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

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 asses...

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Bibliographic Details
Published in:Journal of hematology and oncology 2013-07, Vol.6 (1), p.46-46, Article 46
Main Authors: Greenwald, Daniel R, Li, Hailun, Luger, Selina M, Go, Ronald S, King, David, Patel, Taral, Gascoyne, Randy D, Kolesar, Jill, Kahl, Brad S, Horning, Sandra
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Cancer
Cancer therapies
Care and treatment
Chemotherapy
Colleges & universities
Confidence intervals
Diarrhea
Drug dosages
Drug therapy
Female
Hematology
Humans
Hypotheses
Lymphoma
Lymphoma, Large B-Cell, Diffuse - drug therapy
Male
Medical research
Medicine, Experimental
Middle Aged
Neoplasm Recurrence, Local - drug therapy
Niacinamide - adverse effects
Niacinamide - analogs & derivatives
Niacinamide - therapeutic use
Non-Hodgkin's lymphomas
Oncology
Patients
Phenylurea Compounds - adverse effects
Phenylurea Compounds - therapeutic use
Prognosis
Relapse
Reporting requirements
Statistics
Stem cells
Toxicity
Transplantation
Treatment Outcome
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Summary: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.
ISSN:1756-8722
1756-8722
DOI:10.1186/1756-8722-6-46