Organ-preserving treatment using neoadjuvant chemotherapy during intravesical immunotherapy with roncoleukin (interleukin-2) for invasive bladder carcinoma

Abstract

The results of a prospective randomized study of the efficacy of neoadjuvant chemoimmunotherapy with intravesical roncoleukin (interleukin- 2) versus the standard M-VAC chemotherapy regimen are analyzed. The study protocol included 60 patients. Additional intravesical administration of roncoleukin failed to affect the frequency and severity of the toxic effects of multidrug therapy. The immediate and long-term results of the proposed regimen were better than those of the standard one. Complete regressions were 53.3±9.1 and 26.7±8.1, respectively (p = 0.049; Mann—Whitney U-test). Organ-preserving surgery was made in 24 (80.0%) study-group patients and in 16 (53.3%) control ones; the difference being significant (p = 0.03, χ²). In the study group, cumulative survival was significantly higher than that in the control group (p = 0.02, log-rank-test). In the groups, overall 5-year survival was 81.4±7.6 and 46.5±12.5%, respectively.