Journal article
Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer
Journal of clinical oncology, Vol.27(20), pp.3385-3390
07/10/2009
DOI: 10.1200/JCO.2009.21.9220
PMCID: PMC2717026
PMID: 19414665
Abstract
The National Surgical Adjuvant Breast and Bowel Project C-08 trial was designed to investigate the safety and effectiveness of adding bevacizumab to modified infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX) 6 regimen for the adjuvant treatment of patients with stage II or III colon cancer. We present safety information in advance of the planned analysis of efficacy.
Among 2,710 randomly assigned patients, demographic factors were balanced. Patients received modified FOLFOX6 every 2 weeks x 12 or modified FOLFOX6 plus bevacizumab (5 mg/kg every 2 weeks x 26, experimental group).
Overall rates of grade 4 or 5 toxicities were nearly identical in the FOLFOX6 and FOLFOX6 plus bevacizumab arms (15.2% and 15.0%, respectively). Six-month mortality rates were 0.96% and 0.90% for the control and experimental groups, respectively. Grade 3+ toxicities that occurred more often in the experimental arm versus control arm included hypertension (12% v 1.8%, respectively), wound complications (abdominal incisional hernia or infusion port dehiscence/inflammation; 1.7% v 0.3%, respectively), pain (11.1% v 6.3%, respectively), and proteinuria (2.7% v 0.8%, respectively). Grade 2+ neuropathy was increased in the experimental arm versus the control arm (grade 2, 33% v 29%, respectively; grade 3, 16% v 14%, respectively; and grade 4, < 1% each). In the experimental arm versus control arm, significantly less thrombocytopenia (1.4% v 3.4%, respectively) and fewer allergic reactions (3.1% v 4.7%, respectively) were observed. Advanced age was associated with a significantly greater rate of grade 4 and 5 toxicities regardless of treatment.
Bevacizumab with modified FOLFOX6 is well tolerated in the surgical adjuvant setting in these patients. No significant increase in GI perforation, hemorrhage, arterial or venous thrombotic events, or death with the addition of bevacizumab to modified FOLFOX6 has been observed. Follow-up for potential delayed adverse effects and efficacy is ongoing.
Details
- Title: Subtitle
- Initial safety report of NSABP C-08: A randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer
- Creators
- Carmen J Allegra - Department of Biostatistics, University of Pittsburgh, PA, USA. Carmen.Allegra@medicine.ufl.eduGreg YothersMichael J O'ConnellSaima SharifLinda H ColangeloSamia H LopaNicholas J PetrelliRichard M GoldbergJames N AtkinsThomas E SeayLouis FehrenbacherSeamus O'ReillyLuis ChuCatherine A AzarNorman Wolmark
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.27(20), pp.3385-3390
- DOI
- 10.1200/JCO.2009.21.9220
- PMID
- 19414665
- PMCID
- PMC2717026
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Grant note
- U10 CA012027 / NCI NIH HHS U10-CA-37377 / NCI NIH HHS U10-CA-69974 / NCI NIH HHS U10 CA069651 / NCI NIH HHS U10-CA-12027 / NCI NIH HHS U10-CA-69651 / NCI NIH HHS U10 CA069974 / NCI NIH HHS U10 CA037377 / NCI NIH HHS
- Language
- English
- Date published
- 07/10/2009
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984094561602771
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