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Editorial: Human development and its impact on genitourinary cancers

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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), King’s College London, London, UK

 

References

 

1 Greiman AK, Rosoff JS, Prasad 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 D, Vizor S et al. Effect of patient socioeconomic status on access to early-phase cancer trials. J Clin Oncol 2013; 31: 224– 30.

 

3 Boormans JL, Zwarthoff EC. Limited funds for bladder cancer research and what can we do about it. Bladder Cancer 2016; 2: 49–51

 

4 Morgenstern H . Ecologic studies in epidemiology: concepts, principles, and methods. Annu Rev Public Health 1995; 16: 61–8

 

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

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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

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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 Blazeby, Jenny 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

 

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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?

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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

1 Huddart RA, Birtle A, Maynard L et al. Clinical and patient-reported outcomes of SPARE – a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int 2017; 120: 639–50

 

2 Mak RH, Hunt D, Shipley WU et al. Long-term outcomes in patients with muscle-invasive bladder cancer after selective bladder-preserving combined-modality therapy: a pooled analysis of Radiation Therapy Oncology Group protocols 8802, 8903, 9506, 9706, 9906, and 0233. J Clin Oncol 2014; 32: 3801–9

 

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: 111–17

 

4 Efstathiou JA, Spiegel DY, Shipley WU et al. Long-term outcomes of selective bladder preservation by combined-modality therapy for invasive bladder cancer: the MGH experience. Eur Urol 2012; 61: 705–11

 

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: 1477–88

 

Article of the Week: Detecting SNs in patients with BCa intra-operatively

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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.

Radio-guided sentinel lymph node detection and lymph node mapping in invasive urinary bladder cancer: a prospective clinical study

Firas Aljabery1,2,*, Ivan Shabo2,3,4, Hans Olsson2,5, Oliver Gimm2,6 and Staffan Jahnson1,2

1 Department of Urology, Region Östergötland, Linköping University Hospital, Linköping, Sweden, 2 Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping, sweden 3 Endocrine and Sarcoma Surgery Unit, Department of Molecular Medicine and Surgery, Karolinska Institute, Stockholm, Sweden 4 Department of Breast and Endocrine Surgery, Karolinska University Hospital, Solna Stockholm, Sweden 5 Department of Pathology, Region Östergötland, Linköping University Hospital, Linköping, Sweden 6 Department of Surgery, Region Östergötland, Linköping University Hospital, Linköping, Sweden

Read the full article

Abstract

Objectives

To investigate the possibility of detecting sentinel lymph nodes (SNs) in patients with urinary bladder cancer (BCa) intra-operatively and whether the histopathological status of the identified SNs reflected that of the lymphatic field.

Patients and Methods

We studied 103 patients with BCa pathological stage T1–T4 who were treated with cystectomy and pelvic lymph node (LN) dissection during 2005–2011 at the Department of Urology, Linköping University Hospital. Radioactive tracer Nanocoll 70 MBq and blue dye were injected into the bladder wall around the primary tumour before surgery. SNs were detected ex vivo during the operation with a handheld Geiger probe (Gamma Detection System; Neoprobe Corp., Dublin, OH, USA). All LNs were formalin-fixed, sectioned three times, mounted on slides and stained with haematoxylin and eosin. An experienced uropathologist evaluated the slides.

Results

The mean age of the patients was 69 years, and 80 (77%) were male. Pathological staging was T1–12 (12%), T2–20 (19%), T3–48 (47%) and T4–23 (22%). A mean (range) number of 31 (7–68) nodes per patient were examined, totalling 3 253 nodes. LN metastases were found in 41 patients (40%). SNs were detected in 83 of the 103 patients (80%). Sensitivity and specificity for detecting metastatic disease by SN biopsy (SNB) varied between LN stations, with average values of 67% and 90%, respectively. LN metastatic density (LNMD) had a significant prognostic impact; a value of ≥8% was significantly related to shorter survival. Lymphovascular invasion (LVI) occurred in 65% of patients (n = 67) and was significantly associated with shorter cancer-specific survival (P < 0.001).

Conclusion

We conclude that SNB is not a reliable technique for peri-operative localization of LN metastases during cystectomy for BCa; however, LNMD has a significant prognostic value in BCa and may be useful in the clinical context and in BCa oncological and surgical research. LVI was also found to be a prognostic factor.

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Editorial: Positive messages for bladder cancer management in negative sentinel lymph node study

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I encourage you to read the study by Aljabery et al. [1] in this edition of BJUI. Their findings are based on some very solid methodology and I think provide a robust answer to their question, which often in science means a ‘negative’ result. The principle of sentinel lymph node biopsy (SLNB) needs no introduction. It is primarily intended to detect the principal LN draining a tumour, allowing its removal and pathological determination of LN metastasis status in that individual [2].The avoidance of an unnecessary LN dissection (LND) and its associated risks is at the heart of any SLNB strategy. On the other hand, particularly for bladder cancer, there is a recognition that a higher number of LNs removed at the time of surgery confers a survival advantage to patients through more accurate staging [3]. With greater numbers of LNs removed pN0 patients are more likely to be truly N0 and pN1 patients with limited metastases have a greater chance that all disease has been completely excised. Thus, when considering SLNB in bladder cancer there is the usual conflict between maximising oncological benefit and minimising surgical harm.Aljabery et al. [1] present an excellent series of cystectomies with a 100% negative margin rate and mean LN count of 30. The 40% rate of LN involvement, is perhaps partly due to the meticulous triple sectioning of each excised LN. Their SLN technique involved four cystoscopic injections to the bladder wall surrounding the tumour and focused on the biggest lesion in multiple tumour cases. The LNs were removed in their packets and studied after removal from the patient. While this is likely to be a more precise method for determining the site of the SLN, it clearly differs from the approach one would take if trying to avoid LND in negative-SLN cases. Furthermore, examination of LNs was performed after formalin fixation. Typically when using SLN techniques frozen sections are also used to guide surgeons during surgery.The results clearly show that SLNB using radiolabelled nanocolloid does not allow accurate identification of pathologically LN-negative patients who could then avoid a complete LN dissection. Sensitivity of the technique in the detection of positive LNs ranged from 67% to 90% at the various LN stations. Overall, of patients with an identifiable SLN that was negative, 19% of patients had positive LNs elsewhere (81% negative predictive value). Effectively one in five patients who might be reassured by a negative SLN result would in fact have undetected positive LNs left behind if this technique were employed. Furthermore, this estimation does not consider errors likely to be introduced with in situ SLN identification and the use of frozen-section analysis rather than non-time-critical analysis of formalin-fixed sections.In such a dangerous disease such inaccuracy is not tolerable and so I totally agree with the authors’ [1] findings that SLNB of pelvic LNs at the time of radical cystectomy for bladder cancer is not a reliable technique for identifying LN metastasis.The positive messages from this study [1] are worth noting by those learning and undertaking cystectomy. The authors’ meticulous approach to surgery is evident from the methodology described and the accumulation of such a well-characterised series. This must be a contributing factor in achieving a 100% negative surgical margin rate and such consistently high LN yields. This should certainly be the aim of all cystectomists. The appropriate time, skill and patience should be given to this step and it should not be compromised upon, particularly when developing robot-assisted or laparoscopic cystectomy services.The findings that T-stage, N-stage and lymphovascular invasion are linked to survival are not that surprising. However, the use of LN metastatic density as a prognostic marker is interesting, as it is not usually discussed in our multidisciplinary meetings. This measure incorporates nodal tumour burden and the extent of LND. The finding of better outcomes in those with a LN metastatic density of <8% reinforces the message that even in those with LN metastases, removing greater numbers of LNs may improve prognosis. Furthermore, the finding that 30% of unilateral LN-positive tumours also had contralateral LNs settles any arguments for unilateral LN dissections.In a recent systematic review of SLNB in bladder cancer [4], the negative predictive value was found to be 92% compared to 81% in the Aljabery et al. [1] study. The authors of the systematic review suggested that SLNB is a promising technique; perhaps in view of technology advances they reviewed that might improve future outcomes of SLNB. While improvements may be possible, current evidence would not encourage me to consider SLNB using radiolabelled nanocolloid for fear of impairing cancer outcomes.

Congratulations to Aljabery et al. [1] on their work. I hope you find reading their paper as constructive as I did.

Tim Dudderidge
Department of Urology, University Hospital Southampton,
Southampton, Hampshire, UK

Read the full article

References

1 Aljabery F, Shabo I, Olson H, Gimm O, Jahnson S. Radio-guided sentinel lymph node detection and lymph node mapping in invasive urinary bladder cancer: a prospective clinical study. BJU Int 2017; 120: 329–36

2 Gould EA, Winship T, Philbin PH, Kerr HH. Observations on a “sentinel node” in cancer of the parotid. Cancer 1960; 13: 77–8

3 Koppie TM, Vickers AJ, Vora K, Dalbagni G, Bochner BH. Standardization of pelvic lymphadenectomy performed at radical cystectomy. Cancer 2006; 107: 2368–74

4 Liss M, Noguchi J, Lee H, Vera D, Kader AK. Sentinel lymph node biopsy in bladder cancer: systematic review and technology update. Indian J Urol 2015; 31: 170–5

 

Video: Detecting SNs in patients with BCa intra-operatively

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Radio-guided sentinel lymph node detection and lymph node mapping in invasive urinary bladder cancer: a prospective clinical study

Read the full article

Abstract

Objectives

To investigate the possibility of detecting sentinel lymph nodes (SNs) in patients with urinary bladder cancer (BCa) intra-operatively and whether the histopathological status of the identified SNs reflected that of the lymphatic field.

Patients and Methods

We studied 103 patients with BCa pathological stage T1–T4 who were treated with cystectomy and pelvic lymph node (LN) dissection during 2005–2011 at the Department of Urology, Linköping University Hospital. Radioactive tracer Nanocoll 70 MBq and blue dye were injected into the bladder wall around the primary tumour before surgery. SNs were detected ex vivo during the operation with a handheld Geiger probe (Gamma Detection System; Neoprobe Corp., Dublin, OH, USA). All LNs were formalin-fixed, sectioned three times, mounted on slides and stained with haematoxylin and eosin. An experienced uropathologist evaluated the slides.

Results

The mean age of the patients was 69 years, and 80 (77%) were male. Pathological staging was T1–12 (12%), T2–20 (19%), T3–48 (47%) and T4–23 (22%). A mean (range) number of 31 (7–68) nodes per patient were examined, totalling 3 253 nodes. LN metastases were found in 41 patients (40%). SNs were detected in 83 of the 103 patients (80%). Sensitivity and specificity for detecting metastatic disease by SN biopsy (SNB) varied between LN stations, with average values of 67% and 90%, respectively. LN metastatic density (LNMD) had a significant prognostic impact; a value of ≥8% was significantly related to shorter survival. Lymphovascular invasion (LVI) occurred in 65% of patients (n = 67) and was significantly associated with shorter cancer-specific survival (P < 0.001).

Conclusion

We conclude that SNB is not a reliable technique for peri-operative localization of LN metastases during cystectomy for BCa; however, LNMD has a significant prognostic value in BCa and may be useful in the clinical context and in BCa oncological and surgical research. LVI was also found to be a prognostic factor.

View more videos

Article of the Week: Introduction of RARC within an established enhanced recovery programme

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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.

Introduction of robot-assisted radical cystectomy within an established enhanced recovery programme

Catherine Miller*,†, Nicholas J. Campain†, Rachel Dbeis†, Mark Daugherty†, Nicholas Batchelor†, Elizabeth Waine† and John S. McGrath†

 

*Urology Department, Torbay Hospital, Torquay, and †Exeter Surgical Health Services Research Unit, Royal Devon and Exeter NHS Foundation Trust, Exeter, Devon, UK

 

Read the full article

How to Cite

Miller, C., Campain, N. J., Dbeis, R., Daugherty, M., Batchelor, N., Waine, E. and McGrath, J. S. (2017), Introduction of robot-assisted radical cystectomy within an established enhanced recovery programme. BJU International, 120: 265–272. doi: 10.1111/bju.13702

Abstract

Objectives

To describe the implementation phase of a robot-assisted radical cystectomy (RARC) programme including side-effect profiles and impact on length of stay (LOS).

Patients and Methods

In all, 114 consecutive patients (82% male) underwent RARC and urinary diversion between April 2013 and December 2015 [ileal conduit (97 patients) and orthotopic neobladder (17)]. Surgery was performed by two surgeons within a designated regional cancer centre. No exclusion criteria were applied. All patients were managed on the Exeter Enhanced Recovery Pathway (ERP) in a unit where embedded enhanced recovery practice was already established. Data were collected prospectively on the national cystectomy registry – the British Association of Urological Surgeons (BAUS) Complex Operations Dataset.

aotw-aug-2017-2

Results

RARC was technically feasible in all but one case. The mean operating time was 3–5 h with an overall transfusion rate of 8.8%. There were higher-grade complications (Clavien–Dindo grade III–IV) in 18.4% of patients, with a 30-day mortality rate of 0.9%. The median (range) LOS after RARC was 7 (3–68) days, with a re-admission rate of 18.4%.

Conclusions

The present series shows that RARC can be safely implemented in a unit experienced in robot-assisted surgery (RAS). Case-selection in this setting is not deemed necessary. There are benefits in terms of lower transfusion rates and reduced LOS. The side-effect profile appears to differ from that of open RC, and despite the fact that complication rate is equivalent; ‘technical’ complications are over-represented in the RAS group. As such, they should improve with experience, recognition, and modification of surgical technique. ERPs can be safely applied to all patients undergoing RARC to maximise the benefits of minimally invasive surgery.

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Editorial: Speeding up recovery from radical cystectomy: how low can we go?

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Radical cystectomy (RC) is the ‘gold standard’ treatment for muscle-invasive bladder cancer (BCa) [1]. It offers the best chance of cure in patients with curable disease and excellent palliation in those with local symptoms from advanced disease. Longitudinal reports suggest many patients accept and adapt to the impact of RC, leading to minimal overall impact on their quality of life [2]. As such, RC also offers a viable alternative to BCG for patients with high-risk non-muscle-invasive BCa. Whilst I recognize the vital role that chemotherapy and radiotherapy play in treating this disease, and that radiotherapy may be a better choice for some patients than RC, it is the morbidity from RC that hinders its wider use and encourages alternatives [3]. For example, studies in the USA show that up to one-third of patients with muscle-invasive cancers do not receive radical treatment [4], and implementation of centralized cancer services in the UK has only now shown survival improvements, as morbidity from RC comes down [5]. The lowering of peri-operative morbidity and mortality from RC is changing the face of the operation and increasing its use.

In this month’s issue of BJUI, Miller et al. [6] combine robot-assisted minimal access surgery with enhanced recovery to report outcomes in a consecutive series of ‘state-of-the-art’ RCs in their study from Exeter, UK. The authors show consistent improvements in outcome, such that length of stay halved over the duration of study recruitment. Importantly, recovery becomes more predictable (as shown by the converging mean and median length of stay figures), although it is unclear as to how many patients had prolonged stays. Whilst the authors should be congratulated for their efforts in delivering this service and for charting its implementation so meticulously, some key descriptive findings are missing. For example, what is the extent of the variation in their outcomes (range and quartiles) and do the data differ among surgeons? What happened to the 25% of patients who stayed longer than 10 days? Did all patients receive all components of their enhanced recovery programme, and if not, which were the most impactful? How did length of stay and complication rates differ by reconstructive choice and reconstructive location (intra- or extracorporeal)? Did patient selection stay the same over time, or did improved outcomes lower the ‘fit for cystectomy’ bar? Many of these answers will be missing, given that the primary source of information was the BAUS major operations registry. This self-completed dataset is extremely valuable for comparisons between units and trends over times, but has limited data complexity and granularity. Finally, whilst the field is moving towards total intracorporeal surgery, the reported complication rates appear similar for extra- and intracorporeal reconstruction, questioning the need for the added complexity of intracorporeal surgery.

Economists, commissioners and patients will want to know the importance of the forces driving these improved outcomes. Do the better outcomes reflect centralization of services, the team’s learning curve, the meticulous use of enhanced recovery or minimally invasive surgery through robotics? The latter has vastly different cost implications from the others. My guess is that, whilst all of these aspects were important, it was volume of service (from centralization) and enhanced recovery that were the main contributors. I speak having had a similar experience in my unit, although we started robotic surgery at a later date than did the present authors, and in the knowledge that this group previously published the dramatic impact of enhanced recovery on their length of stays after open RC [7].

Regardless of these concerns, the outcomes are to be welcomed by urologists and patients, and the team should be congratulated. As length of hospital stay becomes shorter, our next scientific focus should be on out-of-hospital recovery. We rarely see data on time taken to return to normal activity and on how patients adjust after surgery. Whilst return to work is important for younger patients, many patients with bladder cancer are retired so for these patients it is return to quality of life that matters most. This question becomes even more important in an era of centralized care, where many patients recover away from their surgical teams and, conversely, surgical teams are less aware of problems and outcomes. Perhaps it will be out of the hospital that the effort and cost of minimally invasive surgery are justified.

James W.F. Catto
Academic Urology Unit, University of Sheffield, Sheffield, UK

 

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References

 

1 Witjes JA, Comperat E, Cowan NC et al. EAU guidelines on muscle- invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol 2014; 65: 778–92

 

2 Hardt J, Filipas D, Hohenfellner R, Egle UT. Quality of life in patients with bladder carcinoma after cystectomy: first results of a prospective study. Qual Life Res 2000; 9: 1–12

 

3 Shabsigh A, Korets R, Vora KC et al. Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2009; 55: 164–74

 

4 Gore JL, Litwin MS, Lai J et al. Use of radical cystectomy for patients with invasive bladder cancer. J Natl Cancer Inst 2010; 102: 802–11

 

5 Hounsome LS, Verne J, McGrath JS, Gillatt DA. Trends in operative caseload and mortality rates after radical cystectomy for bladder cancer in England for 1998–2010. Eur Urol 2015; 67: 1056–62

 

6 Miller C, Campain NJ, Dbeis R et al. Introduction of robot-assisted radical cystectomy within an established enhanced recovery programme. BJU Int 2017; 120: 265–72

 

7 Smith J, Pruthi RS, McGrath J. Enhanced recovery programmes for patients undergoing radical cystectomy. Nat Rev Urol 2014; 11: 437–4

 

Article of the Week: Detection and oncological effect of CTC in patients with variant UCB histology treated with RC

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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.

Detection and oncological effect of circulating tumour cells in patients with variant urothelial carcinoma histology treated with radical cystectomy

Armin Soave*, Sabine Riethdorf†, Roland Dahlem*, Sarah Minner‡, Lars Weisbach*, Oliver Engel*, Margit Fisch*, Klaus Pantel† and Michael Rink*

 

*Department of Urology, †Institute of Tumor Biology, and ‡Department of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany

 

 
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How to Cite

Soave, A., Riethdorf, S., Dahlem, R., Minner, S., Weisbach, L., Engel, O., Fisch, M., Pantel, K. and Rink, M. (2017), Detection and oncological effect of circulating tumour cells in patients with variant urothelial carcinoma histology treated with radical cystectomy. BJU International, 119: 854–861. doi: 10.1111/bju.13782

Abstract

Objectives

To investigate for the presence of circulating tumour cells (CTC) in patients with variant urothelial carcinoma of the bladder (UCB) histology treated with radical cystectomy (RC), and to determine their impact on oncological outcomes.

Patients and methods

We prospectively collected data of 188 patients with UCB treated with RC without neoadjuvant chemotherapy. Pathological specimens were meticulously reviewed for pure and variant UCB histology. Preoperatively collected blood samples (7.5 mL) were analysed for CTC using the CellSearch® system (Janssen, Raritan, NJ, USA).

aotw-results-4

Results

Variant UCB histology was found in 47 patients (25.0%), most frequently of squamous cell differentiation (16.5%). CTC were present in 30 patients (21.3%) and 12 patients (25.5%) with pure and variant UCB histology, respectively. At a median follow-up of 25 months, the presence of CTC and non-squamous cell differentiation were associated with reduced recurrence-free survival (RFS) and cancer-specific survival (pairwise P ≤ 0.016). Patients without CTC had better RFS, independent of UCB histology, than patients with CTC with any UCB histology (pairwise P < 0.05). In multivariable analyses, the presence of CTC, but not variant UCB histology, was an independent predictor for disease recurrence [hazard ratio (HR) 3.45; P < 0.001] and cancer-specific mortality (HR 2.62; P = 0.002).

Conclusion

CTC are detectable in about a quarter of patients with pure or variant UCB histology before RC, and represent an independent predictor for outcomes, when adjusting for histological subtype. In addition, our prospective data confirm the unfavourable influence of non-squamous cell-differentiated UCB on outcomes.

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