A phase 2 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

Alison T Stopeck, Joseph M. Unger, Lisa M Rimsza, Michael LeBlanc, Brent Farnsworth, Maria E Iannone, Martha J. Glenn, Richard I. Fisher, Thomas P Miller

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

S0515 was a phase 2 trial to determine whether the addition of bevacizumab to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab (R-CHOP) would improve progression-free survival (PFS) without adding significant toxicity in patients with newly diagnosed advanced diffuse large B-cell lymphoma. A total of 73 patients were enrolled. For the 64 eligible patients, median age was 68 years, and 60% had International Prognostic Index scores more than or equal to 3. 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 gastrointestinal 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 gastrointestinal perforations. This study is registered at www.clinical trials.gov as #NCT00121199.

Original languageEnglish (US)
Pages (from-to)1210-1217
Number of pages8
JournalBlood
Volume120
Issue number6
DOIs
StatePublished - Aug 9 2012

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Vincristine
B-Cell Lymphoma
Prednisone
Non-Hodgkin's Lymphoma
Doxorubicin
Cyclophosphamide
Toxicity
Disease-Free Survival
Cells
Chemotherapy
Vascular Endothelial Growth Factor A
Lymphoma, Large B-Cell, Diffuse
Plasmas
Left Ventricular Dysfunction
Bevacizumab
Rituximab
Clinical Trials
Urine
Survival
Population

ASJC Scopus subject areas

  • Hematology
  • Biochemistry
  • Cell Biology
  • Immunology

Cite this

A phase 2 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. / Stopeck, Alison T; Unger, Joseph M.; Rimsza, Lisa M; LeBlanc, Michael; Farnsworth, Brent; Iannone, Maria E; Glenn, Martha J.; Fisher, Richard I.; Miller, Thomas P.

In: Blood, Vol. 120, No. 6, 09.08.2012, p. 1210-1217.

Research output: Contribution to journalArticle

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abstract = "S0515 was a phase 2 trial to determine whether the addition of bevacizumab to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab (R-CHOP) would improve progression-free survival (PFS) without adding significant toxicity in patients with newly diagnosed advanced diffuse large B-cell lymphoma. A total of 73 patients were enrolled. For the 64 eligible patients, median age was 68 years, and 60{\%} had International Prognostic Index scores more than or equal to 3. 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 gastrointestinal 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 gastrointestinal perforations. This study is registered at www.clinical trials.gov as #NCT00121199.",
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