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Open Access Research

A phase II study of sorafenib (BAY 43–9006) in recurrent diffuse large B cell lymphoma: an eastern cooperative oncology group study (E1404)

Daniel R Greenwald110*, Hailun Li2, Selina M Luger3, Ronald S Go4, David King5, Taral Patel6, Randy D Gascoyne7, Jill Kolesar8, Brad S Kahl8 and Sandra Horning19

Author Affiliations

1 Stanford University, Stanford, CA, USA

2 Dana Farber Cancer Institute, Boston, Massachusetts, USA

3 University of Pennsylvania, Philadelphia, PA, USA

4 Gundersen Lutheran Health System, La Crosse, WI, USA

5 Health One Mercy Hospital, Coon Rapids, MN, USA

6 Columbus CCOP, Columbus, OH, USA

7 British Columbia Cancer Agency, Vancouver, Canada

8 University of Wisconsin, Madison, WI, USA

9 Roche-Genentech, South San Francisco, CA, USA

10 Cancer Center of Santa Barbara, 540 West Pueblo St, Santa Barbara, CA 93105, USA

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Journal of Hematology & Oncology 2013, 6:46  doi:10.1186/1756-8722-6-46

Published: 5 July 2013

Abstract

Patients with diffuse large B cell lymphoma (DLBCL) who are not candidates for or recur after autologous stem cell transplant have a poor overall prognosis. We conducted a phase II study of sorafenib (formerly BAY 43–9006) in the treatment of relapsed DLBCL. Fourteen patients were enrolled and assessed for response. Median number of cycles administered was 3 (range, 1–12). Common grade 3 toxicities included fatigue (29%), rash/desquamation (21%) and diarrhea (14%). One complete response (CR) was observed (the 14th patient enrolled). Response rate was 7% (90% CI, 0.4 – 30%). Duration of response was 6 months. Median progression-free survival (PFS) was 2 months (90% CI, 1 – 5 months). Median overall survival (OS) was 9 months (90% CI, 5 – 16 months). Although sorafenib has demonstrated activity in solid malignancies it demonstrated low single agent activity in treatment of DLBCL.

Keywords:
NHL; Diffuse large B cell lymphoma; MAP kinase signaling; Sorafenib