Abstract
To examine whether intravesical instillation of low-dose bacillus Calmette-Guérin (BCG) therapy is effective with low toxicity, we reviewed data for 111 patients with superficial bladder cancer (stages Ta and T1). Among them, 74 received the BCG treatment for prophylaxis of intravesical recurrence after transurethral resection, and the remaining 37 therapeutically for Ta or T1 tumours. The patients were divided into two groups by instillation dose of BCG (Tokyo 172 strain): 40 mg (n=55) and 80 mg (n=56), and statistically compared for recurrence, antitumour effect and toxicity. The mean instillations were done 8.4 times in the 40 mg dose group and 8.6 times in the 80 mg dose group. Among the 74 patients with BCG therapy for prophylaxis those with a previous episode of bladder cancer treatment (n=47) experienced a significantly (p=0.006) shorter recurrence-free interval than those with no episode (n=27). Among 47 patients with a previous treatment episode, those receiving the 80 mg dose demonstrated a significantly longer recurrence-free interval than those given the 40 mg dose (p=0.03). Among the 27 patients without previous treatment no significant difference in recurrence-free intervals was found between the two dose groups. Univariate and multivariate aalyses using Cox's proportional hazards model confirmed the above findings. The drecurrence index was also significantly reduced after BCG therapy in the 80 mg and 40 mg groups and similar antitumour effects for Ta or T1 tumours were observed in the two dose groups. The degree of toxicity due to BCG therapy was significantly (p=0.02) lower with the 40 mg dose. The present study suggests that (1) a 40 mg BCG low-dose (Tokyo 172 strain) regimen is useful for preventing recurrence, with sufficient therapeutic efficacy and low frequency of toxicity, among patients without a previous treatment, and (2) prophylactic effects with the 80 mg dose regimen are much superior for previous treatment cases.
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References
Morales, A., Eidinger, D., Bruce, A. W.: Intracavitary bacillus Calmette-Guérin in the treatment of superficial bladder tumors.J. Urol., 116, 180 (1976).
Herr, H. W., Laudone, V. P., Badalament, R. A., Oettgen, H. F., Sogani, P. C., Freedman, B. D., Melamed, M. R., Whitmore, W. F. Jr.: Bacillus Calmette-Guérin therapy alters the progression of superficial bladder cancer.J. Clin. Oncol., 6, 1450 (1988).
Lamm, D. L., van der Meijden, A. P. M., Morales, A., Brosman, S. A., Catalona, W. J., Herr, H. W., Soloway, M. S., Steg, A., Debruyne, F. M. J.: Incidence and treatment of complications of bacillus Calmette-Guérin intravesical therapy in superficial bladder cancer.J. Urol., 147, 596 (1992).
Rawls, W. H., Lamm, D. L., Lowe, B. A., Crawford, E. D., Sarosdy, M. F., Montie, J. E., Grossman, H. B., Scardino, P. T.: Fatal sepsis following intravesical bacillus Calmette-Guérin administration for bladder cancer.J. Urol., 144, 1328 (1990).
Herr, H. W.: Use of bacillus Calmette-Guérin vaccine: Indications and results. In: Soloway, M. S., Paulson, D. F., (eds): Problems in Urology: Transitional Cell Malignancy. Vol. 6, J. B. Lippincott, Philadelphia 1992, pp. 484–492.
Pagano, F., Bassi, P., Milani, C., Meneghini, A., Maruzzi, D. Garbeglio, A.: A low dose bacillus Calmette-Guérin regimen in superficial bladder cancer therapy: Is it effective?J. Urol., 146, 32 (1991).
Takashi, M., Kondo, A., Nakano, Y., Takagi, Y., Sakata, T., Miyake, K.: Total cystectomy after bacillus Calmette-Guérin (Tokyo strain) therapy for superficial bladder cancer: Experience in Japan.Int. Urol. Nephrol., 26, 33 (1994).
Koss, L. G.: Tumors of the Urinary Bladder. Atlas of Tumor Pathology. 2nd ser., fasc. 11. Armed Forces Institute of Pathology, Washington, D.C. 1975.
Union Internationale Contre le Cancer: TNM classification of malignant tumours. Union Internationale Contre le Cancer, Geneva 1974.
Kaplan, E. L., Meier, P.: Nonparametric estimation from incomplete observations.J. Am. Stat. Assoc., 53, 457 (1958).
Gehan, E. A.: A generalized Wilcoxon test for comparing arbitrarily single-censored samples.Biometrika, 52, 1203 (1965).
Cox, D. R.: Regression models and life tables.J. R. Stat. Soc., B 34, 187 (1972).
Brosman, S. A.: Experience with bacillus Calmette-Guérin in patients with superficial bladder carcinoma.J. Urol., 128, 27 (1982).
Mori, K., Lamm, D. L., Crawford, E. D.: A trial of bacillus Calmette-Guérin versus adriamycin in superficial bladder cancer: A South-West Oncology Group study.Urol. Int., 41, 254 (1986).
Soloway, M. S., Jordan, A. M., Murphy, W. M.: Rationale for intravesical chemotherapy in the treatment and prophylaxis of superficial transitional cell carcinoma. In: Debruyne, F. M. J., Denis, L., van der Meijden, A. P. M. (eds) EORTC Genitourinary Group Monograph 6: BCG in Superficial Bladder Cancer. Alan R. Liss, New York 1989, pp. 215–236.
Akaza, H., Kameyama, S., Kakizoe, T., Kojima, H., Koiso, K., Aso, Y., Niijima, T.: Ablative and prophylactic effects of BCG Tokyo 172 strain for intravesical treatment in patients with superficial bladder cancer and carcinoma in situ of the bladder.Jpn. J. Urol., 83, 183 (1992).
Okaneya, T., Ikado, S., Murata, Y., Niwakawa, M., Mizusawa, H., Yamaguchi, K., Yamashita, T., Ogawa, A.: Intravesical bacillus Calmette-Guérin instillation for in situ and superficial bladder cancer: Results of ten successive instillations of 40 milligrams.Jpn. J. Clin. Urol., 45, 129 (1991).
Brosman, S. A.: BCG in the management of superficial bladder cancer.Urology, 23 (Suppl.), 82 (1994).
Morales, A., Nickel, J. C.: Immunotherapy of superficial bladder cancer with BCG.World J. Urol., 3, 209 (1986).
Haaff, E. O., Dresner, S. M., Ratliff, T. L., Catalona, W. J.: Two courses of intravesical bacillus Calmette-Guérin for transitional cell carcinoma of the bladder.J. Urol., 136, 820 (1986).
Loening, S., Slymen, D., Narayana, A., Penick, G., Yoder, L., Culp, D.: Analysis of bladder tumor recurrence in 178 patients.Urology, 16, 137 (1980).
Heney, N. M., Nocks, B. N., Daly, J. J., Prout, G. R. Jr., Newall, J. B., Griffin, P. P., Perrone, T. L., Szyfelbein, W. A.: Ta and T1 bladder cancer: Location, recurrence and progression.Br. J. Urol., 54, 152 (1982).
Dalesio, O., Schulman, C. C., Sylvester, R., De Pauw, M., Robinson, M., Denis, L., Smith, P., Viggiano, G.: Prognostic factors in superficial bladder tumors. A study of the European Organization for Research on Treatment of Cancer: Genitourinary Tract Cancer Cooperative Group.J. Urol., 129, 730 (1983).
Takashi, M., Murase, T., Mitsuya, H., Mizuno, S., Hamajima, N., Aoki, K., Ohno, Y.: Statistical analysis of factors affecting recurrence in superficial bladder cancer: Estimation with Cox's proportional hazards model.Jpn. J. Urol., 78, 39 (1987).
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Takashi, M., Kakai, K., Ohno, Y. et al. Evaluation of a low-dose intravesical bacillus Calmette-Guérin (Tokyo strain) therapy for superficial bladder cancer. International Urology and Nephrology 27, 723–733 (1995). https://doi.org/10.1007/BF02552138
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DOI: https://doi.org/10.1007/BF02552138