Medicine:Cysview

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Cysview (hexaminolevulinate HCl) with blue light cystoscopy, is an optical imaging agent designed to enhance detection and visualization of non-muscle invasive bladder cancer (NMIBC), in particular papillary and carcinoma in situ (CIS). It reveals lesions that may not be seen with standard white light cystoscopy. Cysview is marketed in Europe as Hexvix,[1][2] in the United States of America as Cysview, and in Canada as Cysview.[3]

Cysview is manufactured by Photocure ASA, a Norwegian pharmaceutical company that develops and sells pharmaceuticals and medical devices for the photodynamic treatment and diagnosis of cancer and selected dermatology indications.

The importance and superior efficacy of fluorescence (or blue light) cystoscopy compared to white light cystoscopy alone, with respect to detection of non-muscle invasive tumours, is reflected in the 2008 European Association of Urology Guidelines on TaT1 Bladder Cancer, which clearly endorse the technique in its recommendation: "It has been confirmed that fluorescence-guided biopsy and resection are more sensitive than conventional procedures in detecting malignant tumour, particularly CIS".[4] [5] In 2010, the US Food and Drug Administration (FDA) approved Cysview (hexaminolevulinate HCl) for the detection of non-muscle-invasive papillary cancer of the bladder in patients with known or suspected bladder cancer.[6]

October 5, 2010 - New publication on Hexvix released in the Journal of Urology. This publication shows that Cysview guided fluorescence cystoscopy (Hexvix), as an adjunct to conventional white-light cystoscopy, improves the detection of bladder cancer and reduces the rate of early tumour recurrence, compared with white-light cystoscopy alone.[7]

November 10, 2010 - Nature (journal) published an article claiming that Photodynamic diagnosis (PDD) can improve surgical outcome on bladder cancer.[8]

April 2011 - New publication on Hexvix released in the British Journal of Urology (BJUI). This study confirm the results from a large prospective international study published in the Journal of Urology in November 2010. The results of the trial demonstrate that Hexvix identified lesions, including residual tumours, that were not detected with white light alone in 49% of the patients. It also demonstrated that the improved detection of lesions resulted in a significant reduction in tumour recurrence within 12 months.[9] [10]

May 12, 2011 - Results announced from a clinical study which included retrospective follow up from 526 patients in a prospective randomized Phase III trial in 28 centers in EU and North America. After the follow-up period up to 5.5 years, the number of patients who have experienced recurrence of their bladder cancer is lower, and the time it takes before the recurrence occurs is longer when they had Hexvix-guided fluorescence cystoscopy.[11]

January 2015 - Cysview was approved by Health Canada.[12]

In 2016, the American Urological Association (AUA) updated the Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer Guidelines, which also endorses the technique in its recommendation:[13]

  • "In a patient with a history of NMIBC with normal cystoscopy and positive cytology, a clinician should consider prostatic urethral biopsies and upper tract imaging, as well as enhanced cystoscopic techniques (blue light cystoscopy, when available), ureteroscopy, or random bladder biopsies. (Expert Opinion)"
  • "In a patient with NMIBC, a clinician should offer blue light cystoscopy at the time of TURBT, if available, to increase detection and decrease recurrence. (Moderate Recommendation; Evidence Strength: Grade B)."

References

  1. ↑ GE Healthcare - Medical Diagnostics - Cysview Hexaminolevulinate (HCL)
  2. ↑ "Archived copy". Archived from the original on 23 July 2011. https://web.archive.org/web/20110723070045/http://cysview.net/medical-journalists/clinical-aspects.html. Retrieved 2010-11-16.  Clinical Aspects of Bladder Cancer
  3. ↑ "Cysview - Trademark in the US and Canada - Photocure". Photocure. https://www.photocure.com/Specialty-areas/Bladder-cancer/Products/Cysview---bladder-cancer-detection-US-only/. 
  4. ↑ http://hexvix.com/photocure/pdf/Abstract_Stenzl_EAU.pdf Hexvix fluorescence cystoscopy improves detection and resection of papillary bladder cancer and reduces early recurrence: a multicentre, prospective, randomized studyA. Stenzl et al
  5. ↑ http://hexvix.com/photocure/press/cystoscopy.asp[yes|permanent dead link|dead link}}] EAU Guidelines
  6. ↑ "Archived copy". Archived from the original on 23 July 2011. https://web.archive.org/web/20110723070035/http://cysview.net/medical-journalists/press-release.html. Retrieved 2010-11-14.  Cysview approved by the FDA
  7. ↑ "Archived copy". Archived from the original on 24 July 2011. https://web.archive.org/web/20110724174408/http://www.biotekforum.no/article.php?articleID=724&categoryID=6. Retrieved 2010-11-14.  Hexvix guided fluorescence cystoscopy reduces recurrence in patients
  8. ↑ http://www.nature.com/nrurol/journal/v7/n11/full/nrurol.2010.183.html Bladder cancer: Photodynamic diagnosis can improve surgical outcome Nature Reviews Urology 7, 598-599 (November 2010) | doi:10.1038/nrurol.2010.183
  9. ↑ "Archived copy". Archived from the original on 31 March 2012. https://web.archive.org/web/20120331151159/http://www.urotoday.com/bladder-cancer-1038/fluorescence-guided-transurethral-resection-of-bladder-tumours-reduces-bladder-tumour-recurrence-due-to-less-residual-tumour-tissue-in-t-at1-patients-a-randomized-two-centre-study-abstract.html. Retrieved 2011-04-22.  Fluorescence-guided transurethral resection of bladder tumours reduces bladder tumour recurrence due to less residual tumour tissue in Ta/T1 patients A randomized two-centre study
  10. ↑ http://www.newsweb.no/newsweb/search.do?messageId=278275 British Journal of Urology publishes paper on Hexvix
  11. ↑ http://www.medicalnewstoday.com/releases/225061.php Hexvix(R)/Cysview™ Demonstrates Long Term Benefit: Results From 5.5 Year Follow Up Of Recurrence Of Bladder Cancer
  12. ↑ "BioSyent Pharma Acquires Exclusive Rights For Cysview In Canada". Market Wired. http://www.marketwired.com/press-release/biosyent-pharma-acquires-exclusive-rights-for-cysviewr-in-canada-tsx-venture-rx-2048886.htm. 
  13. ↑ "American Urological Association - Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Joint Guideline" (in en). http://www.auanet.org/guidelines/non-muscle-invasive-bladder-cancer-(aua/suo-joint-guideline-2016). 

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