Maintenance monotherapy with gemcitabine after standard platinum-based chemotherapy in patients with advanced urothelial cancer.

OBJECTIVES: To investigate the outcomes of gemcitabine maintenance monotherapy treatment for metastatic urothelial cancer.
METHODS: Gemcitabine maintenance monotherapy was used for metastatic urothelial cancer patients after standard platinum-based chemotherapy. A standard dose of 1000 mg/m(2)/month was given. If patients suffered adverse events or a noticeably compromised quality of life, treatment intervals were extended and doses lowered. Patients with metastatic urothelial cancer receiving only best supportive care after standard chemotherapy served as the retrospective control group.
RESULTS: A total of 33 patients were included in the study group as well as in the control group. Maintenance therapy was administered a median of nine times (range 2-49 times) with a median dose of 984.2 mg (range 500-1400 mg) per time. An adverse event of the Common Terminology Criteria of Adverse Events grade 3 or greater was observed in 10 (30.3%) patients, while nine patients (27.3%) experienced hematotoxicity. After standard chemotherapy pretreatment, disease-specific survival in the maintenance therapy group was an average of 15.0 months, significantly more favorable (P < 0.001) than that of the control group (4.0 months). On multivariate analysis, efficacy of prior chemotherapy (P = 0.018), visceral metastasis (P = 0.007) and gemcitabine maintenance therapy (P < 0.001) were statistically significant prognostic parameters of disease-specific survival.
CONCLUSION: The present study findings suggest that gemcitabine maintenance monotherapy in metastatic urothelial cancer might not only be useful as a palliative treatment, but it could also have a certain level of therapeutic effectiveness.