Phase II trial of combination interferon-alpha and thalidomide as first-line therapy in metastatic renal cell carcinoma.

Clark PE, Hall MC, Miller A, Ridenhour KP, Stindt D, Lovato JF, Patton SE, Brinkley W, Das S, Torti FM
Urology. 2004 63 (6): 1061-5

PMID: 15183950 · DOI:10.1016/j.urology.2004.01.035

OBJECTIVES - To present the results of a Phase II trial of thalidomide and interferon-alpha in renal cell carcinoma.

METHODS - Patients with metastatic clear cell renal cell carcinoma and no prior systemic therapy were accrued. Interferon-alpha was administered at 5 million units subcutaneously three times per week. Thalidomide was started at 100 mg/day for 2 weeks and then escalated 200 mg every 2 weeks to 1000 mg or until grade 3-4 toxicity developed. Patients were assessed radiographically at baseline and after 12 weeks. Steady-state thalidomide plasma concentrations were determined.

RESULTS - Thirty patients were enrolled. The median age was 62 years. Seventeen patients (57%) had undergone nephrectomy before therapy. One patient died during therapy. Of the 30 patients, 29 had at least grade 2 toxicity and 17 patients had at least grade 3. At 12 weeks, no patient had a complete response, 2 had a partial response (6.7%), 8 had stable disease (26.7%), and 11 (including 1 patient with an initial partial response) had disease progression (36.7%). Nine patients were removed from the study before 12 weeks. The median follow-up was 49.6 weeks (range 2.4 to 123.7). The median time of participation in the study was 11.1 weeks (range 1.4 to 63.9). At last follow-up, 2 patients were receiving the study therapy, 1 with stable disease at 64 weeks and 1 with a partial response at 53 weeks. The median survival was 68 weeks. A linear relationship was found between the thalidomide plasma concentration and dose. No relationship was apparent between the concentration and either treatment-related toxicity or response.

CONCLUSIONS - Interferon-alpha and thalidomide as front-line therapy for metastatic renal cell carcinoma showed limited activity. The objective response rate was 7%. One third of patients experienced toxicity that required discontinuation of thalidomide. Randomized controlled studies are needed to determine any objective benefit of this regimen over either drug alone.

MeSH Terms (18)

Adult Aged Aged, 80 and over Antineoplastic Combined Chemotherapy Protocols Carcinoma, Renal Cell Disease Progression Drug Administration Schedule Female Humans Injections, Subcutaneous Interferon-alpha Kidney Neoplasms Male Middle Aged Prospective Studies Remission Induction Survival Rate Thalidomide

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