REVIEW For reprint orders, please contact: [email protected]
Robotic and standard open radical prostatectomy: oncological and quality-of-life outcomes Prostate cancer is the second leading cause of cancer death among men in the USA. Use of robot-assisted radical prostatectomy (RARP) for the management of localized prostate cancer has increased dramatically in recent years. This review focuses on comparing quality of life following RARP versus retropubic radical prostatectomy. RARP is associated with improved perioperative outcomes, such as reduced blood loss and fewer transfusions. In addition, cancer control after RARP versus retropubic radical prostatectomy is equivalent, with similar incidences of positive surgical margins and comparable early oncological outcomes. RARP appears to provide advantages in recovery of continence, potency and quality of life compared with retropubic radical prostatectomy; however, methodological limitations exist in current literature. Keywords: continence n outcome n potency n prostate cancer n quality of life n retropubic prostatectomy n robot-assisted radical prostatectomy
Kuo-How Huang1,2, Stacey C Carter1, Ya-Chen Tina Shih3 & Jim C Hu*1 Institute of Urologic Oncology, Department of Urology, David Geffen School of Medicine, University of California, LA, USA 2 Department of Urology, National Taiwan University Hospital, Taipei, Taiwan 3 Section of Hospital Medicine, Department of Medicine, The University of Chicago, IL, USA *Author for correspondence: Tel.: +1 310 206 2355 Fax: +1 310 794 6789 [email protected] 1
Prostate cancer is the second leading cause of cancer death among men in the USA [1]. The management of prostate cancer remains controversial owing to the heterogeneous natural history of the disease and the risk of treatment-related side effects [2,3]. Nevertheless, radical prostatectomy (RP) remains the most popular treatment for localized disease [4], particularly among younger men, resulting in a lower risk of metastases and prostate cancer-specific mortality compared with watchful waiting [5]. While open retropubic RP (RRP) is the traditional surgical approach, robotassisted RP (RARP) was first described in 2000 and has been rapidly adopted [6], currently comprising the majority of RPs performed in the USA [7,8]. As of 2009, Intuitive Surgical® (CA, USA), the device manufacturer for the da Vinci® Surgical System, installed 1395 robotic systems worldwide, 1028 in the USA and 248 in Europe [9]. Robotic surgery incurs high fixed costs for hospitals; installation of the robot costs more than US$1.5 million with additional maintenance costs estimated at US$150,000 per year. Moreover, robotic instruments cost approximately US$1500 per RARP case [10,11]. With the advent and aggressive marketing of RARP, the total number of RPs performed has increased overall, suggesting that men who may otherwise have opted for other definitive therapies or active surveillance instead elected to undergo RARP [7]. The greatest revolution in prostate cancer surgery was the introduction of the anatomic, retropubic approach by Walsh and Donker in the early 1980s, which reduced blood loss and improved postprostatectomy urinary continence and erectile function [12]. The introduction of laparoscopic and robotic approaches has not led to markedly improved functional outcomes. Nevertheless, minimally invasive approaches use multiple smaller incisions versus one larger incision and provide 10× magnification of the surgical field as compared with RRP [13]. In addition, population-based studies have shown that RARP is associated with fewer transfusions, fewer perioperative complications and deaths, shorter lengths of hospital stay and fewer anastomotic strictures compared with RRP [14,15]. Similarly, a meta-analysis of 167,184 RRPs and 62,389 RARPs demonstrated that RARP provides significant perioperative
10.2217/CER.13.23 © 2013 Future Medicine Ltd
2(3), 293–299 (2013)
part of
ISSN 2042-6305
293
Review
Huang, Carter, Shih & Hu
advantages, including decreased blood loss, fewer blood transfusions, shorter length of hospital stay and fewer adverse events compared with RRP [16]. These findings were confirmed in a second meta-analysis comparing perioperative outcomes, which also demonstrated significantly reduced blood loss and fewer transfusions for RARP versus RRP, whereas operative times and overall complications were similar [17]. Although robotic surgery is costly and has a prolonged learning curve [18], the decreased blood loss, fewer transfusions and complications, shorter hospitalization and rapid convalescence may justify the additional expense of the robotic approach [19,20]. Scales et al. identified the cost-equivalence of RARP with RRP at ten RARPs per week and cost superiority at 14 RARPs per week [21]. A study of the shortterm cost–effectiveness of RARP versus RRP demonstrated that RARP was more costly than RRP and did not result in any gains in qualityadjusted life-years at 1-year after surgery [22]. Despite the cost disadvantage of RARP versus RRP, the vast majority of RPs in the USA are now performed robotically [7]. However, there continues to be a need for methodologically rigorous studies to determine whether RARP is cost effective in high-volume centers when factoring in the fewer complications and deaths, shorter lengths of hospital stay and shorter convalescence [9]. Given the potential difficulties in achieving patient and surgeon equipoise in generating level 1 evidence demonstrating superior outcomes in favor of RARP versus RRP and spiraling healthcare costs and rapid adoption of expensive robotic technology, the Institute of Medicine has prioritized robotic-assisted surgery for comparative effectiveness research [101]. Prostate-specific antigen (PSA) screening has led to a significant increase in detection of clinically localized prostate cancer [23,24]. Although randomized controlled trials on the efficacy of PSA screening demonstrated conflicting results [25,26], the US Preventative Services Task Force recommended against PSA screening [27]. However, aggressive marketing and our social affinity for new technology has spurred the propagation of RARP. Moreover, studies comparing active surveillance with RP have demonstrated active surveillance to be a sound approach for men aged over 70 years, especially those with comorbidities, or for younger men with very low-risk disease features [28]. Therefore, many
294
J. Compar. Effect. Res. (2013) 2(3)
men with these features who underwent RARP were suitable for active surveillance, without temporary or permanent deficits in urinary continence, erectile dysfunction or disease progression [29]. Therefore, the goal of the current study was to conduct a rigorous comparative effectiveness review of oncological and quality-of-life outcomes following RARP versus RRP (Table 1). This is particularly relevant for prostate cancer, which typically has an indolent clinical course such that treatment sequelae may be worse than the disease itself. Methods
A review of the English language literature was performed using the PubMed database from 2001 to 2012. Relevant reports published were identified using the following keywords: robot or robotic prostatectomy and open or retropubic prostatectomy. Among 267 papers, 202 papers were excluded, including 164 noncomparative and/or small case series, six studies published only as abstracts and/or reports from conferences and 32 studies reporting surgeon-reported outcomes. A total of 60 original and review articles providing data on oncological, functional (e.g., incontinence and erectile function) and quality-of-life outcomes were included in the review. Results ■■ Oncological outcomes Positive surgical margin
Although surgical margins may not reliably serve as a surrogate end point for prostate cancer-specific mortality, positive surgical margins are associated with a significantly greater risk for biochemical recurrence and the need for salvage treatment [30,31]. In addition, positive surgical margins may be used as a surrogate for evaluating surgical techniques [32,33]. In a meta-analysis comparing RARP with RRP positive surgical margins, the absolute difference was 8.0% (16.2 vs 24.2%, respectively); however, after propensity score adjustment, the occurrence of RARP and RRP positive margins was similar (odds ratio [OR]: 1.21; p = 0.19) [34]. In another meta-analysis by Tewari et al., the likelihood of RARP positive surgical margins compared favorably with those for RRP and laparoscopic RP, especially for organ-confined T2 disease [17]. However, in a review by Ficarra et al., RARP was associated with fewer positive surgical margins compared with RRP (relative risk:
future science group
Robotic versus standard prostatectomy: oncological & quality-of-life outcomes
1.58; 95% CI: 1.29–1.94; p
Robotic and standard open radical prostatectomy: oncological and quality-of-life outcomes Prostate cancer is the second leading cause of cancer death among men in the USA. Use of robot-assisted radical prostatectomy (RARP) for the management of localized prostate cancer has increased dramatically in recent years. This review focuses on comparing quality of life following RARP versus retropubic radical prostatectomy. RARP is associated with improved perioperative outcomes, such as reduced blood loss and fewer transfusions. In addition, cancer control after RARP versus retropubic radical prostatectomy is equivalent, with similar incidences of positive surgical margins and comparable early oncological outcomes. RARP appears to provide advantages in recovery of continence, potency and quality of life compared with retropubic radical prostatectomy; however, methodological limitations exist in current literature. Keywords: continence n outcome n potency n prostate cancer n quality of life n retropubic prostatectomy n robot-assisted radical prostatectomy
Kuo-How Huang1,2, Stacey C Carter1, Ya-Chen Tina Shih3 & Jim C Hu*1 Institute of Urologic Oncology, Department of Urology, David Geffen School of Medicine, University of California, LA, USA 2 Department of Urology, National Taiwan University Hospital, Taipei, Taiwan 3 Section of Hospital Medicine, Department of Medicine, The University of Chicago, IL, USA *Author for correspondence: Tel.: +1 310 206 2355 Fax: +1 310 794 6789 [email protected] 1
Prostate cancer is the second leading cause of cancer death among men in the USA [1]. The management of prostate cancer remains controversial owing to the heterogeneous natural history of the disease and the risk of treatment-related side effects [2,3]. Nevertheless, radical prostatectomy (RP) remains the most popular treatment for localized disease [4], particularly among younger men, resulting in a lower risk of metastases and prostate cancer-specific mortality compared with watchful waiting [5]. While open retropubic RP (RRP) is the traditional surgical approach, robotassisted RP (RARP) was first described in 2000 and has been rapidly adopted [6], currently comprising the majority of RPs performed in the USA [7,8]. As of 2009, Intuitive Surgical® (CA, USA), the device manufacturer for the da Vinci® Surgical System, installed 1395 robotic systems worldwide, 1028 in the USA and 248 in Europe [9]. Robotic surgery incurs high fixed costs for hospitals; installation of the robot costs more than US$1.5 million with additional maintenance costs estimated at US$150,000 per year. Moreover, robotic instruments cost approximately US$1500 per RARP case [10,11]. With the advent and aggressive marketing of RARP, the total number of RPs performed has increased overall, suggesting that men who may otherwise have opted for other definitive therapies or active surveillance instead elected to undergo RARP [7]. The greatest revolution in prostate cancer surgery was the introduction of the anatomic, retropubic approach by Walsh and Donker in the early 1980s, which reduced blood loss and improved postprostatectomy urinary continence and erectile function [12]. The introduction of laparoscopic and robotic approaches has not led to markedly improved functional outcomes. Nevertheless, minimally invasive approaches use multiple smaller incisions versus one larger incision and provide 10× magnification of the surgical field as compared with RRP [13]. In addition, population-based studies have shown that RARP is associated with fewer transfusions, fewer perioperative complications and deaths, shorter lengths of hospital stay and fewer anastomotic strictures compared with RRP [14,15]. Similarly, a meta-analysis of 167,184 RRPs and 62,389 RARPs demonstrated that RARP provides significant perioperative
10.2217/CER.13.23 © 2013 Future Medicine Ltd
2(3), 293–299 (2013)
part of
ISSN 2042-6305
293
Review
Huang, Carter, Shih & Hu
advantages, including decreased blood loss, fewer blood transfusions, shorter length of hospital stay and fewer adverse events compared with RRP [16]. These findings were confirmed in a second meta-analysis comparing perioperative outcomes, which also demonstrated significantly reduced blood loss and fewer transfusions for RARP versus RRP, whereas operative times and overall complications were similar [17]. Although robotic surgery is costly and has a prolonged learning curve [18], the decreased blood loss, fewer transfusions and complications, shorter hospitalization and rapid convalescence may justify the additional expense of the robotic approach [19,20]. Scales et al. identified the cost-equivalence of RARP with RRP at ten RARPs per week and cost superiority at 14 RARPs per week [21]. A study of the shortterm cost–effectiveness of RARP versus RRP demonstrated that RARP was more costly than RRP and did not result in any gains in qualityadjusted life-years at 1-year after surgery [22]. Despite the cost disadvantage of RARP versus RRP, the vast majority of RPs in the USA are now performed robotically [7]. However, there continues to be a need for methodologically rigorous studies to determine whether RARP is cost effective in high-volume centers when factoring in the fewer complications and deaths, shorter lengths of hospital stay and shorter convalescence [9]. Given the potential difficulties in achieving patient and surgeon equipoise in generating level 1 evidence demonstrating superior outcomes in favor of RARP versus RRP and spiraling healthcare costs and rapid adoption of expensive robotic technology, the Institute of Medicine has prioritized robotic-assisted surgery for comparative effectiveness research [101]. Prostate-specific antigen (PSA) screening has led to a significant increase in detection of clinically localized prostate cancer [23,24]. Although randomized controlled trials on the efficacy of PSA screening demonstrated conflicting results [25,26], the US Preventative Services Task Force recommended against PSA screening [27]. However, aggressive marketing and our social affinity for new technology has spurred the propagation of RARP. Moreover, studies comparing active surveillance with RP have demonstrated active surveillance to be a sound approach for men aged over 70 years, especially those with comorbidities, or for younger men with very low-risk disease features [28]. Therefore, many
294
J. Compar. Effect. Res. (2013) 2(3)
men with these features who underwent RARP were suitable for active surveillance, without temporary or permanent deficits in urinary continence, erectile dysfunction or disease progression [29]. Therefore, the goal of the current study was to conduct a rigorous comparative effectiveness review of oncological and quality-of-life outcomes following RARP versus RRP (Table 1). This is particularly relevant for prostate cancer, which typically has an indolent clinical course such that treatment sequelae may be worse than the disease itself. Methods
A review of the English language literature was performed using the PubMed database from 2001 to 2012. Relevant reports published were identified using the following keywords: robot or robotic prostatectomy and open or retropubic prostatectomy. Among 267 papers, 202 papers were excluded, including 164 noncomparative and/or small case series, six studies published only as abstracts and/or reports from conferences and 32 studies reporting surgeon-reported outcomes. A total of 60 original and review articles providing data on oncological, functional (e.g., incontinence and erectile function) and quality-of-life outcomes were included in the review. Results ■■ Oncological outcomes Positive surgical margin
Although surgical margins may not reliably serve as a surrogate end point for prostate cancer-specific mortality, positive surgical margins are associated with a significantly greater risk for biochemical recurrence and the need for salvage treatment [30,31]. In addition, positive surgical margins may be used as a surrogate for evaluating surgical techniques [32,33]. In a meta-analysis comparing RARP with RRP positive surgical margins, the absolute difference was 8.0% (16.2 vs 24.2%, respectively); however, after propensity score adjustment, the occurrence of RARP and RRP positive margins was similar (odds ratio [OR]: 1.21; p = 0.19) [34]. In another meta-analysis by Tewari et al., the likelihood of RARP positive surgical margins compared favorably with those for RRP and laparoscopic RP, especially for organ-confined T2 disease [17]. However, in a review by Ficarra et al., RARP was associated with fewer positive surgical margins compared with RRP (relative risk:
future science group
Robotic versus standard prostatectomy: oncological & quality-of-life outcomes
1.58; 95% CI: 1.29–1.94; p
