Tolerability of bacille Calmette-Guerin maintenance therapy for superficial bladder cancer

Objectives, To study the influence of adverse reactions on adherence to an immunotherapy maintenance schedule and the recurrence rate of bladder cance r. Bacille Calmette-Guerin immunotherapy has documented efficacy in the man agement of high-risk superficial bladder cancer. However, the optimal durat ion of intravesical bacille Calmette-Guerin therapy and the risk/benefit ra tio of maintenance therapy are controversial. Methods. From April 1996 to April 2000, 72 patients with superficial bladde r cancer were treated with Immucyst (six consecutive weekly instillations o f 81 mg) and then received maintenance therapy consisting of three consecut ive weekly instillations 3, 6, 12, 18, 24, 30, and 36 months later. Adverse reactions, studied during 518 instillations, were classified in four categ ories using a scale based on the World Health Organization recommendations, and their impact on the adherence to therapy was analyzed. Results. After an average follow-up of 24 months, a durable disease-free re sponse was observed in 84.9% of the patients; 12.5% of patients had a relap se and 2.6% had disease progression. The response rate was similar in patie nts with and without adverse reactions. Only 14 patients (19%) received all the scheduled maintenance instillations. The dose was reduced in 41 patien ts (57%), and treatment was stopped in 28 patients (39%). In multivariate a nalysis, an adverse event score of 1.5 or greater during induction therapy was significantly associated with cessation or modification of maintenance therapy (P = 0.01). Conclusions, The scale developed in this study to monitor the adverse react ions to bacille Calmette-Guerin and their impact on the adherence to mainte nance therapy may be helpful for tailoring maintenance regimens or implemen ting protective measures (dose reduction or treatment postponement). UROLOG Y 57: 883-888, 2001. (C) 2001, Elsevier Science Inc.