Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: The BRiTE observational cohort study

Mark Kozloff, Marianne Ulcickas Yood, Jordan Berlin, Patrick J. Flynn, Fairooz F. Kabbinavar, David M. Purdie, Mark A. Ashby, Wei Dong, Mary M. Sugrue, Axel F Grothey

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Abstract

Background. The Bevacizumab Regimens' Investigation of Treatment Effects (BRiTE) study is a prospective, observational cohort study designed to elucidate safety and effectiveness outcomes associated with bevacizumab combined with chemotherapy as used in clinical practice for first-line treatment of metastatic colorectal cancer (mCRC). Patients and Methods. Baseline characteristics, prespecified bevacizumab-related adverse events, and effectiveness data were collected from 1,953 mCRC patients who were receiving first-line treatment including bevacizumab at 248 U.S. sites. Results. At database lock, the median follow-up was 20.1 months. At baseline, 46% of patients were aged >65 years and 49% had an Eastern Cooperative Oncology Group performance status score >1. Fluorouracil, leucovorin, and oxaliplatin was the most common firstline chemotherapy regimen (56%). Overall rates of be-vacizumab-related adverse events in the BRiTE study, such as gastrointestinal perforation (1.9%), arterial thromboembolic events (2%), grade 3- 4 bleeding (2.2%), and de novo hypertension requiring medication (22%), were consistent with those reported in randomized clinical trials (RCTs) of bevacizumab in first-line mCRC treatment. The median progression-free survival (PFS) and overall survival (OS) times were 9.9 (95% confidence interval [CI], 9.5-10.3) months and 22.9 (95% CI, 21.9 -24.4) months, respectively. Conclusion. The median PFS and OS durations and safety profile of bevacizumab in the BRiTE study were similar to those in RCTs of bevacizumab plus chemotherapy in first-line mCRC patients. The observations from the BRiTE study complement and expand upon RCT data, providing clinical information in a large cohort of bevacizumab-treated patients and subgroups such as the elderly.

Original languageEnglish (US)
Pages (from-to)862-870
Number of pages9
JournalOncologist
Volume14
Issue number9
DOIs
StatePublished - Sep 2009

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Observational Studies
Colorectal Neoplasms
Cohort Studies
Therapeutics
oxaliplatin
Randomized Controlled Trials
Drug Therapy
Disease-Free Survival
Bevacizumab
Confidence Intervals
Safety
Survival
Leucovorin
Fluorouracil
Databases
Hemorrhage
Hypertension

Keywords

  • Antiangiogenesis
  • Biologics
  • GI perforation
  • Registry
  • Systemic therapy
  • VEGF inhibition

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Kozloff, M., Yood, M. U., Berlin, J., Flynn, P. J., Kabbinavar, F. F., Purdie, D. M., ... Grothey, A. F. (2009). Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: The BRiTE observational cohort study. Oncologist, 14(9), 862-870. https://doi.org/10.1634/theoncologist.2009-0071

Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer : The BRiTE observational cohort study. / Kozloff, Mark; Yood, Marianne Ulcickas; Berlin, Jordan; Flynn, Patrick J.; Kabbinavar, Fairooz F.; Purdie, David M.; Ashby, Mark A.; Dong, Wei; Sugrue, Mary M.; Grothey, Axel F.

In: Oncologist, Vol. 14, No. 9, 09.2009, p. 862-870.

Research output: Contribution to journalArticle

Kozloff, M, Yood, MU, Berlin, J, Flynn, PJ, Kabbinavar, FF, Purdie, DM, Ashby, MA, Dong, W, Sugrue, MM & Grothey, AF 2009, 'Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer: The BRiTE observational cohort study', Oncologist, vol. 14, no. 9, pp. 862-870. https://doi.org/10.1634/theoncologist.2009-0071
Kozloff, Mark ; Yood, Marianne Ulcickas ; Berlin, Jordan ; Flynn, Patrick J. ; Kabbinavar, Fairooz F. ; Purdie, David M. ; Ashby, Mark A. ; Dong, Wei ; Sugrue, Mary M. ; Grothey, Axel F. / Clinical outcomes associated with bevacizumab-containing treatment of metastatic colorectal cancer : The BRiTE observational cohort study. In: Oncologist. 2009 ; Vol. 14, No. 9. pp. 862-870.
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abstract = "Background. The Bevacizumab Regimens' Investigation of Treatment Effects (BRiTE) study is a prospective, observational cohort study designed to elucidate safety and effectiveness outcomes associated with bevacizumab combined with chemotherapy as used in clinical practice for first-line treatment of metastatic colorectal cancer (mCRC). Patients and Methods. Baseline characteristics, prespecified bevacizumab-related adverse events, and effectiveness data were collected from 1,953 mCRC patients who were receiving first-line treatment including bevacizumab at 248 U.S. sites. Results. At database lock, the median follow-up was 20.1 months. At baseline, 46{\%} of patients were aged >65 years and 49{\%} had an Eastern Cooperative Oncology Group performance status score >1. Fluorouracil, leucovorin, and oxaliplatin was the most common firstline chemotherapy regimen (56{\%}). Overall rates of be-vacizumab-related adverse events in the BRiTE study, such as gastrointestinal perforation (1.9{\%}), arterial thromboembolic events (2{\%}), grade 3- 4 bleeding (2.2{\%}), and de novo hypertension requiring medication (22{\%}), were consistent with those reported in randomized clinical trials (RCTs) of bevacizumab in first-line mCRC treatment. The median progression-free survival (PFS) and overall survival (OS) times were 9.9 (95{\%} confidence interval [CI], 9.5-10.3) months and 22.9 (95{\%} CI, 21.9 -24.4) months, respectively. Conclusion. The median PFS and OS durations and safety profile of bevacizumab in the BRiTE study were similar to those in RCTs of bevacizumab plus chemotherapy in first-line mCRC patients. The observations from the BRiTE study complement and expand upon RCT data, providing clinical information in a large cohort of bevacizumab-treated patients and subgroups such as the elderly.",
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