title: A phase II study of sorafenib (BAY 43-9006) in recurrent diffuse large B cell lymphoma: an eastern cooperative oncology group study (E1404).
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.
authors.affiliation: Stanford University, Stanford, CA, USA. dgreenwald@ccsb.org
authors.forename: Daniel R
authors.initials: DR
authors.lastname: Greenwald
authors.forename: Hailun
authors.initials: H
authors.lastname: Li
authors.forename: Selina M
authors.initials: SM
authors.lastname: Luger
authors.forename: Ronald S
authors.initials: RS
authors.lastname: Go
authors.forename: David
authors.initials: D
authors.lastname: King
authors.forename: Taral
authors.initials: T
authors.lastname: Patel
authors.forename: Randy D
authors.initials: RD
authors.lastname: Gascoyne
authors.forename: Jill
authors.initials: J
authors.lastname: Kolesar
authors.forename: Brad S
authors.initials: BS
authors.lastname: Kahl
authors.forename: Sandra
authors.initials: S
authors.lastname: Horning
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D009536:Niacinamide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D011379:Prognosis; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib