Prognostic factors for survival with gemcitabine plus 5-fluorouracil based regimens for metastatic renal cancer.

OBJECTIVE

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.

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.