Hexvix fluorescence-guided bladder resection: Recently published data demonstrate favorable overall survival outcome in bladder cancer patients

Ipsen is pleased to note that a study on the impact of Hexvix® on survival in bladder cancer patients has been recently published in the World Journal of Urology¹.

Dr. Georgios Gakis and colleagues investigated the impact on survival in bladder cancer patients of photodynamic diagnosis (PDD)-guided bladder tumor resection (TUR-BT), including that guided by Hexvix® (hexaminolevulinate (HAL)). In patients who underwent RC it was retrospectively investigated whether patients had previously undergone PDD-guided versus white light (WL)-TUR- BT. It was shown for the first time that HAL-guided TUR-BT can be of prognostic importance for those patients who will have to undergo radical cystectomy during the course of their disease.

The findings from this retrospective study of 224 patients demonstrate that Hexvix® guided TUR-BT in bladder cancer patients, who later progressed to requiring RC, significantly improved the three year overall survival (p=0.037) and the median three year recurrence free survival (p=0.002) compared to patients in the comparator group.

Dr. Georgios Gakis of the Department of Urology, Eberhard-Karls University at Tuebingen, Germany and lead author, stated:

"These data indicate for the first time that improved patient management with HAL-guided TUR-BT can make a difference in outcomes even for those bladder patients who later progress to advanced disease and require radical cystectomy."

The paper was a retrospective analysis of data from 224 consecutive bladder cancer patients undergoing RC. Of these patients, prior to RC, 66 (29.5%) underwent hexaminolevulinate (HAL)- guided bladder tumor resection (TUR-BT), 23 (10.3%) 5-aminolevulinate (ALA)-guided TUR-BT and 135 (60.2%) white light (WL)-guided TUR-BT.

Three Year Overall Survival (OS): 74.0% in patients with HAL-TUR-BT compared to 60.9% with ALA-TUR-BT and 56.5% with White Light-guided TUR-BT. (p=0.037 for HAL vs. ALA/WL.)

Median Three Year Recurrence Free Survival (RFS): 77.8% for patients with HAL-based TUR-BT compared to 53.6% for ALA-TUR-BT and 52.4% for White Light-guided TUR-BT. (p=0.002 for HAL: vs. ALA or WL.) The positive results of clinical studies investigating HAL-based TUR-BT are also reflected in the guidance of the scientific societies. The European Association of Urology (EAU) recommends the use of fluorescence-guided resection, as being more sensitive than conventional white-light cystoscopy for detection of bladder cancer tumours². In addition, also the 1st NICE guidelines on bladder cancer acknowledge the clinical value of blue light cystoscopy. The guidelines advise to improve TUR-BT results by using additional techniques like the fluorescence-guided resection³.

Bladder cancer is one of the most frequently diagnosed tumour types, with an estimated 166 583 newly diagnosed cases and 58 742 deaths due to the disease in Europe in 2012 (Witjes et al., Eur Urol 2014; 66: 863-871). The lifetime costs of managing bladder cancer are one of the highest of all cancers (Sievert et al., World J Urol 2009; 27:295-300).