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Article Summary
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Amato RJ et al. – Lenalidomide is a safe and effective therapy for refractory metastatic renal cell cancer (RCC) Methods- Open-label, single-center phase II trial for safety and efficacy of oral lenalidomide in 39 pts age ≥ 18 yrs with newly diagnosed RCC
- Administration of ≥ 3 28-day cycles (21 days on drug; 7 days off) oral lenalidomide (25 mg/d)
- Dose reduced for toxicity cases
- Primary endpoint: tumor response rate
- Secondary endpoints: time to tumor progression, response duration, 6-mo and 12-mo progression-free survival, overall survival, and safety
Results- Most pts (92%) completed at least 3 treatment cycles (12 wks)
- Complete response in 3% of pts, partial response, 8%; stable disease, 53%; progressive or unknown-status disease, 38%
- Time to tumor progression: ≤ 6 mo in 62% of pts; 6-12 mo in 15%; >12 mo in 23%
- Median response duration: 6 (2-22) mo; median overall survival: 17 mo (0.80-39.6)
- Most common treatment-related adverse event: grade ≤ 2 fatigue
- Most common laboratory abnormalities: grade ≥ 3 neutropenia and thrombocytopenia
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