In patients with recurrent, intermediate-risk, low-grade bladder tumors, outpatient laser destruction of the tumors is noninferior to conventional inpatient transurethral resection of bladder tumor (TURBT), according to findings from the phase 3 Laser trial published in European Urology.1,2
The 4-month recurrence-free survival was 8% (95% CI, 8%-24%) higher after laser photocoagulation of bladder tumor(PC-BT) versus TURBT in general anesthesia (TURBT-GA). This met the primary end point of the trial, which was a predefined noninferiority criterion of 15%. PC-BT was also shown to be less burdensome to patients compared with TURBT-GA.
In the study, the outpatient group received laser-mediated ablation of bladder tumors under local anesthesia performed through PC-BT using a 980 nm diode laser. The inpatient group received the gold standard TURBT-GA. Both procedures were performed using photodynamic diagnosis guidance which was done with blue light cystoscopy and Hexvix (Photcure).
"The study outcomes clearly demonstrate that for patients with small low grade stage Ta bladder tumors the procedure can be safely moved from the OR to the office, thereby reducing the burden for patients stemming from general anesthesia and cost related to hospital stays. Safety is the most important term here. Our team find that blue light cystoscopy with Hexvix in the outpatient department support the identification of small bladder tumors which therefore safely can be removed with laser before they become too large for outpatient treatment," lead investigator Gregers G. Hermann, MD, DM Sc, consultant urologist, Department of Urology, Herlev/Gentofte Hospital, Denmark, stated in a news release.
Explaining the rationale for the study, Hermann and his coauthors wrote, “Transurethral resection of recurrent low-grade intermediate-risk Ta bladder tumor in general anesthesia is burdensome to patients and health care system. Laser technologies enable treatment in office-based settings, reducing morbidity and costs.”
The prospective, randomized, noninferiority phase 3 Laser III trial (NCT02886026) enrolled patients with histologically verified Ta low-grade bladder tumor recurrence. Overall, there were 206 patients randomized to the trial from 2016 to 2020 in the Capital Region of Denmark. Of these patients, 176 completed treatment and were available for follow-up per the study protocol.
Patients reported a pain score (1-10) of 2.4 (interquartile range, 0.8-3.3) during PC-BT. The TURBT-GA group had a postoperative lower urinary tract symptom score (0–100) that was 13.9 points (95% CI, 6.9-21.0; P <.001) higher compared with the PC-BT group. Also, the occurrence of minor complications was 8.1% (95% CI, 1.0%-14.6%; P = .026) higher following TURBT-GA versus PC-BT.
The study investigators plan to share 12-month follow-up data in a separate paper.
"We expect to see more scientific studies investigating how some of the more intensive procedures like TURBTs can be reduced, avoided, or made more bearable for patients. In non-muscle-invasive bladder cancer especially, where most patients are over 55 years old, research into reducing patient burden is of great importance. We believe BLC with Hexvix/Cysview can help responsible researchers in these efforts by minimizing the concern of uncertainty when it comes to detecting the tumors," Dan Schneider, president and CEO of Photocure, stated in the news release.
1. New study demonstrates that tumor removal in the outpatient setting is as good as TURBT under general anesthesia. Published online September 20, 2022. Accessed September 23, 2022.
2. Pedersen GL, Erikson MS, Mogensen K, Rosthøj S, Hermann GG. Outpatient Photodynamic Diagnosis-guided Laser Destruction of Bladder Tumors Is as Good as Conventional Inpatient Photodynamic Diagnosis-guided Transurethral Tumor Resection in Patients with Recurrent Intermediate-risk Low-grade Ta Bladder Tumors. A Prospective Randomized Noninferiority Clinical Trial [Published online ahead of print September 1, 2022]. Eur Urol. doi: 10.1016/j.eururo.2022.08.012