Steinberg RL, et al. – Researchers deliberated that further immunostimulation with intravesical interleukin–2 and subcutaneous granulocyte–macrophage colony–stimulating factor may enhance response to intravesical Bacillus Calmette–Guérin (BCG) and interferon (IFN) in patient with prior BCG failure(s). Quadruple immunotherapy illustrated good treatment success in some patients and warrants further evaluation in patients with non–muscle–invasive bladder cancer with prior BCG failure.

Methods

• Researchers conducted a retrospective review.
• Thereafter, patients received 6 treatments of quadruple immunotherapy (intravesical solution with one–third dose BCG, 50 million units IFN, and 22 million units interleukin–2, along with a 250–mcg subcutaneous sargramostim injection).
• Surveillance began 4 to 6 weeks after treatment completion.
• Patients received maintenance if recurrence–free.
• They characterized success as no recurrence (bladder or extravesical) and bladder preservation.
• They conducted analysis by Kaplan–Meier method (P<0.05).

Results

• In this study, 55 patients received treatment with a median recurrence follow–up of 16.3 months and overall follow–up of 41.8 months.
• They observed that all patients had at least 1 prior BCG failure and 13% had 2 or more prior failures.
• Remarkably, only 3 patients (6%) were unable to tolerate full induction.
• It was noted that treatment success was 55% at 1 year, and 53% at 2 years.
• Furthermore, 13 patients (25%) underwent cystectomy at a median time of 17.3 months with disease progression to T2 in 1 patient and T3 in 2 patients.
• They did not find positive surgical margins or positive lymph nodes.