Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study

Flexible Blue Light Study Group Collaborators

Research output: Contribution to journalArticle

22 Citations (Scopus)

Abstract

Purpose: We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance. Materials and Methods: Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy. Results: Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5–32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2–55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious. Conclusions: Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.

Original languageEnglish (US)
Pages (from-to)1158-1165
Number of pages8
JournalJournal of Urology
Volume199
Issue number5
DOIs
StatePublished - May 1 2018

Fingerprint

Cystoscopy
Urinary Bladder Neoplasms
Multicenter Studies
Safety
Light
Carcinoma in Situ
Operating Rooms
5-aminolevulinic acid hexyl ester
Recurrence
Neoplasms
Random Allocation

Keywords

  • bladder neoplasms
  • carcinoma in situ
  • cystoscopy
  • local
  • neoplasm recurrence
  • optical imaging

ASJC Scopus subject areas

  • Urology

Cite this

Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer : A Phase III, Comparative, Multicenter Study. / Flexible Blue Light Study Group Collaborators.

In: Journal of Urology, Vol. 199, No. 5, 01.05.2018, p. 1158-1165.

Research output: Contribution to journalArticle

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title = "Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study",
abstract = "Purpose: We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance. Materials and Methods: Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy. Results: Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6{\%}, 95{\%} CI 11.5–32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41{\%}), which was detected only with blue light cystoscopy in 9 of the 26 (34.6{\%}, 95{\%} CI 17.2–55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46{\%}). The false-positive rate was 9.1{\%} for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious. Conclusions: Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.",
keywords = "bladder neoplasms, carcinoma in situ, cystoscopy, local, neoplasm recurrence, optical imaging",
author = "{Flexible Blue Light Study Group Collaborators} and Siamak Daneshmand and Sanjay Patel and Yair Lotan and Kamal Pohar and Edouard Trabulsi and Michael Woods and Tracy Downs and William Huang and Jeffrey Jones and Michael O'Donnell and Trinity Bivalacqua and Joel DeCastro and Gary Steinberg and Ashish Kamat and Matthew Resnick and Badrinath Konety and Schoenberg, {Mark P.} and Jones, {J. Stephen} and Soroush Bazargani and Hoorman Djaladat and Anne Schuckman and Michael Cookson and Brian Cross and Kelley Stratton and Lallas, {Costas Dan} and Leonard Gomella and Mark Mann and Michael Johnson and Phillip Pierorazio and James McKiernan and Sven Wenske and Sankin, {Alexander I.} and Megan Merrill and Ahmad Shabsigh and Matthew Nielsen and Raj Pruthi and Angela Smith and Shah, {Jay B.} and Jennifer Taylor and Christopher Weight",
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T1 - Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer

T2 - A Phase III, Comparative, Multicenter Study

AU - Flexible Blue Light Study Group Collaborators

AU - Daneshmand, Siamak

AU - Patel, Sanjay

AU - Lotan, Yair

AU - Pohar, Kamal

AU - Trabulsi, Edouard

AU - Woods, Michael

AU - Downs, Tracy

AU - Huang, William

AU - Jones, Jeffrey

AU - O'Donnell, Michael

AU - Bivalacqua, Trinity

AU - DeCastro, Joel

AU - Steinberg, Gary

AU - Kamat, Ashish

AU - Resnick, Matthew

AU - Konety, Badrinath

AU - Schoenberg, Mark P.

AU - Jones, J. Stephen

AU - Bazargani, Soroush

AU - Djaladat, Hoorman

AU - Schuckman, Anne

AU - Cookson, Michael

AU - Cross, Brian

AU - Stratton, Kelley

AU - Lallas, Costas Dan

AU - Gomella, Leonard

AU - Mann, Mark

AU - Johnson, Michael

AU - Pierorazio, Phillip

AU - McKiernan, James

AU - Wenske, Sven

AU - Sankin, Alexander I.

AU - Merrill, Megan

AU - Shabsigh, Ahmad

AU - Nielsen, Matthew

AU - Pruthi, Raj

AU - Smith, Angela

AU - Shah, Jay B.

AU - Taylor, Jennifer

AU - Weight, Christopher

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Purpose: We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance. Materials and Methods: Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy. Results: Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5–32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2–55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious. Conclusions: Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.

AB - Purpose: We compared blue light flexible cystoscopy with white light flexible cystoscopy for the detection of bladder cancer during surveillance. Materials and Methods: Patients at high risk for recurrence received hexaminolevulinate intravesically before white light flexible cystoscopy and randomization to blue light flexible cystoscopy. All suspicious lesions were documented. Patients with suspicious lesions were referred to the operating room for repeat white and blue light cystoscopy. All suspected lesions were biopsied or resected and specimens were examined by an independent pathology consensus panel. The primary study end point was the proportion of patients with histologically confirmed malignancy detected only with blue light flexible cystoscopy. Additional end points were the false-positive rate, carcinoma in situ detection and additional tumors detected only with blue light cystoscopy. Results: Following surveillance 103 of the 304 patients were referred, including 63 with confirmed malignancy, of whom 26 had carcinoma in situ. In 13 of the 63 patients (20.6%, 95% CI 11.5–32.7) recurrence was seen only with blue light flexible cystoscopy (p <0.0001). Five of these cases were confirmed as carcinoma in situ. Operating room examination confirmed carcinoma in situ in 26 of 63 patients (41%), which was detected only with blue light cystoscopy in 9 of the 26 (34.6%, 95% CI 17.2–55.7, p <0.0001). Blue light cystoscopy identified additional malignant lesions in 29 of the 63 patients (46%). The false-positive rate was 9.1% for white and blue light cystoscopy. None of the 12 adverse events during surveillance were serious. Conclusions: Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance. Blue light cystoscopy in the operating room significantly improves the detection of carcinoma in situ and detects lesions that are missed with white light cystoscopy.

KW - bladder neoplasms

KW - carcinoma in situ

KW - cystoscopy

KW - local

KW - neoplasm recurrence

KW - optical imaging

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JO - Journal of Urology

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