Purpose: Combination gemcitabine and 5-fluorouracil (5-FU) may have activity in metastatic renal cell cancer. To identify patient subgroups most likely to benefit and compare survival to that in previously described patient series long-term survival as a function of known and suspected prognostic variables was determined.
Materials and methods: The survival status of 153 patients with metastatic renal cell cancer treated on 1 phase I and 4 phase II trials of gemcitabine/5-FU based regimens was updated. Univariate and multivariate Cox proportional hazards models were constructed using multiple imputation for missing values.
Results: Performance status, prior nephrectomy, number of metastatic sites, decreased albumin and elevated alkaline phosphatase were highly prognostic for survival. Sarcomatoid differentiation and hypercalcemia had borderline prognostic significance. Using a previous described prognostic model that divided patients into 3 risk groups survival in those treated with gemcitabine/5-FU in this series was consistently better than survival in similar patients treated in the Motzer series.
Conclusions: Previously described prognostic factors for survival in metastatic renal cancer were confirmed. There is no clearly identifiable group that is most likely to benefit from a gemcitabine/5-FU regimen but there is a continued suggestion that this regimen provides a modest improvement over historical chemotherapy approaches.