Gemcitabine and paclitaxel chemotherapy effective for good risk advanced urothelial malignancies

Abstract

4675 Background: The prognosis for patients with progressive or recurrent invasive bladder cancer is generally poor. Best responses are seen when patients are treated with a cisplatin based combination chemotherapy. Unfortunately, poor renal function and performance status precludes use of cisplatin in all patients. Identifying those patients who may benefit from a non-platinum combination is important. Poor Performance status and presence of visceral metastases identifies patients who are at a higher risk of relapse and lower survival.Methods: Patients with histological proven metastatic bladder cancer, who have normal organ function and be able to give informed consent, were eligible. Patients received chemotherapy in the outpatient clinic with paclitaxel at110 mg/m2, q weekly day 1 and day 15 and gemcitabine 1000mg/m2 on day 1, and 15 of a 28-day cycle. Patients were evaluated after 2 cycles of therapy with CT scans and bone scans. Response and survival were evaluated in the low risk and intermediate/high risk group.Results: Eleven patients (65%) had an objective response rate. Complete responses were seen in 17% of patients. The median duration of response was 5 months and the toxicity was mild. The median survival was 7.5 months. Grade 3/4 hematological toxicities included fever and neutropenia (9%) and anemia requiring blood transfusions (18%). The most common nonhematologic toxicity was fatigue (36%), anorexia (27%), rash, paraesthesia and myalgias (18%. All patients with low risk disease had a response compared to 27% in intermediate/high risk group (P=0.001) Conclusions:The combination of paclitaxel and gemcitabine given in a q 2 week regimen is very well tolerated and has significant activity in good risk patients with metastatic transitional cell carcinoma of the bladder and disease. Cisplatin based chemotherapy is essential for patients with visceral metastases or impaired performance status. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly