Limited Efficacy of Interferon-α and Vinblastine as Second Line Biochemotherapy Regimen in Patients with Progressive Metastatic Renal Cell Carcinoma

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Abstract
We report on thirty-four patients with metastatic renal cell carcinoma who were treated with a combination of subcutaneous recombinant interferon-α and intravenous vinblastine upon progression after previous antineoplastic therapy. Pretreatment included chemotherapy (n=3), hormonal therapy (n=6) and immunotherapy (interleukin-2/interferon-α, n=25). In this study, treatment courses consisted of subcutaneous doses thrice weekly of recombinant interferon-α at 6 million U/m2 (20 patients, group 2), respectively. Treatment was given over 8 consecutive weeks. Additionally, in all patients, vinblastine was administered intravenously at a dose of 6 mg/m2 in weeks 2, 5 and 8. Of 14 patients treated in group 1, one had a partial response for 6 months (overall response rate 7.14%; 95% confidence interval, 0.18-33.87%), and four had disease stabilization (median duration, 5.0 months). Of 20 patients treated in group 2, there was one patient who achieved a complete response (response duration, 34+ months); in addition, two patients had a partial response (median response duration, 10.5+ months; overall response rate, 15%; 95% confidence interval 3.21-37.89%), and 13 patients exhibited disease stabilization (median duration 5.9+ months). Response rates showed no significant differences when comparing treatment results in patients in group 1 vs group 2. In contrast, significantly less patients treated in group 2 had progressive disease (p = 0.024), as compared to patients in group 1. This treatment combination was overall well tolerated with low to moderate systemic toxicity. In addition, there were no significant differences in frequency or intensity of therapy-related systemic toxicities when comparing patients in group 1 and group 2, respectively. We conclude that the combination of subcutaneous recombinant interferon-α and intravenous vinblastine has limited efficacy as second line biochemotherapy in pretreated progressive metastatic renal cell cancer patients.