Adverse Reactions Related to Treatment Compliance During BCG Maintenance Therapy for Non-muscle-invasive Bladder Cancer

作者：Miyazaki Jun; Hinotsu Shiro; Ishizuka Naoki; Naito Seiji; Ozono Seiichiro; Akaza Hideyuki; Nishiyama Hiroyuki^*

来源：Japanese Journal of Clinical Oncology, 2013, 43(8): 827-834.

DOI：10.1093/jjco/hyt086

• bacillus Calmette
• Gurin
• maintenance therapy
• non-muscle-invasive bladder cancer
• adverse reactions

The aim of the study was to investigate the factor of adverse reactions related to compliance with Mycobacterium bovis bacillus CalmetteGurin maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer. %26lt;br%26gt;This study was a post hoc analysis using the database of a randomized controlled trial that examined the efficacy of bacillus CalmetteGurin (Connaught strain) maintenance therapy. Among the 42 patients assigned to the bacillus CalmetteGurin maintenance therapy group, six patients dropped out or withdrew consent before the bacillus CalmetteGurin maintenance therapy. The adverse reactions and clinical backgrounds of the remaining 36 patients who underwent bacillus CalmetteGurin maintenance therapy were compared between the two groups: the patients who completed the bacillus CalmetteGurin maintenance therapy (the Completed group), and those who discontinued the bacillus CalmetteGurin maintenance therapy (the Discontinued group). %26lt;br%26gt;Of the 36 patients who underwent bacillus CalmetteGurin maintenance therapy, 15 (41.7) were in the Completed group and 21 (58.3) were in the Discontinued group. Local adverse reactions (G2) were observed during maintenance therapy in 86.7 of the Completed group and 95.2 of the Discontinued group. As for adverse reactions during the induction therapy (bacillus CalmetteGurin induction therapy), the frequencies of gross hematuria and systemic adverse reactions (any grade) tended to be higher in the Discontinued group than in the Completed group, although not significantly so. In the CochranArmitage trend test, the linear T trend (i.e. the trend in the risk of an increased rate of discontinuation according to gross hematuria and systemic adverse reactions with bacillus CalmetteGurin induction therapy) was statistically significant (P 0.0179). %26lt;br%26gt;Most patients who completed bacillus CalmetteGurin maintenance therapy experienced local adverse reactions (G2) during the maintenance therapy. Gross hematuria and systemic adverse reactions during bacillus CalmetteGurin induction therapy might be related to the discontinuation of bacillus CalmetteGurin maintenance therapy because of severe adverse reactions.

• 出版日期2013-8