Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study

H. I. Hurwitz; T. S. Bekaii-Saab; J. C. Bendell; A. L. Cohn; M. Kozloff; N. Roach; Y. Mun; S. Fish; E. D. Flick; A. Grothey

doi:10.1016/j.clon.2014.03.001

Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin^® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study

H. I. Hurwitz, T. S. Bekaii-Saab, J. C. Bendell, A. L. Cohn, M. Kozloff, N. Roach, Y. Mun, S. Fish, E. D. Flick, A. Grothey

Research output: Contribution to journal › Article › peer-review

20 Scopus citations

Abstract

Aims: The Avastin^® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. Materials and Methods: Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. Results: ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. Conclusion: Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.

Original language	English (US)
Pages (from-to)	323-332
Number of pages	10
Journal	Clinical Oncology
Volume	26
Issue number	6
DOIs	https://doi.org/10.1016/j.clon.2014.03.001
State	Published - Jun 2014

Keywords

Bevacizumab
Colorectal cancer
Observational cohort study

ASJC Scopus subject areas

Oncology
Radiology Nuclear Medicine and imaging

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10.1016/j.clon.2014.03.001

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Hurwitz, H. I., Bekaii-Saab, T. S., Bendell, J. C., Cohn, A. L., Kozloff, M., Roach, N., Mun, Y., Fish, S., Flick, E. D., & Grothey, A. (2014). Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin^® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study. Clinical Oncology, 26(6), 323-332. https://doi.org/10.1016/j.clon.2014.03.001

Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin^® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study. / Hurwitz, H. I.; Bekaii-Saab, T. S.; Bendell, J. C. et al.
In: Clinical Oncology, Vol. 26, No. 6, 06.2014, p. 323-332.

Research output: Contribution to journal › Article › peer-review

Hurwitz, HI, Bekaii-Saab, TS, Bendell, JC, Cohn, AL, Kozloff, M, Roach, N, Mun, Y, Fish, S, Flick, ED & Grothey, A 2014, 'Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin^® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study', Clinical Oncology, vol. 26, no. 6, pp. 323-332. https://doi.org/10.1016/j.clon.2014.03.001

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title = "Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer: Final results from the Avastin{\textregistered} Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study",

abstract = "Aims: The Avastin{\textregistered} Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. Materials and Methods: Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. Results: ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. Conclusion: Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.",

keywords = "Bevacizumab, Colorectal cancer, Observational cohort study",

author = "Hurwitz, {H. I.} and Bekaii-Saab, {T. S.} and Bendell, {J. C.} and Cohn, {A. L.} and M. Kozloff and N. Roach and Y. Mun and S. Fish and Flick, {E. D.} and A. Grothey",

note = "Funding Information: The authors wish to thank all patients who participated in ARIES, as well as the investigators and study sites that enrolled patients. Support for third-party writing support for this manuscript was provided by Genentech, Inc. The ARIES study was sponsored by Genentech, Inc . The study sponsor was involved in the design of the study and in the collection, analysis and interpretation of data. The study sponsor also provided third-party writing support for the manuscript. All authors had access to all data and participated in the collection, analysis and interpretation of the data; all authors had the final decision to submit the manuscript for publication.",

year = "2014",

month = jun,

doi = "10.1016/j.clon.2014.03.001",

language = "English (US)",

volume = "26",

pages = "323--332",

journal = "Clinical Oncology",

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publisher = "W.B. Saunders Ltd",

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TY - JOUR

T1 - Safety and effectiveness of bevacizumab treatment for metastatic colorectal cancer

T2 - Final results from the Avastin® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study

AU - Hurwitz, H. I.

AU - Bekaii-Saab, T. S.

AU - Bendell, J. C.

AU - Cohn, A. L.

AU - Kozloff, M.

AU - Roach, N.

AU - Mun, Y.

AU - Fish, S.

AU - Flick, E. D.

AU - Grothey, A.

N1 - Funding Information: The authors wish to thank all patients who participated in ARIES, as well as the investigators and study sites that enrolled patients. Support for third-party writing support for this manuscript was provided by Genentech, Inc. The ARIES study was sponsored by Genentech, Inc . The study sponsor was involved in the design of the study and in the collection, analysis and interpretation of data. The study sponsor also provided third-party writing support for the manuscript. All authors had access to all data and participated in the collection, analysis and interpretation of the data; all authors had the final decision to submit the manuscript for publication.

PY - 2014/6

Y1 - 2014/6

N2 - Aims: The Avastin® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. Materials and Methods: Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. Results: ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. Conclusion: Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.

AB - Aims: The Avastin® Registry - Investigation of Effectiveness and Safety (ARIES) observational cohort study (OCS) was designed to prospectively examine outcomes associated with bevacizumab-containing treatment for metastatic colorectal cancer (mCRC) in a community-based setting, where patient populations are less restricted than those in randomised trials. Materials and Methods: Patients with mCRC who were eligible for bevacizumab in combination with chemotherapy in first- or second-line treatment were enrolled from November 2006 to September 2008. There were no protocol-specified treatment regimens; the dose and schedule of bevacizumab and chemotherapy were at the treating physician's discretion. The objectives in the ARIES OCS included analyses of progression-free survival (PFS), overall survival, treatment patterns and safety in each of the first- and second-line treatment cohorts. Results: ARIES enrolled 1550 patients with mCRC receiving first-line therapy with bevacizumab. The median follow-up time was 20.6 months. The median PFS in this cohort was 10.2 months (95% confidence interval 9.8-10.6) and the median overall survival was 23.2 months (95% confidence interval 21.2-24.8). In a separate cohort of 482 patients with second-line mCRC, the median follow-up time was 16.9 months, the median PFS and overall survival from the start of second-line treatment to the end of follow-up was 7.9 months (95% confidence interval 7.2-8.3) and 17.8 months (95% confidence interval 16.5-20.7), respectively. Incidences of known bevacizumab-associated adverse events in ARIES were generally consistent with those previously reported in OCSs and randomised trials. Conclusion: Results from the prospective ARIES OCS add further evidence to support the effectiveness and safety of bevacizumab when added to first- and second-line treatment regimens for patients with mCRC in community treatment settings.

KW - Bevacizumab

KW - Colorectal cancer

KW - Observational cohort study

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