Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 24, No 18S (June 20 Supplement), 2006: 4533
© 2006 American Society of Clinical Oncology

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Abstract

Phase II study of lenalidomide in patients (pts) with metastatic renal cell cancer (MRCC)

Methodist Hospital Research Institute, Houston, TX; Celgene Corporation, Summit, NJ

4533

Background: Immunomodulatory drugs are compounds that originated via the deliberate structural modification of thalidomide. Lenalidomide (Revlimid) is a derivative with enhanced immunological and anti-angiogenic properties lacking toxicities associated with thalidomide. Objectives were to determine response rate, time to progression (TTP), one-year survival, and toxicity in patients with progressive MRCC. Methods: Eligibility included: progressive measurable MRCC, adequate organ/marrow function, zubrod performance status (ZPS) 2, 1 prior therapy, and no active CNS involvement. Lenalidomide is administered orally at a dose of 25mg daily for 21 days with 7 days rest (28-day cycle), with dose modifications for toxicity. Re-evaluation is done every 3 cycles (12 weeks). RECIST criteria is utilized to determine response rate. TTP is determined from entry into study. Results: 40 pts enrolled. 30 male/10 female, range 38–73 (median 63) years. 38 pts had clear cell carcinoma; 2 pts with papillary. 24 pts received prior immunotherapy and/or chemotherapy. 3 pts met criteria for good prognosis, 33 intermediate and 4 poor. Sites of disease included: lung, nodal, bone, adrenal, kidney, and liver. 17 pts had 1 metastatic site, 13 pts 2 metastatic sites, and 10 pts 3 or more metastatic sites. 36 pts completed at least 12 weeks of therapy. 4 pts had early progressive disease. 1 pt had a CR, 2 pts achieved a PR. 52% of pts had a prolonged TTP 6 months and 25% 12 months. Median overall survival of 14.8 months (4.1– 22.2+). Treatment related adverse events included: reversible grade 1/2 non-hematologic toxicity consisting of: nausea, diarrhea, constipation, myalgia and fatigue. 19 pts with grade 3/4 neutropenia and 9 pts with grade 3/4 thrombocytopenia. Median duration of therapy is 6 months (2 - 22). Conclusion: Lenalidomide was well tolerated. Anti-tumor activity has been demonstrated by the following: tumor regression and delayed TTP. The tumor effect was also demonstrated as a second line therapy following cytokine failure.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Council of Health Care Advisors, ImClone Bayer, Onyx, Chiron, Ingenix, Pfizer, sanofi-aventis

Abstract presentation from the 2006 ASCO Annual Meeting