Hexaminolevulinate (HAL) fluorescence cystoscopy vs white light cystoscopy (WL) comparing detection of Ta and T1 TCC of bladder and 9 months recurrence - results of a multi-center trial
Richard K. Babayan, MD1, Lance Mynderse, MD2, Mark Soloway, MD3, Unyime Nseyo, MD4, Seth Lerner, MD5, Ed Messing, MD6, H. Barton Grossman, MD7, H. Barton Grossman, MD7.
1Boston University, Boston, MA, USA, 2Mayo Clinic, Rochester, MN, USA, 3University of Miami, Miami, FL, USA, 4VAMC, Gainesville, FL, USA, 5Baylor College of Medicine, Houston, TX, USA, 6University of Rochester, Rochester, NY, USA, 7MD Anderson Cancer Center, Houston, TX, USA.
Background: Study to compare HAL vs WL cystoscopy for the detection of bladder tumors and follow 9 month recurrence pattern for WL resection vs Hal + WL resection of detected tumors
Methods: Multi-center international randomized phase III trial using WL vs WL + Hal to detect tumors in patients with initial or recurrent TCC of bladder with high risk of recurrence. For patients randomized to HAL group, HAL was instilled in bladder prior to cystoscopy and patients were inspected and mapped with WL first, followed by blue light fluorescence mapping. All suspicious lesions were biopsied and then resected by TURBT. Completeness of resection was checked by blue light in the HAL group. All patients were followed with surveillance cysto at 3,6 and 9 months.
Results: 726 patients were entered into the study. 278 patient entered into the HAL arm were diagnosed with Ta/T1 TCC. 16.9 % randomized to HAL had at least 1 additional lesion detected as compared to WL (p= 0.0005). Of the 41 patients having CIS, 13 (32%) were diagnosed only with HAL. False + rate was 12% with Hal and 10% with WL. Of the 402 patients (202WL and 200 HAL) who completed the protocol, tumor recurrence was reduced in HAL: 72 (36%) vs WL: 92 (46%) (p=0.029)
Conclusion: HAL fluorescence cystosocpy improves the detection, completeness of resection and reduces the recurrence rate of Ta/T1 bladder tumors at 9 months.
Financial support of study: Photocure (Oslo, Norway)