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Editorial: Geography – an increasingly important variable in prostate cancer clinical trials

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Enzalutamide is approved in the post-docetaxel phase for men with metastatic castrate-resistant prostate cancer (mCRPC) in North America (NA) and the European Union (EU). Merseburger et al. [1] now take a first look at comparing the efficacy and safety of enzalutamide in EU and NA patients treated in the AFFIRM trial. AFFIRM was a phase III double-blind, placebo-controlled multinational trial evaluating whether enzalutamide prolongs overall survival (OS) in men with mCRPC after docetaxel chemotherapy. This post hocexploratory analysis found a consistent OS benefit in both NA- and EU-treated patients. The safety profile was comparable in both regions.

Interestingly, the median OS appeared longer in the EU as compared with the NA cohort (‘not yet reached’ vs 17.4 months). With the placebo group in the EU the median survival was 16.2 vs 12.3 months in the NA cohort (3.9 months different). Direct statistical comparisons between regions were not performed but a median survival difference of 3.9 months is not inconsequential. Notably, drugs have been approved with lesser difference in OS.

The populations in AFFIRM have some baseline differences that may be of importance; the median time from diagnosis to randomisation was 68.9 months in the EU cohort vs 78.0 months in the NA cohort. Thus, it was possible that the NA cohort was ‘further along’ in the natural history of the disease despite apparently being well-balanced according to most baseline variables. The NA cohort was slightly more likely to have higher Gleason scores (50.6%) vs the EU cohort (44.0%), suggesting perhaps a slight difference in disease aggressiveness. It is also interesting that cardiac disease was present in 23.3% of the NA cohort vs only 7.2% of the EU cohort. Is it possible that cardiovascular diseases also contributed to a relative increase in mortality in the NA cohort? With regard to the post-protocol therapies, the use of abiraterone was more common in the EU cohort (30.5% of patients in the placebo group subsequently received abiraterone in the EU cohort vs 19.7% in the NA cohort). However, utilisation of cabazitaxel was more common in NA than in the EU (20.5% vs 9.9%). Some combination of pre-treatment and post-protocol variables in AFFIRM is probably the explanation for geographic variations in OS. Protocol treatments were well defined but these variables were not controlled.

These results in AFFIRM should also be considered in the context of geographic differences in medical care that may alter results and/or interpretation of phase III trials. Some of these differences have been previously documented in other phase III mCRPC trials. For instance, the recent phase III trials with orteronel reported no OS differences in the overall study [2]. However, in certain geographic regions (with less access to the newer life-prolonging drugs), the orteronel trials were clearly positive for the OS endpoint. In the TROPIC trial, cabazitaxel was associated with higher febrile neutropenia rates in some EU countries as compared with the USA. This was primarily due to geographic differences in prophylactic administration of granulocyte colony-stimulating factor (G-CSF) [3]. For the ALSYMPCA trial, striking geographic differences were noted in the timing (pre- or post-docetaxel) of radium-223 utilisation [4].

Understanding prognosis and treatment outcomes is increasingly critical in the design and interpretation of phase III clinical trials and particularly amongst trials that are designed to support regulatory approvals. Region or country where treatment takes place is an important variable to consider, especially if approved pre- and post-protocol treatments are not the same. This issue is even more important if the course of the disease is long (as in prostate cancer) and there are different treatments available from country to country.

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Oliver Sartor, Sumanta Kumar Pal*, Terhi Hermanson† and Charles L. Bennett‡,

Tulane Medical School, New Orleans, LA, *City of Hope Comprehensive Cancer Center, Duarte, CA, USA; † Helsinki University Central University, Helsinki, Finland; and ‡ College of Pharmacy, Medical University of South Carolina Cancer Center, Charleston, SC, USA

References

1 Merseburger AS, Scher HI, Bellmunt J et al. Enzalutamide in European and North American men participating in the AFFIRM trial. BJU Int 2015; 115: 41–9

2 Fizazi K, Jones R, Oudard S et al. Regional differences observed in the phase 3 trial (ELM-PC 5) with orteronel (TAK-700) plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed during or following docetaxel. ASCO Meeting Abstracts. J Clin Oncol 2014; 32 (Suppl.): 5s (abstr 5042). Available at: https://meetinglibrary.asco.org/content/126314-144. Accessed November 2014

3 Ozguroglu M, Oudard S, Sartor AO et al. Effect of G-CSF prophylaxis on the occurrence of neutropenia in men receiving cabazitaxel plus prednisone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the TROPIC study. ASCO Meeting Abstracts. J Clin Oncol 2011; 29 (Suppl.): abstr 144. Available at: https://meetinglibrary .asco.org/content/72386-104. Accessed November 2014

4 Parker C, Nilsson S, Heinrich D et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med 2013; 369: 213–23

 

Video: Enzalutamide in European and North American men participating in the AFFIRM trial

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Enzalutamide in European and North American men participating in the AFFIRM trial

Axel S. Merseburger, Howard I. Scher†, Joaquim Bellmunt‡, Kurt Miller§, Peter F.A. Mulders¶, Arnulf Stenzl**, Cora N. Sternberg††, Karim Fizazi‡‡, Mohammad Hirmand§§, Billy Franks¶¶, Gabriel P. Haas¶¶, Johann de Bono*** and Ronald de Wit†††

Medizinische Hochschule Hannover, Hannover, §Charité – Universitätsmedizin Berlin, Berlin, **Universitätsklinikum Tübingen, Tübingen, Germany; †Memorial Sloan-Kettering Cancer Center, New York, NY, ‡Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, §§Medivation, Inc., San Francisco, CA, ¶¶Astellas Scientific and Medical Affairs, Inc., Northbrook, IL, USA; ¶Radboud University Nijmegen Medical Centre, Nijmegen, †††Erasmus University Medical Center, Rotterdam, The Netherlands; ††San Camillo – Forlanini Hospitals, Rome, Italy; ‡‡Institut Gustave Roussy, University of Paris Sud, Villejuif, France; ***Institute of Cancer Research and Royal Marsden NHS Foundation Trust, Sutton, UK

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OBJECTIVE

To explore any differences in efficacy and safety outcomes between European (EU) (n = 684) and North American (NA) (n = 395) patients in the AFFIRM trial (NCT00974311).

PATIENTS AND METHODS

Phase III, double-blind, placebo-controlled, multinational AFFIRM trial in men with metastatic castration-resistant prostate cancer (mCRPC) after docetaxel. Participants were randomly assigned in a 2:1 ratio to receive oral enzalutamide 160 mg/day or placebo. The primary end point was overall survival (OS) in a post hoc analysis.

RESULTS

Enzalutamide significantly improved OS compared with placebo in both EU and NA patients. The median OS in EU patients was longer than NA patients in both treatment groups. However, the relative treatment effect, expressed as hazard ratio and 95% confidence interval, was similar in both regions: 0.64 (0.50, 0.82) for EU and 0.63 (0.47, 0.83) for NA. Significant improvements in other end points further confirmed the benefit of enzalutamide over placebo in patients from both regions. The tolerability profile of enzalutamide was comparable between EU and NA patients, with fatigue and nausea the most common adverse events. Four EU patients (4/461 enzalutamide-treated, 0.87%) and one NA patient (1/263 enzalutamide-treated, 0.38%) had seizures. The difference in median OS was related in part to the timing of development of mCRPC and baseline demographics on study entry.

CONCLUSION

This post hoc exploratory analysis of the AFFIRM trial showed a consistent OS benefit for enzalutamide in men with mCRPC who had previously progressed on docetaxel in both NA- and EU-treated patients, although the median OS was higher in EU relative to NA patients. Efficacy benefits were consistent across end points, with a comparable safety profile in both regions.

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Article of the Week: Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis

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Every week the Editor-in-Chief selects the 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.

Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis

Mauro Gacci, Giovanni Corona*, Linda Vignozzi†, Matteo Salvi, Sergio Serni, Cosimo De Nunzio‡, Andrea Tubaro‡, Matthias Oelke§, Marco Carini and Mario Maggi†

Department of Urology, University of Florence, Careggi Hospital, Florence, *Endocrinology Unit, Maggiore-Bellaria Hospital, Bologna, †Department of Clinical Physiopathology, University of Florence, Florence, ‡Department of Urology, Sant’Andrea Hospital, University ‘La Sapienza’, Rome, Italy; and §Department of Urology, Hannover Medical School, Hannover, Germany

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OBJECTIVE

To summarise and meta-analyse current literature on metabolic syndrome (MetS) and benign prostatic enlargement (BPE), focusing on all the components of MetS and their relationship with prostate volume, transitional zone volume, prostate-specific antigen and urinary symptoms, as evidence suggests an association between MetS and lower urinary tract symptoms (LUTS) due to BPE.

METHODS

An extensive PubMed and Scopus search was performed including the following keywords: ‘metabolic syndrome’, ‘diabetes’, ‘hypertension’, ‘obesity’ and ‘dyslipidaemia’ combined with ‘lower urinary tract symptoms’, ‘benign prostatic enlargement’, ‘benign prostatic hyperplasia’ and ‘prostate’.

RESULTS

Of the retrieved articles, 82 were selected for detailed evaluation, and eight were included in this review. The eight studies enrolled 5403 patients, of which 1426 (26.4%) had MetS defined according to current classification. Patients with MetS had significantly higher total prostate volume when compared with those without MetS (+1.8 mL, 95% confidence interval [CI] 0.74–2.87; P < 0.001). Conversely, there were no differences between patients with or without MetS for International Prostate Symptom Score total or LUTS subdomain scores. Meta-regression analysis showed that differences in total prostate volume were significantly higher in older (adjusted r = 0.09; P = 0.02), obese patients (adjusted r = 0.26; P < 0.005) and low serum high-density lipoprotein cholesterol concentrations (adjusted r = −0.33; P < 0.001).

CONCLUSIONS

Our results underline the exacerbating role of MetS-induced metabolic derangements in the development of BPE. Obese, dyslipidaemic, and aged men have a higher risk of having MetS as a determinant of their prostate enlargement.

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Editorial: The Prostate – The gateway to men’s health

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We have been told for many years that the management of men with LUTS due to BPH was, for most, about treating the impact of those symptoms on their quality of life. However, evidence has been accumulating over recent years to suggest that BPH may be associated with the various components of the metabolic syndrome – a combination of central obesity, impairment of glucose tolerance, dyslipidaemia and hypertension. Hammarsten et al. [1] examined the link between BPH and 22 individual aspects of the metabolic syndrome and found that BPH was linked to 21 of these factors, including increased body mass index (BMI) and waist circumference, hypertension, type 2 diabetes, dyslipidaemia and atherosclerosis, lending support to the hypothesised association with metabolic syndrome as a whole.

In this issue of BJUI, Gacci et al. [2] report the results of a meta-analysis of eight studies examining this link between BPH and metabolic syndrome, including >5000 patients, of which over a quarter had metabolic syndrome. They report a higher prostate volume (and transitional zone volume) in men with metabolic syndrome than in those without, particularly in older and obese patients and those with low high-density lipoprotein (HDL)-cholesterol levels. Interestingly however, no difference was seen between the groups in terms of LUTS, as measured by total IPSS or the storage/voiding sub-scores, although other studies have reported this in the past [1]. They conclude that modification of lifestyle and cardiovascular risk factors, by weight loss, increased exercise, dietary improvements etc., may have a role to play in improving LUTS. In addition, further exploration of the role of medication, such as statins, in the management of LUTS due to BPH is recommended. These conclusions are supported in the literature by observational studies, showing for instance a decrease in the severity of LUTS with increasing exercise, an increased risk of LUTS with obesity, and a delay in the onset of LUTS for patients taking long-term statins of up to 7 years [3, 4].

BPH is not the only urological condition that appears to have links with metabolic syndrome [1]. It is well established that erectile dysfunction has strong associations with type 2 diabetes mellitus, cardiovascular disease, obesity and sedentary lifestyle. Less well known links are also seen with prostate cancer, renal calculi, hypogonadism and overactive bladder [5]. We are familiar with carrying out cardiovascular risk assessment, screening for diabetes and giving lifestyle advice to men with erectile dysfunction. Given the evidence suggesting that erectile dysfunction and BPH are closely associated, with many men suffering from both conditions [6], it would suggest that perhaps we should be doing the same for men presenting with symptomatic BPH.

An awareness and understanding of the connection between BPH and metabolic syndrome should encourage all physicians to assess patients with LUTS/BPH for underlying cardiovascular risk. It suggests that as a minimum, a number of baseline investigations should be carried out: blood pressure measurement, a fasting lipid profile (and formal cardiovascular risk profile using established algorithms, such as QRISK®), assessment for diabetes using fasting glucose or glycated haemoglobin (HbA1c), measurement of weight and BMI, or ideally the measurement of abdominal circumference (as central obesity is a far more sensitive marker of risk than BMI). Identification of features of the metabolic syndrome allows for tailored lifestyle intervention, in terms of increasing exercise, dietary changes, weight loss, smoking cessation advice and alcohol moderation. Medical management of hypertension, diabetes, dyslipidaemia and cardiovascular disease may be required according to national guidelines.

Huge numbers of men die prematurely from cardiovascular disease and complications of type 2 diabetes, and men are renowned for poor engagement with primary preventive strategies to decrease this risk. Men presenting to their GP or Urologist with symptoms from BPH are therefore presenting us with an opportunity to intervene and potentially save lives in the process – the prostate can be considered a gateway to wider aspects of men’s health, far beyond the quality-of-life impact of LUTS.

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Jonathan Rees

Backwell & Nailsea Medical Group, North Somerset, UK

References

1 Hammarsten J, Peeker R. Urological aspects of the metabolic syndrome. Nat Rev Urol 2011; 8: 483–94

2 Gacci M, Corona G, Vignozzi L et al. Metabolic syndrome and benign prostatic enlargement: a systematic review and meta-analysis. BJU Int 2015; 115: 24–31

3 Parsons JK, Messer K, White M et al. Obesity increases and physical activity decreases lower urinary tract symptom risk in older men: the Osteoporotic Fractures in Men Study. Eur Urol 2011; 60: 1173–80

4 St Sauver J, Jacobsen SJ, Jacobson DJ et al. Statin use and decreased risk of benign prostatic enlargement and lower urinary tract symptoms. BJU Int 2011; 107: 443–50

5 Rees J, Kirby M. Metabolic syndrome and common urological conditions: looking beyond the obvious. Trends in Urology and Men’s Health 2014; 5: 9–14

6 Rosen R, Altwein J, Boyle P et al. Lower urinary tract symptoms and male sexual dysfunction: the multinational survey of the aging male (MSAM-7). Eur Urol 2003; 44: 637–49

 

Article of the Week: Cognitive skills assessment during robot-assisted surgery

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Every week the Editor-in-Chief selects the 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 from Dr Khurshid A. Guru discussing his paper. 

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

Cognitive skills assessment during robot-assisted surgery: separating the wheat from the chaff

Khurshid A. Guru, Ehsan T. Esfahani†, Syed J. Raza, Rohit Bhat†, Katy Wang‡,
Yana Hammond, Gregory Wilding‡, James O. Peabody§ and Ashirwad J. Chowriappa

Department of Urology, Roswell Park Cancer Institute, Buffalo, NY; †Brain Computer Interface Laboratory, Department of Mechanical & Aerospace Engineering, University at Buffalo, Buffalo, NY; ‡Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, NY; and §Henry Ford Health System, Detroit, MI, USA

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OBJECTIVE

To investigate the utility of cognitive assessment during robot-assisted surgery (RAS) to define skills in terms of cognitive engagement, mental workload, and mental state; while objectively differentiating between novice and expert surgeons.

SUBJECTS AND METHODS

In all, 10 surgeons with varying operative experience were assigned to beginner (BG), combined competent and proficient (CPG), and expert (EG) groups based on the Dreyfus model. The participants performed tasks for basic, intermediate and advanced skills on the da Vinci Surgical System™. Participant performance was assessed using both tool-based and cognitive metrics.

RESULTS

Tool-based metrics showed significant differences between the BG vs CPG and the BG vs EG, in basic skills. While performing intermediate skills, there were significant differences only on the instrument-to-instrument collisions between the BG vs CPG (2.0 vs 0.2, P = 0.028), and the BG vs EG (2.0 vs 0.1, P = 0.018). There were no significant differences between the CPG and EG for both basic and intermediate skills. However, using cognitive metrics, there were significant differences between all groups for the basic and intermediate skills. In advanced skills, there were no significant differences between the CPG and the EG except time (1116 vs 599.6 s), using tool-based metrics. However, cognitive metrics revealed significant differences between both groups.

CONCLUSION

Cognitive assessment of surgeons may aid in defining levels of expertise performing complex surgical tasks once competence is achieved. Cognitive assessment may be used as an adjunct to the traditional methods for skill assessment during RAS.

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Editorial: Cognitive training and assessment in robotic surgery – is it effective?

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A formal and standardised process of credentialing and certification is required that should not merely be based on the number of completed cases but should be done via demonstration of proficiency and safety in robotic procedural skills. Therefore, validated assessment tools for technical and non-technical skills are required. In addition to effective technical skills, non-technical skills are vital for safe operative practice. These skill-sets can be divided into three categories; social (communication, leadership and teamwork), cognitive (decision making, planning and situation awareness) and personal resource factors (ability to cope with stress and fatigue) [1] (Fig. 1). Robotic surgeons are not exempt in requiring these skills, as situation awareness for example may become of even more significance with the surgeon placed at a distance from the patient. Most of these skills can, just like technical skills, be trained and assessed.

Various assessment tools have been developed, e.g. the Non-Technical Skills for Surgeons (NOTSS) rating system [1] that provides useful insight into individual non-technical skill performance. The Observational Teamwork Assessment for Surgery (OTAS) rating scale has additionally been developed and is suited better for operative team assessment [2]. Decision-making (cognitive skill) is considered as one of the advanced sets of skills and it consolidates exponentially with increasing clinical experience [3]. A structured method for this sub-set of skills training and assessment does not exist.

The present paper by Guru et al. [4] discusses an interesting objective method to evaluate robot-assisted surgical proficiency of surgeons at different levels. The paper discusses the use of utilising cognitive assessment tools to define skill levels. This incorporates cognitive engagement, mental workload, and mental state. The authors have concluded from the results that cognitive assessment offers a more effective method of differentiation of ability between beginners, competent and proficient, and expert surgeons than previously used objective methods, e.g. machine-based metrics.

Despite positive results, we think that further investigation is required before using cognitive tools for assessment reliably. Numbers were limited to 10 participants in the conducted study, with only two participants classified into the beginner cohort. This provides a limited cross-section of the demographic and further expansion of the remaining competent and proficient and expert cohorts used would be desirable. Furthermore, whilst cognitive assessment has the potential as a useful assessment tool, utility within training of surgeons is not discussed at present. Currently cognitive assessment shows at what stage a performer is within his development of acquiring technical skills; however, it does not offer the opportunity for identification as to how to improve the current level of skills. A tool with integration of constructive feedback is lacking. However, via identification of the stage of learning within steps of an individual procedure could provide this feedback. Via demonstration of steps that are showing a higher cognitive input, areas requiring further training are highlighted. Cognitive assessment may via this approach provide not only a useful assessment tool but may be used within training additionally.

The present paper [4] does highlight the current paucity and standardisation of assessment tools within robotics. Few tools have been developed specifically for addressing technical aspects of robotic surgery. The Global Evaluative Assessment of Robotic Skills (GEARS) offers one validated assessment method [5]. Additionally, several metrics recorded in the many robotic simulators available offer validated methods of assessment [6]. These two methods offer reliable methods of both assessing and training technical skills for robotic procedures.

It is now evident that validated methods for assessment exist; however, currently technical and non-technical skills assessments occur as separate entities. A true assessment of individual capability for robotic performance would be achieved via the integration of these assessment tools. Therefore, any assessment procedure should be conducted within a fully immersive environment and using both technical and non-technical assessment tools. Furthermore, standardisation of the assessment process is required before use for purposes of selection and certification.

Cognitive assessment requires further criteria for differentiation of skill levels. However, it does add an adjunct to the current technical and non-technical skill assessment tools. Integration and standardisation of several assessment methods is required to ensure a complete assessment process.

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Oliver Brunckhorst and Kamran Ahmed

MRC Centre for Transplantation, King’s College London, King’s Health Partners, Department of Urology, Guy’s Hospital, London, UK

References

1 Yule S, Flin R, Paterson-Brown S, Maran N, Rowley D. Development of a rating system for surgeons’ non-technical skills. Med Educ 2006; 40: 1098–104

2 Undre S, Healey AN, Darzi A, Vincent CA. Observational assessment of surgical teamwork: a feasibility study. World J Surg 2006; 30: 1774–83

3 Flin R, Youngson G, Yule S. How do surgeons make intraoperative decisions? Qual Saf Health Care 2007; 16: 235–9

4 Guru KA, Esfahani ET, Raza SJ et al. Cognitive skills assessment during robot-assisted surgery: separating the wheat from the chaff. BJU Int 2015; 115: 166–74

5 Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: validation of a clinical assessmenttool to measure robotic surgical skills. J Urol 2012; 187: 247–52

6 Abboudi H, Khan MS, Aboumarzouk O et al. Current status of validation for robotic surgery simulators – a systematic review. BJU Int 2013; 111: 194–205

 

 

Video: Separating the wheat from the chaff – Cognitive skills assessment during RA surgery

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Cognitive skills assessment during robot-assisted surgery: separating the wheat from the chaff

Khurshid A. Guru, Ehsan T. Esfahani†, Syed J. Raza, Rohit Bhat†, Katy Wang‡,
Yana Hammond, Gregory Wilding‡, James O. Peabody§ and Ashirwad J. Chowriappa

Department of Urology, Roswell Park Cancer Institute, Buffalo, NY; †Brain Computer Interface Laboratory, Department of Mechanical & Aerospace Engineering, University at Buffalo, Buffalo, NY; ‡Department of Biostatistics, Roswell Park Cancer Institute, Buffalo, NY; and §Henry Ford Health System, Detroit, MI, USA

Read the full article
OBJECTIVE

To investigate the utility of cognitive assessment during robot-assisted surgery (RAS) to define skills in terms of cognitive engagement, mental workload, and mental state; while objectively differentiating between novice and expert surgeons.

SUBJECTS AND METHODS

In all, 10 surgeons with varying operative experience were assigned to beginner (BG), combined competent and proficient (CPG), and expert (EG) groups based on the Dreyfus model. The participants performed tasks for basic, intermediate and advanced skills on the da Vinci Surgical System™. Participant performance was assessed using both tool-based and cognitive metrics.

RESULTS

Tool-based metrics showed significant differences between the BG vs CPG and the BG vs EG, in basic skills. While performing intermediate skills, there were significant differences only on the instrument-to-instrument collisions between the BG vs CPG (2.0 vs 0.2, P = 0.028), and the BG vs EG (2.0 vs 0.1, P = 0.018). There were no significant differences between the CPG and EG for both basic and intermediate skills. However, using cognitive metrics, there were significant differences between all groups for the basic and intermediate skills. In advanced skills, there were no significant differences between the CPG and the EG except time (1116 vs 599.6 s), using tool-based metrics. However, cognitive metrics revealed significant differences between both groups.

CONCLUSION

Cognitive assessment of surgeons may aid in defining levels of expertise performing complex surgical tasks once competence is achieved. Cognitive assessment may be used as an adjunct to the traditional methods for skill assessment during RAS.

Read more articles of the week

Article of the Week: RA-RPLND – Technique and Initial Case Series of 18 Patients

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Every week the Editor-in-Chief selects the 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 from Mr. Tim Dudderidge discussing his paper. 

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

Robot-assisted retroperitoneal lymph node dissection: technique and initial case series of 18 patients

Scott M. Cheney, Paul E. Andrews, Bradley C. Leibovich* and Erik P. Castle

Mayo Clinic Arizona Department of Urology, Phoenix, AZ, and *Mayo Clinic Rochester Department of Urology, Rochester, MN, USA

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OBJECTIVE

To evaluate outcomes of the first 18 patients treated with robot-assisted retroperitoneal lymph node dissection (RA-RPLND) for non-seminomatous germ cell tumours (NSGCT) and paratesticular rhabdomyosarcoma (RMS) at our institution.

PATIENTS AND METHODS

Between March 2008 and May 2013, 17 patients underwent RA-RPLND for NSGCT and one for paratesticular RMS. Data were collected retrospectively on patient demographics, preoperative tumour characteristics, and perioperative outcomes including open conversion rate, lymph node (LN) yield, rate of positive LNs, operative time, estimated blood loss (EBL), and length of stay (LOS). Perioperative outcomes were compared between patients receiving primary RA-RPLND vs post-chemotherapy RA-RPLND. Medium-term outcomes of tumour recurrence rate and maintenance of antegrade ejaculation were recorded.

RESULTS

RA-RPLND was completed robotically in 15 of 18 (83%) patients. LNs were positive in eight of 18 patients (44%). The mean LN yield was 22 LNs. For cases completed robotically, the mean operative time was 329 min, EBL was 103 mL, and LOS was 2.4 days. At a mean (range) follow-up of 22 (1–58) months, there were no retroperitoneal recurrences and two of 17 (12%) patients with NSGCT had pulmonary recurrences. Antegrade ejaculation was maintained in 91% of patients with a nerve-sparing approach. Patients receiving primary RA-RPLND had shorter operative times compared with those post-chemotherapy (311 vs 369 min, P = 0.03). There was no significant difference in LN yield (22 vs 18 LNs, P = 0.34), EBL (100 vs 313 mL, P = 0.13), or LOS (2.75 vs 2.2 days, P = 0.36).

CONCLUSION

This initial selected case series of RA-RPLND shows that the procedure is safe, reproducible, and feasible for stage I–IIB NSGCT and RMS in the hands of experienced robotic surgeons. Larger studies are needed to confirm the diagnostic and therapeutic utility of this technique.

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Editorial: RPLND – Open Surgery’s Next Challenger Is Ready To Enter The Ring

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By Tim Dudderidge

The da Vinci surgical system delivers the benefits of laparoscopic surgery with an easier and more precise human–tissue interface than conventional laparoscopic instruments. Nearly all major uro-oncological procedures are being performed robotically. In this issue of BJUI, Cheney et al. [1] present their technique and initial experience of robot-assisted retroperitoneal lymph node dissection (RA-RPLND) for patients with primary and post-chemotherapy non-seminoma germ cell tumours. Quality indicators for RA-RPLND include adequate clearance of the desired surgical field, satisfactory lymph node yield, acceptable perioperative morbidity and length of stay, as well as longer-term functional and oncological outcomes. So how well does RA-RPLND stand up to scrutiny?

The technique employed by Cheney et al., placing the robot at the head of the patient, is unfamiliar to most urologists I suspect. It appears to offer excellent access to the retroperitoneum, but still requires a re-docking when performing full bilateral dissections. Whether this technique is superior to the lateral approach that I and others have used for modified dissections requires further study [2,3]. The lymph node yield was lower than that previously reported for open RPLND and while Cheney et al. [1] observe this may be due to the use of a modified template where appropriate, the absence of any in-field recurrences at a median of 22 months is perhaps the more reliable sign that there is oncological equivalence. Concerns that a true template dissection cannot be completed with a robot-assisted laparoscopic approach are probably unjustified in my opinion. The description of surgical technique by Cheney et al., including suture ligation and division of lumbar vessels, confirms that if a surgeon is minded to do so, a complete bilateral or modified template clearance can be completed.

The absence of significant complications in this series is impressive; however, there were three out of 18 conversions to open surgery. The mean length of stay of 2.4 days is close to the 3–4 days stay I would expect after an uncomplicated open RPLND in a young fit man. However, 1–2 night stays were seen in their later cases as they gained experience. Perhaps more importantly in a group of working age men, return to full physical activity within 3 weeks is possible [2].

As highlighted by Cheney et al. [1], minimally invasive primary RPLND has been previously reported both by laparoscopic and robotic approaches. Their larger series provides an important demonstration that the robotic approach facilitates the more complex undertaking of post-chemotherapy RPLND. Furthermore they show that except for operative time, all other outcomes were similar in primary and post-chemotherapy cases.

As an enthusiast for minimally invasive therapies, I of course welcome these results and think that along with other published and presented series, they provide sufficient evidence to consider a more formal evaluation of this approach. However, how feasible is the wider introduction of RA-RPLND? Despite having experience of robotics and working in a team performing around 30 RPLNDs a year, I was only able to identify five cases during a 1-year period suitable for a robotic approach. With experience this could have been a higher proportion, but it is fair to conclude that suitable cases in typical cancer centres would be limited in number. This is particularly so for the UK and other European countries, where primary RPLND is not used. Cheney et al. [1] had similarly low numbers each year and recruited their cohort of 18 cases over 5 years.

An international multicentre registry is arguably the best way to gather more information on the safety and completeness of template dissection RPLND. Existing registries, e.g. the BAUS complex operations database, have already provided valuable insights into the results of RPLND in the UK [4] and could be combined with other international RA-RPLND databases already being compiled (Erik Castle MD personal communication). Partnership of testicular cancer surgeons without robotic experience with experienced robotic surgeons may also facilitate the development of additional centres for development of this procedure. They will also aid optimal patient selection and help avoid incomplete template dissections, which may compromise the excellent cancer control we are now used to.

There are clear potential advantages with a minimally invasive approach to RPLND, not least of which are the avoidance of a laparotomy scar, the reduction of complications and an earlier return to normal activity. Cheney et al. [1] have shown that their technique is feasible, safe and effective in the medium term and their results justify wider consideration of the procedure for further study and improvement.

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Tim Dudderidge

University Hospital Southampton, Southampton, UK

References

1 Cheney SM, Andrews PE, Leibovich BC, Castle EP. Robot-assisted retroperitoneal lymph node dissection: technique and initial case series of 18 patients. BJU Int 2015; 115: 114–20

2 Dudderidge T, Pandian S, Nott D. Technique and outcomes for robotic assisted post-chemotherapy retroperitoneal lymph node dissection (RPLND) in Stage 2 non-seminomatous germ cell tumour (NSGCT). BJU Int 2012; 110: 97

3 Dogra PN, Singh P, Saini AK, Regmi KS, Singh BG, Nayak B. Robot assisted laparoscopic retroperitoneal lymph node dissection in testicular tumor. Urol Ann 2013; 5: 223–6

4 Hayes M, O’Brien T, Fowler S, BAUS RPLND Group. Contemporary retroperitoneal lymph node dissection (RPLND) for testis cancer in the UK – a national study. J Urol 2014; 191 (Suppl.): e89–90

 

Video: Robot Assisted Retroperitoneal Lymph Node Dissection

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Robot-assisted retroperitoneal lymph node dissection: technique and initial case series of 18 patients

Scott M. Cheney, Paul E. Andrews, Bradley C. Leibovich* and Erik P. Castle

Mayo Clinic Arizona Department of Urology, Phoenix, AZ, and *Mayo Clinic Rochester Department of Urology, Rochester, MN, USA

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Abstract

OBJECTIVE

To evaluate outcomes of the first 18 patients treated with robot-assisted retroperitoneal lymph node dissection (RA-RPLND) for non-seminomatous germ cell tumours (NSGCT) and paratesticular rhabdomyosarcoma (RMS) at our institution.

PATIENTS AND METHODS

Between March 2008 and May 2013, 17 patients underwent RA-RPLND for NSGCT and one for paratesticular RMS. Data were collected retrospectively on patient demographics, preoperative tumour characteristics, and perioperative outcomes including open conversion rate, lymph node (LN) yield, rate of positive LNs, operative time, estimated blood loss (EBL), and length of stay (LOS). Perioperative outcomes were compared between patients receiving primary RA-RPLND vs post-chemotherapy RA-RPLND. Medium-term outcomes of tumour recurrence rate and maintenance of antegrade ejaculation were recorded.

RESULTS

RA-RPLND was completed robotically in 15 of 18 (83%) patients. LNs were positive in eight of 18 patients (44%). The mean LN yield was 22 LNs. For cases completed robotically, the mean operative time was 329 min, EBL was 103 mL, and LOS was 2.4 days. At a mean (range) follow-up of 22 (1–58) months, there were no retroperitoneal recurrences and two of 17 (12%) patients with NSGCT had pulmonary recurrences. Antegrade ejaculation was maintained in 91% of patients with a nerve-sparing approach. Patients receiving primary RA-RPLND had shorter operative times compared with those post-chemotherapy (311 vs 369 min, P = 0.03). There was no significant difference in LN yield (22 vs 18 LNs, P = 0.34), EBL (100 vs 313 mL, P = 0.13), or LOS (2.75 vs 2.2 days, P = 0.36).

CONCLUSION

This initial selected case series of RA-RPLND shows that the procedure is safe, reproducible, and feasible for stage I–IIB NSGCT and RMS in the hands of experienced robotic surgeons. Larger studies are needed to confirm the diagnostic and therapeutic utility of this technique.

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