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Clinical Trial
. 2013 Jul 5:6:46.
doi: 10.1186/1756-8722-6-46.

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 Greenwald  1 , Hailun Li, Selina M Luger, Ronald S Go, David King, Taral Patel, Randy D Gascoyne, Jill Kolesar, Brad S Kahl, Sandra Horning
Affiliations
Clinical Trial

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 Greenwald et al. J Hematol Oncol. .

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.

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Figures

Figure 1
Figure 1
Progression-free survival (PFS).
Figure 2
Figure 2
Overall survival (OS).
See this image and copyright information in PMC

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