Hexaminolevulinate 85mg powder and solvent for intravesical solution vials

Introduction: Although there is evidence that hexaminolevulinate (HAL)-based transurethral bladder tumor resection (TURBT) improves the detection of Ta-T1 non-muscle-invasive bladder cancer (NMIBC) as well as carcinoma in situ there is uncertainty about its beneficial effects on progression. Material and Methods: A systematic literature search was conducted according to the PRISMA statement to identify studies reporting on HAL- vs. white-light (WL-) based TUR-BT in non-muscle invasive bladder cancer between 2000 and 2016. A two-stage selection process was utilized to determine eligible studies. Of a total of 294 studies, 5 (4 randomized and one retrospective) were considered for final analysis. The primary objective was the rate of progression. Results: The median follow-up for patients treated with HAL- and WL-TURBT was 27.6 (1–55.1) and 28.9 (1–53) months, respectively. Of a total of 1301 patients, 644 underwent HAL- and 657 WL-based TURBT. Progression was reported in 44 of 644 patients (6.8%) with HAL- and 70 of 657 patients (10.7%) with WL-TURBT, respectively (median odds ratio: 1.64, 1.10–2.45 for HAL vs. WL; p = 0.01). Data on progression-free survival was reported in a single study with a trend towards improved survival for patients treated with HAL-TURBT ( p = 0.05). Conclusions: In this meta-analysis the rate of progression was significantly lower in patients treated with HAL- vs. WL-based TURBT. These results support the initiation of randomized trials on HAL with progression as primary endpoint.

Abstract licence: CC BY-NC 4.0

BackgroundAblative/excisional surgery is the recommended therapy for cervical high-grade squamous intraepithelial lesions (HSILs) but is associated with cervical damage and elevated risk of complications upon subsequent pregnancies.MethodsThis multicenter, randomized, controlled trial compared APL-1702 (2-g ointment containing 5% hexaminolevulinate; photoactivated at 125 J/cm2) versus placebo in adult women with cervical HSILs (randomization ratio: 2:1). Upon completion of 6-month treatment, patients in the APL-1702 group entered into a 6-month extension phase with observation only. The primary efficacy endpoint was treatment response, as defined by normal histology or low-grade squamous intraepithelial lesion (LSIL) histology plus human papillomavirus (HPV) clearance, at 6 months in a modified intent-to-treat (mITT) population.FindingsA total of 402 women were enrolled. The 6-month response rate was 41.1% (104/253) in the APL-1702 group versus 21.7% (28/129) in the placebo group (p ConclusionsAPL-1702 significantly increased the 6-month response rate in patients with cervical HSILs versus placebo control, with a favorable safety profile.FundingThis trial was sponsored by Asieris Pharmaceuticals (Shanghai, China).

Abstract licence: CC BY-NC-ND