Intravesical bacillus Calmette-Guérin versus chemohyperthermia for high-risk non-muscle-invasive bladder cancer

Abstract

Introduction: Patients with high-risk non-muscle invasive bladder cancer (NMIBC) need adjuvant intravesical treatment after surgery. Although bacillus Calmette-Guérin (BCG) is highly effective, new adjuvant treatments to decrease recurrences and toxicity have been studies. We performed a retrospective propensity score-matched study to compare the efficacy of BCG and chemohyperthermia (C-HT). Methods: We included 1937 patients diagnosed with bladder cancer between January 2004 and January 2014. The primary efficacy endpoint was recurrence-free interval. Patients treated with C-HT were matched with patients treated with BCG using propensity score-matched analysis. Cox-regression models were used to estimate the association between intravesical treatments and the presence of recurrence and progression. Results: Of the 710 patients treated with intravesical treatments, 40 and 142 were eligible for inclusion in C-HT and BCG groups, respectively. Following case matching, there were no differences in patient or tumour characteristics between treatment groups. The 2-year recurrence-free interval in C-HT and BCG groups were 76.2% and 93.9%, respectively (p = 0.020). C-HT treatment (hazard ratio [HR] 5.42; 95% confidence interval [CI] 1.11-26.43; p = 0.036) and high-grade tumour (HR 4.60; 95% CI 1.01-20.88; p = 0.048) are associated with an elevated odds of tumour recurrence. In multivariate Cox-regression analysis, there was no significant difference between C-HT and BCG in the odds of recurrence (p = 0.054). There were no differences in progression between C-HT and BCG. Conclusion: C-HT is not as effective treatment as BCG in high-risk NMIBC patients who are BCG-naive. Although, there were no significant difference in the odds of recurrence, recurrence-free interval is significantly improved by the administration of BCG.

Intravesical Chemohyperthermia for NMIBC: Rationale and Results of This Developing Treatment

“…Bladder spasms tend to occur more frequently with neoadjuvant treatment (17.8 vs 10.7%; p = 0.398) [1]. Similar results were seen with BWT TM [70,73] and Combat TM [69,84] recirculant systems. Side effects are frequent, but almost all cases were grades 1 and 2.…”

“…However, Ekin et al [70] showed that the recurrence-free rates of high-risk patients treated with BWT recirculant CHT were 82 and 61% at 1 and 2 years of follow-up…”

“…CHT has less systemic effects and bladder retraction than BCG but has more local effects such as spasm, hematuria, and dysuria [71]. In some cases there were severe or permanent side effects such as urethral perforation or bladder retraction [4,69,70].…”

Inducing intravesical hyperthermia of the ex-vivo porcine bladder wall: radiofrequency-induction versus recirculation using a custom-made device

“…Although this technique seems less complex than RF-ChHT, current evidence for its efficacy is limited. Only five explorative studies using two different devices have been published, showing a 2-year RFS rate in intermediate-high risk NMIBC patients of up to 88% in the adjuvant setting [9][10][11][12][13]. No comparison has been made with MMC or BCG therapy.…”

Intravesical Chemotherapy and Chemohyperthermia in Non-Muscle-Invasive Bladder Cancer; An Overview on Drug Administration Technologies and Pharmacokinetics

“…Another clinical paper [65] comparing the use of a heated MMC solution to the use of BCG, concluded that the Recurrence Free Survival (RFS) was significantly improved with the administration of BCG. In comparison, the recent paper on a multicentric, Randomized Controlled Trial of RITE vs. BCG in first line [66] showed a statistically significant superiority of RF+MMC over BCG in terms of RFS (81.8% vs. 64.8% in the PP, p=0.02).…”