Sequential Bacillus Calmette-guerin plus Chemotherapy for Prevention of Post-operative Recurrence of Superficial Bladder Cancer:A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Yu ¹ ,  WEI Qiang ² , ZENG Hao ² , LUO Rui ¹ , LIU Huayu ¹

1. West China Medical School of Sichuan University, Chengdu 610041, China2. Department of Urology, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

WEI Qiang, Email: wq933@hotmail.com

Keywords：

Superficial bladder cancer; Intravesical; Bacillus calmette-guerin; Chemotherapy; Systematic review

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Objective　 To assess the clinical efficacy and treatment-induced side effects of intravesically administered bacillus calmette-guerin (BCG) plus chemotherapy following TURB-t in patients with superficial bladder cancer compared with BCG alone.
Methods　 Randomized controlled trials (RCTs) were identified from PubMed (1950 to December 2006), Ovid (1966 to December 2006), EMbase (1984 to December 2006), The Cochrane Library (Issue 4, 2006), CBM (1978 to 2006) and VIP (1989 to 2006). We also handsearched relevant published and unpublished reports as well as their references.The quality of included trials was evaluated by two reviewers. We used The Cochrane Collaboration’ s RevMan 4.2.9 software for statistical analysis.
Results　 Four studies involving 681 patients were included. Meta-analyses showed that, in patients with Ta and T1 bladder cancer, there was a significant difference in the recurrence rate between intravesically administered BCG plus chemotherapy and BCG alone (RR 0.69, 95%CI 0.53 to 0.90). In patients with Tis bladder cancer, no significant difference was found in the recurrence rate between the two groups (RR 1.22, 95%CI 0.97 to 1.54). In patients with Ta, T1 and Tis bladder cancer, no statistically significant difference was found in the incidence of side effects (RR 0.85, 95%CI 0.70 to 1.03).
Conclusion　 Compared with BCG alone, intravesically administered BCG plus chemotherapy in patients with Ta and T1 superficial bladder cancer can reduce the incidence of tumor recurrence more effectively. For patients with Tis bladder cancer, the two therapeutic regimens do not differ in the incidence of tumor recurrence. The two regimens have similar side effects. There is a moderate possibil ity of selection bias, performance bias and publ ication bias in the small number of included studies, which weakens the strength of the evidence of our results. Better evidence from more high-quality double-blind randomized controlled trials is needed.

Citation： WANG Yu,WEI Qiang,ZENG Hao,LUO Rui,LIU Huayu. Sequential Bacillus Calmette-guerin plus Chemotherapy for Prevention of Post-operative Recurrence of Superficial Bladder Cancer:A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2007, 07(9): 650-657. doi: Copy

1.	Lum BL, Torti FM. Adjuvant intravesical pharmacology for superficial bladder cancer. J Natl Cancer Inst, 1991, 83(10): 682-694.
2.	Tolley DA, Hargreave TB, Smith PH, et al. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J, 1988, 296(6639): 1759-1761.
3.	Melekos MD, Dauaher H, Fokaefs E, et al. Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study. J Urol, 1992, 147(2): 371-375.
4.	Oosterl inck W, Kurth KH, Schroder F, et al. A prospective European Organization for Research and Treatment of Cancer Genitourinary Group. Randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder. J Urol, 1993, 149(4): 749-752.
5.	Martinez-Pineiro JA, Leon J, Martinez-Pineiro LJr. Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol, 1990, 143(3): 502-506.
6.	Carl L, Bo Johan N, Peter E, et al. A randomized prospective study comparing long-term intravesical instillations of mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. J Urol, 1996, 156(2): 368-376.
7.	Adrian PM, van der Meijden, Brausi M, et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Researchand Treatment of Cancer Genitourinary Group Randomized Phase III Trial. J Urol, 2001, 166: 476-481.
8.	Lamm DL, van der Meijden PM, Morales A, et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol, 1992, 147(3): 596-600.
9.	Koya MP, Simon MA, Soloway MS. Complications of intravesical therapy for urothelial cancer of the bladder. J Urol, 2006, 175(6): 2004-2010.
10.	Higgins J, Green S, editors. Cochrane Handbook for SystematicReviews of Interventions 4.2.6[updated month year]. In: The Cochrane Library, Issue 4, 2006. Chichester: Wiley. Updated quarterly.
11.	Montie JE. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. J Urol, 2006, 176(2): 507-508.
12.	Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Urologic Oncology, 2006, 24(3): 271-272.
13.	Kamat AM, Col in PN. A combination of intravesical and BCG electromotive mitomycin for high-risk superficial bladder cancer. Nat Clin Pract Urol, 2006, 3(9): 472-473.
14.	Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol, 1995, 154(6): 2050-2053.
15.	Jauhiainen K, Rintala E. Superficial urinary bladder cancer. Results from the Finnbladder studies and a review on instillation treatments. Ann Chir Gynaecol Suppl, 1993, 206: 31-38.
16.	Jauhiainen KE, Alfthan OS. Instillation therapy in superficial urinary bladder cancer. Finnbladder Group. Scand J Urol Nephrol Suppl, 1991, 138: 179-185.
17.	Al i-El-Dein B, Sarhan O, Hinev A, et al Superficial bladder tumors: analysis of prognostic factors and construction of a predictive index. BJU International, 2003, 92: 393-399.
18.	Witjes JA, Caris CTM, Mungan NA, et al. Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer. J Urol, 1998, 160(5): 1668-1671.
19.	Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for caicinoma in situ of the bladder. J Urol, 1995, 154(6): 2050-2053.
20.	Rintala E, Jauhiainen K, Kaasinen E, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. J Urol, 1996, 156(1): 56-59.
21.	Al i-El-Dein B, Nabeeh A, Ismail EH, et al. Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study. J Urol, 1999, 162(2): 339-342.
22.	Bilen CY, Ozen H, Aki FT, et al. Clinical experience with BCG alone versus BCG plus epirubicin. Int J Urol, 2000, 7(6): 206-209.
23.	Kaasinen E, Wijkstrom H, Malmstrom PU, et al. Alternating mitomycin C and BCG instillations versus BCG alone in treatment of carcinoma in situ of the urinary bladder: a nordic study. Eur Urol, 2003, 43(6): 637-645.
24.	Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. The lancet oncology, 2006, 7(1): 43-51.
25.	Bohle A, Brandau S. Immune mechanisms in bacillus Calmette-Guerin immunotherapy fou superficial bladder cancer. J Urol, 2003, 170: 964-969.
26.	Wolf H, Melsen F, Pedersen SE, et al. Natural history of carcinoma in situ of the urinary bladder. Scand J Urol Nephrol, 1994, 157(suppl): 147.
27.	Sarosdy MF. Management of high grade superficial bladder cancer: role of BCG. AUA Update Series, 1998, 17(12): 90.
28.	Utz DC, Hanash K A, Farrow GM. The pl ight of the patient with carcinoma of the bladder. Trans Am Assoc Genitourin Surg, 1969, 61: 90-100.

1. Lum BL, Torti FM. Adjuvant intravesical pharmacology for superficial bladder cancer. J Natl Cancer Inst, 1991, 83(10): 682-694.
2. Tolley DA, Hargreave TB, Smith PH, et al. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J, 1988, 296(6639): 1759-1761.
3. Melekos MD, Dauaher H, Fokaefs E, et al. Intravesical instillations of 4-epi-doxorubicin (epirubicin) in the prophylactic treatment of superficial bladder cancer: results of a controlled prospective study. J Urol, 1992, 147(2): 371-375.
4. Oosterl inck W, Kurth KH, Schroder F, et al. A prospective European Organization for Research and Treatment of Cancer Genitourinary Group. Randomized trial comparing transurethral resection followed by a single intravesical instillation of epirubicin or water in single stage Ta, T1 papillary carcinoma of the bladder. J Urol, 1993, 149(4): 749-752.
5. Martinez-Pineiro JA, Leon J, Martinez-Pineiro LJr. Bacillus Calmette-Guerin versus doxorubicin versus thiotepa: a randomized prospective study in 202 patients with superficial bladder cancer. J Urol, 1990, 143(3): 502-506.
6. Carl L, Bo Johan N, Peter E, et al. A randomized prospective study comparing long-term intravesical instillations of mitomycin C and bacillus Calmette-Guerin in patients with superficial bladder carcinoma. J Urol, 1996, 156(2): 368-376.
7. Adrian PM, van der Meijden, Brausi M, et al. Intravesical instillation of epirubicin, bacillus Calmette-Guerin and bacillus Calmette-Guerin plus isoniazid for intermediate and high risk Ta, T1 papillary carcinoma of the bladder: a European Organization for Researchand Treatment of Cancer Genitourinary Group Randomized Phase III Trial. J Urol, 2001, 166: 476-481.
8. Lamm DL, van der Meijden PM, Morales A, et al. Incidence and treatment of complications of bacillus Calmette-Guerin intravesical therapy in superficial bladder cancer. J Urol, 1992, 147(3): 596-600.
9. Koya MP, Simon MA, Soloway MS. Complications of intravesical therapy for urothelial cancer of the bladder. J Urol, 2006, 175(6): 2004-2010.
10. Higgins J, Green S, editors. Cochrane Handbook for SystematicReviews of Interventions 4.2.6[updated month year]. In: The Cochrane Library, Issue 4, 2006. Chichester: Wiley. Updated quarterly.
11. Montie JE. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. J Urol, 2006, 176(2): 507-508.
12. Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. Urologic Oncology, 2006, 24(3): 271-272.
13. Kamat AM, Col in PN. A combination of intravesical and BCG electromotive mitomycin for high-risk superficial bladder cancer. Nat Clin Pract Urol, 2006, 3(9): 472-473.
14. Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for carcinoma in situ of the bladder. The Finnbladder Group. J Urol, 1995, 154(6): 2050-2053.
15. Jauhiainen K, Rintala E. Superficial urinary bladder cancer. Results from the Finnbladder studies and a review on instillation treatments. Ann Chir Gynaecol Suppl, 1993, 206: 31-38.
16. Jauhiainen KE, Alfthan OS. Instillation therapy in superficial urinary bladder cancer. Finnbladder Group. Scand J Urol Nephrol Suppl, 1991, 138: 179-185.
17. Al i-El-Dein B, Sarhan O, Hinev A, et al Superficial bladder tumors: analysis of prognostic factors and construction of a predictive index. BJU International, 2003, 92: 393-399.
18. Witjes JA, Caris CTM, Mungan NA, et al. Results of a randomized phase III trial of sequential intravesical therapy with mitomycin C and bacillus Calmette-Guerin versus mitomycin C alone in patients with superficial bladder cancer. J Urol, 1998, 160(5): 1668-1671.
19. Rintala E, Jauhiainen K, Rajala P, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation therapy for caicinoma in situ of the bladder. J Urol, 1995, 154(6): 2050-2053.
20. Rintala E, Jauhiainen K, Kaasinen E, et al. Alternating mitomycin C and bacillus Calmette-Guerin instillation prophylaxis for recurrent papillary (stages Ta to T1) superficial bladder cancer. J Urol, 1996, 156(1): 56-59.
21. Al i-El-Dein B, Nabeeh A, Ismail EH, et al. Sequential bacillus Calmette-Guerin and epirubicin versus bacillus Calmette-Guerin alone for superficial bladder tumors: a randomized prospective study. J Urol, 1999, 162(2): 339-342.
22. Bilen CY, Ozen H, Aki FT, et al. Clinical experience with BCG alone versus BCG plus epirubicin. Int J Urol, 2000, 7(6): 206-209.
23. Kaasinen E, Wijkstrom H, Malmstrom PU, et al. Alternating mitomycin C and BCG instillations versus BCG alone in treatment of carcinoma in situ of the urinary bladder: a nordic study. Eur Urol, 2003, 43(6): 637-645.
24. Di Stasi SM, Giannantoni A, Giuriol i A, et al. Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial. The lancet oncology, 2006, 7(1): 43-51.
25. Bohle A, Brandau S. Immune mechanisms in bacillus Calmette-Guerin immunotherapy fou superficial bladder cancer. J Urol, 2003, 170: 964-969.
26. Wolf H, Melsen F, Pedersen SE, et al. Natural history of carcinoma in situ of the urinary bladder. Scand J Urol Nephrol, 1994, 157(suppl): 147.
27. Sarosdy MF. Management of high grade superficial bladder cancer: role of BCG. AUA Update Series, 1998, 17(12): 90.
28. Utz DC, Hanash K A, Farrow GM. The pl ight of the patient with carcinoma of the bladder. Trans Am Assoc Genitourin Surg, 1969, 61: 90-100.

Chinese Journal of Evidence-Based Medicine

Sequential Bacillus Calmette-guerin plus Chemotherapy for Prevention of Post-operative Recurrence of Superficial Bladder Cancer:A Systematic Review

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