Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life

Transcription

1 Original Article JO et al. bju_5564.fm Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life YOSHIMASA JO, HIRATSUKA JUNICHI*, FUJII TOMOHIRO, IMAJO YOSHINARI* and FUJISAWA MASATO Departments of Urology and *Radiation Oncology, Kawasaki Medical School, Kurashiki, Japan Accepted for publication 11 February 5 OBJECTIVE To examine the effects of different treatments on the health-related quality of life (HRQoL) of men with localized prostate cancer. PATIENTS AND METHODS Between October 1997 and August 2, 182 men diagnosed with prostate cancer (T1c to T3bNM) had radical prostatectomy (RP, 89) or 192 iridium high-dose rate brachytherapy (HDR-BT, 93) with external beam radiotherapy, and were followed for 6 months. A postal survey was sent in which HRQoL was assessed using the 36-item Short-Form Health Survey (SF-36) QoL questionnaire, and disease- specific QoL using the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). RESULTS Questionnaire responses were obtained from 151 of 182 patients; there was no significant difference in SF-36 scale scores between men treated with RP or HDR-BT. In the UCLA-PCI, the HDR-BT group had better urinary function (P <.1) and sexual function scores (P =.43). Men treated with RP had better bowel bother scores (P =.27). In patients with 2 years of follow-up, urinary function (P <.1) and sexual bother (P =.29) were better for men treated with HDR-BT than for men treated with RP. Men treated with HDR- BT had significantly better urinary function (P =.9) and sexual bother (P =.13) even than 3 men treated with unilateral nervesparing RP. CONCLUSIONS In terms of HRQoL, RP and HDR-BT did not differ, but HDR-BT resulted in better urinary and sexual function than RP. When planning treatment, QoL concerns, including mental health issues associated with prostate cancer, need to be addressed with the patients, as do the potential side-effects. KEYWORDS prostate cancer, quality of life, high-dose-rate brachytherapy, prostatectomy INTRODUCTION The prognosis associated with localized prostate cancer is excellent, with a 5-year relative survival rate approaching 1% [1]. Quality of life (QoL) issues therefore are key to deciding among treatment options which can impinge on everyday activities to differing extents. Several therapeutic options for localized prostate cancer, including radical prostatectomy (RP), external beam radiotherapy (EB), and brachytherapy (BT), affect sexual, urinary, and bowel function deleteriously for many men. In general, men who undergo RP report more urinary dysfunction (greater incontinence and greater need to use absorptive pads) and more sexual dysfunction (reduced erectile capacity and decreased sexual desire) than men treated with EB [2 7]. Bowel dysfunction (urgency and diarrhoea) and irritative urinary dysfunction are reported more often by men treated with EB and BT than by men who undergo RP [4,6]. Several tools have been developed for evaluating QoL. The concept of health-related QoL (HRQoL) is multidimensional and includes physical, psychosocial and emotional status, as well as patient autonomy, and is applicable to various medical conditions. A generic measuring instrument, the 36-item Short- Form Health Survey (SF-36), is used extensively throughout the world [8,9]. This survey is considered to be valid and comprehensive, without being timeconsuming, and is readily applicable to assessing individual patients. In addition, numerous international cross-cultural adaptations of the original instrument, as well as validation data for normal subjects and patients with various chronic conditions, are available [1]. The University of California Los Angeles Prostate Cancer Index (UCLA-PCI) was the first, and is the most often used, measure of diseasespecific QoL available for evaluating treatments for early-stage prostate cancer [11]. The primary objective of the present study was to examine the effects of different treatments on the HRQoL of men with localized prostate cancer. We measured HRQoL (using the SF-36) and diseasespecific QoL (using the UCLA-PCI) in men treated with 192 Ir high-dose rate brachytherapy (HDR-BT), and in men treated with RP. PATIENTS AND METHODS Between October 1997 and August 2, 182 men diagnosed with prostate cancer (T1c to T3bNM) were treated with RP (89) or HDR- BT (93) with 36.8 Gy EB, and were followed for 6 64 months. A postal survey was sent to the patients, including HRQoL assessment using the SF-36, and a urinary and bowel symptom assessment using the UCLA-PCI. We obtained questionnaire responses from 151 of 182 patients (83%), including 7 treated with RP and 81 treated with HDR-BT. Survey 5 BJU INTERNATIONAL 96, doi:1.1111/j x x 43

2 JO ET AL. participation rates of RP and HDR-BT patients were 78.7% and 87.1%, respectively. The patients characteristics at presentation are summarized in Table 1. Clinical classification (HDR-BT) and pathological classification (RP) were determined in accordance with the 1997 unified TNM system. Neoadjuvant hormone therapy was administered to 12 of the 7 RP patients (17%) and 34 of the 81 HDR-BT patients (42%). Unilateral nerve-sparing surgery (NSS) was used in 3 of the 7 RP patients (43%). HDR-BT, using 192 Ir followed by EB, consisted of external irradiation (four-port) of the prostate at 2.3 Gy 16 times (36.8 Gy) and HDR-BT using a microselectron (Nucletron) at 6 Gy four times (24. Gy) within 3 h. We used the Japanese version of the SF-36 (version 1.2); this contains 36 questions to assess eight aspects of HRQoL: physical functioning; role-physical functioning; bodily pain; general health; vitality; social functioning; role-emotional functioning; and mental health. Each question was given a score from to 1, and a mean score was obtained for each, with higher scores indicative of a better outcome. We also used the Japanese version of the UCLA-PCI (version 1.2), a disease-specific instrument focusing on health concerns of men treated for prostate cancer. The questions assess levels of bowel, urinary, bladder and sexual functioning, and the degree to which such symptoms were burdensome: urinary function; urinary bother; bowel function; bowel bother; sexual function; and sexual bother. All scores in each section were given equal weight, being linearly transferred from a scale of 1, with higher scores representing a better level of functioning and less burden. All descriptive data are reported as the mean (SD) with differences in mean values between RP and HDR-BT patients analysed by twotailed, unpaired t-tests or the Mann Whitney test, or by ANOVA as appropriate. Significance was defined at the 5% level. RP (7) HDR-BT (81) Age, years mean (SD) 71.7 (6.3) 72.7 (6.4) median (range) 72 (56 77) 74 (51 84) Median (range) follow-up, months 38 (6 64) 36 (6 64) Prostate cancer stage, n T1c 15 T2a T2b 26 T3a 23 1 T3b 7 9 Gleason sum, n Initial PSA, ng/ml mean (SD) 13.2 (9.2) 21.1 (32.4) median (range) 8.6 (4.3 54) 11.2 ( ) Neoadjuvant hormone therapy, n Unilateral NSS, n 3 TABLE 2 Comparison of patients in the present study with previously reported series Variable [16] PLND, [17] [18] [19] TABLE 1 Patients characteristics Present study RP HDR-BT N Follow-up, years >3 >3 >3 Age, years SF-36 scores physical functioning role-physical bodily pain general health vitality social functioning role-emotional mental health UCLA-PCI scores urinary function urinary bother bowel function bowel bother sexual function sexual bother PLND, pelvic lymph node dissection;, radical radiotherapy. RESULTS Data from the SF-36 are shown in Fig. 1a,b. There was no apparent significant difference for any scale score between RP and HDR-BT, and no significant difference in patients with 2 years and <2 years of follow-up. When patients were divided according to age, those aged 65 years (HDR-BT, 66; RP 56) showed no significant difference in any SF-36 scale score. Men treated with RP including unilateral NSS (3) had significantly higher physical functioning (P =.7) and rolephysical functioning (P =.31) scores than men treated with HDR-BT (Fig. 1b). There were no patients with bilateral preservation of neurovascular bundles in the present study BJU INTERNATIONAL

3 FIG. 1. Comparison of QoL scores; a, SF-36 among patients after RP (red bars) and HDR-BT (green bars); b, SF- 36 among patients after RP and unilateral NSS, and HDR-BT. *P =.7, **P =.31. PF, physical functioning; RP, role-physical functioning; BP, bodily pain; GH, general health; VT, vitality; SF, social functioning; RE, roleemotional functioning; MH, mental health; c, UCLA-PCI among RP patients and HDR-BT patients; *P <.1, **P =.43, ***P =.27; d, UCLA-PCI among patients with RP and unilateral NSS, and HDR-BT patients; *P <.1, **P =.32, ***P =.2; UF, urinary function; UB, urinary bother; BF, bowel function; BB, bowel bother; SF, sexual function; SB, sexual bother. 1 a men in the HDR-BT group. Men in the HDR-BT group had significantly better scores for urinary function and sexual bother than men treated with RP including unilateral NSS. There were no significant treatment-related differences for urinary bother, bowel function and sexual function between RP with unilateral NSS and HDR-BT (Fig. 1d). The SF-36 and UCLA-PCI results showed no significant differences among HDR-BT or RP patients between subgroups with neoadjuvant hormone therapy or not. There were no significant differences comparing patients with the same clinical stage, with the same duration of follow-up. DISCUSSION 1 b PF RP BP GH VT SF RE MH * ** The primary objective of the present study was to examine the effects of different treatments on the HRQoL of men with localized prostate cancer, comparing diseasespecific and general HRQoL outcomes between RP and HDR-BT. The general HRQoL (from the SF-36) showed no significant difference between RP and HDR-BT in overall outcome. Men treated with RP including unilateral NSS had significantly higher physical functioning and role-physical functioning scores than men treated with HDR-BT, but no HRQoL data were obtained before treatment. PF RP BP GH VT SF RE MH As for disease-specific QoL (UCLA-PCI), HDR- BT was associated with better urinary and sexual function than RP. Men treated with HDR-BT had significantly better scores for sexual bother than men treated with RP and unilateral NSS. There was no significant difference in sexual function between RP with unilateral NSS and HDR-BT. The present results show that HDR-BT has a better outcome for sexual life than RP with unilateral NSS. Figure 1c,d present data from the UCLA-PCI; men in the HDR-BT group reported better urinary function (P <.1) and sexual function (P =.43) than men in the RP group, whereas men in the RP group had better bowel bother scores (P =.27). There were no significant treatment-related differences for urinary bother, bowel function and sexual bother. Among patients with 2 years of follow-up (HDR-BT, 51; RP, 46) men treated with HDR-BT had significantly better urinary function (P <.1) and sexual bother scores (P =.29). Among patients with <2 years of follow-up, men treated with HDR-BT (3) had significantly higher scores for urinary function (P <.1) and sexual function (P =.29) than men treated with RP (24). Men aged 65 years treated with HDR-BT had significantly higher scores for urinary function (P <.1) and sexual function (P =.19) than men of similar age treated with RP. Men in the RP group, including unilateral NSS, had significantly high scores for bowel bother (P =.32) than Brandeis et al. [12] compared men treated with BT (low-dose rate BT, both with and with no pretreatment EB) with men who had RP; the RP group reported greater urinary leakage than the BT group, but the BT group reported more obstructive and irritative urinary symptoms (increasing frequency and urgency, nocturia, and weak urine stream). Other authors also concluded that BT has significant effects on the urinary tract. Arterbery et al. [13] evaluated short-term complications of low-dose rate BT, reporting nocturia, 5 BJU INTERNATIONAL 45

4 JO ET AL. frequency, dysuria and hesitancy lasting weeks. Kaye et al. [14] reported that half of patients treated with low-dose rate BT had irritative and/or obstructive urinary symptoms (acute urinary retention, 4%; some degree of incontinence, 13%; urethral stricture, 3%; significant perineal pain, 18%). Thus, while patients treated with either RP or BT had urinary tract symptoms, specific symptoms differed. By contrast, HDR-BT showed an advantage for sexual function compared with RP. Desai et al. [15] reported that after 125 I-interstitial implantation of the prostate gland, IPSS and acute urinary side-effects peaked at 1 month and gradually returned to baseline at 24 months. When comparing the present HDR-BT data with the results from other reports of radical EB (Table 2; [16 19]) there was no difference in SF-36 scores. The present UCLA- PCI data showed that HDR-BT had better results for sexual bother, but Japanese patients might be less concerned about sexual function before treatment. In the present study, patients treated with HDR-BT received subsequent EB (36.8 Gy). In the future, treatment with HDR-BT omitting EB in low-risk patients with low PSA levels, low-grade tumour histology and tumours of < T3 could result in much better HRQoL. Better results would be expected for urinary and sexual function, and bowel function might not differ from that after RP. There are a few limitations of the present study; no information was obtained on pretreatment function, so no firm conclusions can be drawn about treatment-related changes. Future studies will need to be prospective, longitudinal and long-term. Assessing patients at baseline before treatment and following them over time will provide important insights into treatmentrelated differences in QoL. No significant differences were evident between RP and HDR-BT for general HRQoL. By contrast, patients treated with HDR-BT showed better urinary and sexual function than those treated with RP when diseasespecific QoL was assessed. In planning treatment, QoL concerns, including mental health issues associated with prostate cancer, need to be addressed with patients, as do the potential side-effects. FIG. 1. Continued 1 1 c d CONFLICT OF INTEREST None declared. REFERENCES * ** *** UF UB BF BB SF SB * ** *** UF UB BF BB SF SB 1 Greenlee, Murray T, Bolden S, Wingo PA. Cancer statistics,. CA Cancer J Clin ; 5: Litwin MS, Hays RD, Fink A et al. Quality-of-life outcomes in men treated for localized prostate cancer. JAMA 1995; 273: Lubeck DP, Litwin MS, Henning JM, Stoddard ML, Flanders SC, Carroll PR. Changes in health-related quality of life in the first year after treatment for prostate cancer: results from CaPSURE. Urology 1999; 53: Fowler FJ Jr, Barry MJ, Lu-Yao G, Wasson JH, Bin L. Outcomes of externalbeam radiation therapy for prostate cancer: a study of Medicare beneficiaries in three Surveillance, Epidemiology, and End Results areas. J Clin Oncol 1996; 14: Lim AJ, Brandon AH, Fiedler J et al. Quality of life: radical prostatectomy 46 5 BJU INTERNATIONAL

5 versus radiation therapy for prostate cancer. J Urol 1995; 154: Shrader-Bogen CL, Kjellberg JL, McPherson CP, Murray CL. Quality of life and treatment outcomes: prostate carcinoma patients perspectives after prostatectomy or radiation therapy. Cancer 1997; 79: Lilleby W, Fossa SD, Waehre HR, Olsen DR. Long-term morbidity and quality of life in patients with localized prostate cancer undergoing definitive radiotherapy or radical prostatectomy. Int J Radiat Oncol Biol Phys 1999; 43: Stansfeld SA, Roberts R, Foot SP. Assessing the validity of the SF-36 General Health Survey. Qual Life Res 1997; 6: Ware J. SF-36 Health Survey: Manual and Interpretation Guide. Boston: The Health Institute, Fujisawa M, Isotani S, Gotoh H, Okada H, Arakawa S, Kamidono S. Healthrelated quality of life with orthotopic neobladder versus ileal conduit according to the SF-36 survey. Urology ; 55: Litwin MS, Hays RD, Fink A, Ganz PA, Leake B, Brook RH. The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure. Med Care 1998; 36: Brandeis JM, Litwin MS, Burnison CM, Reiter RE. Quality of life outcomes after brachytherapy for early stage prostate cancer. J Urol ; 163: Arterbery VE, Wallner K, Roy J, Fuks Z. Short-term morbidity from CT-planned transperineal I-125 prostate implants. Int J Radiat Oncol Biol Phys 1993; 25: Kaye KW, Olson DJ, Payne JT. Detailed preliminary analysis of 125 iodine implantation for localized prostate cancer using percutaneous approach. J Urol 1995; 153: Desai J, Stock RG, Stone NN, Iannuzzi C, DeWyngaert JK. Acute urinary morbidity following I-125 interstitial implantation of the prostate gland. Radiat Oncol Investig 1998; 6: Johnstone PA, Gray C, Powell CR. Quality of life in T1 3N prostate cancer patient treated with radiation therapy with minimum 1-year follow-up. Int J Radiat Oncol Biol Phys ; 46: Madalinska JB, Essink-Bot ML, de Koning HJ, Kirkels WJ, van der Maas PJ, Schroder FH. Health-related quality-oflife effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer. J Clin Oncol 1; 19: Smith DS, Carvalhal GF, Schneider K, Krygiel J, Yan Y, Catalona WJ. Qualityof-life outcomes for men with prostate carcinoma detected by screening. Cancer ; 88: Livsey JE, Routledge J, Burns M et al. Scoring of treatment-related late effects in prostate cancer. Radiother Oncol 2; 65: Correspondence: Yoshimasa Jo, Department of Urology, Kawasaki Medical School, Kurashiki, Japan. jo@med.kawasaki-m.ac.jp Abbreviations: HR(QoL), health-related (quality of life); RP, radical prostatectomy; BT, brachytherapy; HDR, high-dose rate; EB, external beam radiotherapy; 36-item, shortform health survey; UCLA-PCI, The University of California Los Angeles Prostate Cancer Index; NSS, nerve-sparing surgery. 5 BJU INTERNATIONAL 47