Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 7058
© 2008 American Society of Clinical Oncology

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Abstract

Preliminary results of a phase II study of high dose lenalidomide as initial therapy for acute myeloid leukemia in patients 60 years old

Washington University, St. Louis, MO

7058

Background: AML patients over the age of 60y (AML 60) have a poor prognosis and warrant novel therapeutic approaches. Lenalidomide has clinical activity in MDS, and we hypothesized that lenalidomide may be active against AML. Methods: Eligibility criteria: untreated AML 60 with intermediate- or poor-risk cytogenetics (chromosome 5q- excluded), ECOG PS 0–2, and adequate organ function. Treatment included 2 cycles of high dose lenalidomide (50mg/day x 14d, 30d of rest, 50mg/day x 21d), followed by low dose (10 mg/day) therapy in non-progressing patients. Here, we report the first stage (n=15) of a 2 stage design (n=42 total patients). The primary endpoint was CR (IWG). Results: 15 patients were enrolled (2/07–8/07) with median age 71y (range 60–86y) and 5/15 had prior MDS. Cytogenetics were normal (n=9), -7 (n=2), -20 (n=1), +13 (n=2), or complex (n=2). Median follow-up was 7.1 (range 5.3–10) months. Day 15 BM blast percentages (mean + SD decrease of 53 + 29%, P=0.01) and BM blast index (mean + SD decrease of 66 + 31%, P=0.02) were significantly reduced in 9/12 patients evaluable after 14 days of initial high dose lenalidomide. 5/8 patients cleared their peripheral blasts at day 15. 8/15 patients did not receive the two high dose cycles of lenalidomide due to progressive disease (n=4), rash (n=1), or early mortality (n=3). Overall IWG response rate was 2/15 (13%), with 1 cytogenetic CR and 1 PR. The cytogenetic CR patient had AML M0 with +13 and FLT3-ITD. The treatment regimen was well tolerated in this older AML patient population. The most frequent adverse events were hematologic, including grade 3–4 neutropenia (7/15), thrombocytopenia (11/15), and anemia (6/15). While 11/15 patients experienced grade 3–4 non-hematologic toxicities, these were managed with lenalidomide interruptions or dose reductions. Only 1/15 patients were removed from the study due to non-hematologic toxicity. Conclusions: These preliminary findings indicate that single agent lenalidomide is an active agent against AML, and a revised schedule that eliminates gaps in therapy, to ensure sustained lenalidomide exposure, is now being evaluated.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Celgene Celgene Celgene

Abstract presentation from the 2008 ASCO Annual Meeting