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Published online before print October 11, 2006, doi:10.1212/01.wnl.0000243231.12248.67)
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 Volume 67, Number 10, November 28, 2006
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Received December 1, 2005
Accepted August 1, 2006

Phase II trial of pirfenidone in adults with neurofibromatosis type 1

D. Babovic-Vuksanovic MD*, K. Ballman PhD, V. Michels MD, P. McGrann MD, N. Lindor MD, B. King MD, J. Camp , V. Micic , N. Babovic , X. Carrero , R. Spinner MD, and B. O’Neill MD

From Department of Medical Genetics (D.B.-V., V.M., P.M., N.L.), Radiology (B.K.), Neurology (B.O.), and Neurosurgery (R.S.); Biomedical Imaging Resource (J.C., V.M. N.B.); and Health Sciences Research (X.C.), Mayo College of Medicine, Rochester, MN


* To whom correspondence should be addressed. E-mail: dbabovic{at}mayo.edu.

Abstract--We performed an open-label phase II trial of oral pirfenidone in 24 patients with neurofibromatosis type 1 (NF1). Tumors were monitored by three-dimensional MRI. At the end of treatment, four patients had a decrease in tumor volume by 15% or more, three had tumor progression, and 17 remained stable. Pirfenidone warrants further investigation in NF1, which has until now lacked an effective control therapy.




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