A phase II trial of standard dose cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and rituximab plus bevacizumab for patients with newly diagnosed diffuse large B-cell non-Hodgkin lymphoma: SWOG 0515.

Publication Type:

Journal Article

Source:

Blood (2012)

Keywords:

July 2012, Public Health Sciences Division

Abstract:

S0515 was a phase II trial initiated to determine if the addition of bevacizumab to standard R-CHOP would improve PFS without adding significant toxicity in patients with newly diagnosed advanced diffuse large B-cell lymphoma (DLBCL). 73 patients were enrolled. For the 64 eligible patients, median age was 68 years and 60% had IPI scores ≥> 3. PFS was the primary endpoint. The observed 1 and 2 year PFS estimates were 77% and 69%, respectively. These PFS estimates were not statistically different from the expected PFS for this population if treated with R-CHOP alone. Grade 3 or higher toxicities were observed in 81% of patients, including 2 grade 5 events. The majority of serious toxicities were hematologic, but also included 5 patients with GI perforations, 4 patients with thrombotic events, and 11 patients who developed grade 2 or 3 left ventricular dysfunction. Higher baseline urine VEGF and plasma VCAM levels correlated with worse PFS and overall survival. In conclusion, the addition of bevacizumab to R-CHOP chemotherapy was not promising in terms of PFS and resulted in increased serious toxicities, especially cardiac and GI perforations. This study is registered at www.clinicaltrials.gov as NCT00121199.