Trial Information

The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.

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.