[Gemcitabine and carboplatin chemotherapy in advanced transitional cell carcinoma in regard to patients with impaired renal function].

PURPOSE: The aim of this analysis is the evaluation of the activity and toxicity of gemcitabine and carboplatin in patients with advanced urothelial transitional carcinoma (TCC) with special regard to patients with impaired renal function.

PATIENTS AND

METHODS

30 consecutive patients with metastatic TCC [mean age: 68 (range: 47 - 82) years, median ECOG-PS:1] were treated with gemcitabine (1000 mg/m (2) on days 1 and 8 of a 21-day schedule) and carboplatin (AUC 4.5 day 1). In 15 patients (considered as renal unfit) a creatinine clearance of less than 60 mL/min (range: 31 - 59 mL/min) was seen.

RESULTS

Concerning the survival rate, no significant difference noticed between the two subgroups of renal impaired patients and patients with normal renal function was detected (median 13 vs. 14 months, p = 0.901). An overall response rate of 50 % was obtained. In 16.7 % and 33.3 % of all cases a complete or a partial response was noted. Median time to progression was 5.34 months. The 1-year-survival rate has been calculated as 51.8 %. There was no restriction of renal function under chemotherapy in any single patient.

CONCLUSIONS

The chemotherapy combination of gemcitabine and carboplatin is definitely powerful for a first-line-therapy in patients with advanced TCC. Toxicity is well manageable. Due to the dosage for carboplatin by AUC an adaptation to the glomerular filtration rate is possible. Decreases of effectiveness in cases of impaired renal function were not detected. Patients with metastatic TCC should be entered onto well designed, randomised clinical trials with the gemcitabine/carboplatin combination to afford a tailored chemotherapy.