The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.

Inclusion criteria

• patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)
• WHO performance status ≤2
• age ≤85years
• BCG naive
• patients not treated with intravesical chemotherapy in the last 3 months.

Exclusion criteria

• presence of T1G3 or CIS
• preoperative urinary cytology positive for high-grade atypia
• inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)
• history of genito-urinary tuberculosis
• presence of uncontrolled urinary infections.