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Editorial: Well‐being beyond the bladder. How do we improve the overall health of patients with bladder cancer?

Declines in quality of life and physical function are commonly associated with all cancers 1, and in this month’s issue of BJUI, Smith et al. 2 describe the changes in quality of life that occur specifically in patients with bladder cancer. The authors examine 535 individuals with bladder cancer (of whom 77 [14%] had invasive disease) and matched them to 2770 non‐cancer controls using propensity scores. The Surveillance, Epidemiology and End Results (SEER) registry was linked with the Medicare Health Outcomes Survey. This dataset represents linkages of population‐based SEER data with survey data for Medicare‐managed enrollees. In this study, patients were surveyed at different times with respect to their diagnosis and the authors identified all patients who were surveyed some time before and after their diagnosis. By harnessing this dataset, the authors describe changes that occur in mental and physical function. The authors should be commended for conducting an analysis that seeks to quantify the impact of a bladder cancer diagnosis on multiple dimensions affecting quality of life.

A few findings are worth highlighting. First, the quality of life of a patient with bladder cancer declines more between a pre‐diagnosis and post‐diagnosis assessment as compared with matched, non‐cancer controls. As any urological oncologist can attest, a bladder cancer diagnosis causes permanent changes to a patient’s life. Second, people with bladder cancer have deficits in multiple domains of well‐being and not just in physical function. Third, people with bladder cancer have impairments in well‐being whether they have non‐invasive or invasive disease. Fourth, decrements were more pronounced in those with invasive disease. In fact, patients who underwent cystectomy had statistically significant declines in nearly all physical domains and similar declines in mental health‐related quality of life across several domains, including emotional, vitality and social functioning. Lastly, a predictor of a significant decrease in both the physical component and mental component score included a diagnosis of recent depression. This insightful study shows the potential impact of a bladder cancer diagnosis on mental and physical health‐related quality of life.

So, with these detriments in mind, can urologists do anything to address these declines in quality of life for patients with bladder cancer?

In clinical practice, urologists may be able to play an active role in mitigating the negative consequences of therapy, be it for invasive or non‐invasive disease. If a urologist is following a patient with non‐muscle‐invasive bladder cancer, then there are clinical visits for cystoscopy, intravesical instillation and follow‐up, during which a provider can regularly check in with a patient and offer recommendations. If a patient has muscle‐invasive bladder cancer, they are typically seen a few times before surgery and there is an incentive to address potentially modifiable sources of morbidity before a major operation plagued by complications.

While encouraging healthy behaviours is common sense and may help some patients, understanding the difference between motivating self‐care (e.g. coaching our patients) and recommending programmes that are scientifically established and effective (e.g. recommending a programme proven in a randomized controlled trial) are different. One major challenge in promoting healthy behaviours in our patients is understanding their mindset, i.e. their motivation to make meaningful change. The Transtheoretical Model is a biopsychosocial model that conceptualizes intent for changing behaviour: pre‐contemplation, contemplation, preparation, action, maintenance and termination 3. Based on a continuum of patient activation and knowledge of these stages, interventions can be designed more effectively and focused on individuals. Conversation content, clinician effort and clinical resources can be judiciously allotted instead of offering all options to all patients.

The presence of validated interventions that have been determined to consistently improve quality of life is evolving. A new area of preoperative care known as prehabilitation, is being studied in patients with cancer and seeks to optimize preoperative factors, such as increasing fitness, improving nutritional status, encouraging smoking cessation and decreasing anxiety 4. Although studies vary in quality, content and outcomes measured 5, there is still an opportunity to exercise common sense and make practical suggestions.

For busy urologists who manage patients with bladder cancer, any patient can benefit from:

  1. Mindful conversations: having open and regular communication about quality of life.
  2. Measurements: tracking patient‐reported outcome measures longitudinally to follow well‐being systematically and identify detrimental changes early.
  3. Multidisciplinary resources: offer support (Fig. 1) based on conversations (#1) and scores (#2).

Conversations only require a little provider time, monitoring patient‐reported outcomes can be facilitated by the use of technology such as the electronic health record, and most institutions have previously established resources that patients can use during their care. Strategies may be low‐cost, quick and capable of helping patients or caregivers. Also, data show that routine assessment of patient‐reported outcome measures in patients with advanced cancers may be associated with improved overall survival 6.

Potential targets to improve patient well‐being during bladder cancer care.

Acknowledging that other dimensions of health are affected after a bladder cancer diagnosis may allow us to track, address and ultimately improve the health of our patients. When we care for patients with bladder cancer, focusing cancer treatment is paramount; however, we can also extend this treatment by being cognisant of quality of life. Complementing oncological care with efforts to promote health in other ways allows us to promote well‐being and treat these patients beyond the bladder.

 

Matthew Mossanen*, Justin C. Brown† and Deborah Schrag
*Division of Urology, Brigham and Womens Hospital, Harvard Medical School, Boston, MA, USA and Dana Farber Cancer Institute, Boston, MA, USA

 

References

 

  • Petrick JL, Reeve BB, Kucharska‐Newton AM et alFunctional status declines among cancer survivors: trajectory and contributing factorsJournal of Geriatric Oncology 20145: 359–67

 

  • Smith AB, Jaeger B, Pinheiro LC et alImpact of bladder cancer on health‐related quality of lifeBJU Int 2018121: 549–57

 

 

  • Silver JK, Baima J. Cancer prehabilitation: an opportunity to decrease treatment‐related morbidity, increase cancer treatment options, and improve physical and psychological health outcomesAm J Phys Med Rehabil 201392: 715–27

 

 

  • Basch E, Deal AM, Dueck AC et alOverall survival results of a trial assessing patient‐reported outcomes for symptom monitoring during routine cancer treatmentJAMA 2017318: 197–8

 

Video: Impact of bladder cancer on health‐related quality of life

Impact of bladder cancer on health‐related quality of life

 

Abstract

Objectives

To identify changes in health‐related quality of life (HRQoL) after diagnosis of bladder cancer in older adults in comparison with a group of adults without bladder cancer (controls).

Patients and Methods

Data from the Surveillance, Epidemiology and End Results registries were linked with Medicare Health Outcomes Survey (MHOS) data. Medicare beneficiaries aged ≥65 years in the period 1998–2013, who were diagnosed with bladder cancer between baseline and follow‐up through the MHOS, were matched with control subjects without cancer using propensity scores. Linear mixed models were used to estimate predictors of HRQoL changes.

Results

After matching, 535 patients with bladder cancer (458 non‐muscle‐invasive bladder cancer [NMIBC] and 77 with muscle‐invasive bladder cancer [MIBC]) and 2 770 control subjects without cancer were identified. Both patients with NMIBC and those with MIBC reported significant declines in HRQoL scores over time vs controls: physical component summary −2 and −5.3 vs −0.4, respectively; bodily pain −1.9 and −3.6 vs −0.7; role physical −2.7 and −4.7 vs −0.7; general health −2.4 and −6.1 vs 0; vitality −1.2 and −3.5 vs −0.1; and social functioning −2.1 and −5.7 vs −0.8. All scores ranged from 0 to 100. When stratified by time since diagnosis, HRQoL improved over 1 year for some domains (role physical), but remained lower across most domains.

Conclusions

After diagnosis, patients with bladder cancer experienced significant declines in physical, mental and social HRQoL relative to controls. Decrements were most pronounced among individuals with MIBC. Methods to better understand and address HRQoL decrements among patients with bladder cancer are needed.

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Video: Centralisation of RC for bladder cancer in England

Centralisation of radical cystectomies for bladder cancer in England, a decade on from the ‘Improving Outcomes Guidance’: the case for super centralisation

Read the full article

Abstract

Objective

To analyse the impact of centralisation of radical cystectomy (RC) provision for bladder cancer in England, on postoperative mortality, length of stay (LoS), complications and re-intervention rates, from implementation of centralisation from 2003 until 2014. In 2002, UK policymakers introduced the ‘Improving Outcomes Guidance’ (IOG) for urological cancers after a global cancer surgery commission identified substantial shortcomings in provision of care of RCs. One key recommendation was centralisation of RCs to high-output centres. No study has yet robustly analysed the changes since the introduction of the IOG, to assess a national healthcare system that has mature data on such institutional transformation.

Patients and Methods

RCs performed for bladder cancer in England between 2003/2004 and 2013/2014 were analysed from Hospital Episode Statistics (HES) data. Outcomes including 30-day, 90-day, and 1-year all-cause postoperative mortality; median LoS; complication and re-intervention rates, were calculated. Multivariable statistical analysis was undertaken to describe the relationship between each surgeon and the providers’ annual case volume and mortality.

Results

In all, 15 292 RCs were identified. The percentage of RCs performed in discordance with the IOG guidelines reduced from 65% to 12.4%, corresponding with an improvement in 30-day mortality from 2.7% to 1.5% (P = 0.024). Procedures adhering to the IOG guidelines had better 30-day mortality (2.1% vs 2.9%; P = 0.003) than those that did not, and better 1-year mortality (21.5% vs 25.6%; P < 0.001), LoS (14 vs 16 days; P < 0.001), and re- intervention rates (30.0% vs 33.6%; P < 0.001). Each single extra surgery per centre reduced the odds of death at 30 days by 1.5% (odds ratio [OR] 0.985, 95% confidence interval [CI] 0.977–0.992) and 1% at 1 year (OR 0.990, 95% CI 0.988–0.993), and significantly reduced rates of re-intervention.

Conclusion

Centralisation has been implemented across England since the publication of the IOG guidelines in 2002. The improved outcomes shown, including that a single extra procedure per year per centre can significantly reduce mortality and re-intervention, may serve to offer healthcare planners an evidence base to propose new guidance for further optimisation of surgical provision, and hope for other healthcare systems that such widespread institutional change is achievable and positive.

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Editorial: Examining the role of centralisation of radical cystectomy for bladder cancer

Despite the high risk of postoperative complications and/or death, radical cystectomy (RC) is currently considered as the standard of care for patients with muscle-invasive bladder cancer (MIBC) without clinical evidence of metastases at initial diagnosis. As an alternative, trimodality bladder-sparing therapy with a potentially more favourable toxicity profile has been developed over recent decades, but definitive surgery may provide better cancer control outcomes, especially in fit individuals. Consequently, efforts have been made recently to improve RC quality by introducing new concepts in the perioperative management of patients with MIBC. For example, the implementation of robot-assisted techniques and enhanced recovery protocols may help to reduce surgical stress and facilitate discharge after early rehabilitation. Nonetheless, such valuable interventions are more likely to be delivered at expert centres in MIBC management.

Interestingly, given that surgical experience mostly comes from surgical volume, numerous studies suggest that there is an inverse relationship between hospital as well as surgeon volume and morbidities for major surgeries including RC. Specifically, a recent meta-analysis showed that high-volume hospitals (odds ratio [OR] 0.55, 95% CI: 0.44–0.69; P < 0.001) and surgeons (OR 0.58, 95% CI: 0.46–0.73; P < 0.001) were significantly associated with a lower risk of death after RC [1]. As a result, centralisation of RC at high-output centres has been advocated worldwide to optimise perioperative management of patients with MIBC and improve short-term outcomes.

In this issue of the BJUI, Afshar et al. [2] eloquently show that such a healthcare policy can be effective at the population level. The authors impressively collected perioperative information on >15 000 RC patients from the Hospital Episode Statistics (HES) dataset in England, where the ‘Improving Outcomes Guidance’ (IOG) programme recommends since 2002 that RC should be performed by surgeons operating at least five cases per year at centres carrying out ≥50 procedures per year. Interestingly, they found that the proportion of RC performed in discordance with IOG guidelines decreased from 60.7% in 2003 to 12.4% in 2013. This resulted in a significant improvement in the overall 30-day crude mortality rate, with a reduction from 2.7% to 1.5% over the 11-year period (P = 0.02). After adjusting for available confounding, RC patients in the non-IOG-compliant group were more likely to die at 30 days (OR 1.41, 95% CI: 1.13–1.76) or 1 year (OR 1.31, 95% CI: 1.21–1.43) as compared to those in the IOG-compliant group. When analysing the incremental effect of hospital volume, each extra RC per year reduced the risk of death at 30 days and 1 year by 1.5% (OR 0.985, 95% CI: 0.977–0.992) and 1% (OR 0.990, 95% CI: 0.988–0.993), respectively. Although there was no significant difference in the odds of postoperative complications between the two groups (OR 0.96, 95% CI: 0.88–1.04), the risk of re-intervention was higher in the non-IOG-compliant group (OR 1.20, 95% CI: 1.12–1.30). It is noteworthy that, as observed for the risk of death, each extra RC decreased the risk of re-intervention (OR 0.99, 95% CI: 0.991–0.995). In conclusion, the findings by Afshar et al. [2] suggest that urologists have embraced centralisation of care for RC patients in England and this is likely to have positively affected the short-term outcomes.

Although, as acknowledged by the authors, many limitations related to the administrative nature of the HES dataset (e.g. missing data or coding errors) may have influenced the aforementioned results, other reports from the USA are consistent with this study. Specifically, it has been estimated that up to 40% of the decline in 30-day mortality after RC from 2000 to 2008 was attributable to centralisation of care [3]. In addition, other RC quality criteria, such as adequate pelvic lymph node dissection at the time of surgery, have improved after similar centralisation in the Netherlands between 2006 and 2012 [4]. As such, centralisation of RC offers many undisputable advantages, but given that travel distance to the treating facility may represent an important barrier for patients with MIBC seeking surgical care, concerns have been raised with regards to potential drawbacks, including increased time to definitive surgery. However, a recent report from the USA showed that, although centralisation of RC has led to a decrease overall access to the treating facilities, the process simultaneously improved access to high-volume centres [5]. It is noteworthy that hospital volume standards for centralisation of RC should not be set too high to avoid unreasonable travel burdens on patients with MIBC [6].

To summarise, centralisation of care is arguably the best way to go, to continue improving quality of RC and its associated short-term outcomes in the near future. Despite inherent limitations, virtually all available evidence, including the study by Afshar et al. [2], converge toward the general concept that RC patients should be managed by experienced urologists operating at expert centres with trained surgical teams.

Thomas Seisen 
Department of Urology, Pitie Salpetriere Hospital, Assistance Publique des Hopitaux de Paris, Paris Sorbonne University, Paris, France

 

Read the full article

 

References

 

 

2 Afshar M, Goodfellow H, Jackson-Spence F et al. Centralisation of radical cystectomies for bladder cancer in England, a decade on from the ‘Improving Outcomes Guidance: the case for super centralisation. BJU Int 2018; 121: 21724 166

 

 3 Finks JF, Osborne NH, Birkmeyer JD. Trends in hospital volume and operative mortality for high-risk surgery. N Engl J Med 2011; 364: 212837

 

4 Hermans TJ, Fransen van de Putte EE, Fossion LM et al. Variations in
pelvic lymph node dissection in invasive bladder cancer: a Dutch

 

nationwide population-based study during centralization of care. Urol
Oncol 2016;34:532. e7532.e12

 

5 Casey MF, Wisnivesky J, Le VH et al. The relationship between centralization of care and geographic barriers to cystectomy for bladder cancer. Bladder Cancer 2016; 2: 31927

 

6 Birkmeyer JD, Siewers AE, Marth NJ, Goodman DC. Regionalization of high-risk surgery and implications for patient travel times. JAMA 2003; 290: 27038

 

Article of the Week: Centralisation of RC for bladder cancer in England

Every Week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

Finally, the third post under the Article of the Week heading on the homepage will consist of additional material or media. This week we feature a video discussing the paper.

If you only have time to read one article this week, it should be this one.

Centralisation of radical cystectomies for bladder cancer in England, a decade on from the ‘Improving Outcomes Guidance’: the case for super centralisation

Mehran Afshar*, Henry Goodfellow, Francesca Jackson-Spence, Felicity Evison§John Parkin§, Richard T. Bryan, Helen Parsons, Nicholas D. James§‡ and Prashant Patel§

 

*St Georges Hospital NHS Trust, London, UK, The Royal Free London NHS Trust, London, UK, University of Birmingham, Birmingham, UK, §University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK, and Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK
Read the full article

Abstract

Objective

To analyse the impact of centralisation of radical cystectomy (RC) provision for bladder cancer in England, on postoperative mortality, length of stay (LoS), complications and re-intervention rates, from implementation of centralisation from 2003 until 2014. In 2002, UK policymakers introduced the ‘Improving Outcomes Guidance’ (IOG) for urological cancers after a global cancer surgery commission identified substantial shortcomings in provision of care of RCs. One key recommendation was centralisation of RCs to high-output centres. No study has yet robustly analysed the changes since the introduction of the IOG, to assess a national healthcare system that has mature data on such institutional transformation.

Patients and Methods

RCs performed for bladder cancer in England between 2003/2004 and 2013/2014 were analysed from Hospital Episode Statistics (HES) data. Outcomes including 30-day, 90-day, and 1-year all-cause postoperative mortality; median LoS; complication and re-intervention rates, were calculated. Multivariable statistical analysis was undertaken to describe the relationship between each surgeon and the providers’ annual case volume and mortality.

Results

In all, 15 292 RCs were identified. The percentage of RCs performed in discordance with the IOG guidelines reduced from 65% to 12.4%, corresponding with an improvement in 30-day mortality from 2.7% to 1.5% (P = 0.024). Procedures adhering to the IOG guidelines had better 30-day mortality (2.1% vs 2.9%; P = 0.003) than those that did not, and better 1-year mortality (21.5% vs 25.6%; P < 0.001), LoS (14 vs 16 days; P < 0.001), and re- intervention rates (30.0% vs 33.6%; P < 0.001). Each single extra surgery per centre reduced the odds of death at 30 days by 1.5% (odds ratio [OR] 0.985, 95% confidence interval [CI] 0.977–0.992) and 1% at 1 year (OR 0.990, 95% CI 0.988–0.993), and significantly reduced rates of re-intervention.

Conclusion

Centralisation has been implemented across England since the publication of the IOG guidelines in 2002. The improved outcomes shown, including that a single extra procedure per year per centre can significantly reduce mortality and re-intervention, may serve to offer healthcare planners an evidence base to propose new guidance for further optimisation of surgical provision, and hope for other healthcare systems that such widespread institutional change is achievable and positive.

Read more articles of the week

 

Article of the Week: Association of HDI with global bladder, kidney, prostate and testis cancer

Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Association of Human Development Index with global bladder, kidney, prostate and testis cancer incidence and mortality

Alyssa K. Greiman*, James S. Rosoff† and Sandip M. Prasad*

 

*Department of Urology, Medical University of South Carolina, Charleston, SC, Department of Urology, Yale School of Medicine, New Haven, CT, and Department of Surgery, Ralph M. Johnson VA Medical Center, Charleston, SC, USA

 

Read the full article

Abstract

Objectives

To describe contemporary worldwide age-standardized incidence and mortality rates for bladder, kidney, prostate and testis cancer and their association with development.

Materials and Methods

We obtained gender-specific, age-standardized incidence and mortality rates for 184 countries and 16 major world regions from the GLOBOCAN 2012 database. We compared the mortality-to-incidence ratios (MIRs) at national and regional levels in males and females, and assessed the association with socio-economic development using the 2014 United Nations Human Development Index (HDI).

Results

Age-standardized incidence rates were 2.9 (bladder) to 7.4 (testis) times higher for genitourinary malignancies in more developed countries compared with less developed countries. Age-standardized mortality rates were 1.5–2.2 times higher in more vs less developed countries for prostate, bladder and kidney cancer, with no variation in mortality rates observed in testis cancer. There was a strong inverse relationship between HDI and MIR in testis (regression coefficient 1.65, R2 = 0.78), prostate (regression coefficient −1.56, R2 = 0.85), kidney (regression coefficient −1.34, R2 = 0.74), and bladder cancer (regression coefficient −1.01, R2 = 0.80).

Conclusion

While incidence and mortality rates for genitourinary cancers vary widely throughout the world, the MIR is highest in less developed countries for all four major genitourinary malignancies. Further research is needed to understand whether differences in comorbidities, exposures, time to diagnosis, access to healthcare, diagnostic techniques or treatment options explain the observed inequalities in genitourinary cancer outcomes.

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Editorial: Human development and its impact on genitourinary cancers

Using the extensive data from the WHO International Agency for Research on Cancer and the United Nations Human Development Report, Greiman et al. [1] aimed to investigate how human development is associated with incidence and mortality of genitourinary cancers. Even though they generate some interesting descriptive findings, we have to remain critical of these descriptive statistics and carefully assess what needs to be investigated next.

Firstly, despite having highlighted the need for attention to indicators of longevity, education, and income per head when assessing human development, the human development index (HDI) is a rather crude measurement. As a geometric mean of normalised indices for each of these three domains, the HDI simplifies but only captures part of what human development entails. Important indicators of health care such as inequalities, poverty, human security, and empowerment are not reflected in the HDI (www.hdr.undp.org). In the context of cancer incidence and mortality this is an important limitation, as it has for instance been shown that socioeconomic status affects early phase cancer trial referrals, which can be considered as a proxy for access to health care [2]. This inequality has been hypothesised to be linked to more comorbidities and lower education in those who are most deprived – a complex interaction which may not be completely captured by the HDI.

Secondly, registration of incidence and mortality of cancers may vary substantially between countries based on both medical practice and governance. These differences are important when trying to generate hypotheses following the ecological study of Greiman et al. [1]. In the case of bladder cancer, for instance, mortality has been estimated to be 17% in the Netherlands, compared to 22% in the USA, and 50% in the UK. As cancer treatments are expected to be similar in these developed countries, it has been thought that a lower registration of non-muscle-invasive bladder cancer in the UK could explain this higher proportion [3]. Thus, discrepancies in cancer registration, even between developed countries, may limit our awareness of cancer burden.

Thirdly, the study design suffers from ‘ecological fallacy’. The latter refers to the inability to draw causal inference about the effect of the HDI on genitourinary cancer at the individual level, in conjunction with the underlying problem of heterogeneity of exposure levels [4]. This limitation was not mentioned by Greiman et al. [1], but affects their conclusions. The lack of information on, for instance, smoking data, comorbidities, and ethnicity make it difficult to understand how development is affecting cancer incidence or mortality. It would have been interesting to also investigate cancers other than genitourinary cancers because a comparison of different tumour types might have shed light on differences in medical practice or risk factors across countries and help tease out the ecological effect of human development.

Despite the aforementioned limitations, the descriptive analysis by Greiman et al. [1] can be helpful for generating hypotheses – as also outlined by the authors. This ecological effect of human development on incidence and mortality rates of genitourinary cancers is particularly relevant when evaluating the impacts of prevention and intervention programmes for these cancers. Their findings suggest that further investigation is required to examine the hypothesis regarding human development and incidence/mortality of genitourinary cancers. To further elucidate this association, methodological challenges will need to be overcome, as HDI assessment has been criticised for being too crude. Nevertheless, it should be possible to collect more detailed information to allow for an understanding of which components of a country’s collective resources affect cancer incidence and mortality the most, e.g. differences in resources used for cancer detection and treatment.

Mieke Van Hemelrijck
Division of Cancer Studies, Translational Oncology and Urology Research (TOUR), Kings College London, London, UK

 

References

 

1 Greiman AKRosoff JSPrasad SM. Association of Human Development Index with global bladder, kidney, prostate and testis cancer incidence and mortality. BJU Int2017; 120: 799-807

 

2 Mohd Noor A Sarker DVizor S et al. Effect of patient socioeconomic status on access to early-phase cancer trials. J Clin Oncol 2013; 31: 224– 30.

 

3 Boormans JLZwarthoff EC. Limited funds for bladder cancer research and what can we do about it. Bladder Cancer 2016; 2: 4951

 

4 Morgenstern H . Ecologic studies in epidemiology: concepts, principles, and methods. Annu Rev Public Health 1995; 16: 618

 

Article of the Month: Bladder cancer: diagnosis and management of bladder cancer

Every month the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation. There is also a podcast created by a Urology Resident.

If you only have time to read one article this week, it should be this one.

Read the full article

Introduction

Bladder cancer is the seventh most common cancer in the UK. It is 3–4 times more common in men than in women. In the UK in 2011, it was the fourth most common cancer in men and the thirteenth most common in women. There were 10,399 people diagnosed with bladder cancer and 5081 deaths from bladder cancer in 2011. The majority of cases occur in people aged over 60. The main risk factor for bladder cancer is increasing age, but smoking and exposure to some industrial chemicals also increase risk.

Bladder cancer is usually identified on the basis of visible blood in the urine or blood found on urine testing, but emergency admission is a common way for bladder cancer to present, and is often associated with a poor prognosis.

Most bladder cancers (75–80%) do not involve the muscle wall of the bladder and are usually treated by telescopic removal of the cancer (transurethral resection of bladder tumour [TURBT]). This is often followed by instillation of chemotherapy or vaccine-based therapy into the bladder, with prolonged telescopic checking of the bladder (cystoscopy) as follow-up. Some people in this group who are at higher risk are treated with major surgery to remove the bladder (cystectomy). People with cancer in or through the bladder muscle wall may be treated with intent to cure using chemotherapy, cystectomy or radiotherapy, and those who have cancer too advanced to cure may have radiotherapy and chemotherapy.

The involvement of the urogenital tract and the nature of the treatments give this cancer a strong psychological impact, in addition to the physical impact of the disease and its treatments, which is often profound. The prevalence of the condition and the nature of its management make bladder cancer one of the most expensive cancers for the NHS.

There is thought to be considerable variation across the NHS in the diagnosis and management of bladder cancer and the provision of care to people who have it. There is evidence that the patient experience for people with bladder cancer is worse than that for people with other cancers.

This guideline covers adults (18 years and older) referred from primary care with suspected bladder cancer and those with newly diagnosed or recurrent bladder (urothelial carcinoma, adenocarcinoma, squamous-cell carcinoma or small-cell carcinoma) or urethral cancer. There was insufficient high-quality evidence on which to make specific recommendations for non-urothelial bladder cancer (adenocarcinoma, squamous-cell carcinoma or small-cell carcinoma).

It does not cover people aged under 18 or adults with bladder sarcoma, urothelial cancer of the upper urinary tract, or secondary bladder or urethral cancer (for example, bowel or cervix cancer spreading into the bladder).

Medicines

The guideline assumes that prescribers will use a medicine’s summary of product characteristics to inform decisions made with individual patients.

This guideline recommends some medicines for indications for which they do not have a UK marketing authorisation at the date of publication, if there is good evidence to support that use. The prescriber should follow relevant professional guidance, taking full responsibility for the decision. The patient (or those with authority to give consent on their behalf) should provide informed consent, which should be documented. See the General Medical Council’s Prescribing guidance: prescribing unlicensed medicines for further information. Where recommendations have been made for the use of medicines outside their licensed indications (‘off-label use’), these medicines are marked with a footnote in the recommendations.

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Article of the Week: Clinical and patient-reported outcomes of SPARE

Every Week the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an accompanying editorial written by a prominent member of the urological community. This blog is intended to provoke comment and discussion and we invite you to use the comment tools at the bottom of each post to join the conversation.

If you only have time to read one article this week, it should be this one.

Clinical and patient-reported outcomes of SPARE – a randomised feasibility study of selective bladder preservation versus radical cystectomy

Robert A. Huddart*, Alison Birtle, Lauren Maynard*, Mark Beresford§, Jane BlazebyJenny Donovan, John D. Kelly**, Tony Kirkbank††, Duncan B. McLaren‡‡, Graham Mead§§, Clare Moynihan*, Raj Persad¶¶, Christopher Scrase***, Rebecca Lewis* and Emma Hall*
*The Institute of Cancer Research, London, UK, Royal Marsden NHS Foundation Trust, London, UK, Royal Preston Hospital, Preston and University of Manchester, Manchester, UK, §Royal United Hospital Bath, Bath, UK, University of Bristol, Bristol, UK, **University College London Hospital, London, UK, ††Patient Representative, Edinburgh, UK, ‡‡Western General Hospital, Edinburgh, UK, §§Southampton General Hospital, Southampton, UK, ¶¶North Bristol NHS Trust, Bristol, UK, and ***The Ipswich Hospital NHS Trust, Ipswich, UK

 

Read the full article

Abstract

Objectives

To test the feasibility of a randomised trial in muscle-invasive bladder cancer (MIBC) and compare outcomes in patients who receive neoadjuvant chemotherapy followed by radical cystectomy (RC) or selective bladder preservation (SBP), where definitive treatment [RC or radiotherapy (RT)] is determined by response to chemotherapy.

Patients and Methods

SPARE is a multicentre randomised controlled trial comparing RC and SBP in patients with MIBC staged T2–3 N0 M0, fit for both treatment strategies and receiving three cycles of neoadjuvant chemotherapy. Patients were randomised between RC and SBP before a cystoscopy after cycle three of neoadjuvant chemotherapy. Patients with ≤T1 residual tumour received a fourth cycle of neoadjuvant chemotherapy in both groups, followed by radical RT in the SBP group and RC in in the RC group; non-responders in both groups proceeded immediately to RC following cycle three. Feasibility study primary endpoints were accrual rate and compliance with assigned treatment strategy. The phase III trial was designed to demonstrate non-inferiority of SBP in terms of overall survival (OS) in patients whose tumours responded to neoadjuvant chemotherapy. Secondary endpoints included patient-reported quality of life, clinician assessed toxicity, loco-regional recurrence-free survival, and rate of salvage RC after SBP.

Results

Trial recruitment was challenging and below the predefined target with 45 patients recruited in 30 months (25 RC; 20 SBP). Non-compliance with assigned treatment strategy was frequent, six of the 25 patients (24%) randomised to RC received RT. Long-term bladder preservation rate was 11/15 (73%) in those who received RT per protocol. OS survival was not significantly different between groups.

Conclusions

Randomising patients with MIBC between RC and SBP based on response to neoadjuvant chemotherapy was not feasible in the UK health system. Strong clinician and patient preferences for treatments impacted willingness to undergo randomisation and acceptance of treatment allocation. Due to the few participants, firm conclusions about disease and toxicity outcomes cannot be drawn.

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Editorial: Should we care more about SPARE?

Huddart et al. [1] report the results of a phase III clinical trial (SPARE) evaluating the feasibility of randomising participants with cT2/T3 muscle-invasive bladder cancer (MIBC) to either radiation or radical cystectomy (RC) following neoadjuvant chemotherapy. Whilst attempting to address an important, in fact crucial ongoing point of debate, due to poor patient accrual (45 participants recruited in 30 months) the study was terminated early. Additionally, compliance with study assignment was low, with as many as 24% of participants electing to proceed with a treatment arm that was the opposite of what they were randomised to. This underscores the problems with obtaining randomised data in an era where patient and clinician preference drive clinical decision-making.

Whilst well-performed prospective studies show acceptable results with bladder-sparing approaches (69% complete response and 71% 5-year disease-specific survival [2]), no randomised clinical trials comparing bladder sparing with RC have demonstrated equivocal results. As non-randomised studies are subject to selection bias [many patients with large bulky T3 tumours or those with carcinoma in situ (CIS) or hydronephrosis have not met inclusion criteria for trials of bladder sparing], it is often debated as to whether bladder sparing is appropriate for the entire population of patients with MIBC or a selected subset. This is especially important in a deadly disease such as bladder cancer, where we often have only one chance to get it right and hence recent guidelines state that bladder sparing and radical options should be discussed with the patient.

Whilst we acknowledge the limitations based on the number of participants analysed, these data show some interesting trends [1]. There appears to be more local recurrence with radiation therapy (69%) compared to RC (15%), this despite confirmation of ≤cT1 disease after neoadjuvant chemotherapy. And while most of the local failures are attributed to non-muscle-invasive recurrences; additional treatments, patient anxiety, and potential salvage RC, as well as the cost of surveillance, must be considered in reflecting on these results. It is unclear whether these factors are outweighed by the perceived lower toxicity in these patients.

It is our opinion that until randomised studies show equivalency, radiation-based approaches should definitely be discussed with all patients but patients should also be guided as to who are ideal candidates. Ideal candidates are those who have non-variant histology (pure urothelial carcinoma), non-bulky (minimal) invasive T2 cancer, absence of CIS, absence of a three-dimensional mass on imaging or examination, absence of hydronephrosis, and have an adequate bladder capacity [3]. The role of multidisciplinary care is paramount, maximal transurethral resection is a critical initial step, as incomplete resections can potentially double the odds of eventual RC in bladder-sparing protocols [4]. Additionally, concomitant chemotherapy has shown improved survival and should be considered standard of care based on a randomised control trial [5]. The addition of neoadjuvant chemotherapy is unknown and needs to be further evaluated. In addition to the treatment itself, it is clear that vigilant surveillance is critical in identifying patients at highest risk of failure and requires a combination of both cystoscopy and imaging, with expedient salvage RC.

Beyond the challenges of treating patients with MIBC, this report from Huddart et al. [1] reflects the larger issue of clinical trial accrual. As mentioned, patients and clinicians often have predetermined notions about the ‘best’ course of action, even in the context of a randomised clinical trial. These limitations have plagued early closure of other trials in bladder cancer as well. Similarly in prostate cancer, comparative treatment trials of radiation and surgery are limited as patients are reluctant to relinquish decisions about their treatment. Clearly, an intensive effort is necessary to create clinical trials that are palatable to a multi-disciplinary treatment team committed to answering tough therapy questions. MIBC is no different, where we often offer differing treatment modalities without having quality comparative data, which is a disservice to our patients who look to us to guide their treatment approaches based on best available hard evidence. We again commend the authors for their well-designed clinical trial and presenting their results and challenges from the SPARE trial.

Eugene K. Lee* and Ashish M. Kamat

 

*University of Kansas Medical Center, Kansas City, KS and † Department of Urology, MD Anderson Cancer Center, Houston, TX, USA

 

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References

 

 

3 Smelser WW, Austenfeld MA, Holzbeierlein JM, Lee EK. Where are we with bladder preservation for muscle-invasive bladder cancer in 2017? Indian J Urol 2017; 33: 11117

 

 

5 James ND, Hussain SA, Hall E et al. Radiotherapy with or without chemotherapy in muscle-invasive bladder cancer. N Engl J Med 2012; 366: 147788

 

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