BCG immunotherapy for non-muscle invasive bladder cancer: is efficacy related to toxicity?

Abstract

Objectives: To examine the prevalence of local and systemic adverse effects (AEs) associated with Bacillus Calmette-Guerin (BCG) immunotherapy for non-muscle invasive bladder cancer (NMIBC) and to determine if there was any relationship between adverse effects and efficacy of treatment.Methods: Patients receiving induction intravesical BCG immunotherapy for NMIBC from 1995 to 2013 were identified from a group urology practice. Patients completed an AE scoresheet and an AE was recorded if the patient experienced the symptom at any point in the week following instillation. Patients were dichotomised based on recurrence status (treatment efficacy was defined as non-recurrence) and association with AEs was investigated using univariate Cox regression analysis.Results: One hundred and fifty eight patients were examined with a mean age of 70.2 years (range 41–88) and a male predominance (125, 79%). The most prevalent local AEs were frequency (107, 68%), dysuria (98, 62%) and nocturia (95, 60%). Malaise (54, 34%), myalgia (41, 26%) and fever (32, 20%) were the most common systemic AEs. Recurrencestatus was available for 82 patients, with 43 (52%) diagnosed with recurrence. There was no significant relationship between overall AEs and recurrence [hazard ratio (HR) 0.97, P = 0.57], or for local (HR 0.99, P = 0.90) and systemic (HR 0.88, P = 0.32) AEs. Only frequency was significantly associated with reduced recurrence (HR = 0.42, P = 0.04).Conclusions: AEs due to BCG immunotherapy are common in the induction period with nearly 70% of patients in our cohort experiencing individual symptoms. Local AEs are considerably more prevalent than systemic. Frequency was the only AE to be significantly associated with non-recurrence. Overall, AEs due to BCG instillation treatment werenot related to efficacy for NMIBC.