A Systematic Review of Epirubicin for Prevention of Postoperative Recurrence of Superficial Bladder Cancer_Chinese Journal of Evidence-Based Medicine

Authors：

PENG Guohui , WEI Qiang , GUAN Jing , HAN Ping

Department of Urology; West China Hospital; Sichuan University; Chengdu 610041; China;

Corresponding author：

Keywords：

EPI; Intravesical; Superficial bladder cancer; TURB-t; Systematic review

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Objective 　To assess the efficacy and the treatment-induced side effects of intravesically administered Epirubicin (EPI) following TUR in patients with Ta and T1 superficial bladder cancer compared to TUR alone.
Methods 　According to the Cochrane reviewer’s handbook, included studies were those on patients with histologically confirmed Ta and T1 bladder cancer. EPI and EPI derivatives, dose and schedule would be considerd appropriate for inclusion. The search strategy was developed according to the Collaborative Review Group search strategy. Medline, EMbase, CBMdisc and the Cochrane library, articles of conference proceedings, and academic collections were searched for randomised controlled trials (RCTs) and quasi-RCT comparing intravesical EPI following TUR with TUR alone. Data were extracted from each identified paper independently by two reviewers. Trials were assessed for quality according to the method of Jadad scale. RevMan4.2 software developed by the Cochrane Collaboration was used for satistical analysis.
Results 　Two hundred and thirteen related articles were identified, but only 10 were included in our systematic review. 3 articles were high quality and the rest were low. The pooled RR=1.51 (95%CI 1.32 to 1.72) and the pooled RR=1.49 (95%CI 1.35 to 1.66) in patients with Ta and T1 bladdercancer at 1 and 2 years respectively; The pooled RR=1.34 (95%CI 1.22 to 1.48) when comparing relative efficacy of intravesical EPI (drug dose lt;50 mg) following TUR with TUR alone; The pooled RR=1.63 (95%CI 1.48 to 1.79) when comparing relative efficacy of intravesical EPI (drug dose gt;50 mg) following TUR with TUR alone. RR=1.49 (95%CI 1.33 to 1.66) and RR=1.56 (95%CI 1.36 to 1.84) when comparing relative efficacy of single intravesical EPI following TUR with TUR alone respectively. RR=0.79 (95%CI 0.53 to 1.17) when comparing the incidence of disease progression of intravesical doxorubicin following TUR with TUR alone. RR=4.34 (95%CI 2.62 to 7.19) when comparing side effect of intravesical EPI following TUR with TUR alone.
Conclusions 　Intravesically administered EPI following TUR in patients with Ta and T1 superficial bladder cancer may reduce the incidence of tumour recurrence, but cannot reduce the incidence of disease progreesion. Intravesically administered EPI following TUR has some side effects but can be tolerated and has no influence on the life of patients.

Citation： PENG Guohui,WEI Qiang,GUAN Jing,HAN Ping. A Systematic Review of Epirubicin for Prevention of Postoperative Recurrence of Superficial Bladder Cancer. Chinese Journal of Evidence-Based Medicine, 2004, 04(6): 382-388. doi: Copy

1.	［25］Cumming JA, Kirk D, Newling DW. A multicentre phase Ⅱ study of intravesical EPI rubicin in the treatment of superficial bladder tumor[J]. Eur Urol, 1990;17(31) :20.
2.	［1］Lum BL, Torti. Adjuvant intravesical pharmacology for superficial bladder cancer[J]. Journal of the National Cancer Institute, 1991; 83:682-694.
3.	［2］Jerome P, Ricie MD. Intravesical chemotherapy treatment selection, techniques and results [J ]. Urological Clinics of North America,1992; 19(3): 521-527.
4.	［3］Arnling CL. Diagnosis and management of superficial bladder cancer[J], Curr Probl Cancer, 2001; 25(4): 219-278.
5.	［4］Mulrow CD, Oxman AD. The cochrane Collaboration hand book[ M]. Issue1, 2000, Oxford,Update Sofeware.
6.	［5］Jadad AR, Moore A, Carroll D. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J].Control Clin Trials, 1996; 17:1-12.
7.	［6］Kjaergard LL, Villumsen J, Gluud C. Quality of randomized clinical trials affects estimates of intervention efficacy[ A]. In:Vll Cochrane Colloquium [C], Rome 1999,p:57.
8.	［7］Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M.Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyes [ J ]. Lancet. 1998; 352(21 ) :609-613.
9.	［8］Clarke M, Oxman AD. Editors. Cochrane Reviewers Handbook 4.0 [ updated July 1999 ]; Section 6 [ M ]. In: The Cochrane Library[ database on CD/ROM]. The Cochrane Collaboration. Oxford: Update Software, 2000: Issue 1.
10.	［9］Schulz KF, Chalmers I, Hayes R, Altman D. Empirical evidence of bias[J ]. JAMA, 1995; 273 (35) :408-412.
11.	［10］Vander Meijden AP, Kurth KH, Oosterlinck W. Intravesical therapy with adriamycin and 4-EPI rubicin for superficial bladder cancer: the experience of the EOR TC GU Group[J].Cancer Chemother Pharmacol, 1992; 30 (Suppl): S95-98.
12.	［11］Maekawa S, Suzuki H, Ohkubo K. Continuous intravesical instillation of EPI rubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study[J]. Hinyokika Kiyo, 2000; 46(5): 301-306.
13.	［12］Aliel DB, el Baz M, Aly AN. Intravesical EPI rubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1 ): a randomized prospective study[J]. J Urol, 1997; 158(1): 68-74.
14.	［13］Aliel DB, Nabeeh A, el Baz M, et al. Single ～ dose versus multiple instillations of EPI rubicin as prophylaxis for recurrence after transurethral resection of pTa and pT1 transitionalcell bladder tumours: a prospective, randomized controlled study[J]. Br J Urol, 1997; 79(5): 731-735.
15.	［14］Hirao Y, Ozono S, Momose H. Prospective randomized study of prophylaxis of superficial bladder cancer with EPI rubicin: the role of a central pathology laboratory[J]. Cancer Chemother Pharmacol, 1994; 35 Suppl: S36-40.
16.	［15］Melekos MD, Dauaher H, Fokaefs E. Intravesical instillations of4-EPI-doxorubicin (EPI rubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study[J]. J Urol, 1992; 147(2): 371-375.
17.	［16］Melekos MD, Chionis HS, Paranychianakis GS. Intravesical 4-EPI-doxorubicin (EPI rubicin) versus bacillus Calmette-Guerin. A controlled prospective study on the prophylaxis of superficial bladder cancer[J]. Cancer, 1993; 72(5): 1 749-1755.
18.	［17］Okamura K, Murase T, Obata K. A randomized trial of early intravesical instillation ofEPI rubicin in uperficial bladder cancer[J]. Cancer ChemotherPharnacol, 1994; Suppl: S31-35.
19.	［18］Oosterlinck W, Kurth KH, Schroder F. A prospective European Organization for R.esearch and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of EPI rubicin or water in single stage Ta, T1 papillary carcinoma of the bladder[J]. J Urol, 1993; 149(4): 749-752.
20.	［19］Raitanen MP, Lukkarinen O. A controlled study of intravesical EPI rubicin with or without alpha 2b-interferon as prophylaxis for recurrent superficial transitonal cell carcinoma of the bladder. Finnish Multicentre Study Group [J ]. Br J Urol,1995; 76(6): 697-701.
21.	［20］Rajala P, Liukkonen T, Raitanen M. Transurethral resection with perioperative instilation on interferon ～ alpha or EPI rubicin for the prophylaxis of recurrent primary superficial bladder cancer: a prospective randomized multicenter study-Finnbladder III[J]. J Urol, 1999; 161(4): 1133-1136.
22.	［21］The Hokkaido University Bladder Cancer Collaborative Group. Prophylactic chemotherapy with anthracyclines ( adriamycin, EPI rubicin, and pirarubicin) for primary superficial bladder cancer[J]. Cancer Chemother Pharmacol, 1994; 35(Suppl): S41-45.
23.	［22］Cutler SJ, Heney NM, Friedell GH. Longitudinal studyofpatients with bladder cancer: fators associated with disease recurrence and progression [ M ] . AUA Monographs, Bladder Cancer. Press: Williams&Wilkis,vol. 1; chapt. 4, p. 35, 1982.
24.	［23］Heney NM, Ahmed S, Flanagan MJ. Superficial bladder cancer:progression and recurrence[J]. J urol,1983; 130:1 083-1 086.
25.	［24］Prout GR, Bassil B, Griffin P. The treated histories of patients with Ta grade 1 transitional-cell carcinoma of the bladder [J].Arch Surg,1986;121 (72) :1 463.

1. ［25］Cumming JA, Kirk D, Newling DW. A multicentre phase Ⅱ study of intravesical EPI rubicin in the treatment of superficial bladder tumor[J]. Eur Urol, 1990;17(31) :20.
2. ［1］Lum BL, Torti. Adjuvant intravesical pharmacology for superficial bladder cancer[J]. Journal of the National Cancer Institute, 1991; 83:682-694.
3. ［2］Jerome P, Ricie MD. Intravesical chemotherapy treatment selection, techniques and results [J ]. Urological Clinics of North America,1992; 19(3): 521-527.
4. ［3］Arnling CL. Diagnosis and management of superficial bladder cancer[J], Curr Probl Cancer, 2001; 25(4): 219-278.
5. ［4］Mulrow CD, Oxman AD. The cochrane Collaboration hand book[ M]. Issue1, 2000, Oxford,Update Sofeware.
6. ［5］Jadad AR, Moore A, Carroll D. Assessing the quality of reports of randomized clinical trials: Is blinding necessary[J].Control Clin Trials, 1996; 17:1-12.
7. ［6］Kjaergard LL, Villumsen J, Gluud C. Quality of randomized clinical trials affects estimates of intervention efficacy[ A]. In:Vll Cochrane Colloquium [C], Rome 1999,p:57.
8. ［7］Moher D, Pham B, Jones A, Cook DJ, Jadad AR, Moher M.Does quality of reports of randomized trials affect estimates of intervention efficacy reported in meta-analyes [ J ]. Lancet. 1998; 352(21 ) :609-613.
9. ［8］Clarke M, Oxman AD. Editors. Cochrane Reviewers Handbook 4.0 [ updated July 1999 ]; Section 6 [ M ]. In: The Cochrane Library[ database on CD/ROM]. The Cochrane Collaboration. Oxford: Update Software, 2000: Issue 1.
10. ［9］Schulz KF, Chalmers I, Hayes R, Altman D. Empirical evidence of bias[J ]. JAMA, 1995; 273 (35) :408-412.
11. ［10］Vander Meijden AP, Kurth KH, Oosterlinck W. Intravesical therapy with adriamycin and 4-EPI rubicin for superficial bladder cancer: the experience of the EOR TC GU Group[J].Cancer Chemother Pharmacol, 1992; 30 (Suppl): S95-98.
12. ［11］Maekawa S, Suzuki H, Ohkubo K. Continuous intravesical instillation of EPI rubicin immediately after transurethral resection of superficial bladder cancer: a prospective controlled study[J]. Hinyokika Kiyo, 2000; 46(5): 301-306.
13. ［12］Aliel DB, el Baz M, Aly AN. Intravesical EPI rubicin versus doxorubicin for superficial bladder tumors (stages pTa and pT1 ): a randomized prospective study[J]. J Urol, 1997; 158(1): 68-74.
14. ［13］Aliel DB, Nabeeh A, el Baz M, et al. Single ～ dose versus multiple instillations of EPI rubicin as prophylaxis for recurrence after transurethral resection of pTa and pT1 transitionalcell bladder tumours: a prospective, randomized controlled study[J]. Br J Urol, 1997; 79(5): 731-735.
15. ［14］Hirao Y, Ozono S, Momose H. Prospective randomized study of prophylaxis of superficial bladder cancer with EPI rubicin: the role of a central pathology laboratory[J]. Cancer Chemother Pharmacol, 1994; 35 Suppl: S36-40.
16. ［15］Melekos MD, Dauaher H, Fokaefs E. Intravesical instillations of4-EPI-doxorubicin (EPI rubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study[J]. J Urol, 1992; 147(2): 371-375.
17. ［16］Melekos MD, Chionis HS, Paranychianakis GS. Intravesical 4-EPI-doxorubicin (EPI rubicin) versus bacillus Calmette-Guerin. A controlled prospective study on the prophylaxis of superficial bladder cancer[J]. Cancer, 1993; 72(5): 1 749-1755.
18. ［17］Okamura K, Murase T, Obata K. A randomized trial of early intravesical instillation ofEPI rubicin in uperficial bladder cancer[J]. Cancer ChemotherPharnacol, 1994; Suppl: S31-35.
19. ［18］Oosterlinck W, Kurth KH, Schroder F. A prospective European Organization for R.esearch and Treatment of Cancer Genitourinary Group randomized trial comparing transurethral resection followed by a single intravesical instillation of EPI rubicin or water in single stage Ta, T1 papillary carcinoma of the bladder[J]. J Urol, 1993; 149(4): 749-752.
20. ［19］Raitanen MP, Lukkarinen O. A controlled study of intravesical EPI rubicin with or without alpha 2b-interferon as prophylaxis for recurrent superficial transitonal cell carcinoma of the bladder. Finnish Multicentre Study Group [J ]. Br J Urol,1995; 76(6): 697-701.
21. ［20］Rajala P, Liukkonen T, Raitanen M. Transurethral resection with perioperative instilation on interferon ～ alpha or EPI rubicin for the prophylaxis of recurrent primary superficial bladder cancer: a prospective randomized multicenter study-Finnbladder III[J]. J Urol, 1999; 161(4): 1133-1136.
22. ［21］The Hokkaido University Bladder Cancer Collaborative Group. Prophylactic chemotherapy with anthracyclines ( adriamycin, EPI rubicin, and pirarubicin) for primary superficial bladder cancer[J]. Cancer Chemother Pharmacol, 1994; 35(Suppl): S41-45.
23. ［22］Cutler SJ, Heney NM, Friedell GH. Longitudinal studyofpatients with bladder cancer: fators associated with disease recurrence and progression [ M ] . AUA Monographs, Bladder Cancer. Press: Williams&Wilkis,vol. 1; chapt. 4, p. 35, 1982.
24. ［23］Heney NM, Ahmed S, Flanagan MJ. Superficial bladder cancer:progression and recurrence[J]. J urol,1983; 130:1 083-1 086.
25. ［24］Prout GR, Bassil B, Griffin P. The treated histories of patients with Ta grade 1 transitional-cell carcinoma of the bladder [J].Arch Surg,1986;121 (72) :1 463.

Chinese Journal of Evidence-Based Medicine

A Systematic Review of Epirubicin for Prevention of Postoperative Recurrence of Superficial Bladder Cancer

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