Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-Bevacizumab or FOLFIRI-bevacizumab: Results from ARIES, a bevacizumab observational cohort study

Johanna C. Bendell, Tanios Bekaii-Saab, Allen L. Cohn, Herbert I. Hurwitz, Mark Kozloff, Haluk Tezcan, Nancy Roach, Yong Mun, Susan Fish, E. Dawn Flick, Darshan Dalal, Axel F Grothey

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Abstract

Background. The Avastin® Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community- based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan-Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX-bevacizumab (n = 968) or FOLFIRI- bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX-bevacizumab and FOLFIRI-bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI-bevacizumab resulted in a similar PFS (HR, 1.03; 95% confidence interval [CI], 0.88 -1.21) and OS (HR, 0.95; 95% CI, 0.78 -1.16) outcome as with FOLFOX-bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-linemCRCpatients, the FOLFOX- bevacizumab and FOLFIRI-bevacizumab regimens were associated with similar treatment patterns and clinical outcomes.

Original languageEnglish (US)
Pages (from-to)1486-1495
Number of pages10
JournalOncologist
Volume17
Issue number12
DOIs
StatePublished - 2012

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Observational Studies
Registries
Colorectal Neoplasms
Cohort Studies
Safety
Therapeutics
Disease-Free Survival
irinotecan
oxaliplatin
Leucovorin
Fluorouracil
Bevacizumab
Survival
Confidence Intervals
Drug Therapy
Multivariate Analysis
Regression Analysis

Keywords

  • Bevacizumab
  • FOLFIRI protocol
  • FOLFOX protocol
  • Safety
  • Treatment outcome

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-Bevacizumab or FOLFIRI-bevacizumab : Results from ARIES, a bevacizumab observational cohort study. / Bendell, Johanna C.; Bekaii-Saab, Tanios; Cohn, Allen L.; Hurwitz, Herbert I.; Kozloff, Mark; Tezcan, Haluk; Roach, Nancy; Mun, Yong; Fish, Susan; Dawn Flick, E.; Dalal, Darshan; Grothey, Axel F.

In: Oncologist, Vol. 17, No. 12, 2012, p. 1486-1495.

Research output: Contribution to journalArticle

Bendell, Johanna C. ; Bekaii-Saab, Tanios ; Cohn, Allen L. ; Hurwitz, Herbert I. ; Kozloff, Mark ; Tezcan, Haluk ; Roach, Nancy ; Mun, Yong ; Fish, Susan ; Dawn Flick, E. ; Dalal, Darshan ; Grothey, Axel F. / Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-Bevacizumab or FOLFIRI-bevacizumab : Results from ARIES, a bevacizumab observational cohort study. In: Oncologist. 2012 ; Vol. 17, No. 12. pp. 1486-1495.
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title = "Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-Bevacizumab or FOLFIRI-bevacizumab: Results from ARIES, a bevacizumab observational cohort study",
abstract = "Background. The Avastin{\circledR} Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community- based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan-Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX-bevacizumab (n = 968) or FOLFIRI- bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX-bevacizumab and FOLFIRI-bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI-bevacizumab resulted in a similar PFS (HR, 1.03; 95{\%} confidence interval [CI], 0.88 -1.21) and OS (HR, 0.95; 95{\%} CI, 0.78 -1.16) outcome as with FOLFOX-bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-linemCRCpatients, the FOLFOX- bevacizumab and FOLFIRI-bevacizumab regimens were associated with similar treatment patterns and clinical outcomes.",
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T1 - Treatment patterns and clinical outcomes in patients with metastatic colorectal cancer initially treated with FOLFOX-Bevacizumab or FOLFIRI-bevacizumab

T2 - Results from ARIES, a bevacizumab observational cohort study

AU - Bendell, Johanna C.

AU - Bekaii-Saab, Tanios

AU - Cohn, Allen L.

AU - Hurwitz, Herbert I.

AU - Kozloff, Mark

AU - Tezcan, Haluk

AU - Roach, Nancy

AU - Mun, Yong

AU - Fish, Susan

AU - Dawn Flick, E.

AU - Dalal, Darshan

AU - Grothey, Axel F

PY - 2012

Y1 - 2012

N2 - Background. The Avastin® Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community- based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan-Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX-bevacizumab (n = 968) or FOLFIRI- bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX-bevacizumab and FOLFIRI-bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI-bevacizumab resulted in a similar PFS (HR, 1.03; 95% confidence interval [CI], 0.88 -1.21) and OS (HR, 0.95; 95% CI, 0.78 -1.16) outcome as with FOLFOX-bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-linemCRCpatients, the FOLFOX- bevacizumab and FOLFIRI-bevacizumab regimens were associated with similar treatment patterns and clinical outcomes.

AB - Background. The Avastin® Registry: Investigation of Effectiveness and Safety (ARIES) study is a prospective, community- based observational cohort study that evaluated the effectiveness and safety of first-line treatment patterns, assessing the impact of chemotherapy choice and treatment duration. Methods. The ARIES study enrolled patients with metastatic colorectal cancer (mCRC) receiving first-line chemotherapy with bevacizumab and followed them longitudinally. The protocol did not specify treatment regimens or assessments. Analyses included all patients who initiated bevacizumab in combination with either first-line oxaliplatin with infusional 5-fluorouracil and leucovorin (FOLFOX) or irinotecan with infusional 5-fluorouracil and leucovorin (FOLFIRI). Progression-free survival (PFS) and overall survival (OS) times were estimated using Kaplan-Meier methods. Hazard ratios (HRs) were estimated with multivariate Cox regression analysis, adjusting for potential confounding factors. Results. In total, 1,550 patients with first-line mCRC were enrolled (median follow-up, 21 months) and most received FOLFOX-bevacizumab (n = 968) or FOLFIRI- bevacizumab (n = 243) as first-line therapy. The baseline characteristics and median treatment duration were generally similar between subgroups. There were no significant differences in the median PFS (10.3 months vs. 10.2 months) or OS (23.7 months vs. 25.5 months) time between the FOLFOX-bevacizumab and FOLFIRI-bevacizumab subgroups, respectively, by unadjusted analyses. Multivariate analyses showed FOLFIRI-bevacizumab resulted in a similar PFS (HR, 1.03; 95% confidence interval [CI], 0.88 -1.21) and OS (HR, 0.95; 95% CI, 0.78 -1.16) outcome as with FOLFOX-bevacizumab. The incidence proportions of bevacizumab-associated adverse events were similar for FOLFOX- and FOLFIRI-based therapies. Conclusions. In first-linemCRCpatients, the FOLFOX- bevacizumab and FOLFIRI-bevacizumab regimens were associated with similar treatment patterns and clinical outcomes.

KW - Bevacizumab

KW - FOLFIRI protocol

KW - FOLFOX protocol

KW - Safety

KW - Treatment outcome

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