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Article of the week: Does the robot have a role in radical cystectomy?

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 editorial written by a prominent member of the urological community, and a video prepared by the authors. These are 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, we recommend this one.

Does the robot have a role in radical cystectomy?

Abstract

Between 2014 and 2015, 3742 radical cystectomies (RCs) were performed in the UK. The majority of these were open RCs (ORCs), and only 25% were performed with robot assistance. These data contrast starkly with the picture in radical prostatectomy (RP), for which most operations are robot assisted (79.4% of the 7673 in 2016). Given that most pelvic surgeons have access to robotic facilities (as shown by the RP trends) and urologists are typically early adopters, one must question why many surgeons have yet to be convinced by robot‐assisted RC (RARC). This question is particularly perplexing given that RC is a more morbid operation than RP and most patients with bladder cancer are considerably less fit than the average man with prostate cancer, and therefore, reductions in morbidity are especially rewarding in this cohort.

Editorial: Evidence trumps consensus

We read with great interest the article by Khetrapal et al. [1]. Certain advantages of robotic cystectomy have been shown in retrospective studies and confirmed in the RAZOR trial [2]. Robotic cystectomy has been associated with lower blood loss, lower transfusion rates and a shorter length of stay; however, two randomized trials have shown no difference in complication rates, which was the original reason robotic cystectomy was attempted [2,3]. Khetrapal et al. seem to believe that this was because diversions were performed extracorporeally, and intracorporeal diversion would allow urologists to uncover the true benefit of robotic cystectomy. When the RAZOR trial was being designed (in 2009), intracorporeal diversion was early in development. Even today its use in the USA is restricted to a few centres and the Pasadena consensus statement (2015) acknowledges that only 3% of all diversions were performed intracorporeally [4]. While more commonly performed in Europe, intracorporeal diversions still form the minority of all urinary diversions. To date there are no reliable prospective data to convince us that intracorporeal diversion is superior, and the low quality of available evidence has been acknowledged in the Pasadena statement [4]. The iROC trial is a step in the right direction and we await its results with interest [5].

We agree with the authors that cost analysis is essential in evaluating the exact role of robotic cystectomy. It is also worth factoring in the indirect costs of the two procedures, given that most patients undergoing robotic cystectomy will have a shorter hospital stay and fewer blood transfusions, although robotic cystectomies may take longer to perform. We anticipate that as newer robotic systems are introduced the direct surgical costs may be reduced.

There is no universally accepted learning curve for performing a cystectomy based on prospective studies. Ten cystectomies in the preceding year before enrolment in the RAZOR trial was the lowest number of cystectomies permitted for the surgeon to be eligible to participate [2]. All surgeons were fellowship-trained with high-volume bladder cancer practices, and the majority had performed significantly more than 10 cystectomies. The high quality of surgical surrogates for both approaches that we reported, namely, lymph node yield, positive margins and complication rates, are testament to this. We believe that the authors’ statement that novice surgeons may have operated on trial patients is simply inaccurate. It is largely self-serving to fit the results of the RAZOR trial into their own narrative about their beliefs in the advantages of robotic surgery. The iROC trial requires surgeons to have carried out 30 or more intracorporeal diversions in their entire career, with accredited surgeons being required to perform more than 10 cystectomies per year for the last 2 years as primary surgeon, which does not seem remarkably different from the RAZOR trial criteria for surgeon participation [5].While it is clear that large volumes are associated with better outcomes, the magic number is unclear. The Pasadena Consensus Statement cites the National Institute for Health and Care Excellence (NICE) guidelines in the UK, which mandate a minimum of five cystectomies per year per surgeon as adequate surgical volume [4].

Operating time in RAZOR was defined as the time from patient entry to the time the patient exited the operating theatre [2]. In most instances, the time for positioning and anaesthesia (preparation and induction) before making any incision and the time after closure for extubation and leaving the room is generally ~60–80 min. The Pasadena Consensus statement recommends that experienced surgeons should aim to complete robotic cystectomies within 5–6 h, depending on the type of diversion, basing their recommendation on three available studies [4]. Of those papers, Hayn et al. (overall mean operating time 386 min and mean operating time after 50th case 339 min) and Richards et al. (mean operating time 449 min after 40th case of learning curve) defined operating time in their papers as incision to closure time [6,7]. The paper by Collins et al. does not define operating time; however, the mean operating time for cystectomy with intracorporeal diversion for both surgeons in that study was 438 min, and 87.5% of the cases selected in this study had ≤pT2 disease, suggesting a significant selection bias [8]. This institution is a part of the International Robotic Cystectomy Consortium (IRCC) which defines operating time as incision to closure time, leading us to believe that this was the probably the definition they used [8]. A recent study from the IRCC reported a mean operating time (incision to closure) of 364 min in 2134 patients [9]. All these data suggest that operating times in RAZOR were extremely competitive if not actually faster, once again attesting to the proficiency of the participating surgeons. Khetrapal et al. would have reached a different conclusion about the RAZOR trial results had they accurately interpreted the scientific data from the above-mentioned studies.

The RAZOR trial provided level 1 evidence proving the oncological efficacy of robotic cystectomy and confirming advantages such as reduced blood loss and length of stay [2]. We agree that the true place for robotic cystectomy will be determined once a cost–benefit analysis can be performed, and after we obtain high-level prospective data about intracorporeal diversions. To this end, we look forward to the successful completion of the iROC trial and await its publication. Until such time, we suggest more reliance on high-level evidence than on consensus statements and narratives.

by Vivek Venkatramani and Dipen J. Parekh on behalf of RAZOR trial investigators

References

  1. Khetrapal P, Kelly J, Catto J, Vasdev N. Does the robot have a role in radical cystectomy? BJU Int 2019; 123(3): 380-2.
  2. ParekhDJ, Reis IM, Castle EP et al. Robot-assisted radical cystectomy versus open radical cystectomy in patients with bladder cancer (RAZOR): an openlabel, randomised, phase 3, non-inferiority trial. Lancet 2018; 391: 2525–36
  3. Bochner BH, Dalbagni G, Sjoberg DD et al. Comparing open radical cystectomy and robot-assisted laparoscopic radical cystectomy: a randomized clinical trial. Eur Urol 2015; 67: 1042–50
  4. Wilson TG, Guru K, Rosen RC et al. Best practices in robot-assisted radical cystectomy and urinary reconstruction: recommendations of the Pasadena Consensus Panel. Eur Urol 2015; 67: 363–75
  5. Catto JWF, Khetrapal P, Ambler G et al. Robot-assisted radical cystectomy with intracorporeal urinary diversion versus open radical cystectomy (iROC): protocol for a randomised controlled trial with internal feasibility study. BMJ Open 2018; 8: e020500
  6. Hayn MH, Hussain A, Mansour AM et al. The learning curve of robot- assisted radical cystectomy: results from the international robotic cystectomy consortium. Eur Urol 2010; 58(2): 197–202
  7. Richards KA, Kader K, Pettus JA et al. Does initial learning curve compromise outcomes for robot-assisted radical cystectomy? A critical evaluation of the first 60 cases while establishing a robotics program. J Endourol 2011; 25(9): 1553–8
  8. Collins JW, Tyritzis S, Nyberg T et al. Robot-assisted radical cystectomy (RARC) with intracorporeal neobladder – what is the effect of the learning curve on outcomes? BJU Int 2014; 113(1): 100-7
  9. Hussein AA, May PR, Ahmed YE et al. Development of a patient and institutional-based model for estimation of operative times for robot-assisted radical cystectomy: results from the international robotic cystectomy consortium. BJU Int 2017; 120(5): 695–701

Video: Does the robot have a role in radical cystectomy?

Does the robot have a role in radical cystectomy

Read the full article

Abstract

Between 2014 and 2015, 3742 radical cystectomies (RCs) were performed in the UK. The majority of these were open RCs (ORCs), and only 25% were performed with robot assistance. These data contrast starkly with the picture in radical prostatectomy (RP), for which most operations are robot assisted (79.4% of the 7673 in 2016). Given that most pelvic surgeons have access to robotic facilities (as shown by the RP trends) and urologists are typically early adopters, one must question why many surgeons have yet to be convinced by robot‐assisted RC (RARC). This question is particularly perplexing given that RC is a more morbid operation than RP and most patients with bladder cancer are considerably less fit than the average man with prostate cancer, and therefore, reductions in morbidity are especially rewarding in this cohort.

View more videos

 

Article of the week: Adjuvant radiation with androgen‐deprivation therapy for men with lymph node metastases after radical prostatectomy

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 editorial written by a prominent member of the urological community. These are 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.

Adjuvant radiation with androgen‐deprivation therapy for men with lymph node metastases after radical prostatectomy: identifying men who benefit

Mohit Gupta*, Hiten D. Patel*, Zeyad R. Schwen*, Phuoc T. Tran*† and Alan W. Partin*

 

*Department of Urology, James Buchanan Brady Urological Institute, and Department of Radiation Oncology and Molecular Radiation Sciences and Oncology, The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, MD, USA

 

Read the full article

Abstract

Objectives

To perform a comparative analysis of three current management strategies for patients with lymph node metastases (LNM; pN1) following radical prostatectomy (RP): observation, androgen‐deprivation therapy (ADT), and external beam radiation therapy (EBRT) + ADT.

Patients and Methods

Patients with LNM after RP were identified using the National Cancer Database (2004–2013). Exclusion criteria included any use of radiation therapy or ADT before RP, clinical M1 disease, or incomplete follow‐up data. Patients were categorised according to postoperative management strategy. The primary outcome was overall survival (OS). Kaplan–Meier curves and adjusted multivariable Cox proportional hazards models were employed. Sub‐analyses further evaluated patient risk stratification and time to receipt of adjuvant therapy.

Results

A total of 8 074 patients met the inclusion criteria. Postoperatively, 4 489 (55.6%) received observation, 2 065 (25.6%) ADT, and 1 520 (18.8%) ADT + EBRT. The mean (median; interquartile range) follow‐up was 52.3 (48.0; 28.5–73.5) months. Patients receiving ADT or ADT + EBRT had higher pathological Gleason scores, T‐stage, positive surgical margin rates, and nodal burden. Adjusted multivariable Cox models showed improved OS for ADT + EBRT vs observation (hazard ratio [HR] 0.77, 95% confidence interval [CI] 0.64–0.94; P = 0.008) and vs ADT (HR 0.76, 95% CI: 0.63–0.93; P = 0.007). There was no difference in OS for ADT vs observation (HR 1.01, 95% CI: 0.87–1.18; P = 0.88). Findings were similar when restricting adjuvant cohorts for timing of adjuvant therapy. There was no difference in OS between groups for up to 2 549 (31.6%) patients lacking any of the following adverse features: ≥pT3b disease, Gleason score ≥9, three or more positive nodes, or positive surgical margin.

Conclusions

For patients with LNM after RP, the use of adjuvant ADT + EBRT improved OS in the majority of patients, especially those with adverse pathological features. Conversely, adjuvant therapy did not confer significant OS benefit in up to 30% of patients without high‐risk features, who may be managed with observation and forego the morbidity associated with immediate ADT or radiation.

Read more Articles of the week

Editorial: Postoperative radiation and hormonal therapy for men with node‐positive prostate cancer: a new standard?

The best management strategy for men with pathologically node‐positive (pN+) prostate cancer after radical prostatectomy (RP) has been debated for decades [1]. In the 1990s, the Radiation Therapy and Oncology Group (RTOG) initiated the RTOG 9608 trial to test the impact of radiotherapy (RT) and androgen‐deprivation therapy (ADT) in this setting. However, due to the rise in PSA screening and the practice of treating high‐risk prostate cancer with primary RT, the incidence of pN+ disease fell. Consequently, the trial closed due to poor accrual and the question faded in prominence. Today, both trends have reversed. PSA screening is less common and men with high‐risk prostate cancer are more frequently opting for RP. As such, physicians increasingly face the dilemma of pN+ disease. Guidelines provide little assistance, as they support everything from observation to multimodal treatment with RT and ADT. Patients and providers want to know, is there a standard treatment for all patients, and if not, how should one choose between such disparate options?

To answer these questions, one must start with the little randomised data that exist in this setting. The seminal trial by Messing et al. [1] randomised men with pN+ prostate cancer to ADT or observation with initiation of ADT after the development of symptomatic progression or distant metastases. ADT clearly improved overall survival and prostate cancer‐specific survival. However, critics noted the relatively poor outcomes in the observation group and the small sample size. Later, retrospective studies called the benefit of immediate ADT into question [2].

Against this backdrop, it is interesting that Gupta et al. [3] found the most common management approach in the USA National Cancer Database (NCDB) was observation rather than immediate ADT. Despite the randomised data, the cumulative side‐effects from lifelong ADT in a cohort of patients with no disease‐related symptoms and a median survival of well over 10 years are unappealing. Ultimately, many men do not appear to be willing to endure the diminished quality of life in exchange for a small improvement in quantity of life.

In contrast to the non‐curative nature of ADT, the possibility exists that the combination of postoperative RT and ADT could provide durable disease control, perhaps even without lifelong ADT. The data reported by Gupta et al. [3] in this edition of the BJUI provide support for this paradigm. These data add to a growing body of literature [4] that tells a consistent story with two common themes: (i) postoperative RT with ADT appears to be associated with improved survival in men with pN+ prostate cancer, and (ii) RT appears to convey the largest benefit to men with certain high‐risk pathological features. Should this body of literature lead us to eschew the old standard and advise observation for low‐risk men and RT with ADT for men at higher risk?

Before a new standard is declared, the limitations of retrospective population‐based research must be addressed. The authors performed a sophisticated analysis to reduce the impact of selection bias. However, due to the limitation of the available data, the authors were not able to account for possibly the most important variable: the postoperative PSA. One study showed that men with pN+ disease with a persistent PSA had an 8‐year clinical recurrence rate of 69% vs 12% for those with undetectable PSA [5].

It is likely that men with persistent PSA in the NCDB would have received immediate ADT with or without RT rather than observation. As such, one must be cautious of the similar survival between the observation and ADT group, especially in light of contradictory randomised data. That being said, it is reasonable for some men to conclude that the side‐effects of ADT outweigh the potential benefit, especially those with low‐risk features such as an undetectable postoperative PSA, low Gleason score, and limited lymph node involvement.

As RT with ADT appears superior to either observation or ADT alone, should more men receive RT? Probably. Of the men with high‐risk features, only 22% actually received postoperative RT. Should postoperative RT now be considered the standard for all men? Probably not. Whilst it appears that some men may indeed benefit from RT, the possibility of selection bias driving this result is real. Even if there is a true effect, identifying which patients harbour residual local disease, but do not already have subclinical distant metastatic disease is challenging. RT for all would lead to unnecessary side‐effects for men that would not benefit from the treatment. Ultimately, a randomised trial will be required to establish the benefit of RT and to define subgroups of men that may or may not benefit. Until then, we will continue to rely on excellent work like the accompanying paper from Gupta et al. [3] to identify men who may benefit from postoperative RT and ADT.

References

  1. Messing EM, Manola J, Sarosdy M, Wilding G, Crawford ED, Trump D. Immediate hormonal therapy compared with observation after radical prostatectomy and pelvic lymphadenectomy in men with node‐positive prostate cancer. N Engl J Med 1999341: 1781–8
  2. Wong YN, Freedland S, Egleston B, Hudes G, Schwartz JS, Armstrong K. Role of androgen deprivation therapy for node‐positive prostate cancer. J Clin Oncol 200927: 100–5
  3. Gupta M, Patel HD, Schwen ZR, Tran PT, Partin AW. Adjuvant radiation with androgen deprivation therapy for men with lymph node metastases following radical prostatectomy: identifying men who benefit. BJU Int 2019123: 252–60
  4. Abdollah F, Karnes RJ, Suardi N et al. Impact of adjuvant radiotherapy on survival of patients with node‐positive prostate cancer. J Clin Oncol 201432: 3939–47
  5. Bianchi L, Nini A, Bianchi M et al. The role of prostate‐specific antigen persistence after radical prostatectomy for the prediction of clinical progression and cancer‐specific mortality in node‐positive prostate cancer patients. Eur Urol 201669: 1142–8

 

The beginning of #UroSoMe

I had been using Twitter for a while but I never experienced the true power of this social media platform. It was a cold call from @VerranDeborah and @juliomayol when I started to notice the hashtag #SoMe4Surgery. I was pleasantly surprised and impressed by the active engagement of the #SoMe4Surgery participants. After participating in a #SoMe4Surgery live conversation event on #surgicalinfection, I finally realized the potential impact of a simple hashtag.

While I was amazed by how #SoMe4Surgery brought the surgical community together, many of the topics being discussed were not entirely relevant or specific to a urologist per se. I felt the need of a hashtag specific to Urology, and I quickly started to conceptualize and plan ahead in building up the #UroSoMe community. The #UroSoMe twitter account was officially registered in August 2018.

#UroSoMe stands for ‘Urology Social Media’. My initial thought about #UroSoMe was simple. I wanted to develop a hashtag specific to urology. I wanted to increase public awareness about different urological conditions. Most importantly, I wanted to bring the urology community closer together through this social media platform. I believe there is so much for us to learn from each other, and such interactions should never be bounded by physical or geographical restrictions. Coincidentally, I was invited to talk about social media at the 27th Malaysian Urological Conference 2018, and I decided to take this opportunity to introduce #UroSoMe to the urology community.

The initial response from the audience was promising. Even after the meeting, many urologists came to me for in-depth discussions about the opportunities and applications of social media in urology. I felt that #UroSoMe might really work and it was time to gather more people to establish the community. The first invitation sent in on 14 December 2018, which I often regard as the ‘start date’ of the #UroSoMe community.

By inviting and encouraging people around to use a common hashtag, the #UroSoMe community keeps growing. With increasing momentum, the first #LiveCaseDiscussions was planned. It was a pre-planned event for urologists to get ‘online’ and discuss about some posted cases. A polling had been held in advance, and the topic to be discussed was chosen to be ‘Stone’.

The #LiveCaseDiscussions was on air at 4pm (CET) on 5 January 2019. A total of 9 cases had been presented and discussed. Hosting this event was overwhelming with vigorous discussions among the participants. It took approximately 2 hours to ‘complete’ the event, but the conversations went on for the next few days. Special thanks must be given to the most active users. #UroSoMe and the first #LiveCaseDiscussions would never be successful without their tremendous support.

The immediate effect of the #UroSoMe #LiveCaseDiscussions event was overwhelming. This graph represents a network of 515 twitter users whose tweets contained the hashtag #UroSoMe. 6692 mentions, 1044 retweets and 617 replies were recorded within a 10-day period from 27 December 2018 to 6 January 2019. From a social science point of view, this picture represents a ‘tight crowd’, in which discussions are characterized by highly interconnected people with few isolated participants. I guess this is exactly how we feel about the urology community!

Apart from #LiveCaseDiscussions, the #UroSoMe working group is also keen to host events including #LiveForum, #LiveJournalClub and #LiveTeaching. This is only the beginning of #UroSoMe and we believe there is huge potential to be explored. It is only with your support that #UroSoMe can continue to grow. We look forward to meeting you on Twitter and, hopefully, at #EAU19 and #AUA19 as well!

P.S. I must thank @juliomayol for the inspiration of #UroSoMe, @gmacscotland for his teaching on social media analytics, and @marc_smith for his support in NodeXL.

About the author:

Jeremy Teoh (@jteoh_hk) is a Urologist based in Hong Kong, China.

The #UroSoMe working group:

@jteoh_hk, @adelmesbah2, @BelloteMateus, @DocGauhar, @DrTortolero, @D_Castellani, @EdgarLindenMD, @EIvanBravoC, @HegeltS, @JontxuM, @gudaruk, @MarcelaPelayo, @RdonalisioMD, @Urologeman, @wroclawski_uro and @zainaladwin.

 

Residents’ podcast: Implementation of mpMRI technology for evaluation of PCa in the clinic

Giulia Lane M.D. is a Fellow in Neuro-urology and Pelvic Reconstruction in the Department of Urology at the University of Michigan; Kyle Johnson is a Urology Resident in the same department.

In this podcast they discuss the following BJUI Article of the Month:

Implementation of multiparametric magnetic resonance imaging technology for evaluation of patients with suspicion for prostate cancer in the clinical practice setting

Abstract

Objectives

To investigate the impact of implementing magnetic resonance imaging (MRI) and ultrasonography fusion technology on biopsy and prostate cancer (PCa) detection rates in men presenting with clinical suspicion for PCa in the clinical practice setting.

Patients and Methods

We performed a review of 1 808 consecutive men referred for elevated prostate‐specific antigen (PSA) level between 2011 and 2014. The study population was divided into two groups based on whether MRI was used as a risk stratification tool. Univariable and multivariable analyses of biopsy rates and overall and clinically significant PCa detection rates between groups were performed.

Results

The MRI and PSA‐only groups consisted of 1 020 and 788 patients, respectively. A total of 465 patients (45.6%) in the MRI group and 442 (56.1%) in the PSA‐only group underwent biopsy, corresponding to an 18.7% decrease in the proportion of patients receiving biopsy in the MRI group (P < 0.001). Overall PCa (56.8% vs 40.7%; P < 0.001) and clinically significant PCa detection (47.3% vs 31.0%; P < 0.001) was significantly higher in the MRI vs the PSA‐only group. In logistic regression analyses, the odds of overall PCa detection (odds ratio [OR] 1.74, 95% confidence interval [CI] 1.29–2.35; P < 0.001) and clinically significant PCa detection (OR 2.04, 95% CI 1.48–2.80; P < 0.001) were higher in the MRI than in the PSA‐only group after adjusting for clinically relevant PCa variables.

Conclusion

Among men presenting with clinical suspicion for PCa, addition of MRI increases detection of clinically significant cancers while reducing prostate biopsy rates when implemented in a clinical practice setting.

Read the full article

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February 2019 – About the cover

 

February’s Article of the Month (Implementation of mpMRI technology for evaluation of patients with suspicion for PCa in the clinical practice setting) is from work carried out at Northwell Health in New York, and various other institutions in the USA.

Northwell Health was founded in 1997 and is a not-for-profit healthcare network that includes around 20 hospitals, Donald and Barbara Zucker School of Medicine at Hofstra/NorthwellThe Feinstein Institute for Medical Research, a Center for Emergency Medical Services and a range of outpatient services.

February’s cover shows Gapstow Bridge in Central Park, Manhattan: this stone version was constructed in 1896 replacing the earlier wooden version. It provides a welcome contrast to the modern skyscrapers which form part of the Manhattan skyline beautifully viewed to the South of the bridge. The bridge has been famously used in many films and TV shows, including Home Alone 2 and Dr Who.

 

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