Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
BAUS Comments on Diagnosis and treatment of prostate cancer: summary of NICE guidance
- Anthony R Mundy, Professor F C Hamdy (19 March 2008)
-
NICE guidance on prostate cancer and the role of active surveillance for low risk, localised disease
- Howard P Marsh, Simon F Brewster (25 March 2008)
-
Response to BAUS Comments
- John Graham, Mark Baker, David Gillatt, Fergus Macbeth, Victoria Titshall on behalf of the NICE Prostate Cancer Guideline Development Group (8 April 2008)
-
Surveillance guideline goes too far
- Laurence Klotz (29 April 2008)
|
|
|||
|
Anthony R Mundy, President of British Association of Urological Surgeons BAUS, WC2A 3PE, Professor F C Hamdy
Send response to journal:
|
We were pleased to see Dr Wilke’s critique of the recent NICE Guidance on prostate cancer. Most of the recommendations in the final guidelines are entirely reasonable and reflect good state-of-the-art practice. It is regrettable however that some of the most important comments were argued weakly and largely ignored. The consequences of the guidelines as issued are far reaching, and will harm men in the UK, at a time when cancer mortality has been shown to be worse in this country compared with Europe and the US, in particular for prostate cancer. The following points highlight some of our main concerns: NICE guideline - Diagnosis: To help men decide whether to have a prostate biopsy, healthcare professionals should discuss with them their prostate specific antigen (PSA) level, digital rectal examination (DRE) findings (including an estimate of prostate size) and comorbidities, together with their risk factors (including increasing age and black African and Caribbean ethnicity) and any history of a previous negative prostate biopsy. The serum PSA level alone should not automatically lead to a prostate biopsy. Comment: Having agreed that the decision to undertake a prostate biopsy is complex, and should be made by a fully informed patient who knows the risks and benefits and the uncertainty of the need for treatment if cancer is found, it should be emphasized in the recommendation and for the benefit of men involved that at present, only trained urologists have the specific expertise required to advise men whether a biopsy is warranted in their particular case through an open discussion. If inadequately trained staff is responsible for this process, men who will benefit from a biopsy and the diagnosis of prostate cancer will be denied the investigation and will be harmed as a consequence. NICE guideline - Treatment: Men with low-risk localised prostate cancer who are considered suitable for radical treatment should first be offered active surveillance. Comment: This statement will encourage clinicians and health care professionals to offer no intervention to men who would otherwise benefit from treatment, and who will be harmed by this approach. Active surveillance is a valid but still experimental option for men with ‘indolent’ prostate cancer, and there is no reliable method at present to identify this disease. Low-risk prostate cancer is not necessarily indolent disease, particularly in younger men with a long life-expectancy. We do not know what the best treatment is for low risk prostate cancer, and whilst we can identify disease which has already progressed, we have unreliable methods to determine which patients are progressing within the window of curability and who will benefit from treatment. Patients need to be informed about active surveillance and active intervention and their respective risks equally. The NICE panel regrettably continues to ignore the fact that there is no evidence in this area to suggest best practice. Ongoing trials are addressing the uncertainties and controversies, and it is therefore premature and inappropriate to make strong recommendations about ‘how best’ to manage prostate cancer without highlighting these uncertainties. In addition, the statement is completely contradictory and incompatible with the Key Research priorities in the same guidelines: “The greatest uncertainties in managing prostate cancer are around the identification of which cancers are of clinical significance and over the choice of radical treatment, and in which settings they are appropriate. With the diagnosis of prostate cancer being made more frequently in asymptomatic men, it is of growing importance to know which of these men are likely to benefit from aggressive treatment.” NICE guideline – Treatment: Active surveillance follow-up: Active surveillance should include at least one re-biopsy and may be performed in accordance with the ProSTART protocol. Comment: There is absolutely no evidence that re-biopsy should be undertaken routinely in men receiving active surveillance. It is completely unethical, unacceptable and potentially harmful to adopt as a national guideline an experimental protocol from a clinical trial which is just about to commence as a feasibility study in the UK. This recommendation could be seriously misleading and will harm patients. NICE guideline – Treatment of hormone-refractory disease: The use of bisphosphonates to prevent or reduce the complications of bone metastases in men with hormone-refractory prostate cancer is not recommended. Comment: There are very few interventions in urological oncology which are based on high level evidence from well conducted randomized controlled trials. Such evidence exists to justify the use of bisphosphonates to reduce morbidity from established skeletal metastases in patients with hormone resistant prostate cancer, and was chosen to be ignored by NICE with weak argumentation. Advanced prostate cancer is a disease complex which requires a combination of interventions to palliate patients and improve quality of life, whilst we applaud the recommendations regarding chemotherapy and other interventions, we deplore the continuing failure by the NICE panel to recognize this very important aspect of patient care. NICE guideline – Follow-up after treatment: After at least 2 years, men with a stable PSA and who have had no significant treatment complications, should be offered follow-up outside hospital (for example, in primary care) by telephone or secure electronic communications, unless they are taking part in a clinical trial that requires more formal clinic- based follow-up. Direct access to the urological cancer MDT should be offered and explained. Comment: Whilst shared-care protocols can be developed with primary care, there is no evidence or mechanisms to suggest that this is in place in the UK. Expertise in following-up such patients in the community is lacking, and the impact of this approach on patients who will relapse has not been measured. To suggest further that methods such as telephone or electronic communication could be used without testing and validation is inappropriate as a national guidance recommendation. Final Comment: The profession, represented by our Association is extremely concerned by the points raised in this document. Whilst guidelines should reflect evidence, these specific recommendations are based on lack of evidence and biased views. As published, they have the potential of harming men with prostate cancer in the UK, and are likely to increase mortality rate from this increasingly common malignancy. The main body of clinicians in the UK is not prepared to follow the recommendations highlighted above, and discussion is now ongoing between commissioners, PCTs and NSSGs in Urology to agree on local/regional guidelines and omit reference to the inappropriate guidance given in the final NICE document. We recognize that this in itself risks discrediting the huge effort made by the NICE organization, and will set an unfortunate precedent. We regret to have to formulate our views so forcefully, but see no alternative to voice our deep concerns and protect our patients. Professor Freddie Hamdy Professor Tony Mundy On behalf of the British Association of Urological Surgeons Competing interests: None declared |
|||
|
|
|||
|
Howard P Marsh, Urology SpR Dept of Urology, Churchill Hospital, Oxford OX3 7LJ, Simon F Brewster
Send response to journal:
|
The NICE guidelines on prostate cancer [1] recommend active surveillance for men with low risk (clinical stage T1-2a and PSA <10 and biopsy Gleason score <7) localised disease who are considered suitable for radical treatment, using an unproven follow-up protocol. The lack of evidence to support active surveillance as a safe management strategy, let alone as the preferred option, is of concern. Pathological studies of radical prostatectomies have shown that it is not possible to predict accurately insignificant disease using the above variables [2]; nomograms are helpful when talking to patients [3] but have limitations. Reliable predictors of disease progression during surveillance must be identified, or the window of opportunity for cure may be missed. The few published active surveillance studies [4] are non- randomised, short-term and lack standardised criteria for inclusion, follow-up, or triggers for delayed intervention. We understand that active surveillance addresses the concerns of over -diagnosis and over-treatment, and should be discussed with suitable patients as an option. However we find it hard to see how it can be justified as the preferred option until randomised evidence to support it is forthcoming. Howard Marsh, Urology SpR Simon Brewster, Consultant Urological Surgeon Churchill Hospital, Oxford OX3 7LJ,UK 1. Graham, J., et al., Diagnosis and treatment of prostate cancer: summary of NICE guidance. Bmj, 2008. 336(7644): p. 610-2. 2. Boccon-Gibod, L.M., et al., Micro-focal prostate cancer: a comparison of biopsy and radical prostatectomy specimen features. Eur Urol, 2005. 48(6): p. 895-9. 3. Kattan, M.W., et al., Counseling men with prostate cancer: a nomogram for predicting the presence of small, moderately differentiated, confined tumors. J Urol, 2003. 170(5): p. 1792-7. 4. van As, N.J. and C.C. Parker, Active surveillance with selective radical treatment for localized prostate cancer. Cancer J, 2007. 13(5): p. 289-94. Competing interests: None declared |
|||
|
|
|||
|
John Graham, Consultant in Clinical Oncology Taunton & Somerset NHS Foundation Trust, Mark Baker, David Gillatt, Fergus Macbeth, Victoria Titshall on behalf of the NICE Prostate Cancer Guideline Development Group
Send response to journal:
|
We are grateful for Professor Wilt’s supportive views in his Commentary on the recently published NICE Guideline for prostate cancer. He expressed disappointment that we did not address issues of service structure but this was not within the remit of our guideline and has been covered in the Improving Outcomes Guidance published in 2002. He can be reassured that NICE is developing tools to encourage implementation by the NHS in England and Wales. The comments by Hamdy and Mundy representing the British Association of Urological Surgeons (BAUS) are less welcome and partly misleading. We are surprised that BAUS thinks that only urologists can counsel men on the risks and benefits of prostate biopsy. For many years urologists have been happy to allow other healthcare professionals to perform prostate biopsies. Do they really see themselves as the only qualified gatekeepers? We believe that appropriately trained members of the urological cancer team can undertake the counselling role. Their comment that prostate cancer mortality is worse in the UK than in Europe and the USA is incorrect. The EUROCARE-4 study showed that prostate cancer survival in the UK was worse than some European countries (almost certainly due to lead-time bias from PSA testing of asymptomatic men) but prostate cancer mortality across Europe is very similar as explained by Autier et al in a recent publication (Lancet Oncology 8:1050- 52, 2007). The recommendation for active surveillance in men with localised low risk prostate cancer was made after a review of the literature found no evidence that any radical treatment improved survival in this group. A logical outcome of this would have been for the Guideline Development Group (GDG) to recommend that the NHS not spend any money on radical treatment of low risk disease. However the clinicians on the GDG felt that this was a step too far and that some men with low risk disease should be treated. The GDG have therefore sought to reduce the scale of unnecessary, potentially harmful overtreatment of low risk disease while at the same time not denying men with localised disease the potential, if unproven benefits, of radical treatment. Active surveillance with deferred radical treatment when there is evidence of significant disease progression, as opposed to watchful waiting where there is no intention to give radical treatment, is the logical alternative to immediate radical treatment of low risk disease even though there is a relative paucity of clinical evidence supporting it. Rebiopsy is an inherent part of active surveillance. PSA kinetics are helpful but not totally reliable. The Scandinavian trial of radical prostatectomy versus watchful waiting suggests a benefit for radical treatment in men with higher Gleason scores. A proportion of men presenting with low risk disease will be found to have higher Gleason scores on repeat biopsy as part of an active surveillance protocol. What would BAUS recommend as an alternative to active surveillance with rebiopsy in low risk disease? Overtreat many men rather than expose them to the small risks of rebiopsy? Risk missing higher grade disease by relying on only one set of biopsies? The recommendation to consider active surveillance first does not deny radical treatment for selected men with low risk disease. It is an attempt to guide clinicians to consider the risks of overtreatment of a group of men with low risk prostate cancer when there is little or no evidence of long-term benefit. The bisphosphonate recommendations in the guideline were made after review of all the available literature and are supported by a recent Cochrane review. The criticism of the follow-up recommendation is unfounded. The urological cancer team have a duty of care to ensure that appropriate care pathways are in place before men are discharged from outpatient clinics. There is therefore no basis for their claim that these guidelines have 'the potential for harming men with prostate cancer'. They suggest that local guidelines, ignoring NICE guidance, should be negotiated. We hope that the commissioners, PCTs and NSSGs will have the good sense to look carefully at the NICE guidelines and their recommendations and will not necessarily yield to these opinions. Competing interests: As previously declared in BMJ 2008;336:610-12. |
|||
|
|
|||
|
Laurence Klotz, Professor of Urology Sunnybrook Health Sciences Centre M4N3M5
Send response to journal:
|
The NICE guidelines emphasize the importance of active surveillance as a treatment option for localized prostate cancer. However, they go too far in suggesting that this approach should supercede all others in patients with favorable risk disease. ("Men with low risk, localised prostate cancer should be offered active surveillance before radical treatment options"). The reasons for this are the following: a) ‘Low risk’ prostate cancer is broadly inclusive. It includes men with a single microfocus of Gleason 6 prostate cancer and a low PSA (very low risk) to those with extensive Gleason 6 cancer and a moderately elevated PSA, particularly in those without significant BPH (‘marginally low risk’). The latter group is almost certainly at much higher risk for cancer progression. A policy that advocates active surveillance as the first treatment of choice for men with a 20-30 year life expectancy who harbour extensive disease is misleading. b) Support from active surveillance comes from modelling, epidemiologic data, and a number of large phase 2 trials. However, follow up beyond 10 years using an active surveillance approach is still lacking. The risk of delaying therapy in patients who are reclassified as higher risk and treated in a delayed fashion is likely to be low, but not zero. Until this risk is quantified (which will occur through the completion of several long term randomized trials currently underway, including the Protect trial and the START trial), active surveillance should be considered a treatment option, rather than the first treatment option, for young men with more substantial, albeit favorable risk disease. The blanket recommendation in the recently released guideline thus somewhat overstates the case for surveillance. Sincerely,
Competing interests: None declared |
|||