Recently, a UK-based team (Challacombe et al.) working at a major London teaching hospital reported very poor 2-year follow-up data after treating a series of 31 newly diagnosed and 12 salvage patients with high-intensity focused ultrasound (HIFU) using second-generation Ablatherm equipment. They stated in their original paper that they had suspended their HIFU program as a consequence of their results.
The “New” Prostate Cancer InfoLink commented on the original report at the end of March. Now, in a “Beyond the Abstract” commentary just published on UroToday web site, the authors of the original paper have added additional remarks. Their observations include the following:
- “Large numbers of men with localised disease are looking for treatments that minimise their morbidity (continence and erectile function) whilst maximising oncological effectiveness.”
- “There is often significant initial enthusiasm for new technologies due to huge range of technological innovation in medicine today; however, treatments for localised prostate cancer need at least a 10 year follow-up to show efficacy over standard techniques.”
- “Much of this enthusiasm is generated by companies that have invested heavily in these new technologies and often market them aggressively, irresponsibly and unwisely with immature data. It is suggested that HIFU is morbidity-free with better oncological outcomes than traditional treatments.”
- “National medical bodies can also be drawn in by publicity; such as the National Institute for Clinical Excellence (NICE) in the UK, which initially supported HIFU but has subsequently changed its guidance and now recommend using it only within clinical trials.”
- “Early HIFU case studies showing promising results have been widely publicised generating more clinician awareness and interest, and proponents of this technique have gained notoriety presenting their data internationally.”
- “There is a huge publication bias in surgical trials as positive results have a much better chance of being published, are published earlier, and are published in journals with higher impact factors. Conclusions exclusively based on published studies, therefore, can be misleading and selective underreporting of research might be widespread and more likely to have adverse consequences for patients than publication of deliberately falsified data. This publication bias is likely to apply to HIFU.”
- “There is a significant lack of good quality outcomes and efficacy data as patients often refuse to enter randomised controlled surgical trials.”
- “In our hands, HIFU was unable to match traditional treatment modalities (minimally-invasive radical prostatectomy, external beam radiotherapy or brachytherapy) for oncological efficacy. In addition it generated significant and devastating complications in some patients.”
- “We would urge urologists against commencing a HIFU programme until high quality long-term data becomes available as we seriously question its safety and ability to cure localised prostate cancer.”
Physicians who have poor experience using a specific technique are liable to feel strongly about the low value of that technique, just as those who get good results will feel strongly about the quality of the care that they offer.
It is also worth noting that, according to a very thorough report in the Austin American-Statesman, there is “a rising tide of medical tourists going abroad” for HIFU, “which heats the prostate to destroy cancerous tissue.” The report continues that HIFU is “being done successfully in about 30 countries, and has lower rates of impotence and incontinence than the standard treatments,” whereas “traditional external beam radiation therapy can result in bladder problems for one in three men” and “impotence can occur in as many as 50 to 75 percent of men. … For those who had surgery to remove the prostate, impotence rates were similar,” and “cryotherapy … had impotence rates of up to 80 percent.”
We don’t know who provided those side effect data to the Austin American-Statesmen, but they are certainly at the high end of the scale, and they clearly play on the very normal male fear of impotence and incontinence.
Dr. Brantley Thrasher (a member of the Scientific Advisory Board of The “New” Prostate Cancer InfoLink) is quoted as saying that “until clinical trials in the US are completed, claims that HIFU is safe and effective and has fewer complications than more established treatments can’t be assured.
The “New” Prostate Cancer InfoLink has consistently advised patients to be cautious about the effectiveness and safety of HIFU. We do not believe that things are necessarily as bad as Dr. Challacombe and his colleagues may seem to be suggesting, nor do we believe the hyperbolic enthusiasm for this technique that has been expressed by some patients, based on their personal experience and the limited data available. We think that, at this point in time, there are four very clear points that need to be made:
- It appears that there may be significant differences in patient outcome based on the type of HIFU equipment used — but there are insufficient, well-controlled, and published data available to be able to make such a statement with absolute certainty.
- HIFU is still an evolving technique. Any patient who wishes to consider this form of treatment would be wise either to get a referral to one of the few physicians who has carried out at least a couple of hundred procedures (and ideally a physician who can document patient outcomes over a period of years) or to enroll in a clinical trial of HIFU treatment at a respected institution under highly controlled conditions.
- Patients should always be skeptical of corporate publicity about new forms of treatment, even when that treatment has been “approved” by relevant regulatory agencies (such as NICE or the FDA) because the early results with new treatments (based on highly controlled clinical trials) may not reflect what happens out in the “real world.”
- Physicians who do not voluntarily advise patients that HIFU has been associated with significant adverse events, and who do not discuss the adverse events that have occurred in patients they themselves have treated with HIFU, are not acting in the best interests of their patients.
With these cautions, The “New” Prostate Cancer InfoLink also recognizes the right of patients and their doctors to try to get and provide the best possible treatment for each individual with prostate cancer or with any other disease. We expect many men to continue to elect HIFU as a treatment for prostate cancer. We expect many of these men to do well. We also expect a significant number to have significant problems and complications. As usual, caveat emptor!