Use of BCG in Immunotherapy of Superficial Bladder Cancer: Multicentric Investigation on Safety and Compliance

Abstract Aim: Instillation-induced toxicity of BCG immunotherapy represent a real drawback. We decided to carry out a multicentric study to evaluate the tolerability of intravesical immunotherapy with BCG and in particular its effect on patient compliance and quality of life (QoL). Methods: A total of 92 patients were enrolled in the study, males and females aged >18 years, undergoing transurethral resection for superficial bladder cancer, Ta–T1, G1–GIII. After TUR, an induction cycle was started consisting of BCG Connaught at the dose of ∼81 mg/week per 6 consecutive weeks. This was followed by the SWOG 8507 maintenance scheme (3×3). Tolerability to the immunotherapy was assessed by determining the main BCG-induced side effects, such as dysuria, macrohematuria, strangury, fever and rarer symptoms (urethral bleeding, diarrhea, nausea, renal pain, penile pain). The percentage of patients who did not stop BCG therapy as a result of side effects was measured. To estimate the influence of the side effects of the intravesical immunotherapy on QoL, a simple questionnaire consisting of three questions was used. Assessment was carried out before treatment, at the end of the induction period, and 3 and 18 months after treatment (long term). Results: Apart from two patients who presented mild strangury and dysuria, none of the patients presented any symptoms before treatment, while the greatest frequency of side effects was observed at the end of the induction period, decreasing considerably at the 3-month control. All the remaining patients underwent the treatment at the established times, without any need for postponement due to side effects. The irritative rate of 52.2% was calculated according to the appearance of symptoms caused by the treatment; the overall drop-out rate was 15.2% and drop-out for poor tolerance was 9.8%. The results of the questionnaire on the QoL showed that the total score of three items was good; 85% of the study patients recorded an overall score of 5–6 ( ). Conclusion: Our study results revealed that most patients tolerated BCG treatment well and the main symptoms were local-regional irritation that responded to drugs, and reduced QoL only slightly. Keywords: BCG safetyComplianceImmunotherapyTrans urethral resection