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ISSN: 2168-9857
Medical & Surgical Urology
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Efficacy of Hexaminolevulinate Photodynamic Diagnosis of Non-Muscle Invasive Bladder Cancer

Ioannis Papazoglou1, Ioannis Varkarakis2, Michael Chrisofos2, Venetiana Panaretou1*, Ioannis Kastriotis2, Apostolos Rempelakos1 and Charalambos Deliveliotis2

1Urology Department, Hippokratio Hospital of Athens, Greece

2Urology Department, Sismanoglio Hospital of Athens, Greece

*Corresponding Author:
Venetiana Panaretou
Urology Department, Hippokratio Hospital of Athens
Greece
Tel: +00306974719130
E-mail: [email protected]

Recieved date: January 18, 2017; Accepted date: February 07, 2017; Published date: February 14, 2017

Citation: Papazoglou I, Varkarakis I, Chrisofos M, Panaretou V, Kastriotis I, et al. (2017) Efficacy of Hexaminolevulinate Photodynamic Diagnosis of Non-Muscle Invasive Bladder Cancer. Med Sur Urol 6:180. doi: 10.4172/2168-9857.1000180

Copyright: © 2017 Papazoglou I, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited., M.D., M.S.

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Abstract

Objective: This study evaluated the efficacy of hexaminolevulinate fluorescence cystoscopy as a diagnostic tool for bladder cancer. The study was a case series in the Department of Urology in Hippokratio General Hospital of Athens between October 2008 and May 2012. Methods: Fifty patients (43 males and 7 females) who were investigated for hematuria were included in the study. White light cystoscopy (WLC) was first performed in all patients and after was performed a fluorescence cystoscopy (BLC-blue light cystoscopy). Biopsies were collected from any suspicious area and resection of the tumors identified (TUR).Whenever no suspicious areas could be seen, a standard random mapping including 8 biopsies overall was completed. Results: Patients demographic data and clinical history are presented in Table 1. Two-hundred twenty specimens were extracted and bladder cancer was diagnosed in 137. There were 17 CIS lesions all diagnosed with BLC whereas only 11 with WLC. WLC correctly diagnosed 109/140 specimens and the positive and negative predictive values were 77.9% and 65% respectively. The sensitivity and specificity were 79.6% and 62.6% respectively. BLC diagnosed 125/169 specimens and the positive and negative predictive values were 73.9% and 76.5% respectively. The sensitivity of BLC was 91.2% and the specificity 46.9%. Conclusion: Hexaminolevulinate-guided cystoscopy is a valuable diagnostic method, with considerably improved accuracy and improvement in diagnosis of non-muscle-invasive bladder cancer and especially CIS.

Keywords

Hexaminolevulinate-Guided cystoscopy; Bladder cáncer; Transurethral resection

Introduction

Bladder cancer is a very common malignancy of the urinary tract in the Western world, especially in men, three times more than women [1].

North America and Western Europe have very high incidence rates of bladder cancer in contrast with Asian countries and Central Africa where the incidence rates are very low [2,3]. Most (75-85%) bladder cancers incidences are non–muscle invasive at first diagnosis (pTa, pT1, carcinoma in situ [CIS]) [4]. In non-muscle-invasive bladder cancer (NMIBC), approximately 70% of patients present as pTa, 20% as pT1, and 10% as CIS lesions [1]. Generally, the prognosis of NMIBC is good, although 30-80% of cases will recur and 1-45% of cases will progress to muscle invasion within 5 yr [1,5]. Early detection of bladder cancer is therefore mandatory in order to reduce the mortality rate. It has been estimated that 10-20% of bladder tumors are overlooked in conventional WLC [6].

Hexaminolevulinate acid (HAL), an ester derivative of 5-ALA (ALA-Aminolevulinic acid) bioavailability is better, thus a higher tissue accumulation of photoactive porphyrins is achieved and this advantage is added to the diagnostic value of WLC [7]. Clinical trials of phases 1-3 led to the approval of HAL (Hexvix) for the detection of bladder cancer in 26 European countries. The aim of our study was to compare WLC and PDD (photodynamic diagnosis) with HAL in the diagnosis of bladder tumors.

Materials and Methods

The study was a case series and was conducted between October 2008 and May 2012. Fifty patients (43 men and 7 women) with primary bladder cancer were included in the study. All patients have been admitted and investigated for hematuria and/or positive urinary cytology (Table 1) [8-11]. A standard investigative protocol which included general clinical examination, blood tests, urine culture, abdominal ultrasonography, IVP (intravenous pyelography) and eventually a CT scan was applied in all cases. The study was approved by the Hospital Ethical Committee and informed consent was obtained by all patients.

Characteristic Value
No. of patients 50
Age(years) 64.8 ± 8.4
Gender(M/F) 43/7
Smokers ratio 41/50
Urinary cytology  
Positive 14
Negative 20
Suspicious 8
Hematouria 39

Table 1: Patients characteristics.

A standard WLC was always performed as a first step of the evaluation and all suspicious areas were accurately described and reported on a bladder map. Thereafter, a fluorescence cystoscopy was accurately performed and any suspicious area was reported on the same map. Biopsies were collected from any suspicious area either under blue or white light and resection of the tumors identified (TUR) [13-16].Whenever no suspicious areas could be seen, a standard random mapping including 8 biopsies overall was completed. All WLCs and BLCs were performed by the same expert urologist (Table 2) [17].

  Presence of Ca Absence Total         
WLC+
WLC-
BLC+
BLC-
Total
109
28
125
12
137
31
52
44
39
83
140
80
169
51
220

Table 2: WLC and BLC findings and diagnosis.

Patients with acute or chronic urinary tract infection, urinary tract lithiasis, multi-drug allergies as well as patients underwent recent BCG installation, radiotherapy and multi bladder catheterizations were excluded [12].

For BLC, patients received 85mg HAL- Hexvix® bladder instillation (85 mg dissolved in 50 mL phosphate buffer solution), using a 14Ch bladder catheter 1 hour prior to cystoscopy [18-22]. The Storz D-light- C system with a xenon arc lamp as source was used in all cases.

Bladder biopsies were performed in selected cases from bladder mucosa areas considered suspicious at WLC or BLC as well as from normal bladder mucosa [23].

Within six hours after TUR all patients included in the study underwent a postoperative chemotherapy instillation of 50 mg Epirubicin. All patients received an adjuvant intravescical immunotherapy with BCG vaccine as all patients had high or intermediate-risk cancer.

Categorical data were examined by chi-square test, while continuous variables were evaluated by the t-test. Specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with the usual mathematical formulas (Table 3) [24].

  Sensitivity(%) Specificity (%) PPV (%) NPV (%)
WLC 79.6 62.6 77.9 65
BLC 91.2 46.9 73.9 76.5

Table 3: Sensitivity, Specificity, PPV and NPV of WLC and BLC respectively.

Results and Discussion

The study was a case series and was conducted between October 2008 and May 2012. Fifty patients (43 men and 7 women) with primary bladder cancer were included in the study. All patients have been admitted and investigated for hematuria and/or positive urinary cytology [25]. A standard investigative protocol which included general clinical examination, blood tests, urine culture, abdominal ultrasonography, IVP (intravenous pyelography) and eventually a CT scan was applied in all cases. The study was approved by the Hospital Ethical Committee and informed consent was obtained by all patients.

Patients with acute or chronic urinary tract infection, urinary tract lithiasis, multi-drug allergies as well as patients underwent recent BCG installation, radiotherapy and multi bladder catheterizations were excluded.

A standard WLC was always performed as a first step of the evaluation and all suspicious areas were accurately described and reported on a bladder map. Thereafter, a fluorescence cystoscopy was accurately performed and any suspicious area was reported on the same map. Biopsies were collected from any suspicious area either under blue or white light and resection of the tumors identified (TUR).Whenever no suspicious areas could be seen, a standard random mapping including 8 biopsies overall was completed. All WLCs and BLCs were performed by the same expert urologist.

For BLC, patients received 85mg HAL – Hexvix® bladder instillation (85mg dissolved in 50mL phosphate buffer solution), using a 14Ch bladder catheter 1 hour prior to cystoscopy. The Storz D-light-C system with a xenon arc lamp as source was used in all cases.

Bladder biopsies were performed in selected cases from bladder mucosa areas considered suspicious at WLC or BLC as well as from normal bladder mucosa.

Within six hours after TUR all patients included in the study underwent a postoperative chemotherapy instillation of 50 mg Epirubicin. All patients received an adjuvant intravescical immunotherapy with BCG vaccine as all patients had high or intermediate-risk cancer.

Categorical data were examined by chi-square test, while continuous variables were evaluated by the t-test. Specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) were calculated with the usual mathematical formulas.

Conclusion

Hexaminolevulinate-guided cystoscopy is a valuable diagnostic method, with considerably improved accuracy and improvement in diagnosis of non-muscle-invasive bladder cancer and especially CIS.

Consent: All patients have given their informed consent for the study. All signed forms are available on request.

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