Gemcitabine might be a second-line treatment option for patients with high-risk non-muscle-invasive bladder cancer (BC) who fail therapy with bacille Calmette-Guérin (BCG), according to Italian researchers.

In a multicenter trial, a team led by Riccardo Autorino, MD, PhD, of Clinica Urologica, Seconda Università degli Studi di Napoli, Napoli, Italy, studied 80 patients with the malignancy who failed a single course of BCG treatment who were randomly assigned to receive intravesical gemcitabine (Group A; 40 patients) or intravesical BCG (Group B; 40 patients).

Group A received the gemcitabine at a dose of 2000 mg/50 mL twice weekly for six consecutive weeks and then weekly for three consecutive weeks at three, six, and 12 months. Group B received the BCG at a dose of 81 mg/50 mL over a six-week induction course and each week for three weeks at three, six, and 12 months. The median follow-up for Group A and Group B was 15.2 months and 15.8 months, respectively.

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Twenty-one patients in Group A (52.5%) experience disease recurrence compared with 35 patients in Group B (87.5%), the investigators reported in Cancer (2010; published online ahead of print). The mean time to first recurrence—3.9 and 3.1 months in Group A and Group B—was not significantly different between the groups. Two-year recurrence-free survival was 19% for Group A and 3% for Group B, a significant difference. Both groups had similar rates of disease progression. The gemcitabine and BCG treatments were well tolerated.

“High-risk non-muscle-invasive BC patients in whom BCG fails remain a challenge to the urologist,” the authors concluded. “Even if radical cystectomy still remains the best treatment, some patients refuse it or are unsuitable for it. Gemcitabine used as second-line treatment after BCG failure in high-risk non-muscle-invasive BC patients might represent a safe and effective option.”

Treatment options for these patients are severely limited, the researchers pointed out, so clinical trials of novel intravesical agents for patients who fail BCG treatment should be supported to improve the standard of care.