GE Healthcare, a division of General Electric Company has announced the launch of a new standard for early diagnosis of urinary bladder cancer through a new diagnostic agent called HexvixÒ (hexaminolevulinate) at the 9th Asian Congress of Urology being held in New Delhi.
Bladder cancer forms 4.7 per cent of all the cancers in the body in India and is the second most common genito-urinary cancer as per the Delhi Cancer Registry 2002. This could be only a tip of the iceberg as cancer incidence in India is largely unknown as the registries are covered in urban centres only. In the Western world urinary bladder cancer is the fourth most common form of cancer in men, with an estimated 47,010 new cases diagnosed in 2005 in the US and 7,250 new cases diagnosed in 2002 in the UK. While it is often regarded as a 'men's condition' - affecting 3-4 times more men - its prevalence in women must not be underestimated.
Medical research has tried to address the difficulties in diagnosing bladder cancer and this research eventually led to the development of HexvixÒ fluorescence cystoscopy. This technique involves instilling a photosensitizing agent - HexvixÒ into the bladder via a catheter leading to preferential intracellular accumulation of photoactive (fluorescent) endogenous porphyrins in malignant cells as opposed to non-malignant cells. Subsequently illuminated with blue light, the neoplastic lesions emit red fluorescence that stands out against the normal mucosa.
"Early and accurate detection is the key to save lives in any disease conditions, especially killer diseases like cancer. GE Healthcare is committed to usher in Early Health in India. GE Healthcare's Hexvix is a proven early detection agent for Bladder Cancer and we are happy to introduce this in India," said Sarvadeep Sachdev, director, Medical Diagnostics Division, GE Healthcare South Asia.
"Smoking has been found to be a common etiological factor in 55 per cent of the cases, out of which 45 per cent had smoked for more than 20 years, as per our 1985 study. Apart from cigarette smoking, beedi and hukka smoking is more prevalent in India and in male population," says Prof Narmada Prasad Gupta, chairman, Department of Urology at AIIMS, New Delhi. Tobacco smoking intensity is directly correlated with the likelihood of its occurrence. However, its origins are still not fully understood. While occupational and lifestyle exposures to carcinogens play an important role, a connection with hereditary factors remains controversial.
Two multicentre phase-III studies leading to the approval of HexvixÒ as a diagnostic tool were conducted in Europe. The trials including 146 and 211 patients respectively demonstrated the efficacy of the new technique. Both studies revealed that Hexvix cystoscopy identified more patients with CIS bladder lesions than white light cystoscopy, which is commonly used. In addition, Jocham et al indicated that 1 in 5 patients may receive more appropriate treatment through the use of HexvixÒ fluorescence cystoscopy.
A recent phase-III study, involving 789-patients, compared HexvixÒ with standard white-light cystoscopy, and found that Hexvix was significantly better at detecting non-invasive bladder cancer. Recurrence of bladder cancer nine months after the initial procedure was also significantly reduced in the HexvixÒ group.
"HexvixÒ fluorescence cystoscopy is a new diagnostic tool with high sensitivity for detecting bladder tumours, in particular CIS tumours," explained Prof Karl-Dietrich Sievert, Professor of Urology, vice chair Department of Urology, University of Tübingen, Germany. "A statistically significant superiority of fluorescence cystoscopy over standard cystoscopy in the detection of CIS has been established in all published studies to date. Its high sensitivity and negative predictive value improves the diagnosis of malignancies and of CIS tumours. The cases missed by white-light inspection were typically CIS lesions, confirming the superiority of HexvixÒ fluorescence cystoscopy in these cases."
Since 2006, more than 500 institutions have adopted this technique throughout Europe, where HexvixÒ is already available, because better margin detection and more lesions being detected result in overall better transurethral resections of the bladder.
HexvixÒ fluorescence cystoscopy, an accurate diagnostic technique, is an effective adjunct in the diagnosis of urinary bladder cancer. Hexvix is undergoing approval process in India for medical use and it may be available by end 2009.
"Recent trends point to increased incidence of bladder cancer in India due to life style choices. The battle of bladder cancer is won or lost in the first assessment. If you get your first assessment wrong, then you would have done a great injustice to the patient. The number of lesions, size, associated carcinoma in situ etc. are important parameters that decide the future of treatment and prognosis. So the first assessment has to be absolutely right.
The current method of white light cystoscopy has some limitations in this regard. Use of fluorescence cystoscopy has an edge in detecting lesions early and supports in follow-up assessments as well," said Dr Makarand Khochikar, Uro-Oncologist, Miraj, Maharashtra.