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Gemcitabine/5-Fluorouracil Does Not Appear To Be More Effective In One Metastatic Renal Cancer Subgroup Over Another

In patients with metastatic renal cancer, gemcitabine/5-fluorouracil (5-FU) provides a modest improvement over traditional chemotherapy approaches, but no clearly identifiable subgroup is most likely to benefit from this regimen, new research suggests.

According to the researchers, therapies for patients with metastatic renal cell cancer are limited. Immunotherapy with interleukin-2 and/or interferon benefits only a minority of patients, and no standard therapy exists for patients in whom first-line immunotherapy fails.

Combination gemcitabine/5-FU may have activity in metastatic renal cell cancer, with previous clinical trials suggesting a combined overall response rate of about 14% and possibly a prolonged time to progression compared to other chemotherapy treatments.

To identify the subgroups that may benefit the most from gemcitabine/5-FU, Walter M. Stadler, MD, with the University of Chicago, Illinois, United States, and colleagues analysed data on 153 patients with metastatic renal cell cancer from 1 phase I and 4 phase II trials.

Of these patients, 15 partial and 1 complete responses were observed for an overall response rate of 10%. Median survival was 12.5 months (95% confidence interval 10.7 to 15.2).

The researchers found that independent risk factors for poor survival included poor performance status, absent prior nephrectomy, 3 or more metastatic sites, decreased albumin, and elevated alkaline phosphatase, while sarcomatoid features and elevated calcium had borderline significance.

According to the researchers, these observations are "similar to those reported previously in other studies and suggest that they are consistent prognostic factors for metastatic renal cancer and not specific to the underlying treatment."

They also note that the current study supports previous observations of a modest survival benefit with gemcitabine/5-fluorouracil, although definitive conclusions would require a randomised study.

"Perhaps the most surprising observation was that lack of prior nephrectomy maintained independent prognostic importance on multivariate analysis," Dr. Stadler and colleagues note. They suggest that this "raises the hypothesis that nephrectomy is an important part of therapy for patients with metastatic disease even in those not treated with immunotherapy."

J Urol 2003;170:4 Pt 1:1141-1145. "Prognostic Factors for Survival With Gemcitabine Plus 5-fluorouracil Based Regimens for Metastatic Renal Cancer"

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