What to do during Bacillus Calmette-Guérin shortage? Valid strategies based on evidence

Curr Opin Urol. 2018 Nov;28(6):570-576. doi: 10.1097/MOU.0000000000000544.

Abstract

Purpose of review: Over the last decade, the world has experienced health-threatening supply shortages of Bacillus Calmette-Guérin (BCG) immunotherapy for nonmuscle-invasive bladder cancer (NMIBC). We summarize the current literature to assist in treatment decisions in light of suboptimal supply.

Recent findings: Currently available data do not support a superiority of one BCG strain over the other. Intravesical chemotherapy seems to provide similar results in term of disease progression but not recurrence in intermediate-risk patients. One trial has shown that a 3-year maintenance course of BCG in high-risk NMIBC has no advantage in term of progression or overall survival in comparison with 1-year maintenance. Synergo radiofrequency-induced hyperthermia is a reliable alternative in intermediate or high-risk NMIBC with at least similar recurrence rates compared with BCG.

Summary: Patients with intermediate-risk NMIBC can be offered multiple instillations of intravesical chemotherapy for up to 12 months. In high-risk patients and in case of BCG shortage, BCG instillations can be terminated when the patient has completed 1 year of maintenance. Mitomycin C is an alternative in lowest risk high-risk (G3Ta) NMIBC, whereas patients with pT1/carcinoma in situ can be offered Synergo with mitomycin C when radical cystectomy is not feasible. Immediate radical cystectomy should always be considered in highest risk NMIBC after weighing up benefit to risk.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Administration, Intravesical
  • Antineoplastic Agents / administration & dosage*
  • BCG Vaccine / administration & dosage
  • BCG Vaccine / supply & distribution*
  • Clinical Decision-Making
  • Cystectomy
  • Disease Progression
  • Humans
  • Immunotherapy / methods*
  • Neoplasm Invasiveness
  • Neoplasm Recurrence, Local / immunology
  • Neoplasm Recurrence, Local / mortality
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Recurrence, Local / therapy*
  • Treatment Outcome
  • Urinary Bladder / immunology
  • Urinary Bladder / pathology
  • Urinary Bladder / surgery
  • Urinary Bladder Neoplasms / immunology
  • Urinary Bladder Neoplasms / mortality
  • Urinary Bladder Neoplasms / pathology
  • Urinary Bladder Neoplasms / therapy*

Substances

  • Antineoplastic Agents
  • BCG Vaccine