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Combination therapy confers no survival benefit, better response rates relative to interferon-alfa therapy alone in patients with metastatic renal cell carcinoma, data reveal

Tuesday, March 02 2010 | Comments

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What's This? Combination therapy with interferon-alfa therapy, interleukin-2, and fluorouracil does not appear to improve overall or progression-free survival compared with interferon-alfa treatment alone in patients with untreated metastatic renal cell carcinoma (RCC), according to researchers. However, they said the combination therapy might still play a role because it can provide clinically relevant remission in some patients.

The investigators conducted an open-label trial in which treatment-naive patients with advanced metastatic RCC were randomized to receive interferon-alfa therapy alone (n=502) or combination therapy with interferon-alfa, interleukin-2 (Proleukin [aldesleukin]; Prometheus Laboratories Inc.), and fluorouracil (n=504). The trial was conducted in eight European countries and, depending on the location, the interferon-alfa therapy used was interferon alfa-2b (Intron-A; Merck & Co. Inc.) or interferon alfa-2a (Roferon-A; Roche).

Lead investigator Martin Gore, medical director of the U.K.-based Royal Marsden Hospital, said both interferon alfa-2b and interferon alfa-2a are used in Europe. "It is generally felt that these are interchangeable, certainly in relation to RCC," he noted.

The main objective of the study, which had a median follow-up of 37.2 months, was to compare overall survival between the treatment groups.

There was no evidence of a difference between the 2 groups for overall survival. At 1 year, overall survival was 67% in both groups. At 3 years, overall survival was 30% for the interferon-alfa monotherapy group and 26% for the combination therapy group. Median overall survival was 18.8 months for the patients who received interferon-alfa only and 18.6 months for those given the combination therapy.

Progression-free survival rates also did not differ between the groups. Median progression-free survival for the interferon-alfa-treated patients was 5.5 months, versus 5.3 months for the combined therapy-treated patients.

However, the overall response rate was significantly higher for the patients under the combined treatment plan (23%) than it was for the patients who received interferon-alfa alone (16%).

The researchers noted that the combined treatment was associated with more severe toxic effects overall than was treatment with interferon-alfa alone. (Lancet 2010;375:641-648.)

This information concerns uses that have not been approved by the Food and Drug Administration.

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