Combined Reporting of Cancer Control and Functional Results of Radical Prostatectomy $

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1 European Urology European Urology 44 (2003) Combined Reporting of Cancer Control and Functional Results of Radical Prostatectomy $ Laurent Salomon a,*, Fabien Saint a, Aristotelis G. Anastasiadis b, Philippe Sebe a, Dominique Chopin a, Clément-Claude Abbou a a Department of Urology, Henri Mondor Hospital, Assistance Publique des Hôpitaux de Paris, EMI 03-37, 51 avenue du Maréchal de Lattre de Tassigny, Creteil Cedex, France b Department of Urology, University of Tübingen, Tübingen, Germany Accepted 12 September 2003 First published online 2 October 2003 Abstract Introduction: The results of radical prostatectomy (cancer control, continence and sexual potency) are currently presented separately, while the success of this surgery depends on a combination of good cancer control with maintenance of continence and erections. We propose a score to jointly evaluate and report cancer control and functional results. Methods: The results of 205 radical prostatectomies were studied at one year. Cancer control was evaluated by PSA. Continence and sexual potency were evaluated by a self-administered questionnaire. Each patient was attributed 0 or 4 points according to the presence of absence of biochemical progression (PSA > 0:2 ng/ml), 0 or 2 points according to the presence or absence of urinary incontinence (use of pads) and 0 or 1 point according to the presence or absence of impotence (no erections). The sum of these points provided a score classifying the patient into 8 distinct categories, from 0 to 7, each corresponding to a specific status (from 0 (0 þ 0 þ 0): no cancer controlincontinence-impotence to 7 (4 þ 2 þ 1): cancer control-continence-sexual potency). Results: One year after the operation, 175 (85%) of patients had a PSA less than 0.2 ng/ml, 135 (65.8%) were continent and 64 (32.7%) reported erections. All patients with a score 4 had good cancer control, with no functional disorders for a score of 7 (4 þ 2 þ 1) (20%), no disorders of continence for a score of 6 (4 þ 2 þ 0) (31.5%), no disorders of erection for a score of 5 (4 þ 0 þ 1) (8.3%), or with incontinence and impotence for a score of 4 (4 þ 0 þ 0) (21.9%). All patients with a score <4 had a PSA > 0:2 ng/ml, but with no functional disorders for a score of 3 (0 þ 2 þ 1) (2.4%), no incontinence for a score of 2 (0 þ 2 þ 0) (8.3%), and no impotence for a score of 1 (0 þ 0 þ 1) (1.9%). 1.9% of patients were incontinent, impotent and showed signs of biochemical progression (score 0 ¼ 0 þ 0 þ 0). Conclusion: This score allows analysis of the global (cancer control and functional) results of radical prostatectomy and would facilitate comparisons between various surgical techniques (type of approach, nerve-sparing techniques) and various centres. # 2003 Elsevier B.V. All rights reserved. Keywords: Prostate cancer; Radical prostatectomy; Outcome assessment; Erectile dysfunction; Urinary incontinence 1. Introduction $ Co-published in Progrès en Urologie. * Corresponding author. Tel. þ ; Fax: þ address: laurent.salomon@hmn.ap-hop-paris.fr (L. Salomon). Radical prostatectomy is one of the main curative treatments for localized prostate cancer and can be performed via a retropubic or perineal approach and, since 1997, by laparoscopy [1 3]. Most urologists use /$ see front matter # 2003 Elsevier B.V. All rights reserved. doi: /j.eururo

2 L. Salomon et al. / European Urology 44 (2003) the retropubic approach described by Walsh [4]. According to Walsh, the objectives of radical prostatectomy are cancer control, preservation of continence and possibly erections [5]. However, the population of patients presenting with localized prostate cancer has changed over the last 10 years: the majority of patients now have low PSA levels, a Gleason score on positive biopsies 6 and normal digital rectal examination (clinical stage T1c) [6]. As the cancer control has been considerably improved in this patient population, the functional results (postoperative continence and sexual potency) are becoming increasingly important for these patients. Although most operated patients consider that their sex life or even their urinary continence take second place to the possibility of curing their cancer, they are nevertheless not indifferent to these functional results [7,8]. The results of radical prostatectomy (cancer control, continence and sexual potency) are usually presented separately. Monitoring of postoperative PSA is used to detect biochemical progression and to present the results according to biochemical progression-free survival in the form of Kaplan Meier survival curves [9], while urinary continence is evaluated by the number of pads used and sexual potency is evaluated according to the status of the neurovascular bundles [10 12]. However, the criteria for success of radical prostatectomy must combine good cancer control, good postoperative continence and maintenance of sexual potency. Although the results of this operation have been abundantly described in the literature, it is impossible to determine, due to the way in which these results are presented, whether patients who obtained good cancer control also obtained a good functional result. The objective of this study is to propose a new method, based on a simple score, in order to report the combined cancer control and functional (continence and sexual potency) results of radical prostatectomy. 2. Methods 2.1. Determination of the score We have devised a simple score based on the following criteria: Each patient is attributed: 4 points if the PSA level <0.2 ng/ml or 0 points if PSA >0.2 ng/ml 2 points if he is continent or 0 points if he is incontinent 1 point if he has erections or 0 points if he is impotent. The sum of these points corresponds to the score, which ranges from a score of 0 (0 þ 0 þ 0) (cancer control, incontinence and impotence) to a score of 7 (4 þ 2 þ 1) (good cancer control, continence and sexual potency) and each score corresponds to a particular clinical situation. Table 1 Patient characteristics (205 patients) Age (years) (46 77) PSA (ng/ml) (1.2 80) Gleason score (biopsies) (3 10) Clinical stage T1a b 4 (1.9%) T1c 146 (71.2%) T2a 49 (23.9%) T2b 6 (2.9%) Weight of specimen (g) (20 210) Gleason score (specimen) 6.7 1(4 10) Pathological stage pt2a 25 (12.2%) pt2b 122 (59.5%) pt3a 37 (18.1%) pt3b 21 (10.2%) Nþ 4 (1.9%) Positive surgical margins 48 (23.4%) 2.2. Patients We used this score to evaluate the results of 205 radical prostatectomies performed consecutively between 1998 and 2000 by retropubic, perineal and laparoscopic approaches. Clinical examination and preoperative PSA assay (Hybritech, normal <4 ng/ml) were performed in all patients. Ultrasound-guided transrectal biopsies were performed. Radical prostatectomy specimens were analysed according to the Stanford technique by the same pathologist [13]. The prostate weight, pathological stage according to the TNM 1997 classification [14] and the surgical margin status were studied. The data for the 205 patients are presented in Table 1. The results of radical prostatectomy were evaluated one year after the operation in the following way Cancer control Postoperative follow-up comprised clinical examination and postoperative PSA assay one month and three months after the operation, then every 6 months. Biochemical progression was defined by a postoperative PSA >0.2 ng/ml [9] Functional results All patients prospectively completed a self-administered questionnaire concerning their voiding and sexual disorders, preoperatively and 1, 3, 6, and 12 months after the operation [15]. The results at one year are reported here. Urinary continence was defined as the absence of pads, and sexual potency was defined by the presence of erections allowing sexual intercourse with penetration, with or without sildenafil. Patients using other medications, such as intracavernous prostaglandin injections, intraurethral prostaglandin gel or a vacuum were considered to be impotent. 3. Results One year after radical prostatectomy, 175 (85.4%) patients had a PSA level <0.2 ng/ml (Fig. 1), 135 (65.8%) were continent and 64 (32.7%) were potent.

3 658 L. Salomon et al. / European Urology 44 (2003) Patients (%) Cum. Survival ,8,6,4,2 0 The mean score was 5:05 1:78 with a median score of 6. Patients with a score >4 obtained good cancer control and consisted of 41 (20%) continent and potent patients (score 7 ¼ 4 þ 2 þ 1), 72 (35.1%) continent but impotent patients (score 6 ¼ 4 þ 2 þ 0), 17 (8.3%) incontinent and potent patients (score 5 ¼ 4 þ 0 þ 1) and 45 (21.9%) incontinent and impotent patients (score 4 ¼ 4 þ 0 þ 0). Similarly, patients with a score <4 did not obtain good cancer control and consisted of 5 (2.4%) continent and potent patients (score 3 ¼ 0 þ 2 þ 1), 17 (8.3%) continent but impotent patients (score 2 ¼ 0 þ 2 þ 0), and 4 (1.9%) incontinent and potent patients (score 1 ¼ 0 þ 0 þ 1). Finally 4 (1.9%) patients did not obtain good cancer control, and were incontinent and impotent (score 0 ¼ 0 þ 0 þ 0) (Fig. 2). 4. Discussion Follow-up (months) Fig. 1. Biochemical progression-free actuarial survival Score Fig. 2. Score distribution of the 205 patients. The objectives of radical prostatectomy are cancer control, and maintenance of urinary continence and sexual potency [5]. With the use of PSA as a screening tool, localized prostatic tumours are now discovered in young men [6]. In these patients, in whom cancer control is usually obtained, the functional results still remain relatively unsatisfactory [4,10,11]. Maintenance of quality of life is going to become increasingly important with improvement of cancer control. The long-term complications of radical prostatectomy are urinary incontinence and erectile dysfunction, which have negative repercussions on the patient s quality of life [16,17]. However, incontinence and erectile dysfunction do not influence the desire to be cured of the cancer and do not cause patients to regret their treatment, as, despite these consequences, most patients would have chosen the same treatment [16,19]. They are usually satisfied with treatment and accept the subsequent disorders of continence and erection [7,17,19]. However, separate presentation of the cancer control and functional results of radical prostatectomy does not provide the patient with sufficiently precise information and these patients should be provided with functional results reported in combination with cancer control results [18]. Cancer control and functional results can now be presented together by means of the score developed in this study. Biochemical progression was defined by the postoperative PSA level [9]. The results on continence and potency, obtained by non-objective processes or directly by the surgeon, are no longer considered to be the best method to evaluate functional disorders [10]. Since 1998, we have used a prospective method based on a self-administered questionnaire completed by the patient in the absence of any medical intervention. By using this questionnaire, we defined continence as the absence of pads. Like Walsh et al., we defined sexual potency as the presence of erections allowing sexual intercourse with penetration [12]. There is obviously no clearly defined consensus concerning the definition of continence and sexual potency after radical prostatectomy, but the purpose of this study was not to propose these definitions, but to propose a way of combined presentation of the results of radical prostatectomy. We allocated scores of 4 points, 2 points and 1 point, respectively when cancer control, urinary continence and sexual potency were obtained according to our definitions. Cancer control is the primary objective of radical prostatectomy [5], and urinary continence appears to have greater repercussions on quality of life than sexual potency. Urinary incontinence induces more severe disorders and repercussions on social life than erectile dysfunction, as demonstrated by Fowler et al. [7]. However, it was not for these reasons that we

4 L. Salomon et al. / European Urology 44 (2003) proposed 4 points, 2 points and 1 point, respectively for cancer control, urinary continence and sexual potency, as this system provides us with 8 different scores, each corresponding to a precise clinical situation. For example, a patient with a score of 5 is inevitably a patient with good cancer control, incontinent, but with preserved sexual potency (score 5 ¼ 4 þ 0 þ 1). A patient with a score of 3 (score 3 ¼ 0 þ 2 þ 1) is inevitably a potent and continent patient, but without good cancer control. The same results would not have been obtained if we had used scores of 3, 2 and 1 points. Like Litwin et al. [17], our one-year results show that not all patients with good cancer control are continent or potent. One year after surgery, 85.4% patients have good cancer control, 65.8% are continent, and 32.7% have preserved sexual potency. On the basis of the score proposed here, the three objectives of radical prostatectomy are achieved in only 22.6% of patients (score 7 ¼ 4 þ 2 þ 1) and 35.1% of patients have good cancer control and remain continent (score 6 ¼ 4 þ 2 þ 0). These results obviously depend on the preoperative assessment, patient selection, the surgical techniques used (for example nerve-sparing techniques) and histological results. It would be perfectly feasible to use this score to report the results of radical prostatectomy in a given population of operated patients: for example, what proportion of patients undergoing radical prostatectomy with bilateral neurovascular bundle preservation have a score of 7? The score may also change with time, as the patient s clinical situation changes with improvement of postoperative continence and erectile dysfunction. We used this score at one year exclusively to demonstrate its potential value, but a longer follow-up would obviously be required to evaluate the results of radical prostatectomy in this series of 205 patients. This was not the objective of the present study, which, as shown in Fig. 2, was designed to present the three components of the results of radical prostatectomy on a single diagram. Finally, this score could be used to easily compare the results of radical prostatectomy according to the various surgical techniques used and between various centres. 5. Conclusion We have designed a score allowing us to evaluate and present the combined results of radical prostatectomies (cancer control and functional results). This score could be used to easily compare the results of radical prostatectomy according to the various surgical techniques used and between various centres. Appendix A. Questionnaire During the day... Do you leak urine with no apparent reason and without feeling the need to urinate? Sometimes (less than once a week) Often (at least once a day) All the time Under what circumstances does it happen? During intense effort (sport, carrying suitcases, etc.) During moderate effort (climbing stairs, etc.) During the slightest effort (coughing, laughing, etc.) Do you wear pads during the day? As a precaution Not more than 1 pad/day More than 1 pad During the night... Do you leak urine during your sleep? Sometimes (less than once a week) Often (at least once a week) All the night

5 660 L. Salomon et al. / European Urology 44 (2003) Do you use pads at night? As a precaution Not more than 1 pad/day More than 1 pad Sexuality Do you desire to have sexual intercourse? Yes No Do you have sexual intercourse? Yes No Do you get erections? Yes, normal erections Yes, not very rigid, but sufficicnt for full intercourse Yes, but not rigid enough for full intercourse No erections References [1] Young HH. The early diagnosis and radical cure of carcinoma of the prostate: being a study of 40 cases and presentation of a radical operation which was carried out in four cases. Bull Johns Hopkins Univ 1905;16: [2] Millin T. Retropubic prostatectomy: a new extravesical technique. Report on 20 cases. Lancet 1945;2: [3] Schuessler WW, Shulam PG, Clayman RY, Kavoussi LR. Laparoscopic radical prostatectomy: initial short term experience. Urology 1997;50: [4] Walsh PC, Lepor H, Eggleston JD. Radical prostatectomy with preservation of sexual function: anatomical and pathological considerations. Prostate 1983;4: [5] Walsh PC. The status of radical prostatectomy in the United States in Where do we go from here? J Urol 1994;152:1816. [6] Partin AW, Mangold LA, Lamm DM, Walsh PC, Epstein JI, Pearson JD. Contemporary update of prostate cancer staging nomograms (Partin Tables) for the new millenium. Urology 2001;58: [7] Fowler FJ, Barry MJ, Lu-Yao G, Wasson J, Roman A, Wennberg J. Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a medicare survey. Urology 1995;45: [8] Talcott JA, Rieker P, Propert KJ, Clark JA, Wishnow KI, Loughlin KR, et al. Patient-reported impotence and incontinence after nervesparing radical prostatectomy. J Natl Cancer Inst 1997;89: [9] Pound CR, Partin AW, Epstein JI, Walsh PC. Prostate-Specific Antigen after anatomic radical retropubic prostatectomy. Urol Clin North Am 1997;24: [10] Catalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, continence and complications rates in 1870 consecutive radical retropubic prostatectomies. J Urol 1999;159: [11] Quinlan DM, Epstein JI, Carter BS, Walsh PC. Sexual function following radical prostatectomy: influence of preservation of neurovascular bundles. J Urol 1991;145: [12] Walsh PC, Marschke P, Ricker D, Burnett AL. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. Urology 2000;55: [13] Stamey TA, Mcneal JE, Freiha FS, Redwine E. Morphometric and clinical studies on 68 consecutive radical prostatectomies. J Urol 1988;139: [14] TNM Classification of Malignant Tumors: International Union Against Cancer. In: Sobin LH, Wittekind C, editors. 5th ed., New York: Wiley-Liss; p [15] Hoznek A, Salomon L, Olsson LE, Antiphon P, Saint F, Cicco A, et al. Laparoscopic radical prostatectomy: the Créteil experience. Eur Urol 2001;40: [16] Herr HW. Quality of life of incontinent men after radical prostatectomy. J Urol 1994;151: [17] Litwin MS, Hays RD, Fink A, Ganz PA, Leake B, et al. Quality-oflife outcomes in men treated for localized prostate cancer. JAMA 1995;273: [18] Moul JW, Mooneyhan RM, Kao TC, McLeod DG, Cruess DF. Preoperative and operative factors to predict incontinence, impotence and stricture after radical prostatectomy. Prostate Cancer and Prostatic Diseases 1998;5: [19] Litwin MS, Pasta DJ, Yu J, Stoddard ML, Flanders SC. Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the cancer of the prostate strategic urologic research endeavor. J Urol 2000;164: