Abstract

ABSTRACT Aim: For patients with metastatic urothelial cancer, overall survival is poor after progression from first-line chemotherapy (CT). In Europe, vinflunine is the only approved drug for second-line treatment – however, in Portugal, it has not been approved for reimbursement. Several phase II studies using gemcitabine and paclitaxel (GPac) have shown it to be an active and well tolerated second-line regimen. Our aim is to assess the effectiveness of the GPac regimen after failure of platinum-based CT. Methods: Consecutive series of patients with metastatic urothelial cancer, who experienced progression during or after platinum-based CT and were subsequently treated with GPac, at our center, from January 2007 to December 2013. Data on demographics, prognostic factors, response, survival and toxicity were extracted from clinical files. Results: Twenty five patients were included. Baseline characteristics: median age 63 years (range 48 – 78), 96% males, 12% ECOG performance status (PS) 0 and 88% PS 1 or 2, 20% hemoglobin level 24 months. Of known prognostic factor, only presence of liver metastasis was a predictor of a poorer prognosis. Grade 3–4 toxicity was identified in 88% of patients: neutropenia (60%), thrombocytopenia (56%), anemia (16%) and sepsis (12%). Conclusions: GPac was active, with 8% complete responses and durable remissions in 24% of patients. Toxicity, although high, was manageable. Disclosure: All authors have declared no conflicts of interest.

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