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Keywords:

  • second-line chemotherapy;
  • gemcitabine;
  • paclitaxel;
  • recurrent transitional cell carcinoma

Abstract

BACKGROUND

An every-2-week regimen of gemcitabine and paclitaxel was adapted for patients with advanced transitional cell carcinoma (TCC) who had received prior cisplatin-based chemotherapy.

METHODS

Forty-one patients with advanced or metastatic TCC who had received prior cisplatin-based systemic chemotherapy were treated with an outpatient regimen of gemcitabine 2500–3000 mg/m2 and paclitaxel 150 mg/m2 every 2 weeks.

RESULTS

Forty of 41 patients had measurable disease. Response was observed in 24 patients (60%; 95% confidence interval [CI], 45–75%). Eleven (28%) achieved complete response, and 13 (33%) obtained partial response. Twenty of 25 patients (80%; 95% CI, 64–96%) who had been previously treated in the neoadjuvant or adjuvant setting responded versus 4 of 15 (27%; 95% CI, 5–49%) in patients who received prior methotrexate, vinblastine, doxorubicin, cisplatin (M-VAC) for metastatic disease. The median duration of survival for patients given gemcitabine and paclitaxel after failing neoadjuvant or adjuvant M-VAC was 12 months (range, 2–43+), as compared with only 8 months (range, 2–28) for patients who had been treated after failure of prior therapy for metastatic disease. For all patients, the median duration of response was 6.4 months (range, 2–43.3+ months), and the median survival was 14.4 months (range, 2–43+). Thirteen patients (32%) developed World Health Organization Grade 3–4 neutropenia, with febrile neutropenia in 3 (7%) patients. Granulocyte colony-stimulating factor was given to 10 (24%) patients. There was no Grade 3–4 anemia or thrombocytopenia.

CONCLUSIONS

The combination of gemcitabine and taxol in previously treated patients with recurrent TCC is highly effective and produces objective durable responses. This every-2-week schedule is a well tolerated outpatient regimen with minimal toxicity. Cancer 2001;92:2993–8. © 2001 American Cancer Society.