- Email: [email protected]
Re: Robot-assisted Laparoscopic Prostatectomy Versus Open Radical Retropubic Prostatectomy: Early Outcomes from a Randomised Controlled Phase 3 Study
EURURO-7042; No. of Pages 2 EUROPEAN UROLOGY XXX (2016) XXX–XXX
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Words of Wisdom Re: Robot-assisted Laparoscopic Prostatectomy Versus Open Radical Retropubic Prostatectomy: Early Outcomes from a Randomised Controlled Phase 3 Study Yaxley JW, Coughlin GD, Chambers SK, et al Lancet 2016;388(10049);1057–66 Experts’ summary Yaxley and colleagues recently reported the results of this welldesigned and well-conducted prospective randomised clinical trial. In this study, men with localised prostate cancer were randomised to receive robot-assisted radical prostatectomy (RARP; n = 157) or open radical prostatectomy (ORP; n = 151). RARPs were performed by a surgeon with 200-case experience and ORPs by a surgeon with 1500-case experience. Primary outcomes were urinary function and sexual function (EPIC) [1], recorded at 6 and 12 wk and 24 mo. EPIC urinary function and sexual function scores did not differ between the ORP and RARP groups at 6 and 12 wk.Operative time was shorter for RARP, with fewer intraoperative adverse events (8% vs 2%; p = 0.02). In addition, blood loss was lower by an average of 895 ml (p < 0.001) in the RARP arm. The duration of hospital stay was shorter by 1.7 d (p < 0.001) with a strong trend for fewer postoperative complications for the RARP group (9% vs 4%, p = 0.051). Patients undergoing RARP also reported significantly lower scores for worst pain and pain during activity at 1 d and 1 wk after surgery (p = 0.002). At 6 wk, the RARP patients reported higher physical quality of life [2], and a lower Hospital Anxiety and Depression Scale score at 12 wk. Experts’ comments: Although RARP and ORP appeared similar when assessing the primary endpoints of urinary and sexual scores, there were many other areas in which RARP outperformed ORP. These included blood loss, operative time, operative adverse events, hospital stay, and pain. The pad-use data at 12 wk showed that only 6% of the ORP group and 10% of the RARP group used more than 1 pad/d, which demonstrates excellent outcomes in the ORP patients [3,4]. By the same token, RARP outcomes during the learning curve for this procedure may not be anywhere close to the results reported in this study, which is another important factor to consider when analysing the results of this study. Given the reported difference in the baseline procedure experience of the surgeons, it can be argued that
robotic-assisted surgery overcame 15 yr and nearly 1300-case experience and managed to achieve similar outcomes in the primary endpoints and better results in many other areas. Interestingly, ORP did not have superior outcomes for any of the endpoints measured in this study. Routine use of a cell saver system for autologous blood recovery during ORP as in this study is not the standard of care in many centres. It is likely that the differences in estimated blood loss observed may translate to higher transfusion rates in real-world practice. Only 17% of the ORP and 15% of the RARP patients had a preoperative Gleason score of 8 (11% and 10% postoperatively). This relatively lower proportion of high-risk high-grade patients may be different to what is seen in many other centres, which may limit the generalisability of the data, particularly with respect to higher-risk disease. In this study, time to return to work was assessable for 44% of the ORP and 40% of the RARP patients, and was 42.71 d in both groups. This is exactly the standard 6-wk recuperation period often recommended following major surgery. It is uncertain whether the patients were encouraged to resume normal work at an earlier stage or the minimum of 6 wk off work was recommended for all patients. The longer-term outcomes of the study are yet to be reported, and oncologic, functional, and complication outcomes — in particular bladder neck stricture rates — are also worthy of close scrutiny. The issue is not if RARP is advantageous; the question remains whether it is cost-effective. This may not be relevant in some health systems; for example, >85% of prostatectomies in the USA are already performed robotically [5]. Arguably, some of the benefits mentioned here may potentially balance the cost of RARP against ORP. However, the initial cost of obtaining the robot and the ongoing cost of consumables are always against robotassisted surgery. With the potential arrival of other competing systems, costs associated with robotic surgery may become less of an issue in the future. In conclusion, we agree with the authors that the surgeon is the key element affecting the outcomes of radical prostatectomy. However, on the basis of the secondary outcomes of this study, we would like to highlight that the
http://dx.doi.org/10.1016/j.eururo.2016.09.016 0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EURURO-7042; No. of Pages 2 2
EUROPEAN UROLOGY XXX (2016) XXX–XXX
robotic platform allows the surgeon to improve results by shortening the learning curve, minimising blood loss and perioperative adverse events, and reducing postoperative pain and the length of hospital stay.
[4] Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000;55:58–61. [5] Hu JC, Gandaglia G, Karakiewicz PI, et al. Comparative effectiveness of robot-assisted versus open radical prostatectomy cancer control. Eur Urol 2014;66:666–72.
Conflicts of interest: The authors have nothing to disclose.
References
Kamran Zargar-Shoshtaria, Declan G. Murphyb,c, Homayoun Zargard,e,f,* a
Division of Urology, Department of Surgery, University of Auckland, Auckland, New Zealand
[1] Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite
b
Division of Cancer Surgery, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia
(EPIC) for comprehensive assessment of health-related quality of c
life in men with prostate cancer. Urology 2000;56:899–905. [2] Wei JT, Dunn RL, Sandler HM, et al. Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer. J Clin Oncol 2002;20:557–66.
Epworth Prostate Centre, Epworth Healthcare, Richmond, Australia
d
Department of Urology, Royal Melbourne Hospital, Melbourne, Australia e
Australian Prostate Cancer Research Centre, Melbourne, VIC, Australia f
University of Melbourne, Melbourne, Australia
[3] Touijer K, Eastham JA, Secin FP, et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008;179: 1811–7.
*Corresponding author. Royal Melbourne Hospital, 300 Grattan Street, Parkville 3052, Victoria, Australia. E-mail address: [email protected] (H. Zargar).
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Words of Wisdom Re: Robot-assisted Laparoscopic Prostatectomy Versus Open Radical Retropubic Prostatectomy: Early Outcomes from a Randomised Controlled Phase 3 Study Yaxley JW, Coughlin GD, Chambers SK, et al Lancet 2016;388(10049);1057–66 Experts’ summary Yaxley and colleagues recently reported the results of this welldesigned and well-conducted prospective randomised clinical trial. In this study, men with localised prostate cancer were randomised to receive robot-assisted radical prostatectomy (RARP; n = 157) or open radical prostatectomy (ORP; n = 151). RARPs were performed by a surgeon with 200-case experience and ORPs by a surgeon with 1500-case experience. Primary outcomes were urinary function and sexual function (EPIC) [1], recorded at 6 and 12 wk and 24 mo. EPIC urinary function and sexual function scores did not differ between the ORP and RARP groups at 6 and 12 wk.Operative time was shorter for RARP, with fewer intraoperative adverse events (8% vs 2%; p = 0.02). In addition, blood loss was lower by an average of 895 ml (p < 0.001) in the RARP arm. The duration of hospital stay was shorter by 1.7 d (p < 0.001) with a strong trend for fewer postoperative complications for the RARP group (9% vs 4%, p = 0.051). Patients undergoing RARP also reported significantly lower scores for worst pain and pain during activity at 1 d and 1 wk after surgery (p = 0.002). At 6 wk, the RARP patients reported higher physical quality of life [2], and a lower Hospital Anxiety and Depression Scale score at 12 wk. Experts’ comments: Although RARP and ORP appeared similar when assessing the primary endpoints of urinary and sexual scores, there were many other areas in which RARP outperformed ORP. These included blood loss, operative time, operative adverse events, hospital stay, and pain. The pad-use data at 12 wk showed that only 6% of the ORP group and 10% of the RARP group used more than 1 pad/d, which demonstrates excellent outcomes in the ORP patients [3,4]. By the same token, RARP outcomes during the learning curve for this procedure may not be anywhere close to the results reported in this study, which is another important factor to consider when analysing the results of this study. Given the reported difference in the baseline procedure experience of the surgeons, it can be argued that
robotic-assisted surgery overcame 15 yr and nearly 1300-case experience and managed to achieve similar outcomes in the primary endpoints and better results in many other areas. Interestingly, ORP did not have superior outcomes for any of the endpoints measured in this study. Routine use of a cell saver system for autologous blood recovery during ORP as in this study is not the standard of care in many centres. It is likely that the differences in estimated blood loss observed may translate to higher transfusion rates in real-world practice. Only 17% of the ORP and 15% of the RARP patients had a preoperative Gleason score of 8 (11% and 10% postoperatively). This relatively lower proportion of high-risk high-grade patients may be different to what is seen in many other centres, which may limit the generalisability of the data, particularly with respect to higher-risk disease. In this study, time to return to work was assessable for 44% of the ORP and 40% of the RARP patients, and was 42.71 d in both groups. This is exactly the standard 6-wk recuperation period often recommended following major surgery. It is uncertain whether the patients were encouraged to resume normal work at an earlier stage or the minimum of 6 wk off work was recommended for all patients. The longer-term outcomes of the study are yet to be reported, and oncologic, functional, and complication outcomes — in particular bladder neck stricture rates — are also worthy of close scrutiny. The issue is not if RARP is advantageous; the question remains whether it is cost-effective. This may not be relevant in some health systems; for example, >85% of prostatectomies in the USA are already performed robotically [5]. Arguably, some of the benefits mentioned here may potentially balance the cost of RARP against ORP. However, the initial cost of obtaining the robot and the ongoing cost of consumables are always against robotassisted surgery. With the potential arrival of other competing systems, costs associated with robotic surgery may become less of an issue in the future. In conclusion, we agree with the authors that the surgeon is the key element affecting the outcomes of radical prostatectomy. However, on the basis of the secondary outcomes of this study, we would like to highlight that the
http://dx.doi.org/10.1016/j.eururo.2016.09.016 0302-2838/# 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EURURO-7042; No. of Pages 2 2
EUROPEAN UROLOGY XXX (2016) XXX–XXX
robotic platform allows the surgeon to improve results by shortening the learning curve, minimising blood loss and perioperative adverse events, and reducing postoperative pain and the length of hospital stay.
[4] Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000;55:58–61. [5] Hu JC, Gandaglia G, Karakiewicz PI, et al. Comparative effectiveness of robot-assisted versus open radical prostatectomy cancer control. Eur Urol 2014;66:666–72.
Conflicts of interest: The authors have nothing to disclose.
References
Kamran Zargar-Shoshtaria, Declan G. Murphyb,c, Homayoun Zargard,e,f,* a
Division of Urology, Department of Surgery, University of Auckland, Auckland, New Zealand
[1] Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite
b
Division of Cancer Surgery, Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australia
(EPIC) for comprehensive assessment of health-related quality of c
life in men with prostate cancer. Urology 2000;56:899–905. [2] Wei JT, Dunn RL, Sandler HM, et al. Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer. J Clin Oncol 2002;20:557–66.
Epworth Prostate Centre, Epworth Healthcare, Richmond, Australia
d
Department of Urology, Royal Melbourne Hospital, Melbourne, Australia e
Australian Prostate Cancer Research Centre, Melbourne, VIC, Australia f
University of Melbourne, Melbourne, Australia
[3] Touijer K, Eastham JA, Secin FP, et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008;179: 1811–7.
*Corresponding author. Royal Melbourne Hospital, 300 Grattan Street, Parkville 3052, Victoria, Australia. E-mail address: [email protected] (H. Zargar).