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Intravesical Bacillus Calmette-Guérin for the treatment of superficial bladder cancer following hematopoietic stem cell transplantation

Bladder cancer is the seventh most common cancer in men worldwide and accounts for approximately 5–10% of all malignancies among men in Europe. Superficial transitional cell carcinoma (TCC) represents the most frequent type of bladder cancer and presents a high incidence of recurrence and progression [1]. The use of intravesical instillations with Bacillus Calmette-Guérin (BCG) is considered an efficacious treatment for TCC, either for prevention of recurrence and progression or for eradication of residual tumor after transurethral resection [2]. The antitumor activity of BCG is based on immunomodulatory processes, such as the stimulation of cytotoxic T lymphocytes (CTL) or of natural killer (NK) cells and the production of cytokines such as interferon-gamma (IFN-g). An intact immune system is therefore required for BCG antitumor activity [3]. Furthermore, BCG is a live, attenuated Mycobacterium bovis bacillus that maintains an immunostimulating action but also a decreased infection ability. Thus, BCG vaccine is contraindicated in immunocompromised patients, because of an increased risk of morbidity and sepsis [4]. We report herein on two patients having received hematopoietic stem cell transplantation (HSCT) for hematological malignancies and who underwent BCG instillations for the treatment of urothelial carcinoma. The first patient, a 55-year-old man, was treated in our Department for an acute myelomonocytic leukaemia with eosinophilia (AML4eo) and inversion of the chromosome 16 in the karyotype (inv16), diagnosed on July 2001. On February 2000 the patient had undergone transurethral resection of a papillary urothelial carcinoma, grade G1 and stage PTA. He received a chemotherapy regimen consisting of cytosine arabinoside and anthracycline for the AML, while on September 2001 he underwent transurethral resection of recurrent TCC grade G1, stage PTA. On October 2001 the patient received an autologous HSCT after conditioning with busulphan/melphalan. He achieved complete cytological and cytogenetic remission. Afterwards, he received three cures of intravenous interleukin-2 (IL-2) as a maintenance treatment. On June 2002 the patient relapsed. A second complete remission was achieved by two cures of high dose aracytine and idarubicin. On October 2002 he received an allogeneic genoidentical hematopoietic stem-cell transplant (HSCT) following reduced intensity conditioning regimen consisting of fludarabine and 2 Gy of total body irradiation. Immunosuppressive prophylaxis treatment consisted of cyclosporine 6.25 mg/kg twice daily p.o. from day-3 and mycophenolate mofetil 15 mg/kg twice daily p.o. from day 0 until day þ27. The patient did not present any graft-versus-host disease (GVHD) and cyclosporine was interrupted on April 2003. On February 2004 he presented a recurrence of the papillary carcinoma and underwent transurethral resection. On April 2004 the patient received six intravesical instillations of ametycine for the prevention of recurrence of the TCC. On February 2006 he