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Editorial: Obesity is associated with worse oncological outcomes in patients treated with radical cystectomy

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Michael R. Abern, Stephen J. Freedland and Brant A. Inman

Division of Urologic Surgery, Duke University Medical Center, Durham, NC, USA

Obesity is a worldwide epidemic: it is estimated over 300 million adults are obese and over 1 billion are overweight. As obesity is a risk factor for cancers and is modifiable, the authors of this report retrospectively analyse the association between body mass index (BMI) and outcomes in a large multinational cohort of bladder cancer patients that underwent radical cystectomy. They found that obese patients were older and more likely to have high-grade tumours. Furthermore, obese patients received inferior lymphadenectomies, had more positive margins, and were less likely to receive adjuvant chemotherapy. The end result is an association between obesity and bladder cancer recurrence, and both cancer-specific and overall mortality.

Although these data suggest that obesity is associated with poor radical cystectomy outcomes, this contrasts with evidence showing no link between obesity and bladder cancer mortality in population-based trials such as the Cancer Prevention Study II, which prospectively followed over 900 000 participants. Why the discrepancy? One possible explanation is the presence of confounding factors and one possible confounder is the presence of type 2 diabetes. In population-based studies that considered both BMI and diabetes, people with diabetes were noted to have an increased risk of developing bladder cancer independent of BMI, whereas the converse was not true. Additionally, diabetes has been associated with recurrence and progression of non-muscle invasive bladder cancer whereas obesity has not. The impact of diabetes was not adequately addressed in the current study.

Other limitations also probably affect the results. In the current study, overweight patients (BMI 25–30) had significantly better cancer-specific survival (hazard ratio 0.80, P = 0.01) than those of ‘normal’ weight (BMI < 25). However, a threshold BMI ≥ 30 has been shown to have poor sensitivity for obesity in elderly populations, with over 25% of patients with BMI under 30 qualifying as obese based on body fat. This may result in an overstatement of the effect of obesity. Conversely, the inclusion of underweight patients (BMI < 18.5) in the ‘normal’ group may underestimate the effect between obesity and outcome, as cachexia may be associated with poor outcomes. Another factor mentioned by the authors is the inferior lymphadenectomies performed in obese patients, which introduces a detection bias for lymph node positivity, the strongest predictor after advanced stage for all of their tested outcomes on multivariate analysis (hazard ratio 2.01–2.33, P < 0.001).

Although the true effect of obesity may be hard to quantify with these data, all would agree that maintaining a non-obese bodyweight will help many disease states with little apparent harm. Patients undergoing neoadjuvant chemotherapy before radical cystectomy have a 3-month window to lose weight and exercise more. This could improve surgical outcomes, and possibly tolerance of chemotherapy. Furthermore, if we can prove that obesity leads to increased bladder cancer recurrence or progression, a window of opportunity may exist when a low-risk tumour is diagnosed. Otherwise, we are left with the eighteenth century wisdom of Benjamin Franklin: ‘An ounce of prevention is worth a pound of cure.’

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EWTD: Quantity or Quality?

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The European Working Time Directive (EWTD) was due to be in full implementation from August 2009 limiting junior doctors to a 48-hour week averaged over a 6-month period. The reality of this is somewhat different from the legislation. In truth, the questions needed to be asked were – was it ever feasible? What was the training impact in a craft-based speciality going to be? Where are we now?

The detrimental effects to training in a reduced working environment has been documented in both hemispheres. Canter, in a review of the EWTD in the United Kingdom and Ireland reported ~90% non-compliance of the restricted working week. ‘Time for Training’ reviewed the implications of the EWTD and Professor Temple felt ‘high quality training can be delivered in 48 hours’; however, this is precluded where trainees have a ‘major role in out of hours services’. As most trainees, in all health systems, will attest to junior doctors do play a ‘major role’ in on-call services.

As a current urological trainee, the pressures to develop skills to operate in an ever-changing and exciting field are evident. A limited working week, twinned with health service cut backs and limited hospitals beds is without doubt a concern when filling in our logbooks. ‘Could a passage to India be the way to get more surgical experience?’, a feature in the BMJ in 2012, Elliot sends trainees abroad to gain the invaluable exposure to numbers we are limited by here.

There are two sides to the impact that a limited working week will have to an aspiring surgeon’s experience, the quantity and quality of time spent in the hospital. The debate remains regarding the length of surgical training the current structures are changing in Ireland, led by the RCSI, in an effort to shorten the length of surgical training in line with other jurisdictions. We need to strive to efficiently and effectively train surgeons within an appropriate timeframe within the restraints of legislation without a drop in the standard of skills required.

As time has passed, it remains to be seen if the EWTD will ever be implementable in keeping with the continuity of patient care to the highest standard they deserve and that we aspire to offer them. The EWTD is currently being debated at a European Commission level in order to negotiate a revised directive more in line with the challenges of healthcare professionals in a 21st century health service. Revisions to the directive may allow for longer hours in certain disciplines such as the skill based surgical specialities.

Gregory J. Nason, MRCSI, is currently Registrar in Urology, St Vincent’s University Hospital, Dublin.

 

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Prostate Cancer Outcomes Study Meets Twitter Face to Face

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The International Urology Journal Club on Twitter discussion for February 2103 was based upon the recently published Prostate Cancer Outcomes Study in the New England Journal of Medicine on 31 January 2013.

The originally planned discussion paper that was only hours away from being announced when it became apparent through Twitter notification by @NEJM that the PCOS paper was going to be published that day. With this news, ‘urology twitter’ spoke loud and clearly (well, tweeted to be technically correct), and it was clear that this paper required our urgent attention.

The primary and senior authors of the PCOS manuscript in Matthew Resnick and David Penson, respectively, were kind enough to commit to making themselves available for the twitter discussion and proved to be valuable contributors.

 

In short, PCOS examined 1655 men who had been diagnosed with prostate cancer in 1994 or 1995, between the ages of 55 and 74 years, and who had either undergone radical prostatectomy (1164 men) or radiotherapy (491 men). Functional status was assessed at ‘baseline’ and at 2, 5 and 15 years after diagnosis. The study found patients undergoing surgery were more likely to have urinary incontinence and erectile dysfunction at 2 and 5 years, but there was no significant difference at 15 years. Patients undergoing surgery were less likely to have bowel urgency at 2 and 5 years, but again, there was no discernible distinction between the two groups at 15 years.

The functional results as stated in the manuscript are poor and this generated discussion that attempted to place these results into context. It was pointed out by Stacey Loeb that with the Massachusetts Male Aging Study (MMAS), 79% of men had ED as defined by IIEF and that there was a concern that, with the present data, the media could interpret it as that all prostate cancer treatments universally cause ED. A later constructive comment was made that if the study had followed matched controls to 15 years, it would allow for meaningful estimation of risk with treatment superimposed on aging.

Discussion shifted to the changes that have occurred over time since men entered the study. A number contributors, including Matt Coward, Rajiv Singal, Quoc Trinh and others commented to the effect that many of the men treated in that era would probably no longer be treated radically and would be managed conservatively. Ben Davies in agreement declared that he would promise never to operate on a man with a Gleason score 2–4 prostate cancer. However, Sean Williamson, Alanna Jacobs and others pointed out that this was not really relevant to the study, which was an examination of functional outcomes.

Is the data applicable to today? In response to Tony Finelli’s tweet of “Why is it that the urologic community always criticizes longterm well designed studies with ’The data are no longer applicable today?’“, Rajiv Singal made a very sobering comment that “Data is very applicable. Study well designed. It’s just that over Tx in many in this group makes side effects more appalling”

Prokar Dasgupta provided some British input with “are patients happier if they are clear of cancer @15 years or would they rather be potent?” Michael Leveridge from Canada provided constructive input with “As rational CaPr treatment shifts toward higher risk (wide fields, less nerve sparing), functional outcomes may actually get worse”

Criticism made that there were many men who missed out on completing their 2 and 5 year questionnaires was responded to by Dave Penson who explained that they were included in the study by using imputed data with a hot deck technique – whilst imperfect, it was the best that they could do to overcome this issue.

Stacey Loeb pointed out that a key strength of the study was that it showed that many short-term differences functional outcomes between RP & RT dissipate over time. From a functional perspective, Tim Averch may have a point when he commented that at 15 years that it may not make any difference as to whether we had performed surgery or radiotherapy.

The question was raised about correlating nerve-sparing surgery and subsequent results. Author Matt Resnick indicated that this was something that was being analysed right now with results forthcoming. On the general issue of improvements in surgery and radiotherapy leading to improved functional outcomes, Matt Resnick indicated that “While tech. improvements in RP and EBRT may incrementally improve outcomes, likely non-differential.” Towards the end of the discussion, it was generally agreed that robotic surgery was the primary manner by which surgery was being performed (at least in the US) and that it was an ‘operative leveler’ in terms of how well surgeons performed a radical prostatectomy.

Helen Nicholson from Australia asked if the late serious effects of radiotherapy were considered and on a similar theme, Matt Cooperberg raised the issue of where only incontinence was reported with regard to urinary function but irritative urinary symptoms were often of greater bother and worse with radiotherapy. Dave Penson responded in that they had data on bother from urinary symptoms and that it was worse at 2 and 5 years for surgery but the same for both radiotherapy and surgery at 15 years.

To complete the round up of the discussion content, the Best Tweet Prize was awarded to Dr Rajiv Singal for the following tweet:-

The Best Tweet Prize was kindly donated by Urology Match.

The above summary only touches upon the discussion, which had 32 participants who made a total of 171 recorded tweets to the hashtag #urojc. This does not include participants and their tweets where the #urojc had been omitted. We had quite a number of new participants this month who were still learning the necessity to include #urojc in all tweets in order for them to be visible to the discussion.

It is also interesting to look at the impact of the Superbowl. The first dip is related to our North American friends signing off to concentrate on the Superbowl and the last dip correlates when the majority of participants are with their heads buried in a robot console/wound or asleep on the other side of the world.

We look forward to seeing your participation in the March #urojc. For further information about what #urojc is all about, see my earlier blog entry on the subject.

 

Henry Woo is an Associate Professor of Surgery at the Sydney Adventist Hospital Clinical School of the University of Sydney in Australia. He has been appointed as the inaugural BJUI CME Editor. He is currently the coordinator of the International Urology Journal Club on Twitter. Follow him on Twitter @DrHWoo

 

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The Journal that never sleeps

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Thank you all for your overwhelming support of the new web and paper versions of the BJUI. For those who have missed it, please check out the web journal at: www.bjui.org.

We hope you had a relaxing holiday period – we certainly did and recharged our batteries. Despite this, the editorial team at the BJUI handled 76 articles between Christmas 2012 and New Year’s Day 2013; an average of 10 per day.

This is a reflection of the global popularity of the BJUI. We have papers coming in from all over the world from many different time zones. Furthermore, New Year celebrations in the West do not necessarily match others, such as the Chinese New Year or the Baisakhi in the Northern Indian subcontinent. The BJUI wants to continue receiving the best papers from our authors irrespective of where they are on this planet.

As a celebration of our truly global presence we are delighted to present content from around the world at www.bjui.org as articles, blogs and videos, and we invite you to post your comments on any or all of these.

The BJUI poll shows that our readers love the ‘article of the week’, which is available completely free to everyone, everywhere.

In this issue we highlight the role of tadalafil, not just in erectile dysfunction but also in ejaculatory and orgasmic dysfunction. This article provides Level 1 evidence and is accompanied by an editorial from Mike Wyllie, our expert in Sexual Medicine.

Please keep the conversations going on Twitter, Facebook and Blogs@BJUI. Your web journal needs you.

Prokar Dasgupta, Editor-in-Chief

Ashutosh Tewari, Editorial Board

Video of Ashutosh Tewari reading the Journal in New York

Editorial: Oncological outcomes: open vs robotic prostatectomy

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John W. Davis and Prokar Dasgupta*

Departments of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA and *Guy’s Hospital, Kings College London, London, UK
e-mail: [email protected]

For men at significant risk of dying from untreated prostate cancer within reasonably estimated remaining life spans, which technique offers the best disease-free survival: open radical prostatectomy (RP) or robot-assisted RP (RARP)? The practice patterns in many countries suggest RARP, but many concerns have been raised about the RARP technique for high-risk disease, including positive surgical margin rates, adequate lymph node dissections (LNDs), and the learning curve. In this issue of the BJUI, Silberstein et al provide a convincing study, short of a randomised trial, that suggests that in experienced hands both techniques can be effective, and that surgeon experience had a stronger effect than technique. In contrast to large population-based studies, this study sought to take the learning curve and low-volume surgeon variables out of the equation by restricting the inclusion criteria to four high-volume surgeons from a single centre. The follow-up is short (one year), and may underestimate the true biochemical relapse rates, and needs follow-up study, but for now offers no difference in relapse rates nor pathological staging outcomes.

Beyond the comparative effectiveness research (CER), Silberstein et al also provide a valuable vision for prostate cancer surgeons using any standard technique. Several recent landmark studies on PSA screening, the Prostate cancer Intervention Versus Observation Trial (PIVOT), and comparisons of metastatic progression between RP and radiation, all indicate the need to shift our practice pattern towards active surveillance for lower risk patients (with or without adjunctive focal therapy, but the former still experimental in our view), and curative therapy for intermediate- to high-risk disease. Such a practice pattern is evident when you compare this study (2007–2010) with a similar effort from this institution (2003–2005) comparing RP with laparoscopic RP (LRP). In the former study, >55% had low-risk disease compared with <35% from the current study. As expected, the present study shows higher N1 stage (9%) and positive surgical margin rates (15%) than the former (7% and 11%, respectively). While erectile function recovery was not presented, the authors noted the familiar reality that patients demand nerve sparing whenever feasible, only 2% in this study had bilateral non-nervesparing and 91% had a combination of bilateral or partial nerve sparing. The number of LNs retrieved has increased from 12–13/case to 15–16, and the authors state that even with nomogram-based exclusion of mandatory pelvic LNDs with <2% risk of N1 staging, this modern cohort had a pelvic LND in 94% of cases, including external iliac, obturator, and hypogastric templates.

We fully concur with this practice pattern, and have recently provided a video-based illustration of how to learn the technique, and early experience showing an increase in median LN counts from eight to 16, and an increase in positive LNs from 7% to 18%. By risk group, our positive-LN rate was 3% for low risk, 9% for intermediate risk, and 39% for high risk. We certainly hope that future multi-institutional studies will no longer reflect what these authors found, in that RARP surgeons are five times more likely to omit pelvic LNDs than open, even for high-risk cancers.

Finally, Silberstein et al and related CER publications leave us the question, does each publication on CER in RP have to be comprehensive (i.e. oncological, functional, and morbidity) or can it focus on one question. Members of this authorship line have published the ‘trifecta’ (disease control, potency, and continence) and others the ‘pentafecta’ (the trifecta plus negative surgical margins and no complications). Indeed, Eastham and Scardino stated in an editorial that ‘data on cancer control, continence, or potency in isolation are not sufficient for decision making and that patients agreeing to RP should be informed of functional results in the context of cancer control’. We feel that the answer should be no, focused manuscripts have their merit and publication space/word limits create this reality. But we should not discount the sometimes surprising results when one institution using the same surgeons and methodologies publishes on the broader topic: the Touijer et al. paper discussed above found the same oncological equivalence between RP and LRP as this comparison of RP and RARP, but also included functional data showing significantly lower recovery of continence with LRP. Nevertheless, the recent body of work in the BJUI now provides a well-rounded picture of modern CER including oncological outcomes, complications, recovery of erectile dysfunction, continence and costs. We feel it is reasonable to conclude that patients should be counselled that RARP has potential benefits in terms of blood loss, hospital stay, and complications (at increased costs), but oncological and functional results are probably based upon surgeon experience.

Abbreviations

CER, comparative effectiveness research; LN(D), lymph node dissection; (RA)(L)RP, (robot-assisted) (laparoscopic) radical prostatectomy

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Through My Father’s Eyes

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Growing up with a father who was a general surgeon, now retired, I was frequently exposed to the life and practice of a doctor. I witnessed a caring, compassionate physician rush off in the middle of the night to take out an appendix or manage a local trauma or an acute abdomen. What I was also witnessing was traditional and now, almost historic, medicine at its finest. The days of constant call, pay-for-service, and the prestige of medicine were in their hayday.

Since then, the transition to this current era has been dramatic. We’ve seen the evolution of evidence-based medicine, and more active involvement by the government within the practice of medicine, including governmental acts in healthcare laws to both protect patient’s privacy and to expand medical coverage for all. We’ve seen the reduction in residents’ hours leading to expectations of new practicing physicians to want to work less (and get paid more!). We are seeing hospitals purchasing practices by and the painful extinction of the private practitioner. There are more practice requirements, as well as restrictions, from both regulators and specialty societies. Accompanying this change has been the evolution and revolution of medical science that is slowly changing from what used to be significantly experiential and anecdotal to a more data-driven knowledge base in the formation of guidelines and best practice statements. This is going even further to include quality measurements that will not only improve outcomes but influence payment models and reimbursements. Additionally, the maturation of the Internet allows instant access to information: from being able to access everything from your pocket smart phone to the expansion of social media exemplified by the efforts of BJUI herein and the recent journal clubs conducted entirely on Twitter; technologies tying specialists together from all over the world.

Medicine has never just been about helping people, it is really about change: learning new science whether it be pathophysiology, medications or techniques. The ability for the practitioner to acclimatize to that change is how medicine has weathered the test of time. We adapt, we learn, and, ideally, we grow and become better doctors providing better care.

I recently had the pleasure of introducing my son, a high school student, to surgery just as my father had done with me (my first case was an appendectomy): he was able to observe a PCNL. Previously, if asked, he had disavowed any concept of pursuing medicine. Now, after seeing “cool” surgery that was like playing a video game, he is reconsidering. If he does enter into it, what will medicine look like in his time? How many more changes will occur going forward? How will we continue to evolve? Will he one day reflect upon medicine as it was through his father’s eyes? Time will tell…

 

Timothy D. Averch, MD, FACS is Professor and Vice Chair for Quality and Director of Endourology at the University of Pittsburgh Medical Centre Department of Urology, Pittsburgh, USA.

 

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BJUI at USICON

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BJUI had a very successful meeting at USICON in Pune. The hospitality was superb and a very well organised meeting. BJUI was represented by myself as Chairman of the Executive and by Prof Prokar Dasgupta as our new Editor. Prokar and his USICON counterparts put on a superb three hour symposium on how to organise a research project for publication. This symposium was extremely well attended with a vigorous interaction with the audience – it was very lively. In addition, Prokar had a significant input into a symposium on robotic prostatectomy as well as other scientific areas. Clearly, USICON were very pleased to see such an input into the USI from the BJUI and our attendance seemed to re-invigorate the relationship.

David Quinlan is Chairman of the BJU International Charity; Consultant Urologist at St Vincent’s University Hospital, Dublin; Senior Lecturer in Surgery at University College, Dublin, Ireland.

BJUI Editor-in-Chief Prokar Dasgupta with Drs Rane, Kochikar and Patel at USICON

 

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Editorial: Phosphodiesterase Inhibitors (PDEi) improve orgasm. The power of meta-analysis?

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Ever since the potential utility of meta-analyses in the assessment of clinical data was brought to the notice of the urological community by Peter Boyle [1], they have been used increasingly. Indeed this approach to evaluation of drug effects has become de rigueur for healthcare providers and regulatory bodies. In particular, invaluable insight has been given into the benefit : risk ratios of drugs in BPH/LUTS and overactive bladder. Even to the extent, where sufficiently large databases have been made available, it has been possible to identify characteristics predictive of subpopulations of responders and non-responders [1].

The most recent example of the power of meta-analysis is the rigorous statistical dissection of the impact tadalafil on sexual function in erectile dysfunction (ED) by the Department of Urology atWeill Cornell published in BJUI [2]. As would be anticipated from previously published individual clinical trials, there was confirmation in this review of 3581 subjects in 17 placebo-controlled studies, of the positive effect of tadalafil (exemplifying the phosphodiesterase inhibitor [PDEi] class) on erectile function. It could perhaps be argued that with a clinical effect as large and clear-cut as that of PDEi in ED, the meta-analysis was superfluous. Only in situations where the clinical impact beyond that of placebo was of lower magnitude does it come to the fore, e.g. a-adrenoceptor antagonists in the treatment of LUTS [3]. However, at this point the following health warning should be issued, PDEi in the hands of the skilled meta-analysts and marketeers: caveat lector (let the reader beware).
Returning, however, to the material in hand, the analysis of the tadalafil data also shows unequivocally that there is an additional positive effect of the drug (and presumably the PDEi class) on orgasm and sexual satisfaction. These products and class attributes have often been alluded to with varying degrees of conviction, but this is the first time convincing evidence has been tabulated and documented.

Also described is the positive effect of tadalafil on co-morbid ejaculatory dysfunction (EjD) which, at first sight, would tend to provide supportive evidence for the off-label use of tadalafil and other PDEi in the treatment of premature ejaculation (PE). Although the words in the manuscript [3] fall short of advocating this practice, the inference is there for all to read and potentially be detailed astutely by the field-force.We now move into the ‘grey’ area between caveat lector and caveat emptor (let the buyer beware). EjD can mean different things to different men and can represent a continuum from premature to delayed or even anejaculation. Almost certainly most of the patients in the clinical trials analysed would not meet the definition of PE crafted by the International Society for Sexual Medicine (ISSM) [4], so little conclusion about the benefit to men with PE can be drawn.

Ironically, a meta-analysis on the impact of PDEi on men with unequivocal PE (or at least meet the ISSM definition) has just been published [5]. The conclusion was that there is no clinically or statistically significant improvement in PE with acute or chronic treatment with PDEi.

Although, at least in the case of ejaculatory function the conclusion of the two meta-analyses appear to be at variance, in actuality they are addressing different questions. It remains, that, although in the use of meta-analysis we have the means of creating a level playing field, we have to be careful to consider what questions are being asked, by whomand with what objective.

References
1 Boyle P, Gould AL, Roehrborn CG. Prostate volume predicts outcome of treatment of benign prostatic hyperplasia with finasteride: meta-analysis of randomized clinical trials. Urology 1996; 48: 398–405
2 Paduch DA, Bolyakov A, Polzer PK, Watts SD. Effects of 12 weeks of tadalafil treatment on ejaculatory and orgasmic dysfunction and sexual satisfaction in patients with mild to severe erectile dysfunction: integrated analysis of 17 placebo-controlled studies. BJU Int 2013; 111: 333–42
3 Boyle P, Robertson C, Manski R, Padley RJ, Roehrborn CG. Meta-analysis of randomized trials of terazosin in the treatment of benign prostatic hyperplasia. Urology 2001; 58: 717–22
4 McMahon CG, Althof S, Waldinger MD et al. International Society for Sexual Medicine Ad Hoc Committee for Definition of Premature Ejaculation. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine Ad Hoc Committee for the Definition of Premature Ejaculation. BJU Int 2008; 102: 338–50
5 Asimakopoulos AD, Miano R, Agrò EF, Vespasiani G, Spera E. Does current scientific and clinical evidence support the use of phosphodiesterase type 5 inhibitors for the treatment of premature ejaculation? A systematic review and meta-analysis. J Sex Med 2012; 9: 2404–16

Mike Wyllie
Plethora Solutions Ltd London, London, UK.
e-mail: [email protected]

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