Methotrexate-paclitaxel-epirubicin-carboplatin as second-line chemotherapy in patients with metastatic transitional cell carcinoma of the bladder pretreated with cisplatin-gemcitabine: a phase II study.

AIMS

To assess the efficacy and toxicity of methotrexate-paclitaxel-epirubicin-carboplatin combination as second-line chemotherapy in patients with metastatic transitional cell carcinoma (TCC) of the bladder pretreated with cisplatin-gemcitabine.

METHODS

In this prospective phase II study, patients with metastatic TCC of the bladder pretreated with first-line cisplatin-gemcitabine received on progression paclitaxel 175 mg/m(2) i.v. and carboplatin (area under curve of 5) on day 1, and methotrexate 40 mg/m(2) and epirubicin 40 mg/m(2) on day 15. The whole course was repeated every 28 days. The end-points included clinical tumor response, treatment toxicity, quality of life and survival.

RESULTS

A total of 40, predominantly male, patients were enrolled (median age 62 years [range 46-69]). Efficacy and survival were assessed in 38 patients only, as two patients refused treatment after the first cycle. Grade 3 neutropenia was the commonest acute severe toxicity (12/40 patients; 30%). The overall response rate was 39% (15/38 patients). The median follow up was 14 months (range 3-45). The median progression-free and overall survival were 12 and 12.5 months, respectively. The 1-year progression-free and overall survival were 24 and 35%, respectively.

CONCLUSION

Methotrexate-paclitaxel-epirubicin-carboplatin combination as second-line chemotherapy in patients with metastatic TCC of the bladder results in a modest response rate with acceptable toxicity.