The development and approval of high-intensity focused ultrasound doesnâ€™t qualify as moving at a glacial pace; if anything, it seems quite measured. In a crowded field of treatments, the technology is trying to gain a toehold.
Change is inevitable. It can move at a glacial pace or with the speed of an idea. The outcome of change can be a detriment or a benefit, depending on whom it affects. Healthcare, in general, is a conservative business, so the uptake of anything new can take time. The development and approval of high-intensity focused ultrasound (HIFU)—featured this month— doesn’t qualify as moving at a glacial pace; if anything, it seems quite measured. In a crowded field of treatments, the technology is trying to gain a toehold.
HIFU has been around for about 15 years in Europe, Asia, and elsewhere in the world, but until now, not in the United States. In fact, a cottage industry of medical tourism developed around this technology’s availability in Europe and Asia, where US physicians have performed the procedure at international clinics in London or Tokyo.
But in November 2015, the FDA voted to approve this technology for prostate tissue ablation. This is not quite an indication for prostate cancer but, as we all know, once a treatment or technology is cleared for approval, a physician can prescribe or use it as he or she deems medically appropriate. Some urologists view HIFU as a viable treatment for the patient who prefers not to partake in active surveillance but who thinks surgery is too aggressive; others voice concern that every Tom, Dick, and Harry is going to open standalone clinics without the proper training and overtreat patients who could be managed conservatively over time. Whichever is the case, urologists are going to do what’s best for their patients, and what’s best for their practice.
What seems to have moved fast, compared with the approval of HIFU technology, is the role of immunotherapy in genitourinary cancers. In medical meetings covered in this issue, urologists were energized by the possibility of checkpoint blockade inhibitors in renal and bladder cancer. Specifically, at the 16th Annual Meeting of the Society of Urologic Oncology (SUO), data from CheckMate-025 with the clinical development of PD-1 and PD-L1 inhibitors in renal cell carcinoma demonstrated the extended durability associated with nivolumab over everolimus.
A similar buzz was generated by ongoing research on the potential role of PARP inhibitors in prostate cancer. The FDA recently granted olaparib (Lynparza) breakthrough therapy designation as a treatment for patients with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer (mCRPC) in those who have received a prior taxanebased chemotherapy.
Perhaps the most compelling research involving PD-1 and PD-L1 inhibitors has to do with their potential role in combination therapy. If one immune checkpoint inhibitor works well, what about combining two different ones?
At the 2016 Genitourinary Cancers Symposium in San Francisco, data involving the antitumor activity and low toxicity in bladder cancer of anti-PD-L1 antibody avelumab continues to accumulate, as noted by clinical investigator Andrea B. Apolo, MD. Immunotherapy for the treatment of bladder cancer has been available for years, but now researchers are learning a lot more about how active it is in the metastatic setting.
Similarly, updated data from IMvigor 210 that involved atezolizumab in bladder cancer showed a median overall survival of 11.4 months in patients with locally advanced or metastatic urothelial carcinoma who had high PD-L1 levels. The agent’s second-line potential seems firmly in place.
To close out this month’s issue, we highlight a local practice—First Urology of Louisville, Kentucky. Created by a merger between two large private practices, First Urology, now encompasses greater Louisville and parts of Indiana. As a dominant player in the genitourinary space, it boasts its own laboratory and, according to its president, Ganesh Rao, MD, “conducts more genitourinary clinical trials than the local cancer center.” Rao explained that in order for his practice to remain viable, ancillary services needed to be identified. Most notable was his practice’s adoption of HIFU technology, making it the first private practice center in the United States to do so. Yes, change is inevitable.