title: Does the Compliance to Intravesical BCG Differ between Common Clinical Practice and International Multicentric Trials?
abstract: BACKGROUND
  The aim of this study was to analyze the reasons for intravesical BCG interruption in clinical practice. BCG for at least one year is advocated as the best regimen to treat high-risk non-muscle invasive bladder cancer (NMIBC). However, almost 50% of patients don't complete it. Toxicity accounts for 10% of dropouts in international trials.
  
  
  METHODS
  Patients with T1HG NMIBC undergoing 1-year BCG were enrolled in this study. BCG was administered for one year. Toxicity and causes of treatment interruption were recorded.
  
  
  RESULTS
  A total of 411 patients were enrolled in the study. Out of these total number of patients, 380 (92.5%) completed the induction cycle and 215 (52.3%) completed one year. Toxicity requiring interruption or postponement was recorded in 25 (6.1%) and 60 (14.6%) patients. Ninety-three patients (30.2%) stopped BCG, 9 (9.7%) for recurrence and 14 (15.1%) for grade-3 toxicity. Intriguingly, 55 (59.1%) patients refused BCG due to mild discomfort and deterioration in quality of social life.
  
  
  CONCLUSIONS
  Grades 2-3 toxicity causes BCG interruption in a few cases. Almost 60% of interruptions are attributable to persistent grade-1 toxicity, which is inadequately treated.
authors.affiliation: Section of Urology, Department of Surgical, Oncological and Stomatological Sciences, University of Palermo, Palermo, Italy.
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Serretta
authors.forename: Cristina
authors.initials: C
authors.lastname: Scalici Gesolfo
authors.forename: Vincenza
authors.initials: V
authors.lastname: Alonge
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cicero
authors.forename: Marco
authors.initials: M
authors.lastname: Moschini
authors.forename: Renzo
authors.initials: R
authors.lastname: Colombo
mesh_terms: D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000009:adverse effects* / Q000627:therapeutic use*; D015331:Cohort Studies; D018450:Disease Progression; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis; D010349:Patient Compliance; D012008:Recurrence; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D001500:BCG Vaccine