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The Devil Is in the Details
EUROPEAN UROLOGY 59 (2011) 708–711
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 702–707 of this issue
The Devil Is in the Details James A. Eastham *, Peter T. Scardino Memorial Sloan-Kettering Cancer Center, New York, NY, USA
Patients with a diagnosis of clinically localized prostate cancer face a daunting variety of treatment choices, including conservative management (watchful waiting or active surveillance), cryotherapy, high-intensity focused ultrasound, brachytherapy and/or external-beam radiation therapy with or without concurrent hormonal therapy, and surgery. To make an appropriate treatment choice, a patient must weigh the threat posed by the cancer, the effectiveness of the treatment in rendering him cancer-free, his life expectancy, and the potential side effects of the treatment. An appropriate decision can be made only by having an accurate estimate of each of these factors. Previous studies have evaluated patient regret after radical prostatectomy (RP). Schroeck et al examined variables influencing satisfaction and regret in men who had undergone retropubic RP (RRP) or robot-assisted laparoscopic RP (RALP) between 2000 and 2007 [1]. Patients were mailed cross-sectional surveys composed of sociodemographic information, the Expanded Prostate Cancer Index Composite (EPIC), and questions regarding satisfaction and regret. A total of 400 patients responded (61% response rate), of which 84% were satisfied and 19% regretted their treatment choice. In terms of regret, RALP versus RRP (odds ratio [OR]: 3.02; 95% confidence interval [CI], 1.50–6.07), lower urinary domain scores (OR: 0.58; 95% CI, 0.37–0.91), hormonal domain scores (OR: 0.67; 95% CI, 0.45–0.98), and years since surgery (OR: 1.63; 95% CI, 1.13– 2.36) were predictive ( p 0.041). Although sociodemographic factors and quality of life were important variables associated with satisfaction and regret, patients who underwent RALP were more likely to be regretful and dissatisfied, possibly because of higher expectations of an ‘‘innovative’’ procedure. The investigators suggested that urologists carefully portray the risks and benefits of RP
during preoperative counseling to minimize regret and maximize satisfaction. Numerous reports are available documenting the individual risks of erectile dysfunction (ED), incontinence, and disease recurrence after RP, but in isolation, they do not adequately inform patients of the possibility of becoming cancer-free while returning to their preoperative functional state. In an effort to better inform patients about outcomes after RP, Salomon et al proposed a scoring system to assess functional and oncologic outcomes following RP [2]. We and others agreed with the assertion that data on cancer control, continence, or potency in isolation are not sufficient for decision making and that patients agreeing to RP should be informed of functional results in the context of cancer control, the so-called trifecta [3,4]. Models have been developed based on variables available preoperatively to estimate the likelihood that a man undergoing RP will be cancer-free while recovering continence and potency [2,3]. Noting the concept of the trifecta, Patel et al propose the pentafecta: freedom from biochemical recurrence (BCR), recovery of continence and potency, no perioperative complications, and a negative surgical margin [5]. The investigators state in their results that ‘‘the pentafecta rate at 12 mo was 70.8%.’’ Should the average patient undergoing RP by this surgeon be counseled that the likelihood of achieving pentafecta is 70.8%? The answer is an emphatic no. Let’s look more closely at the data used to estimate the rate of pentafecta in this series. The total study population is 1111 consecutive patients. Immediately, 485 men (44%) are eliminated because they are considered to have ED (Sexual Health Inventory for Men [SHIM] score 20) prior to RP. This percentage is perplexingly high considering that the mean age is 58.6 yr. The second exclusion is potent men (the remaining 626 patients) not undergoing bilateral
DOI of original article: 10.1016/j.eururo.2011.01.032 * Corresponding author. Memorial Sloan-Kettering Cancer Center, Department of Urology, 353 East 68th Street, Suite 527, New York, NY 10021, USA. Tel. +1 646 422 4390; Fax: +1 212 988 0759. E-mail address: [email protected] (J.A. Eastham). 0302-2838/$ – see back matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 59 (2011) 708–711
neurovascular bundle (NVB) preservation. This exclusion is odd in that prior to RP (when the man is being counseled about his likelihood to achieve pentafecta), the intraoperative assessment of the status of the NVBs is unknown. As such, all potent men, regardless of the ultimate assessment of their NVB status, should be included in this analysis. Regardless, the investigators exclude an additional 294 men based on NVB status, leaving only 332 (30%) of the original 1111 men as candidates to achieve pentafecta. Viewed in this light, the overall pentafecta rate for the entire population is 21% (70.8% 332/1111); if only potent men are evaluated, the estimated likelihood of pentafecta is 38% (70.8% 332/626). Which of these figures—21%, 38%, or 70.8%—is likely to be quoted to the patient? Several other aspects of this analysis should be highlighted. The investigators demonstrate that the procedure can be performed safely. Using a validated, internationally accepted method for recording the severity of complications, the incidence of major complications (grade 3) in this series was <1.5%, which is certainly quite good. Follow-up for the end point of BCR was only 12 mo. With appropriate longerterm follow-up, there will be a far higher rate of BCR than the 3.6% noted by Patel et al, thus producing an overestimate of the pentafecta rate. The definition of potency is different when used preoperatively (SHIM >21) and postoperatively (ability to achieve and maintain erections firm enough for penetration at least 50% of the time). The stringent preoperative definition excludes a man with even a hint of ED, yet the postoperative definition would include many men who have SHIM scores far lower than 21. This disparity is disingenuous when counseling a patient regarding the fidelity of his functional outcomes and implies that a perfect recovery is likely when, in truth, it is defined as something less. It is little wonder that patient disappointment can result. The rate of positive surgical margins (PSMs) is concerning, especially considering the low-risk nature of the study population. The overall PSM rate was an acceptable 9.3%, but this is driven by the overwhelming percentage of pT2 cancers. In patients with pT3 cancers, the PSM rate was 33.3%, a rate far higher than has been reported [6,7]. Swindle et al, for example, reported a 23% likelihood of a PSMs in 522 patients with pT3 cancer [6]. Additionally, this is an amazingly low-risk group to be undergoing any treatment. Fully 67% of the study population is low risk using D’Amico risk classification. In comparison, our group performed RP on 1968 men between 2008 and 2010, and
709
33% were low risk, 52% were intermediate risk, and 16% were high risk. Certainly many of the patients in the series by Patel et al. [5] would have been better served with active surveillance. The investigators state that these patients ‘‘desire’’ surgery (the leading line in the conclusion), but the enthusiasm with which the patient was presented treatment alternatives may better explain their ultimate satisfaction. How can patient satisfaction with RP be improved? The simple answer is to be truthful. The surgeon should provide the patient with a realistic understanding of the probable outcomes at that individual surgeon’s hand. The surgeon should discuss his or her own results rather than describe the ‘‘best case scenario’’ from the literature. Actual, rather than theoretical, data should be provided. The benefit to the patient is that he will know what to expect. The benefit to the surgeon is not only having a patient who is more likely to be satisfied with his outcome but also identifying areas where technique might be modified to improve results. Conflicts of interest: The authors have nothing to disclose.
References [1] Schroeck FR, Krupski TL, Sun L, et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol 2008;54:785–93. [2] Salomon L, Saint F, Anastasiadis AG, et al. Combined reporting of cancer control and functional results of radical prostatectomy. Eur Urol 2003;44:656–60. [3] Saranchuk JW, Kattan MW, Elkin E, Touijer AK, Scardino PT, Eastham JA. Achieving optimal outcomes after radical prostatectomy. J Clin Oncol 2005;23:4146–51. [4] Pierorazio PM, Spencer BA, McCann TR, McKiernan JM, Benson MC. Preoperative risk stratification predicts likelihood of concurrent PSA-free survival, continence, and potency (the trifecta analysis) after radical retropubic prostatectomy. Urology 2007;70:717–22. [5] Patel VP, Ananthakrishnan S, Coelho RF, et al. Pentafecta: a new concept for reporting outcomes of robot-assisted laparoscopic radical prostatectomy. Eur Urol 2011;59:702–7. [6] Swindle P, Eastham JA, Ohori M, et al. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol 2008;179(Suppl):S47–51. [7] Eastham JA, Kuroiwa K, Ohori M, et al. Prognostic significance of location of positive margins in radical prostatectomy specimens. Urology 2007;70:965–9. doi:10.1016/j.eururo.2011.01.049
available at www.sciencedirect.com journal homepage: www.europeanurology.com
Platinum Priority – Editorial Referring to the article published on pp. 702–707 of this issue
The Devil Is in the Details James A. Eastham *, Peter T. Scardino Memorial Sloan-Kettering Cancer Center, New York, NY, USA
Patients with a diagnosis of clinically localized prostate cancer face a daunting variety of treatment choices, including conservative management (watchful waiting or active surveillance), cryotherapy, high-intensity focused ultrasound, brachytherapy and/or external-beam radiation therapy with or without concurrent hormonal therapy, and surgery. To make an appropriate treatment choice, a patient must weigh the threat posed by the cancer, the effectiveness of the treatment in rendering him cancer-free, his life expectancy, and the potential side effects of the treatment. An appropriate decision can be made only by having an accurate estimate of each of these factors. Previous studies have evaluated patient regret after radical prostatectomy (RP). Schroeck et al examined variables influencing satisfaction and regret in men who had undergone retropubic RP (RRP) or robot-assisted laparoscopic RP (RALP) between 2000 and 2007 [1]. Patients were mailed cross-sectional surveys composed of sociodemographic information, the Expanded Prostate Cancer Index Composite (EPIC), and questions regarding satisfaction and regret. A total of 400 patients responded (61% response rate), of which 84% were satisfied and 19% regretted their treatment choice. In terms of regret, RALP versus RRP (odds ratio [OR]: 3.02; 95% confidence interval [CI], 1.50–6.07), lower urinary domain scores (OR: 0.58; 95% CI, 0.37–0.91), hormonal domain scores (OR: 0.67; 95% CI, 0.45–0.98), and years since surgery (OR: 1.63; 95% CI, 1.13– 2.36) were predictive ( p 0.041). Although sociodemographic factors and quality of life were important variables associated with satisfaction and regret, patients who underwent RALP were more likely to be regretful and dissatisfied, possibly because of higher expectations of an ‘‘innovative’’ procedure. The investigators suggested that urologists carefully portray the risks and benefits of RP
during preoperative counseling to minimize regret and maximize satisfaction. Numerous reports are available documenting the individual risks of erectile dysfunction (ED), incontinence, and disease recurrence after RP, but in isolation, they do not adequately inform patients of the possibility of becoming cancer-free while returning to their preoperative functional state. In an effort to better inform patients about outcomes after RP, Salomon et al proposed a scoring system to assess functional and oncologic outcomes following RP [2]. We and others agreed with the assertion that data on cancer control, continence, or potency in isolation are not sufficient for decision making and that patients agreeing to RP should be informed of functional results in the context of cancer control, the so-called trifecta [3,4]. Models have been developed based on variables available preoperatively to estimate the likelihood that a man undergoing RP will be cancer-free while recovering continence and potency [2,3]. Noting the concept of the trifecta, Patel et al propose the pentafecta: freedom from biochemical recurrence (BCR), recovery of continence and potency, no perioperative complications, and a negative surgical margin [5]. The investigators state in their results that ‘‘the pentafecta rate at 12 mo was 70.8%.’’ Should the average patient undergoing RP by this surgeon be counseled that the likelihood of achieving pentafecta is 70.8%? The answer is an emphatic no. Let’s look more closely at the data used to estimate the rate of pentafecta in this series. The total study population is 1111 consecutive patients. Immediately, 485 men (44%) are eliminated because they are considered to have ED (Sexual Health Inventory for Men [SHIM] score 20) prior to RP. This percentage is perplexingly high considering that the mean age is 58.6 yr. The second exclusion is potent men (the remaining 626 patients) not undergoing bilateral
DOI of original article: 10.1016/j.eururo.2011.01.032 * Corresponding author. Memorial Sloan-Kettering Cancer Center, Department of Urology, 353 East 68th Street, Suite 527, New York, NY 10021, USA. Tel. +1 646 422 4390; Fax: +1 212 988 0759. E-mail address: [email protected] (J.A. Eastham). 0302-2838/$ – see back matter # 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.
EUROPEAN UROLOGY 59 (2011) 708–711
neurovascular bundle (NVB) preservation. This exclusion is odd in that prior to RP (when the man is being counseled about his likelihood to achieve pentafecta), the intraoperative assessment of the status of the NVBs is unknown. As such, all potent men, regardless of the ultimate assessment of their NVB status, should be included in this analysis. Regardless, the investigators exclude an additional 294 men based on NVB status, leaving only 332 (30%) of the original 1111 men as candidates to achieve pentafecta. Viewed in this light, the overall pentafecta rate for the entire population is 21% (70.8% 332/1111); if only potent men are evaluated, the estimated likelihood of pentafecta is 38% (70.8% 332/626). Which of these figures—21%, 38%, or 70.8%—is likely to be quoted to the patient? Several other aspects of this analysis should be highlighted. The investigators demonstrate that the procedure can be performed safely. Using a validated, internationally accepted method for recording the severity of complications, the incidence of major complications (grade 3) in this series was <1.5%, which is certainly quite good. Follow-up for the end point of BCR was only 12 mo. With appropriate longerterm follow-up, there will be a far higher rate of BCR than the 3.6% noted by Patel et al, thus producing an overestimate of the pentafecta rate. The definition of potency is different when used preoperatively (SHIM >21) and postoperatively (ability to achieve and maintain erections firm enough for penetration at least 50% of the time). The stringent preoperative definition excludes a man with even a hint of ED, yet the postoperative definition would include many men who have SHIM scores far lower than 21. This disparity is disingenuous when counseling a patient regarding the fidelity of his functional outcomes and implies that a perfect recovery is likely when, in truth, it is defined as something less. It is little wonder that patient disappointment can result. The rate of positive surgical margins (PSMs) is concerning, especially considering the low-risk nature of the study population. The overall PSM rate was an acceptable 9.3%, but this is driven by the overwhelming percentage of pT2 cancers. In patients with pT3 cancers, the PSM rate was 33.3%, a rate far higher than has been reported [6,7]. Swindle et al, for example, reported a 23% likelihood of a PSMs in 522 patients with pT3 cancer [6]. Additionally, this is an amazingly low-risk group to be undergoing any treatment. Fully 67% of the study population is low risk using D’Amico risk classification. In comparison, our group performed RP on 1968 men between 2008 and 2010, and
709
33% were low risk, 52% were intermediate risk, and 16% were high risk. Certainly many of the patients in the series by Patel et al. [5] would have been better served with active surveillance. The investigators state that these patients ‘‘desire’’ surgery (the leading line in the conclusion), but the enthusiasm with which the patient was presented treatment alternatives may better explain their ultimate satisfaction. How can patient satisfaction with RP be improved? The simple answer is to be truthful. The surgeon should provide the patient with a realistic understanding of the probable outcomes at that individual surgeon’s hand. The surgeon should discuss his or her own results rather than describe the ‘‘best case scenario’’ from the literature. Actual, rather than theoretical, data should be provided. The benefit to the patient is that he will know what to expect. The benefit to the surgeon is not only having a patient who is more likely to be satisfied with his outcome but also identifying areas where technique might be modified to improve results. Conflicts of interest: The authors have nothing to disclose.
References [1] Schroeck FR, Krupski TL, Sun L, et al. Satisfaction and regret after open retropubic or robot-assisted laparoscopic radical prostatectomy. Eur Urol 2008;54:785–93. [2] Salomon L, Saint F, Anastasiadis AG, et al. Combined reporting of cancer control and functional results of radical prostatectomy. Eur Urol 2003;44:656–60. [3] Saranchuk JW, Kattan MW, Elkin E, Touijer AK, Scardino PT, Eastham JA. Achieving optimal outcomes after radical prostatectomy. J Clin Oncol 2005;23:4146–51. [4] Pierorazio PM, Spencer BA, McCann TR, McKiernan JM, Benson MC. Preoperative risk stratification predicts likelihood of concurrent PSA-free survival, continence, and potency (the trifecta analysis) after radical retropubic prostatectomy. Urology 2007;70:717–22. [5] Patel VP, Ananthakrishnan S, Coelho RF, et al. Pentafecta: a new concept for reporting outcomes of robot-assisted laparoscopic radical prostatectomy. Eur Urol 2011;59:702–7. [6] Swindle P, Eastham JA, Ohori M, et al. Do margins matter? The prognostic significance of positive surgical margins in radical prostatectomy specimens. J Urol 2008;179(Suppl):S47–51. [7] Eastham JA, Kuroiwa K, Ohori M, et al. Prognostic significance of location of positive margins in radical prostatectomy specimens. Urology 2007;70:965–9. doi:10.1016/j.eururo.2011.01.049