Intravesical bacille Calmette-Guérin (BCG) in immunologically compromised patients with bladder cancer

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Intravesical bacille Calmette-Guérin (BCG) is generally considered to be contraindicated in immunologically compromised patients with bladder cancer because it may be ineffective and potentially toxic. Therefore, there is little experience with BCG in individuals with impaired immune systems. The present study provides evidence that intravesical BCG is safe and effective in the short term against non-muscle-invasive bladder cancer affecting patients who were receiving immunosuppressive medications. This included anti-rejection drugs to support a solid organ transplant, high-dose steroids for autoimmune inflammatory diseases, and the first description of BCG use in patients who were receiving concomitant systemic chemotherapy for unrelated malignant neoplasms.

To investigate the outcomes of bacille Calmette-Guérin (BCG) therapy in patients with bladder cancer who were immunologically compromised.

In all, 45 immunosuppressed patients with high-grade non-muscle-invasive bladder cancer received BCG therapy. Twelve had functioning organ transplants, 23 were undergoing systemic chemotherapy for unrelated cancers, and 10 were taking steroids for autoimmune or related diseases. Patients received a 6-week induction course of BCG therapy. Relapsing patients were eligible for retreatment. All patients were followed for median (range) of 40 (12-72) months. End points were response to BCG and 5-year recurrence-free, progression-free and overall survival rates.

In all, nine of the 12 transplant patients responded completely to one or two cycles of BCG compared with 99% (32/33) of other immunosuppressed patients. Half the patients with unrelated cancers and autoimmune diseases recurred vs all but one of the transplant patients (P = 0.008). Of the 12 transplant patients, six of 12 progressed vs five of 33 (15%) of the other patient groups (P = 0.02). Five patients died (11%), two of bladder cancer (both in transplant patients), and three of unrelated causes. BCG was well tolerated. None of the patients developed bacterial or BCG sepsis. Although this is largest series evaluating BCG in transplant and other immune-suppressed patients, it represents few patients and results must be interpreted with caution.

We conclude that intravesical BCG is safe and effective in immunologically compromised patients with bladder cancer. Transplant patients fare worse and should be considered for early cystectomy if they fail BCG therapy.