Sunitinib in relapsed or refractory diffuse large B-cell lymphoma: a clinical and pharmacodynamic phase II multicenter study of the NCIC Clinical Trials Group

Leuk Lymphoma. 2011 May;52(5):833-41. doi: 10.3109/10428194.2011.555892. Epub 2011 Apr 4.

Abstract

There are limited effective therapies for most patients with relapsed diffuse large B-cell lymphoma (DLBCL). We conducted a phase II trial of the multi-targeted vascular endothelial growth factor receptor (VEGFR) kinase inhibitor, sunitinib, 37.5 mg given orally once daily in adult patients with relapsed or refractory DLBCL. Of 19 enrolled patients, 17 eligible patients were evaluable for toxicity and 15 for response. No objective responses were seen and nine patients achieved stable disease (median duration 3.4 months). As a result, the study was closed at the end of the first stage. Grades 3-4 neutropenia and thrombocytopenia were observed in 29% and 35%, respectively. There was no relationship between change in circulating endothelial cell numbers (CECs) and bidimensional tumor burden over time. Despite some activity in solid tumors, sunitinib showed no evidence of response in relapsed/refractory DLBCL and had greater than expected hematologic toxicity.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Angiogenesis Inhibitors
  • Antineoplastic Agents
  • Female
  • Humans
  • Indoles / administration & dosage
  • Indoles / adverse effects*
  • Lymphoma, Large B-Cell, Diffuse / complications
  • Lymphoma, Large B-Cell, Diffuse / drug therapy*
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Pyrroles / administration & dosage
  • Pyrroles / adverse effects*
  • Receptors, Vascular Endothelial Growth Factor / antagonists & inhibitors
  • Salvage Therapy
  • Sunitinib
  • Thrombocytopenia / chemically induced
  • Treatment Failure
  • Tumor Burden / drug effects

Substances

  • Angiogenesis Inhibitors
  • Antineoplastic Agents
  • Indoles
  • Pyrroles
  • Receptors, Vascular Endothelial Growth Factor
  • Sunitinib