DOI QR코드

DOI QR Code

Are there Time-period-related Differences in the Prophylactic Effects of Bacille Calmette-Guérin Intravesical Instillation Therapy in Japan?

  • Okamura, Takehiko (Department of Urology, JA Aichi Anjo Kosei Hospital) ;
  • Ando, Ryosuke (Department of Urology, JA Aichi Anjo Kosei Hospital) ;
  • Akita, Hidetoshi (Department of Urology, JA Aichi Anjo Kosei Hospital) ;
  • Hashimoto, Yoshihiro (Department of Urology, JA Aichi Toyota Kosei Hospital) ;
  • Iwase, Yutaka (Department of Urology, JA Aichi Toyota Kosei Hospital) ;
  • Naiki, Taku (Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences) ;
  • Kawai, Noriyasu (Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences) ;
  • Tozawa, Keiichi (Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences) ;
  • Kohri, Kenjiro (Department of Nephro-Urology, Nagoya City University Graduate School of Medical Sciences)
  • Published : 2012.09.30

Abstract

Objective: The guidelines on indications for prophylactic use of Bacille Calmette-Gu$\acute{e}$rin (BCG) against non-muscle-invasive bladder cancer (NMIBC) have changed over the years. In order to assess the impact on outcome, the present retrospective comparison of BCG efficacy by time period with Japanese patients was conducted. Patients and Methods: A total of 146 cases of NMIBC treated with BCG since February 1985 were retrospectively evaluated. All patients received 80 mg of BCG (Tokyo 172 strain) six to eight times a week for prophylactic use. Comparison was made among three historical groups (Group A: 1980's, 39 cases; Group B: 1990's, 61 cases; Group C: 2000's, 46 cases). Results: In total, recurrence was seen in 55 of the 146 cases (37.7%), and progression in 14 (9.6%), 1 patient dying of cancer. These overall results were similar to those outlined in previous reports. However, the outcomes of this time-period-based analysis indicated a tendency for a shorter time to recurrence in patients after 2000, although a log-rank test showed no significance (P=0.229). Seven of the cases featuring progression (i.e., half of all such cases) were among the 46 Group C patients (15.2%). Excluding these progressive cases, there was no significant difference among the remaining 132 patients in the three groups. Conclusion: This study results revealed a tendency for a lower non-recurrence rate after 2000 in our series. This could stem from a number of factors, including changes in BCG indication criteria and the evolution of histopathological diagnostic criteria.

References

  1. Ao T, Uchida T, Yokoyama E, et al (1993). Prophylactic combination therapy afterTUR of superficial bladder cancer. Acta Urol Jpn, 39, 987-91.
  2. Ao T, Uchida T, Muramoto M, et al (1996). Postoperative intravesical pirarubicin plus bacillus Calmette-Guerin with or without interleukin-2 instillation therapy for superficial bladder cancer. Nishinihon J Urol, 5, 538-41.
  3. Bladder cancer practice guideline : Japanese Urological Association (2009).
  4. Brausi M, Witjes JA, LammD, et al (2011). A Review of Current Guidelines and Best Practice Recommendations for the Management of Nonmuscle Invasive Bladder Cancer by the International Bladder Cancer Group. J Urol, 186, 2158-167 https://doi.org/10.1016/j.juro.2011.07.076
  5. Cho IC, Kim EK, Joung JY, et al (2012). Adjuvant intravesical instillation for primary T1G3 bladder cancer: BCG versus MMC in Korea. Anticancer Res, 32, 1493-98.
  6. Hinotsu S,Akaza H, Isaka S, et al (2006). BCG Tokyo 172 Strain Study Group. Sustained prophylactic effect of intravesical bacille Calmette-Guerin for superficial bladder cancer: a smoothed hazard analysis in a randomized prospective study. Urology, 67, 545-49. https://doi.org/10.1016/j.urology.2005.09.045
  7. Hinotsu S, Akaza H, Naito S, et al (2011). Maintenance therapy with bacillus Calmette-Guerin Connaught strain clearly prolongs recurrence-free survival following transurethral resection of bladder tumour for non-muscleinvasive bladder cancer. BJU Int, 108,187-95. https://doi.org/10.1111/j.1464-410X.2010.09891.x
  8. http://www.auanet.org/content/clinical-practice-guidelines/ clinical-guidelines.cfm?sub=bc
  9. http://www.nccn.org/professionals/physician_gls/PDF/bladder.pdf
  10. http://www.uroweb.org/gls/pdf/05_TaT1_Bladder_Cancer_LR %20March %20 13th%2020 12.pelf
  11. Irie A, Lee KE, Kadowaki K, et al (1994). Long-term results and complications of intravesical instillation of bacillus Calmette-Guerin for prophylaxis of bladder cancer recurrence. Acta Urol Jpn, 40, 873-77.
  12. Irie A, Uchida T, Yamashita H, et al (2003). Sufficient prophylactic efficacy with minor adverse effects by intravesical instillation of low-dose bacillus Calmette- Guerinfor superficial bladder cancer recmrence. Int J Urol, 10 ,183-89. https://doi.org/10.1046/j.0919-8172.2003.00607.x
  13. Joudi FN, Smith BJ, O'Donnell MA, et al (2006). The impact of age on the resJXlnse of patients with superficial bladder cancer to intravesical immunotherapy. J Urol, 175,1634-640. https://doi.org/10.1016/S0022-5347(05)00973-0
  14. Kano M, Kanemura M, Yokoyama M (1993). Risk factor of tumor recurrence following intravesical instillation of bacillus Calmette-Guerin (BCG) therapy for superficial bladder cancer. Ann Soc BCG BRM Imm, 17, 39-44.
  15. Kikuchi E, Fujimoto H, Mizutani Y, et al (2009). Cancer Registration Committee of the Japanese Urological Association. Clinical outcome of tumor recurrence for Ta, T1 non-muscle invasive bladder cancer from the data on registered bladder cancer patients in Japan: 1999-2001 report from the Japanese Urological Association. Int J Urol, 16, 279-86. https://doi.org/10.1111/j.1442-2042.2008.02235.x
  16. Kohjimoto Y, Iba A, Shintani Y, et al (2010). Impact of Patient Age on Outcome Following Bladder-Preserving Treatment for Non-Muscle-Invasive Bladder Cancer. World J Urol, 28,425-30. https://doi.org/10.1007/s00345-010-0514-x
  17. Librenjak D, Situm M, Vrdoljak E, et al (2012). Results of longterm follow- up of patients with superficial bladder carcinoma treated with intravesically applied bacillus Calmette-Guerin vaccine according to the schedule of 6 weekly + 6 monthly instillations. Urol Oncol, B, 259-65.
  18. Margel D, Tal R, Golan S, et al (2007). Long-term follow-up of patients with stage T1 high grade transitional cell carcinoma managed by bacillus Calmette-Guerin immunotherapy. Urology , 69, 78-2. https://doi.org/10.1016/j.urology.2006.09.019
  19. Margel D, Alkhateeb SS, Finelli A, et al (2011). Diminished Efficacy of Bacille Cahnette-GuerinAmong Elderly Patients with Nonmuscle Invasive Bladder Cancer. Urology, 78, 848-55. https://doi.org/10.1016/j.urology.2011.04.070
  20. Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, et al (2005). Has a 3-fold decreased dose of Bacillus Cahnette-Guerin the same efficacy against recurrences and progression ofT 1 G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol, 174, 1242-47. https://doi.org/10.1097/01.ju.0000173919.28835.aa
  21. Meijer RP, van Rhijn BW (2012). A plea for long-term surveillance in bacillus Calmette-Guerin-treated nonmuscle- invasive bladder cancer. Eur Urol, 61, 508-09. https://doi.org/10.1016/j.eururo.2011.11.052
  22. Ojea A, Nogueira JL, Solsona E, et al (2007). A multicentre, randomised prospective trial comparing three intravesical adjuvant therapies for intermediate-risk superficial bladder cancer: low-dose bacillus Calmette-Guerin (27 mg) versus very low-dose bacillus Calmette-Guerin (13.5 mg) versus mitomycin C. Eur Urol, 52,1398-406. https://doi.org/10.1016/j.eururo.2007.04.062
  23. Okamura T, Tozawa K, Yamada Y, et al (1996). Clinicopathological evaluation of repeated courses of intravesical bacillus Calmette-Guerin instillation for preventing the recurrence of initially resistant superficial bladder cancers. J Urol, 156, 967-969. https://doi.org/10.1016/S0022-5347(01)65674-X
  24. Okamma T, Akita H, Hashimoto Y, et al (2010). Non Muscle Invasive Bladder Cancer Cases Initially Failing to Respond to Bacillus Calmette-Guerin Intravesical Instillation Therapy. Curr Urol, 4, 18-24. https://doi.org/10.1159/000253403
  25. Oosterlinck W, Lobel B, Jackse G, et al (2001). EAU Recommendations 2001. "Guidelines on bladder cancer".
  26. Ozono S, Tabata S, Kaneko Y, et al (1992). Outcomes of intravesical instillation of bacillus Calmette-Guerin (BCG) therapy for superficial bladder cancer. Ann Soc BCG BRM Imm, 16, 79-83.
  27. Ozono S, Takashima K, Yoshida K, et al (1997). Intravesical bacillus Calmette-Guerin (BCG) therapy for prophylaxis of the superficial bladder cancer -Outcomes of randomized study-. Ann Soc BCG BRM Imm, 21, 87-91.
  28. Segal R, Yafi FA, Brimo F, et al (2012). Prognostic factors and outcome in patients with T1 high-grade bladder cancer: can we identify patients for early cystectomy? BJU Int, 109, 1026-1030. https://doi.org/10.1111/j.1464-410X.2011.10462.x
  29. Segawa N, Inamoto T, Nomi H, et al (2009). Effect of prophylactic intravesical instillation of BCG for superficial bladder cancer. Acta Urol Jpn, 55,175-80.
  30. Smith JA Jr, Labasky RF, Cockett AT, et al (1999). Bladder cancer clinical guidelines panel summary report on the management of nonmuscle invasive bladder cancer (stages Ta, T1 and TIS). The American Urological Association. J Urol, 162, 1697-701. https://doi.org/10.1016/S0022-5347(05)68208-0
  31. Sylvester RJ (2011). Bacillus Calmette-Guerin treatment of non-muscle invasive bladder cancer. Int J Urol, 18, 113-20. https://doi.org/10.1111/j.1442-2042.2010.02678.x
  32. Tachibana M, Jitsukawa S, Iigaya T, et al (1989). Comparative study on prophylactic intravesical instillation of bacillus Calmette-Guerin (BCG) and adriamycin for superficial bladder cancers. Jpn J Urol, 80, 1459-65. https://doi.org/10.5980/jpnjurol1989.80.1459
  33. Tachibana M, Nakamura S, Jitsukawa S, et al (1993). Long-term results and risk factors of tumor recurrence in patients with superficial bladder cancer who were treated by intravesical bacillus Calmette-Guerin (BCG) instillation. Jpn J Urol, 84, 656-661. https://doi.org/10.5980/jpnjurol1989.84.656
  34. Takashi M, Wakai K, Ohno Y, et al (1995). Evaluation of a low-dose intravesical bacillus Calmette-Guerin (Tokyo strain) therapy for superficial bladder cancer. Int Urol and Nephrol, 27, 723-733. https://doi.org/10.1007/BF02552138
  35. Tanaka T, Shinoda M, Maruyama T, et al (1994). The 25 cases of tumor recurrence after intravesical bacillus Calmette-Guerin therapy for superficial bladder cancer. Ann Soc BCG BRM Imm, 18, 95-100.
  36. Thomas F, Rosario DJ, Rubin N, et al (2012). The long-term outcome of treated high-risk nonmuscle-invasive bladder cancer-Time to change treatment paradigm? Cancer online, 27th April. https://doi.org/10.1002/cncr.27587
  37. Tozawa K, Okamura T, Sasaki S, et al (2001). Intravesical combined chemoimmunotherapy with epirubicin and bacillus Calmette-Guerin is not indicated for superficial bladder cancer. Urol lnt, 67, 289-292.
  38. Yabusaki N, Komatsu H, Tago K, et al (1991). Intravesical instillation of bacillus Calmette-Guerin for superficial bladder carcinoma: study on significance of additional maintenance instillations of bacillus Calmette-Guerin. Jpn J Urol, 82, 290-296. https://doi.org/10.5980/jpnjurol1989.82.290
  39. Yamamoto T, Hagiwara M, Nakazono M, et al (1990). Intravesical bacillus Calmette-Guerin (BCG) in the treatment of superficial bladder cancer. Prospective randomized study for prophylactic effect. Jpn J Urol, 81, 997-1001. https://doi.org/10.5980/jpnjurol1989.81.997
  40. Yoneyama T, Ohyama C, Imai A, et al (2008). Low-dose instillation therapy with bacille Calmette-Guerin Tokyo 172 strain after transurethral resection: historical cohort study. Urology, 71,1161-1165. https://doi.org/10.1016/j.urology.2007.11.080

Cited by

  1. Prognostic Significance of Nestin Expression in pT1 High-Grade Bladder Urothelial Carcinoma Patients Treated with Intravesical BCG vol.15, pp.24, 2015, https://doi.org/10.7314/APJCP.2014.15.24.10813
  2. Results of Intravesical Chemo-Hyperthermia in High-risk Non-muscle Invasive Bladder Cancer vol.16, pp.8, 2015, https://doi.org/10.7314/APJCP.2015.16.8.3241