Low-dose gemcitabine and paclitaxel combination therapy as second- or third-line treatment in patients with advanced urothelial cancer: Pain relief and tolerability.

Abstract

310 Background: Pain is the most devastating symptom of advanced urothelial cancer (UC). In addition, analgesics often decrease quality of life. So, pain relief and reduction of dosage are important goals for patients with such advanced UC. Cisplatin (CDDP)-containing chemotherapy is most effective regimen in patients with metastatic or recurrent UC. On the other hand, there is no established regimen for advanced UC after CDDP-containing chemotherapy. We performed low-dose combined therapy of gemcitabine (GEM) and paclitaxel (PTX), named GP therapy, as second- or third-line treatment for these patients. Methods: Thirty-three patients with metastatic and/or recurrent urothelial cancer (upper urinary tract = 13 and bladder =20 patients) previously treated with CDDP-containing chemotherapy were treated with GP therapy (GEM = 70 mg/m2 and PTX = 700 mg/m2 on day 1 and 8, repeated every 28 days). Survival was calculated from judgment of tumor progression. Pain was measured on a visual analog scale of 0–10. Positive effects for pain relief were defined as a decrease in analgesic consumption or a decrease in pain grade according to the visual analog scale, without increasing the dose of analgesics. Regulation of analgesics was performed by independent team that did not know this study. Pain relief and survival were compared with other chemotherapy (control; GEM alone = 9 and PTX-based chemotherapy except for GP therapy = 14). Results: At the start of this treatment, 31 patients had abdominal or back pain due to UC. In addition, 3 patients also had bone pain of metastatic tumors. In GP therapy, 28 patients (84.8%) were judged as positive in pain and only 1 patient needed to increase analgesics. On the other hand, control group showed 13 of 23 patients (56.5%) were stable and 7 (30.4%) were judged as positive in pain. Kaplan-Meier survival curves showed overall survival periods in patients with GP therapy were better compared to control group (p=0.023). All patients were received in the outpatient setting because severe side effect was not occurred. Conclusions: Low-dose GP therapy is feasible and well-tolerated as second/third-line chemotherapy in patients with advanced UC.