Bevacizumab 5 mg/kg can be infused safely over 10 minutes Journal Article
| Authors: | Reidy, D. L.; Chung, K. Y.; Timoney, J. P.; Park, V. J.; Hollywood, E.; Sklarin, N. T.; Muller, R. J.; Saltz, L. B. |
| Article Title: | Bevacizumab 5 mg/kg can be infused safely over 10 minutes |
| Abstract: | Purpose: Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor. As a result of concerns for potential infusion-related hypersensitivity reactions (HSRs), initial phase I trials used a 90-, 60-, 30-minute initial infusion sequence. We sought to determine if the initial prolonged infusion was still necessary and if an infusion time of fewer than 30 minutes could be safely used. Methods: We used computerized pharmacy records to identify all patients who received bevacizumab at our institution in the first 2 years of commercial availability (February 1, 2004, to June 30, 2006). Our institutional adverse drug reaction reporting program was used to identify any infusion reactions possibly related to bevacizumab, and patient medical records were reviewed for confirmation. Results: A total of 1,077 patients were treated with 10,606 doses of bevacizumab, and 765 of these patients received a 5-mg/kg dose (total of 8,494 doses). No HSRs occurred with the 90-, 60-, 30-minute infusion sequence in the first 202 patients. The standard infusion rate was then modified to 30 minutes for all bevacizumab doses. No HSRs were encountered. The infusion was again modified to a rate of 0.5 mg/kg/min. Of the 370 patients who received a total of 2,311 doses of bevacizumab at 5 mg/kg over 10 minutes, six (1.6%) experienced events of minor clinical consequence that were possibly consistent with nonsehous HSRs. Conclusion: Ninety- and 60-minute initial infusion times are unnecessary. Use of a standard infusion rate of 0.5 mg/kg/min is safe, logical, and the current policy at our institution. © 2007 by American Society of Clinical Oncology. |
| Keywords: | adult; controlled study; aged; middle aged; vascular endothelial growth factor a; major clinical study; clinical trial; drug tolerability; angiogenesis inhibitor; bevacizumab; fluorouracil; drug efficacy; drug safety; paclitaxel; neoplasm; neoplasms; carboplatin; controlled clinical trial; phase 2 clinical trial; breast cancer; randomized controlled trial; vomiting; lung cancer; medical record review; patient identification; time; time factors; monoclonal antibody; abdominal pain; chill; dyspnea; electronic medical record; antibodies, monoclonal; drug antagonism; folinic acid; colon cancer; medical record; medical records systems, computerized; vasculotropin a; hot flush; phase 3 clinical trial; oxaliplatin; angiogenesis inhibitors; clinical trials; urticaria; diphenhydramine; dose time effect relation; ranitidine; hypersensitivity |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 25 |
| Issue: | 19 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2007-07-01 |
| Start Page: | 2691 |
| End Page: | 2695 |
| Language: | English |
| DOI: | 10.1200/jco.2006.09.3351 |
| PUBMED: | 17602073 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 17" - "Export Date: 17 November 2011" - "CODEN: JCOND" - "Source: Scopus" |
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