Authors: Rabih Said Eugenia Kakadiaris Sarina PihaPaul Siqing Fu Gerald Falchook Filip Janku Jennifer J Wheler Ralph Zinner David S Hong Razelle Kurzrock Apostolia M Tsimberidou
Publish Date: 2016/04/16
Volume: 77, Issue: 5, Pages: 1097-1102
Abstract
A “3 + 3” study design was used Lenalidomide 10 or 20 mg orally days 1–21 and bevacizumab 5 75 or 10 mg/kg intravenously every 2 weeks were given at four escalating dose levels followed by an expansion phase at the highest maximum tolerated dose MTD 1 cycle = 4 weeks Doselimiting toxicity DLT MTD adverse events and clinical outcomes were assessedThirtyone patients were enrolled median age 60 years men 52 The most common tumor types were colorectal carcinoma n = 11 and melanoma n = 5 Overall 105 cycles median 2 were administered No DLTs were observed The maximum tested dose level 4 was used in the expansion phase The most common toxicities were fatigue n = 7 23 and skin rash n = 4 13 One patient developed a transient ischemic attack 32 prophylactic anticoagulation became mandatory in the subsequent 17 treated patients Of 31 patients 27 were evaluable for response Stable disease SD was noted in 10 37 patients including five patients with SD for ≥6 months tumor types clear cell sarcoma germ cell tumor colorectal carcinoma and melanoma The median progressionfree survival and overall survival were 28 and 55 months respectively
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