非肌层浸润性膀胱肿瘤膀胱灌注治疗进展_West China Medical Journal

Authors：

 李金洪 ¹ , 张朝晖 ² , 员海超 ¹ ,  韩平 ¹

1. ;
2. ;

Corresponding author：

韩平, Email: hanping@scu.edu.cn

Keywords：

膀胱肿瘤; 灌注治疗; 药物疗法

DOI：

10.7507/1002-0179.20140300

Video：

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Abstract Full text Figures/Tables Video References Cited by

膀胱肿瘤是泌尿系统常见的恶性肿瘤。经尿道膀胱肿瘤电切术是治疗非肌层浸润性膀胱肿瘤的有效方法，但术后存在较高的肿瘤复发与进展风险,膀胱灌注治疗的应用在一定程度上降低了膀胱肿瘤术后复发与进展风险。近年来，研究者们针对膀胱灌注治疗的药物、疗程方案及临床新药的研发等进行了大量的临床研究,旨在更好提高灌注疗效，降低术后复发，减少不良反应的发生。现就近年来非肌层浸润性膀胱肿瘤膀胱灌注治疗的新进展予以阐述与总结。

Citation： 李金洪, 张朝晖, 员海超, 韩平. 非肌层浸润性膀胱肿瘤膀胱灌注治疗进展. West China Medical Journal, 2014, 29(5): 982-987. doi: 10.7507/1002-0179.20140300 Copy

1.	Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder:update 2013[J]. Eur Urol, 2013, 64(4):639-653.
2.	Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013[J]. CA Cancer J Clin, 2013, 63(1):11-30.
3.	温登瑰, 单保恩, 张思维, 等. 2003-2007年中国肿瘤登记地区膀胱癌的发病与死亡分析[J]. 肿瘤, 2012, 32(4):256-262.
4.	Witjes JA, Hendricksen K. Intravesical pharmacotherapy for non-muscle-invasive bladder cancer:a critical analysis of currently available drugs, treatment schedules, and long-term results[J]. Eur Urol, 2008, 53(1):45-52.
5.	Mariappan P, Zachou A, Grigor KM, et al. Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience[J]. Eur Urol, 2010, 57(5):843-849.
6.	Williams SK, Hoenig DM, Ghavamian R, et al. Intravesical therapy for bladder cancer[J]. Expert Opin Pharmacother, 2010, 11(6):947-958.
7.	Clarke NS, Basu S, Prescott S, et al. Chemo-prevention in superficial bladder cancer using mitomycin C:a survey of the practice patterns of British urologists[J]. BJU Int, 2006, 97(4):716-719.
8.	Nilsson S, Ragnhammar P, Glimelius B, et al. A systematic overview of chemotherapy effects in urothelial bladder cancer[J]. Acta Oncol, 2001, 40(2-3):371-390.
9.	De Nunzio C, Carbone A, Albisinni S, et al. Long-term experience with early single mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer:prospective, single-centre randomised trial[J]. World J Urol, 2011, 29(4):517-521.
10.	Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer:a meta-analysis of published results of randomized clinical trials[J]. J Urol, 2004, 171(6 Pt 1):2186-2190, quiz 2435.
11.	Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C:results of a randomized phase Ⅲ trial[J]. J Natl Cancer Inst, 2001, 93(8):597-604.
12.	Huland H, Klöppel G, Feddersen I, et al. Comparison of different schedules of cytostatic intravesical instillations in patients with superficial bladder carcinoma:final evaluation of a prospective multicenter study with 419 patients[J]. J Urol, 1990, 144(1):68-71; discussion 71-72.
13.	Conrad S, Friedrich MG, Schwaibold H, et al. Long term prophylaxis with mitomycin C(MMC) further reduces tumor recurrence compared to short term prophylaxis with MMC or bacillus Calmette-Guerin (BCG)[J]. J Urol, 2004, 171(4):71.
14.	Okamura K, Ono Y, Kinukawa T, et al. Randomized study of single early instillation of (2"R)-4'-O-tetrahydropyranyl-doxorubicin for a single superficial bladder carcinoma[J]. Cancer, 2002, 94(9):2363-2368.
15.	Arakawa M, Nakamura K, Yamada Y, et al. Intravesical administration of pirarubicin against superficial bladder cancer:Relationship between tumor tissue concentration and exposure time in the bladder or therapeutic effect[J]. Exp Ther Med, 2011, 2(5):901-905.
16.	高建国, 田涛, 宋亚林, 等. 围手术期大剂量吡柔比星膀胱灌注预防膀胱癌复发的临床观察[J]. 中华外科杂志, 2010, 48(21):1650-1652.
17.	Di Lorenzo G, Perdonà S, Damiano R, et al. Gemcitabine versus Bacille Calmette-Guérin after initial Bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer:a multicenter prospective randomized trial[J]. Cancer, 2010, 116(8):1893-1900.
18.	Böhle A, Leyh H, Frei C, et al. Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder:a randomised, double-blind, placebo-controlled phase Ⅲ multicentre study[J]. Eur Urol, 2009, 56(3):495-503.
19.	Puri R, Palit V, Loadman PM, et al. PhaseⅠ/Ⅱ pilot study of intravesical apaziquone (EO9) for superficial bladder cancer[J]. J Urol, 2006, 176(4 Pt 1):1344-1348.
20.	van der Heijden AG, Moonen PM, Cornel EB, et al. PhaseⅡ marker lesion study with intravesical instillation of apaziquone for superficial bladder cancer:toxicity and marker response[J]. J Urol, 2006, 176(4 Pt 1):1349-1353.
21.	Hendricksen K, Cornel EB, de Reijke TM, et al. Phase 2 study of adjuvant intravesical instillations of apaziquone for high risk nonmuscle invasive bladder cancer[J]. J Urol, 2012, 187(4):1195-1199.
22.	Lu CC, Lin MY, Chen SY, et al. The investigation of a traditional Chinese medicine, Guizhi Fuling Wan (GFW) as an intravesical therapeutic agent for urothelial carcinoma of the bladder[J]. BMC Complement Altern Med, 2013, 23(13):44.
23.	Di Stasi SM, Storti L, Giurioli A, et al. Single immediate preoperative instillation of electromotive mitomycin-C plus transurethral resection versus transurethral resection alone versus transurethral resection plus immediate mitomycin-C for pTa bladder tumors:long-term results of a prospective randomized trial[J]. J Urol, 2008, 179(Suppl 4):585.
24.	Di Stasi SM, Valenti M, Verri C, et al. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer:a randomised controlled trial[J]. Lancet Oncol, 2011, 12(9):871-879.
25.	刘克普, 薛庆, 张更, 等. 术前早期膀胱内灌注吡柔比星预防非肌层浸润性膀胱癌术后复发疗效分析[J]. 现代泌尿生殖肿瘤杂志, 2010, 2(6):357-358, 360.
26.	Morales A, Eidinger D, Bruce AW. Intracavitary bacillus Calmette-Guerin in the treatment of superficial bladder tumors[J]. J Urol, 1976, 116(2):180-183.
27.	Shelley MD, Wilt TJ, Court J, et al. Intravesical bacillus Calmette-Guérin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer:a meta-analysis of randomized trials[J]. BJU Int, 2004, 93(4):485-490.
28.	Han RF, Pan JG. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials[J]. Urology, 2006, 67(6):1216-1223.
29.	Böhle A, Bock PR. Intravesical bacille Calmette-Guérin versus mitomycin C in superficial bladder cancer:formal meta-analysis of comparative studies on tumor progression[J]. Urology, 2004, 63(4):682-686.
30.	Shang PF, Kwong J, Wang ZP, et al. Intravesical bacillus Calmette-Guérin versus epirubicin for ta and T1 bladder cancer[J]. Cochrane Database Syst Rev, 2011, 11(5):CD006885.
31.	Herr HW, Wartinger DD, Fair WR, et al. Bacillus Calmette-Guerin therapy for superficial bladder cancer:a 10-year follow-up[J]. J Urol, 1992, 147(4):1020-1023.
32.	Kumar A, Dubey D, Bansal P, et al. Urinary interleukin-8 predicts the response of standard and low dose intravesical bacillus Calmette-Guerin (modified Danish 1331 strain) for superficial bladder cancer[J]. J Urol, 2002, 168(5):2232-2235.
33.	Sylvester RJ, van der Meijden AP, Lamm DL. Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer:a meta-analysis of the published results of randomized clinical trials[J]. J Urol, 2002, 168(5):1964-1970.
34.	van der Meijden AP, Sylvester RJ, Oosterlinck W, et al. Maintenance bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increase toxicity:results from a European organisation for research and treatment of cancer Genito-Urinary group phaseⅢ trial[J]. Eur Urol, 2003, 44(4):429-434.
35.	Colombel M, Saint F, Chopin D, et al. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer:results of a randomized, prospective, double-blind, placebo controlled, multicenter study[J]. J Urol, 2006, 176(3):935-939.
36.	Baron S, Tyring SK, Fleischmann WR, et al. The interferons. Mechanisms of action and clinical applications[J]. JAMA, 1991, 266(10):1375-1383.
37.	Moltó L, Alvarez-Mon M, Carballido J, et al. Use of intracavitary interferon-alpha-2b in the prophylactic treatment of patients with superficial bladder cancer[J]. Cancer, 1995, 75(11):2720-2726.
38.	Torti FM, Shortliffe LD, Williams RD, et al. Alpha-interferon in superficial bladder cancer:a Northern California Oncology Group Study[J]. J Clin Oncol, 1988, 6(3):476-483.
39.	Portillo J, Martin B, Hernandez R, et al. Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder[J]. Urology, 1997, 49(2):187-190.
40.	Kälble T, Beer M, Mendoza E, et al. BCG vs interferon A for prevention of recurrence of superficial bladder cancer. A prospective randomized study[J]. Urologe A, 1994, 33(2):133-137.
41.	Joudi FN, Smith BJ, O' donnell MA, et al. Final results from a National multicenter phaseⅡ trial of combination bacillus Calmette-Guérin plus interferon alpha-2B for reducing recurrence of superficial bladder cancer[J]. Urol Oncol, 2006, 24(4):344-348.
42.	Bazarbashi S, Soudy H, Abdelsalam M, et al. Co-administration of intravesical bacillus Calmette-Guérin and interferon α-2B as first line in treating superficial transitional cell carcinoma of the urinary bladder[J]. BJU Int, 2011, 108(7):1115-1118.
43.	Waidelich R, Stepp H, Baumgartner R, et al. Clinical experience with 5-aminolevulinic acid and photodynamic therapy for refractory superficial bladder cancer[J]. J Urol, 2001, 165(6 Pt 1):1904-1907.
44.	Berger AP, Steiner H, Stenzl A, et al. Photodynamic therapy with intravesical instillation of 5-aminolevulinic acid for patients with recurrent superficial bladder cancer:a single-center study[J]. Urology, 2003, 61(2):338-341.
45.	Colombo R, Salonia A, Leib Z, et al. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC)[J]. BJU Int, 2011, 107(6):912-918.
46.	Chen CH, Yang HJ, Shun CT, et al. A cocktail regimen of intravesical mitomycin-C, doxorubicin, and cisplatin (MDP) for non-muscle-invasive bladder cancer[J]. Urol Oncol, 2012, 30(4):421-427.

1. Babjuk M, Burger M, Zigeuner R, et al. EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder:update 2013[J]. Eur Urol, 2013, 64(4):639-653.
2. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013[J]. CA Cancer J Clin, 2013, 63(1):11-30.
3. 温登瑰, 单保恩, 张思维, 等. 2003-2007年中国肿瘤登记地区膀胱癌的发病与死亡分析[J]. 肿瘤, 2012, 32(4):256-262.
4. Witjes JA, Hendricksen K. Intravesical pharmacotherapy for non-muscle-invasive bladder cancer:a critical analysis of currently available drugs, treatment schedules, and long-term results[J]. Eur Urol, 2008, 53(1):45-52.
5. Mariappan P, Zachou A, Grigor KM, et al. Detrusor muscle in the first, apparently complete transurethral resection of bladder tumour specimen is a surrogate marker of resection quality, predicts risk of early recurrence, and is dependent on operator experience[J]. Eur Urol, 2010, 57(5):843-849.
6. Williams SK, Hoenig DM, Ghavamian R, et al. Intravesical therapy for bladder cancer[J]. Expert Opin Pharmacother, 2010, 11(6):947-958.
7. Clarke NS, Basu S, Prescott S, et al. Chemo-prevention in superficial bladder cancer using mitomycin C:a survey of the practice patterns of British urologists[J]. BJU Int, 2006, 97(4):716-719.
8. Nilsson S, Ragnhammar P, Glimelius B, et al. A systematic overview of chemotherapy effects in urothelial bladder cancer[J]. Acta Oncol, 2001, 40(2-3):371-390.
9. De Nunzio C, Carbone A, Albisinni S, et al. Long-term experience with early single mitomycin C instillations in patients with low-risk non-muscle-invasive bladder cancer:prospective, single-centre randomised trial[J]. World J Urol, 2011, 29(4):517-521.
10. Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer:a meta-analysis of published results of randomized clinical trials[J]. J Urol, 2004, 171(6 Pt 1):2186-2190, quiz 2435.
11. Au JL, Badalament RA, Wientjes MG, et al. Methods to improve efficacy of intravesical mitomycin C:results of a randomized phase Ⅲ trial[J]. J Natl Cancer Inst, 2001, 93(8):597-604.
12. Huland H, Klöppel G, Feddersen I, et al. Comparison of different schedules of cytostatic intravesical instillations in patients with superficial bladder carcinoma:final evaluation of a prospective multicenter study with 419 patients[J]. J Urol, 1990, 144(1):68-71; discussion 71-72.
13. Conrad S, Friedrich MG, Schwaibold H, et al. Long term prophylaxis with mitomycin C(MMC) further reduces tumor recurrence compared to short term prophylaxis with MMC or bacillus Calmette-Guerin (BCG)[J]. J Urol, 2004, 171(4):71.
14. Okamura K, Ono Y, Kinukawa T, et al. Randomized study of single early instillation of (2"R)-4'-O-tetrahydropyranyl-doxorubicin for a single superficial bladder carcinoma[J]. Cancer, 2002, 94(9):2363-2368.
15. Arakawa M, Nakamura K, Yamada Y, et al. Intravesical administration of pirarubicin against superficial bladder cancer:Relationship between tumor tissue concentration and exposure time in the bladder or therapeutic effect[J]. Exp Ther Med, 2011, 2(5):901-905.
16. 高建国, 田涛, 宋亚林, 等. 围手术期大剂量吡柔比星膀胱灌注预防膀胱癌复发的临床观察[J]. 中华外科杂志, 2010, 48(21):1650-1652.
17. Di Lorenzo G, Perdonà S, Damiano R, et al. Gemcitabine versus Bacille Calmette-Guérin after initial Bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer:a multicenter prospective randomized trial[J]. Cancer, 2010, 116(8):1893-1900.
18. Böhle A, Leyh H, Frei C, et al. Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder:a randomised, double-blind, placebo-controlled phase Ⅲ multicentre study[J]. Eur Urol, 2009, 56(3):495-503.
19. Puri R, Palit V, Loadman PM, et al. PhaseⅠ/Ⅱ pilot study of intravesical apaziquone (EO9) for superficial bladder cancer[J]. J Urol, 2006, 176(4 Pt 1):1344-1348.
20. van der Heijden AG, Moonen PM, Cornel EB, et al. PhaseⅡ marker lesion study with intravesical instillation of apaziquone for superficial bladder cancer:toxicity and marker response[J]. J Urol, 2006, 176(4 Pt 1):1349-1353.
21. Hendricksen K, Cornel EB, de Reijke TM, et al. Phase 2 study of adjuvant intravesical instillations of apaziquone for high risk nonmuscle invasive bladder cancer[J]. J Urol, 2012, 187(4):1195-1199.
22. Lu CC, Lin MY, Chen SY, et al. The investigation of a traditional Chinese medicine, Guizhi Fuling Wan (GFW) as an intravesical therapeutic agent for urothelial carcinoma of the bladder[J]. BMC Complement Altern Med, 2013, 23(13):44.
23. Di Stasi SM, Storti L, Giurioli A, et al. Single immediate preoperative instillation of electromotive mitomycin-C plus transurethral resection versus transurethral resection alone versus transurethral resection plus immediate mitomycin-C for pTa bladder tumors:long-term results of a prospective randomized trial[J]. J Urol, 2008, 179(Suppl 4):585.
24. Di Stasi SM, Valenti M, Verri C, et al. Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer:a randomised controlled trial[J]. Lancet Oncol, 2011, 12(9):871-879.
25. 刘克普, 薛庆, 张更, 等. 术前早期膀胱内灌注吡柔比星预防非肌层浸润性膀胱癌术后复发疗效分析[J]. 现代泌尿生殖肿瘤杂志, 2010, 2(6):357-358, 360.
26. Morales A, Eidinger D, Bruce AW. Intracavitary bacillus Calmette-Guerin in the treatment of superficial bladder tumors[J]. J Urol, 1976, 116(2):180-183.
27. Shelley MD, Wilt TJ, Court J, et al. Intravesical bacillus Calmette-Guérin is superior to mitomycin C in reducing tumour recurrence in high-risk superficial bladder cancer:a meta-analysis of randomized trials[J]. BJU Int, 2004, 93(4):485-490.
28. Han RF, Pan JG. Can intravesical bacillus Calmette-Guérin reduce recurrence in patients with superficial bladder cancer? A meta-analysis of randomized trials[J]. Urology, 2006, 67(6):1216-1223.
29. Böhle A, Bock PR. Intravesical bacille Calmette-Guérin versus mitomycin C in superficial bladder cancer:formal meta-analysis of comparative studies on tumor progression[J]. Urology, 2004, 63(4):682-686.
30. Shang PF, Kwong J, Wang ZP, et al. Intravesical bacillus Calmette-Guérin versus epirubicin for ta and T1 bladder cancer[J]. Cochrane Database Syst Rev, 2011, 11(5):CD006885.
31. Herr HW, Wartinger DD, Fair WR, et al. Bacillus Calmette-Guerin therapy for superficial bladder cancer:a 10-year follow-up[J]. J Urol, 1992, 147(4):1020-1023.
32. Kumar A, Dubey D, Bansal P, et al. Urinary interleukin-8 predicts the response of standard and low dose intravesical bacillus Calmette-Guerin (modified Danish 1331 strain) for superficial bladder cancer[J]. J Urol, 2002, 168(5):2232-2235.
33. Sylvester RJ, van der Meijden AP, Lamm DL. Intravesical bacillus Calmette-Guerin reduces the risk of progression in patients with superficial bladder cancer:a meta-analysis of the published results of randomized clinical trials[J]. J Urol, 2002, 168(5):1964-1970.
34. van der Meijden AP, Sylvester RJ, Oosterlinck W, et al. Maintenance bacillus Calmette-Guerin for Ta T1 bladder tumors is not associated with increase toxicity:results from a European organisation for research and treatment of cancer Genito-Urinary group phaseⅢ trial[J]. Eur Urol, 2003, 44(4):429-434.
35. Colombel M, Saint F, Chopin D, et al. The effect of ofloxacin on bacillus calmette-guerin induced toxicity in patients with superficial bladder cancer:results of a randomized, prospective, double-blind, placebo controlled, multicenter study[J]. J Urol, 2006, 176(3):935-939.
36. Baron S, Tyring SK, Fleischmann WR, et al. The interferons. Mechanisms of action and clinical applications[J]. JAMA, 1991, 266(10):1375-1383.
37. Moltó L, Alvarez-Mon M, Carballido J, et al. Use of intracavitary interferon-alpha-2b in the prophylactic treatment of patients with superficial bladder cancer[J]. Cancer, 1995, 75(11):2720-2726.
38. Torti FM, Shortliffe LD, Williams RD, et al. Alpha-interferon in superficial bladder cancer:a Northern California Oncology Group Study[J]. J Clin Oncol, 1988, 6(3):476-483.
39. Portillo J, Martin B, Hernandez R, et al. Results at 43 months' follow-up of a double-blind, randomized, prospective clinical trial using intravesical interferon alpha-2b in the prophylaxis of stage pT1 transitional cell carcinoma of the bladder[J]. Urology, 1997, 49(2):187-190.
40. Kälble T, Beer M, Mendoza E, et al. BCG vs interferon A for prevention of recurrence of superficial bladder cancer. A prospective randomized study[J]. Urologe A, 1994, 33(2):133-137.
41. Joudi FN, Smith BJ, O' donnell MA, et al. Final results from a National multicenter phaseⅡ trial of combination bacillus Calmette-Guérin plus interferon alpha-2B for reducing recurrence of superficial bladder cancer[J]. Urol Oncol, 2006, 24(4):344-348.
42. Bazarbashi S, Soudy H, Abdelsalam M, et al. Co-administration of intravesical bacillus Calmette-Guérin and interferon α-2B as first line in treating superficial transitional cell carcinoma of the urinary bladder[J]. BJU Int, 2011, 108(7):1115-1118.
43. Waidelich R, Stepp H, Baumgartner R, et al. Clinical experience with 5-aminolevulinic acid and photodynamic therapy for refractory superficial bladder cancer[J]. J Urol, 2001, 165(6 Pt 1):1904-1907.
44. Berger AP, Steiner H, Stenzl A, et al. Photodynamic therapy with intravesical instillation of 5-aminolevulinic acid for patients with recurrent superficial bladder cancer:a single-center study[J]. Urology, 2003, 61(2):338-341.
45. Colombo R, Salonia A, Leib Z, et al. Long-term outcomes of a randomized controlled trial comparing thermochemotherapy with mitomycin-C alone as adjuvant treatment for non-muscle-invasive bladder cancer (NMIBC)[J]. BJU Int, 2011, 107(6):912-918.
46. Chen CH, Yang HJ, Shun CT, et al. A cocktail regimen of intravesical mitomycin-C, doxorubicin, and cisplatin (MDP) for non-muscle-invasive bladder cancer[J]. Urol Oncol, 2012, 30(4):421-427.

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非肌层浸润性膀胱肿瘤膀胱灌注治疗进展

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