Chemohyperthermia using mitomycin C offers a safe and effective alternative to bacillus Calmette-Guérin (BCG) for adjuvant treatment of patients with intermediate- and high-risk papillary non–muscle-invasive bladder cancer (NMIBC), researchers reported.
Chemohyperthermia for bladder cancer involves the use of radiofrequency energy (Synergo-system) to heat the bladder wall while delivering intravesical chemotherapy.
Tom J. H. Arends, MD, of Radboud University Medical Centre in Nijmegen, The Netherlands, and colleagues studied 190 intermediate- and high-risk NMIBC patients randomized to receive adjuvant therapy with either CHT using mitomycin C or BCG. The primary endpoint was 24-month recurrence-free survival (RFS) in the intention-to-treat (ITT) and per-protocol (PP) analyses in the 147 papillary NMIBC patients . In these patients, the 24-month RFS in the ITT analysis was 78.1% in the CHT group and 64.8% in the BCG group, a non-significant difference (p=0.08), Dr. Arends’ team reported online in European Urology. The 24-month RFS in the PP analysis was 81.8% in the CHT group compared with 64.8% in the BCG group, a significant difference (p=0.02). Progression rates were less than 2% in both groups, without any statistical difference between the groups.
“These data suggest that CHT therapy is more effective than BCG therapy,” the authors concluded.
Based on study findings and the recent worldwide shortage of BCG, “urologists might consider CHT as an option instead of BCG therapy as adjuvant treatment for papillary intermediate- and high-risk NMIBC.”
The investigators observed no unexpected adverse events and no new safety concerns in either treatment arm compared with the previous literature.