Archive for category: Article of the Week

Video: Does TT status modify a man’s risk of cancer?

Testosterone Therapy and Cancer Risk

Michael L. Eisenberg*, Shufeng Li*, Paul Betts§, Danielle Herder, Dolores J. Lamb¶ and Larry I. Lipshultz

 

Departments of *Urology, Obstetrics/Gynecology and Dermatology, Stanford University School of Medicine, Stanford, CA§Cancer Epidemiology and Surveillance Branch, Texas Cancer Registry, Texas Department of State Health Services, Austin, TX, and Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA

 

OBJECTIVE

To determine if testosterone therapy (TT) status modifies a man’s risk of cancer.

PATIENTS AND METHODS

The Urology clinic hormone database was queried for all men with a serum testosterone level and charts examined to determine TT status. Patient records were linked to the Texas Cancer Registry to determine the incidence of cancer. Men accrued time at risk from the date of initiating TT or the first office visit for men not on TT. Standardised incidence rates and time to event analysis were performed.

RESULTS

In all, 247 men were on TT and 211 did not use testosterone. In all, 47 men developed cancer, 27 (12.8%) were not on TT and 20 (8.1%) on TT. There was no significant difference in the risk of cancer incidence based on TT (hazard ratio [HR] 1.0, 95% confidence interval [CI] 0.57–1.9; P = 1.8). There was no difference in prostate cancer risk based on TT status (HR 1.2, 95% CI 0.54–2.50).

CONCLUSION

There was no change in cancer risk overall, or prostate cancer risk specifically, for men aged >40 years using long-term TT.

Article of the Month: Indications for Intervention During Active Surveillance of Prostate Cancer

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. Max Kates discussing his paper. 

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

Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

 

Editorial: How active should active surveillance be?

 Many investigators, including those from Johns Hopkins University (JHU) and the Prostate cancer Research International: Active Surveillance project (PRIAS), have provided meaningful data to strongly support the increasing use of active surveillance (AS) across the world. There are a multitude of strategies to minimise excessive rates of prostate cancer over detection and overtreatment. After the diagnosis of prostate cancer, the single best is AS for appropriately selected men.

 For decades, the concept of not treating a prostate cancer in otherwise healthy men, even if low-grade and low-volume was typically considered nihilistic and heretical, particularly in the USA. Thankfully, data have largely made this line of thinking anachronistic. The era of sensibly applied AS is upon us, and single-institution series with intermediate-term follow-up are excellent, with exceedingly low rates of metastasis or cancer-related death. However, we await longer-term (>10 years) outcomes from the contemporary PSA screening era.

 The ‘success’ of AS is largely dependent on the entry criteria, follow-up strategies, and indications for curative intervention. Highly restrictive inclusion criteria, rigorous biopsy based follow-up and strict definitions of reclassification triggering treatment have produced superb outcomes. Critics appropriately argue these criteria exclude a significant proportion of men with a low rate of requiring treatment or having metastases, if allowed on AS. Conversely, other programmes with looser entry criteria, more lax follow-up, and relaxed indications for intervention will be more inclusive and have lower rates of immediate or delayed intervention but must be counterbalanced against the expected higher rate of metastases or death.

 The current study [1] evaluates two different AS follow-up strategies from JHU and PRIAS. In general, JHU uses annual biopsies with progression defined as a new PSA density >0.15 ng/mL/mL or increasing tumour volume or grade beyond a certain threshold, while PRIAS recommends less frequent biopsies (years 1, 4, and 7) while relying on serological (PSA doubling time, PSADT) alongside histological indicators for defining progression and recommending treatment.

 Not surprisingly, different strategies lead to varying expected outcomes. Among the JHU patients, 38% were reclassified at a median of 2.1 years. Nearly two-thirds of the reclassified would have been identified at the PRIAS year 1 or triennial biopsies with 16% identified between PRIAS biopsies at a median delay of 1.9 years. The unanswerable but incredibly important question is whether this delay is essentially a non-issue, perhaps a favourable attribute (more AS time without compromising cure rates), or clinically disastrous (patients no longer curable).

 PRIAS relies heavily on PSA kinetics, which can be a double-edged sword. Among men in the JHU programme with >5 years follow-up, 11% would have delayed reclassification compared with PRIAS at a median time of 4.7 years. Additionally, 12% would have undergone intervention due to PRIAS-defined PSADT but not progressed based on the JHU protocol. It is convenient and perhaps intuitive that PSA kinetics should predict progression and meaningful clinical events for men on AS; however, the data from multiple studies have simply not supported this concept [2, 3].

 The JHU programme has restrictive entry rules compared with most other programmes, a rigorous biopsy based follow-up protocol, and strict criteria to treat, which is exactly why no metastasis or death have been reported among 769 men, some with up to 15 years follow-up[4]. Guidelines are needed but should not be overly prescriptive or rigid. For example, a surveillance biopsy showing a single core of Gleason 6 encompassing 60% of the total core or three cores of Gleason 6 with total cancer length of 3 mm would lead to a recommendation of treatment according to published JHU criteria. Many of us would not be phased with these biopsy reports and comfortably recommend ongoing AS.

 Data from AS series are very encouraging but it is highly likely we can do even better. For example, 10-year cancer-specific survival is 97% in the Sunnybrook AS experience and all five cancer-related deaths occurred in patients that would not meet most contemporary AS entry criteria [5, 6]. I am hopeful and confident that emerging data incorporating MRI imaging, serum biomarkers (e.g. prostate health index), or tissue-based biomarkers (e.g. Prolaris, Oncotype Dx) will provide us with a more comprehensive understanding of these men’s cancer such that tailored, evidence-based recommendations can be even more accurate.

 There is much yet to be learned about AS and this study [1] adds to our knowledge. Surveillance for prostate cancer is definitely active, but it is also dynamic and evolving.

Read the full article
Scott Eggener
Associate Professor of Surgery, University of Chicago, Chicago, IL, USA

 

References

 

 

Video: Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Indications for Intervention During Active Surveillance of Prostate Cancer: A Comparison of the Johns Hopkins and PRIAS Protocols

Max Kates, Jeffrey J. Tosoian, Bruce J. Trock, Zhaoyong Feng, H. Ballentine Carter and Alan W. Partin
James Buchanan Brady Urological Institute, Johns Hopkins Medical Institutions, Baltimore, MD, USA
Read the full article
OBJECTIVE

To analyse how patients enrolled in our biopsy based surveillance programme would fare under the Prostate Cancer Research International Active Surveillance (PRIAS) protocol, which uses PSA kinetics.

PATIENTS AND METHODS

Since 1995, 1125 men with very-low-risk prostate cancer have enrolled in the AS programme at the Johns Hopkins Hospital (JHH), which is based on monitoring with annual biopsy. The PRIAS protocol uses a combination of periodic biopsies (in years 1, 4, and 7) and prostate-specific antigen doubling time (PSADT) to trigger intervention. Patients enrolled in the JHH AS programme were retrospectively reviewed to evaluate how the use of the PRIAS protocol would alter the timing and use of curative intervention.

RESULTS

Over a median of 2.1 years of follow up, 38% of men in the JHH AS programme had biopsy reclassification. Of those, 62% were detected at biopsy intervals corresponding to the PRIAS criteria, while 16% were detected between scheduled PRIAS biopsies, resulting in a median delay in detection of 1.9 years. Of the 202 men with >5 years of follow-up, 11% in the JHH programme were found to have biopsy reclassification after it would have been identified in the PRIAS protocol, resulting in a median delay of 4.7 years to reclassification. In all, 12% of patients who would have undergone immediate intervention under PRIAS due to abnormal PSA kinetics would never have undergone reclassification on the JHH protocol and thus would not have undergone definitive intervention.

CONCLUSIONS

There are clear differences between PSA kinetics-based AS programmes and biopsy based programmes. Further studies should address whether and how the differences in timing of intervention impact subsequent disease progression and prostate cancer mortality.

Article of the Week: An assessment of the physical impact of complex surgical tasks on surgeon errors and discomfort

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.

An assessment of the physical impact of complex surgical tasks on surgeon errors and discomfort: a comparison between robot-assisted, laparoscopic and open approaches

Oussama Elhage*, Ben Challacombe*, Adam Shortland‡ and Prokar Dasgupta*
§*The Urology Centre, Guy’s and St Thomas’ NHS Foundation Trust, Medical Research Council (MRC) Centre for Transplantation, King’s College London, One Small Step Laboratory, and §MRC Centre for Transplantation & National Institute for Health Research (NIHR) comprehensive Biomedical Research Centre, King’s College London, King’s Health Partners, Guy’s Hospital, London, UK

 

Read the full article
OBJECTIVES

To evaluate, in a simulated suturing task, individual surgeons’ performance using three surgical approaches: open, laparoscopic and robot-assisted.

SUBJECTS AND METHODS

Six urological surgeons made an in vitro simulated vesico-urethral anastomosis. All surgeons performed the simulated suturing task using all three surgical approaches (open, laparoscopic and robot-assisted). The time taken to perform each task was recorded. Participants were evaluated for perceived discomfort using the self-reporting Borg scale. Errors made by surgeons were quantified by studying the video recording of the tasks. Anastomosis quality was quantified using scores for knot security, symmetry of suture, position of suture and apposition of anastomosis.

RESULTS

The time taken to complete the task by the laparoscopic approach was on average 221 s, compared with 55 s for the open approach and 116 s for the robot-assisted approach (anova, P < 0.005). The number of errors and the level of self-reported discomfort were highest for the laparoscopic approach (anova, P < 0.005). Limitations of the present study include the small sample size and variation in prior surgical experience of the participants.

CONCLUSIONS

In an in vitro model of anastomosis surgery, robot-assisted surgery combines the accuracy of open surgery while causing lesser surgeon discomfort than laparoscopy and maintaining minimal access.

Editorial: Conventional laparoscopic surgery – more pain, no gain!

Advances in surgical technology have revolutionized the way surgery is performed today. Conventional laparoscopic surgery dominated the surgical paradigm for several decades, until robot-assisted surgery created the next giant leap. In the pressent article, Elhage et al. [1] compare and correlate physical stress and surgical performances among three modes of a standardized surgical step. Their study shows the obvious physical strain and technical limitations faced while performing conventional laparoscopic surgery, subsequently leading to compromised surgical outcomes. The physical impact of conventional laparoscopic surgery has been well documented through surgeon feedback as well as ergonomic assessment [2, 3]. Various studies have reported that higher physical stress, associated with ergonomic limitations, is experienced when performing conventional laparoscopy compared to the comfort and ease of robot-assisted surgery, as highlighted in the present study. Increased workload has also been associated with performance errors, with a steep learning curve needed to achieve surgical excellence during conventional laparoscopy [4].

Currently, the use of robot-assisted surgery is on the rise, as an alternative to both open and conventional laparoscopic surgery across the developed world, despite its obvious economic limitations. Better ergonomics during robot-assisted surgery will increase the comfort of the surgeon, but the future of surgery may easily be linked to the improvements experienced by all of us in the automobile industry. Developments, from manual gear-clutch control to automatic speed control and the luxury of adaptive cruise control today, make us safe drivers with minimal physical stress. The concept of adaptive cruise control, which adjusts the speed of a vehicle in relation to its surroundings, sounds similar to the leap from manual camera control during conventional laparoscopy to console-based control during camera navigation in robot-assisted surgery. With advances in the speed and size of computers, pneumatic-based joint mechanics and mindfulness meditation on the horizon, it will not be long before surgeons will sit back and watch the marvel of the machine. Surgeons just need to learn to hold on to their seats!

Read the full article
Syed J. Raza*, Khurshid A. Guru† anRobert P. Huben†
*Fellow, †Endowed Professor of Urologic Oncology, Department of Urology and A.T.L.A.S (Applied Technology Laboratory for Advanced Surgery) Program, Roswell Park Cancer Institute, Buffalo, NY, USA

 

References

 

2 Plerhoples TA, Hernandez-Boussard T, Wren SM. The aching surgeon: a survey of physical discomfort and symptoms following open, laparoscopic and robotic surgery.

J Robotic Surg 2012; 6: 65–723 Hubert N, Gilles M, Desbrosses K, Meyer JP, Felblinger J, Hubert J. Ergonomic assessment of the surgeon’s physical workload during standard and robotic assisted laparoscopic procedures. Int J Med Robot 2013; 9:142–147

4 Yurko YY, Scerbo MW, Prabhu AS, Acker CE, Stefanidis D. Higher mental workload is associated with poorer laparoscopic performance as measured by the NASA-TLX tool. Simul Healthc 2010; 5: 267–271

 

Article of the Week: HLE and PVP for Patients with BPH and CUR

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. Axel Merseburger discussing his paper. 

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

Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary Retention

Christopher D. Jaeger, Christopher R. Mitchell, Lance A. Mynderse and Amy E. Krambeck

Department of Urology, Mayo Clinic School of Medicine, Rochester, MN, USA

Read the full article
OBJECTIVES

To evaluate short-term outcomes of holmium laser enucleation of the prostate (HoLEP) and photoselective vaporisation of the prostate (PVP) in patients with benign prostatic hyperplasia (BPH) and chronic urinary retention (CUR).

PATIENTS AND METHODS

A retrospective chart review was performed of all patients with CUR who underwent HoLEP or PVP at our institution over a 3-year period. CUR was defined as a persistent post-void residual urine volume (PVR) of >300 mL or refractory urinary retention requiring catheterisation.

RESULTS

We identified 72 patients with CUR who underwent HoLEP and 31 who underwent PVP. Preoperative parameters including median catheterisation duration (3 vs 5 months, P = 0.71), American Urological Association Symptom Index score (AUASI; 18 vs 21, P = 0.24), and PVR (555 vs 473 mL, P = 0.096) were similar between the HoLEP and PVP groups. The HoLEP group had a larger prostate volume (88.5 vs 49 mL, P < 0.001) and higher PSA concentration (4.5 vs 2.4 ng/mL, P = 0.001). At median 6-month follow-up, 71 (99%) HoLEP patients and 23 (74%) PVP patients were catheter-free (P < 0.001). Of the voiding patients, postoperative AUASI (3 vs 4, P = 0.06), maximum urinary flow rate (23 vs 18 mL/s, P = 0.28) and PVR (56.5 vs 54 mL, P = 1.0) were improved in both groups.

CONCLUSIONS

Both HoLEP and PVP are effective at improving urinary parameters in men with CUR. Despite larger prostate volumes, HoLEP had a 99% successful deobstruction rate, thus rendering patients catheter-free.

Editorial: Opening the flood gates – HLE is superior to PVP for the treatment of CUR

With the expansion in laser technology for treating symptomatic BPH, there are now two main techniques available to the budding urologist. Yet the management of chronic urinary retention (CUR) remains a significant challenge. In this issue of BJUI Jaeger et al. [1]present a retrospective study comparing holmium laser enucleation of the prostate (HoLEP) and photoselective vaporization of the prostate (PVP; using XPS 180 watt and HPS 120 watt systems) in the treatment of CUR.

Both HoLEP and PVP are now well-established treatment methods. Although PVP has seen a greater level of acceptance because of its shorter learning period, its use remains limited by prostate size and concerns about long-term durability. In contrast the favourable and enduring outcomes reported for HoLEP have meant that it is gaining recognition as the new ‘gold standard’ surgical treatment for BPH. Whilst PVP ablates the tissue laterally from the prostatic urethra, HoLEP involves an anatomical enucleation of all the prostatic adenoma before morcellation.

Over the past decade, there has been a shift towards medical management of BPH. Despite the resultant increase in numbers of men developing CUR, best practice for this challenging and clinically important group remains highly debated. The term CUR is used to describe a constellation of presentations, and current imprecise, even arbitrary, definitions make the interpretation of existing studies difficult. Historically, CUR has been almost universally excluded from trials because of the anticipation of poor outcomes and high complication rates, while the presence of detrusor hypotonia, particularly with low-pressure retention, has led to concerns of treatment failure following surgery. This dilemma for urologists has been aggravated by conflicting evidence in the published literature [2].

Jaeger et al. [1] assessed all patients with CUR who were treated in their institution either with HoLEP (72 patients) or PVP (31 patients). CUR was defined as a persistent post-void residual urine volume (PVR) >300 mL or urinary retention refractory to multiple voiding trials. While preoperative urodynamic studies were not routinely performed, those patients found to have low bladder contractility or acontractility were not excluded.

Both HoLEP and PVP produced similarly effective outcomes in terms of symptom score improvement, PVR reduction and Qmax increase in voiding patients. Complication rates were also similar in the two groups (15 and 26% for HoLEP and PVP, respectively, P = 0.27), but, importantly, HoLEP was shown to offer substantially better rates of spontaneous voiding than PVP, 99 vs 74% of patients, in spite of a lower median bladder contractility index in the HoLEP group (73 vs 90, P = 0.012).

Both PVP and HoLEP have previously been studied in isolation in treating patients with CUR. Whilst Woo et al. [3] demonstrated significant reductions in PVR after PVP (GreenLight HPS 120-W), the presence of detrusor under-activity was not established. Outcomes after PVP in patients with urodynamically proven detrusor hypotonia have been shown to be significantly worse than in patients with normal detrusor funtion [4].

The effectiveness of HoLEP has been shown in treating CUR secondary to BPH in a large study of 169 patients with symptom score improvements of 159% and spontaneous voiding in 98.25% [5]. Furthermore, even in patients with proven impaired bladder contractility, HoLEP led to spontaneous voiding in 95% [6] at least in the short term.

The findings from the present study further support the use of HoLEP specifically in CUR. Jaeger et al. are the first to compare the two technologies head on, albeit in a non-randomised study, in the treatment of CUR. Whilst both treatments showed reasonable efficacy despite low or absent bladder contractility in a number of patients, a significant advantage was seen with HoLEP, with the total removal of any obstructing tissue. These results were unaffected by the presence of preoperative impaired bladder on urodynamic studies. This study suggests that HoLEP is superior to PVP in the treatment of CUR, probably because of the larger prostatic channel that enucleation produces. Measurement of postoperative PSA readings would have been a useful addition to illustrate this. Nevertheless, the findings add to the growing body of evidence to support the use of HoLEP in treating CUR, irrespective of preoperative bladder function.

Read the full article

Nicholas Raison and Ben Challacombe

Urology Department, Guy’s and St Thomas’ NHS Trust, Guy’s Hospital, Great Maze Pond, London, UK

References

1 Jaeger CD, Mitchell CR, Mynderse LA, Krambeck AE. Holmium laser enucleation and photoselective vaporization of the prostate for patients with benign prostatic hyperplasia and chronic urinary retention. BJU Int 2015; 115: 295–9

2 Ghalayini IF, Al-Ghazo MA, Pickard RS. A prospective randomized trial comparing transurethral prostatic resection and clean intermittent self-catheterization in men with chronic urinary retention. BJU Int 2005; 96: 93–7

3 Woo H, Reich O, Bachmann A et al. Outcome of GreenLight HPS 120-W laser therapy in specific patient populations: those in retention, on anticoagulants, and with large prostates (≥ 80 ml). Eur Urol Suppl 2008; 7: 378–83

4 Monoski MA, Gonzalez RR, Sandhu JS, Reddy B, Te AE. Urodynamic predictors of outcomes with photoselective laser vaporization prostatectomy in patients with benign prostatic hyperplasia and preoperative retention. Urology 2006; 68: 312–7

5 Elzayat EA, Habib EI, Elhilali MM. Holmium laser enucleation of prostate for patients in urinary retention. Urology 2005; 66: 789–93

6 Mitchell CR, Mynderse LA, Lightner DJ, Husmann DA, Krambeck AE. Efficacy of holmium laser enucleation of the prostate in patients with non-neurogenic impaired bladder contractility: results of a prospective trial. Urology 2014; 83: 428–32

Video: Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary

Holmium Laser Enucleation and Photoselective Vaporization of the Prostate for Patients with Benign Prostatic Hyperplasia and Chronic Urinary Retention

Christopher D. Jaeger, Christopher R. Mitchell, Lance A. Mynderse and Amy E. Krambeck

Department of Urology, Mayo Clinic School of Medicine, Rochester, MN, USA

Read the full article
OBJECTIVES

To evaluate short-term outcomes of holmium laser enucleation of the prostate (HoLEP) and photoselective vaporisation of the prostate (PVP) in patients with benign prostatic hyperplasia (BPH) and chronic urinary retention (CUR).

PATIENTS AND METHODS

A retrospective chart review was performed of all patients with CUR who underwent HoLEP or PVP at our institution over a 3-year period. CUR was defined as a persistent post-void residual urine volume (PVR) of >300 mL or refractory urinary retention requiring catheterisation.

RESULTS

We identified 72 patients with CUR who underwent HoLEP and 31 who underwent PVP. Preoperative parameters including median catheterisation duration (3 vs 5 months, P = 0.71), American Urological Association Symptom Index score (AUASI; 18 vs 21, P = 0.24), and PVR (555 vs 473 mL, P = 0.096) were similar between the HoLEP and PVP groups. The HoLEP group had a larger prostate volume (88.5 vs 49 mL, P < 0.001) and higher PSA concentration (4.5 vs 2.4 ng/mL, P = 0.001). At median 6-month follow-up, 71 (99%) HoLEP patients and 23 (74%) PVP patients were catheter-free (P < 0.001). Of the voiding patients, postoperative AUASI (3 vs 4, P = 0.06), maximum urinary flow rate (23 vs 18 mL/s, P = 0.28) and PVR (56.5 vs 54 mL, P = 1.0) were improved in both groups.

CONCLUSIONS

Both HoLEP and PVP are effective at improving urinary parameters in men with CUR. Despite larger prostate volumes, HoLEP had a 99% successful deobstruction rate, thus rendering patients catheter-free.

Article of the Week: Enzalutamide in European and North American men participating in the AFFIRM trial

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. Axel Merseburger discussing his paper. 

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

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

Read the full article
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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