OBJECTIVE: We investigated the efficacy, safety and an optimal schedule of maintenance therapy with intravesical instillation of Bacillus-Calmette Guérin in patients with non-muscle-invasive bladder cancer.
METHODS: We compared the oncological outcome and adverse events of maintenance Bacillus-Calmette Guérin therapy (n = 40) with control subjects (n = 64) of Bacillus-Calmette Guérin induction therapy. Maintenance therapy was scheduled to be administered in 3-week cycles at 6, 12, 18, 24 and 36 months after the induction therapy.
RESULTS: There was a significant difference in the 5-year recurrence-free survival rate between the maintenance and induction groups in all patients (72.4 vs. 62.0%; P = 0.019) and in patients with high recurrence risk (100.0 vs. 17.9%; P = 0.009). There was a significant difference in the 5-year progression-free survival rate between the maintenance and induction groups in patients with high progression risk (100.0 vs. 69.3%; P = 0.047). Maintenance Bacillus-Calmette Guérin instillations for a total of four times or more (recurrence-free survival: hazard ratio: 0.2, P = 0.039) or with a total dosage of >243 mg (recurrence-free survival: hazard ratio: 0.2, P = 0.041) after 6 months of induction therapy significantly improve tumor recurrence-free survival and progression-free survival. There were no significant differences between induction therapy and maintenance therapy in the frequency of all adverse drug reactions.
CONCLUSIONS: Bacillus-Calmette Guérin maintenance therapy was effective in preventing the recurrence and progression of high-risk non-muscle-invasive bladder cancer. Maintenance Bacillus-Calmette Guérin instillations for a total of four times or more or with a total dosage of >243 mg after 6 months of induction therapy are necessary to obtain the optimal effect as maintenance therapy.
Written by:
Muto S, Nakajima A, Horiuchi A, Inoue M, China T, Saito K, Isotani S, Hisasue SI, Yamaguchi R, Ide H, Horie S. Are you the author?
Department of Urology, Teikyo University School of Medicine, Tokyo, Japan.
Reference: Jpn J Clin Oncol. 2013 Jan 9. Epub ahead of print.
doi: 10.1093/jjco/hys225
PubMed Abstract
PMID: 23303841
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