy for patients with a suspected perforation or extensive resection. In addition, clinicians should not administer induction intravesical therapy in low-risk patients. For intermediate-risk patients, clinicians should consider administration of a 6 week course of induction intravesical chemotherapy or immunotherapy. The guidelines strongly recommend administration of a 6-week induction course of BCG to high-risk patients with newly diagnosed carcinoma in situ, high-grade T1, or high-risk Ta urothelial carcinoma.
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Afatinib, a drug approved in 2013 to treat lung cancer, may help patients with metastatic urothelial carcinoma who have certain genetic abnormalities, a small study finds. “Compared to other drugs which have been tried for refractory metastatic bladder cancer, including immune therapies which will likely be approved, the time to disease progression is significantly longer with afatinib in patients carrying the genetic abnormalities,” lead researcher Peter O'Donnell, MD, of the University of Chicago, stated in a press release. “There have been no other drugs approved in the US in decades in this disease setting, and only one drug approved in Europe. Its progression-free time was half of what we are seeing with afatinib in this same population of patients.” For the phase 2 trial, Dr O'Donnell and his team enrolled 23 patients with urothelial carcinoma of the bladder, upper tract, or urethra whose disease had progressed despite platinum-based combination chemotherapy. Each patient received afatinib 40 mg per day continuously until their cancer progressed or intolerance developed. Afatinib is an oral, irreversible tyrosine kinase inhibitor of the ErbB receptor family. The main endpoint was 3-month progression-free survival (PFS3). Five of the 23 patients experienced delayed tumor progression for at least 3 months: 2 with partial response to the drug and 3 with stable disease, according to results published online ahead of print in the Journal of Clinical Oncology. Based on an analysis of tumor specimens, the investigators determined that 3 of 4 patients with multiple copies of human epidermal growth factor receptor (HER2) and all 3 patients with somatic mutations of ERBB3 met the PFS3 endpoint. None of the patients without the molecular alterations responded to treatment. The single patient with both HER2 amplification and ERBB3 mutation did not progress with afatinib, but treatment was stopped after 10.3 months due to depressed ejection fraction. Toxicity was as expected. Two patients had dose reductions for grade 3 rash and fatigue. The most common side effect was diarrhea, experienced by 83% of patients. The potential contribution of ERBB3 to afatinib sensitivity is a novel finding, according to Dr O'Donnell and colleagues. They expect to conduct a follow-up trial focused entirely on patients with at least 1 of the genetic alterations. The study was funded in part by Boehringer Ingelheim Pharmaceuticals, Inc., manufacturers of afatinib. |
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