OSLO: Photocure ASA, The Bladder Cancer Company, announces the publication of first results from the Laser III clinical study in the medical journal, European Urology. The study is part of a systematic program aimed at verifying the safe treatment of bladder tumors in the outpatient setting. Laser III results demonstrate the non-inferiority of outpatient laser-mediated destruction of bladder tumors in conjunction with blue light cystoscopy (BLC[®]) and Hexvix[®] versus inpatient BLC TURBT* under general anesthesia. Photocure has supported this program and the specific study since 2016.
Laser III is a prospective, randomized, non-inferiority trial conducted in the Capital Region of Denmark from 2016 to 2020 (NCT02886026).
Patients with histologically verified Ta low-grade bladder tumor recurrence were enrolled. A total of 206 patients were randomized; 176 finished treatment and were available for follow-up as per protocol. The first results, now published in European Urology, evaluated 4-month non-inferiority of outpatient laser-mediated ablation of recurrent Ta tumors with flexible cystoscopes under local anesthesia, compared to TURBT under general anesthesia. Both the out-patient laser procedure and TURBT procedure were performed under BLC-guidance.
Four-month recurrence-free survival was assessed as the primary endpoint with a predefined non -inferiority criterion of 15%. Secondary outcome measures were pain during the outpatient laser ablation, postoperative morbidity, postoperative complications, and patient’s preference. The 12-month follow-up results are expected to be presented in a second paper.
Four-month recurrence-free survival was 8% higher after laser-ablation of the bladder tumor compared to TURBT, and the predefined noninferiority criterion was met. The study authors conclude that laser intervention in the outpatient setting is as good as TURBT with general anesthesia, and has less complications.
In addition, the paper also advocates the importance of enhanced cystoscopy to mediate this practice change. As recommended by the guidelines, enhanced cystoscopy should be used during surgical treatment of non-muscle invasive bladder cancer to improve detection and reduce recurrence.
“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 OPD support the identification of small bladder tumors which therefore safely can be removed with laser before they become too large for outpatient treatment.” said Dr. Gregers G Hermann, the Lead Investigator of this study and Consultant Urologist, MD, DM Sc, F.E.B.U., Dept. of Urology, Herlev/Gentofte hospital, Denmark.
“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,” said Dan Schneider, President and CEO of Photocure.