Immunosuppressed patients with high-risk non-muscle-invasive bladder cancer (NIMBC) can be treated successfully and safely with intravesical bacilli Calmette-Guérin (BCG), new findings suggest.
Transplant recipients fare worse than other immunosuppressed patients, however, and should be considered for early cystectomy if BCG treatment fails, researchers concluded in a report published online ahead of print in BJU International.
Intravesical BCG is considered to be contraindicated in immunosuppressed patients with bladder cancer because of the potential for the development of sepsis and the possibility that BCG may be ineffective in patients who cannot mount a robust immune response, according to investigators Harry W. Herr, MD, and Guido Dalbagni, MD, of Memorial Sloan-Kettering Cancer Center in New York.
Drs. Herr and Dalbagni studied 45 immunosuppressed patients with NMIBC who underwent transurethral resection (TUR) of the bladder. All received patients received adjuvant intravesical induction BCG treatment.
Of the 45 patients, 12 were transplant recipients with a functioning organ, 23 had unrelated cancer and were undergoing systemic chemotherapy, and 10 were taking steroids for auto-immune or related diseases.
Nine of the 12 transplant recipients (75%) responded completely to one or two cycles of BCG compared with 32 (99%) of the 33 other patients. The investigators defined a complete response as a negative biopsy and negative urinary cytology at six months.
Six (50%) of the 12 transplant patients progressed compared with five (15%) of the 33 other patients. Of the six transplant patients who progressed, metastatic disease without bladder relapse developed in two, muscle-invasive disease developed in three, and one underwent TUR plus chemotherapy.
Five patients died (11%), two from bladder cancer and three from unrelated causes. BCG was well tolerated. No patient experienced bacterial or BCG sepsis.
The median follow-up period was 40 months. The median follow-up time for survivors has not been reached, the researchers reported.
Of the 45 patients, 34 were followed for more than three years, and 15 were followed for five years or more. The median recurrence-free survival time was significantly shorter for the transplant recipients than the other groups: 17 months compared with 47 months for the patients with unrelated cancers and 50 months for auto-immune patients.
Transplant patients had a median progression-free survival time of 40 months. The median time to progression has not been reached in cancer or auto-immune patients.
The overall BCG response rates are similar to the 80% complete responses observed in the majority of non-immune suppressed patients, the researchers stated.
“Recurrence-free and progression-free survival times are inferior in transplant patients compared to immunosuppressed patients in general, indicating that early response to BCG does not translate into long-term disease-free intervals,” the authors wrote.
The researchers noted that their results should be interpreted with caution because the study included only a small number of patients.