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.
Highlights
The non-Hodgkin lymphomas remain among the most treatable forms of cancer
Sorafenib was reasonably well tolerated in pretreated patients with relapsed diffuse large B cell lymphoma (DLBCL)
We demonstrated one complete response in a patient who subsequently progressed
Summary
The non-Hodgkin lymphomas remain among the most treatable forms of cancer. In spite of success with present chemotherapy and antibody-based regimens, a large subset of patients will recur after primary and secondary treatment. While effective in many cases, chemotherapy based treatment carries risks of substantial short and long-term toxicity. Patients who relapse after standard therapy may be eligible for high dose therapy with stem cell transplant. This approach cures fewer than half of patients with relapsed disease [1,2] and many patients are not eligible on the basis of age or other comorbidities.
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