Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: A randomized phase III noninferiority study

M. L. Rothenberg, J. V. Cox, C. Butts, M. Navarro, Y. J. Bang, R. Goel, S. Gollins, L. L. Siu, S. Laguerre, D. Cunningham

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Abstract

Background: To demonstrate the noninferiority of capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX-4) as second-line therapy in patients with metastatic colorectal cancer after prior irinotecan-based chemotherapy. Patients and methods: A total of 627 patients were randomly assigned to receive XELOX (n = 313) or FOLFOX-4 (n = 314) following disease progression/recurrence or intolerance to irinotecan-based chemotherapy. The primary end point was progression-free survival (PFS). Results: PFS for XELOX was noninferior to FOLFOX-4 [hazard ratio (HR) = 0.97; 95% confidence interval (CI) 0.83-1.14] in the intention-to-treat (ITT) population. Median PFS was 4.7 months with XELOX versus 4.8 months with FOLFOX-4. The robustness of the primary analysis was supported by multivariate and subgroup analyses. Median overall survival in the ITT population was 11.9 months with XELOX versus 12.5 months with FOLFOX-4 (HR = 1.02; 95% CI 0.86-1.21). Treatment-related grade 3/4 adverse events occurred in 50% of XELOX- and 65% of FOLFOX-4-treated patients. Whereas grade 3/4 neutropenia (35% versus 5% with XELOX) and febrile neutropenia (4% versus < 1%) were more common with FOLFOX-4, grade 3/4 diarrhea (19% versus 5% with FOLFOX-4) and grade 3 hand-foot syndrome (4% versus < 1%) were more common with XELOX. Conclusion: XELOX is noninferior to FOLFOX-4 when administered as second-line treatment in patients with metastatic colorectal cancer.

Original languageEnglish (US)
Pages (from-to)1720-1726
Number of pages7
JournalAnnals of Oncology
Volume19
Issue number10
DOIs
StatePublished - Oct 7 2008

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oxaliplatin
Leucovorin
Fluorouracil
Colorectal Neoplasms
irinotecan
Disease-Free Survival
Therapeutics
Hand-Foot Syndrome
Confidence Intervals
Capecitabine
XELOX
Drug Therapy
Febrile Neutropenia

Keywords

  • 5-fluorouracil/folinic acid
  • Capecitabine
  • FOLFOX-4
  • Metastatic colorectal cancer
  • Oxaliplatin
  • XELOX

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer : A randomized phase III noninferiority study. / Rothenberg, M. L.; Cox, J. V.; Butts, C.; Navarro, M.; Bang, Y. J.; Goel, R.; Gollins, S.; Siu, L. L.; Laguerre, S.; Cunningham, D.

In: Annals of Oncology, Vol. 19, No. 10, 07.10.2008, p. 1720-1726.

Research output: Contribution to journalArticle

Rothenberg, M. L. ; Cox, J. V. ; Butts, C. ; Navarro, M. ; Bang, Y. J. ; Goel, R. ; Gollins, S. ; Siu, L. L. ; Laguerre, S. ; Cunningham, D. / Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer : A randomized phase III noninferiority study. In: Annals of Oncology. 2008 ; Vol. 19, No. 10. pp. 1720-1726.
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title = "Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer: A randomized phase III noninferiority study",
abstract = "Background: To demonstrate the noninferiority of capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX-4) as second-line therapy in patients with metastatic colorectal cancer after prior irinotecan-based chemotherapy. Patients and methods: A total of 627 patients were randomly assigned to receive XELOX (n = 313) or FOLFOX-4 (n = 314) following disease progression/recurrence or intolerance to irinotecan-based chemotherapy. The primary end point was progression-free survival (PFS). Results: PFS for XELOX was noninferior to FOLFOX-4 [hazard ratio (HR) = 0.97; 95{\%} confidence interval (CI) 0.83-1.14] in the intention-to-treat (ITT) population. Median PFS was 4.7 months with XELOX versus 4.8 months with FOLFOX-4. The robustness of the primary analysis was supported by multivariate and subgroup analyses. Median overall survival in the ITT population was 11.9 months with XELOX versus 12.5 months with FOLFOX-4 (HR = 1.02; 95{\%} CI 0.86-1.21). Treatment-related grade 3/4 adverse events occurred in 50{\%} of XELOX- and 65{\%} of FOLFOX-4-treated patients. Whereas grade 3/4 neutropenia (35{\%} versus 5{\%} with XELOX) and febrile neutropenia (4{\%} versus < 1{\%}) were more common with FOLFOX-4, grade 3/4 diarrhea (19{\%} versus 5{\%} with FOLFOX-4) and grade 3 hand-foot syndrome (4{\%} versus < 1{\%}) were more common with XELOX. Conclusion: XELOX is noninferior to FOLFOX-4 when administered as second-line treatment in patients with metastatic colorectal cancer.",
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author = "Rothenberg, {M. L.} and Cox, {J. V.} and C. Butts and M. Navarro and Bang, {Y. J.} and R. Goel and S. Gollins and Siu, {L. L.} and S. Laguerre and D. Cunningham",
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T1 - Capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid plus oxaliplatin (FOLFOX-4) as second-line therapy in metastatic colorectal cancer

T2 - A randomized phase III noninferiority study

AU - Rothenberg, M. L.

AU - Cox, J. V.

AU - Butts, C.

AU - Navarro, M.

AU - Bang, Y. J.

AU - Goel, R.

AU - Gollins, S.

AU - Siu, L. L.

AU - Laguerre, S.

AU - Cunningham, D.

PY - 2008/10/7

Y1 - 2008/10/7

N2 - Background: To demonstrate the noninferiority of capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX-4) as second-line therapy in patients with metastatic colorectal cancer after prior irinotecan-based chemotherapy. Patients and methods: A total of 627 patients were randomly assigned to receive XELOX (n = 313) or FOLFOX-4 (n = 314) following disease progression/recurrence or intolerance to irinotecan-based chemotherapy. The primary end point was progression-free survival (PFS). Results: PFS for XELOX was noninferior to FOLFOX-4 [hazard ratio (HR) = 0.97; 95% confidence interval (CI) 0.83-1.14] in the intention-to-treat (ITT) population. Median PFS was 4.7 months with XELOX versus 4.8 months with FOLFOX-4. The robustness of the primary analysis was supported by multivariate and subgroup analyses. Median overall survival in the ITT population was 11.9 months with XELOX versus 12.5 months with FOLFOX-4 (HR = 1.02; 95% CI 0.86-1.21). Treatment-related grade 3/4 adverse events occurred in 50% of XELOX- and 65% of FOLFOX-4-treated patients. Whereas grade 3/4 neutropenia (35% versus 5% with XELOX) and febrile neutropenia (4% versus < 1%) were more common with FOLFOX-4, grade 3/4 diarrhea (19% versus 5% with FOLFOX-4) and grade 3 hand-foot syndrome (4% versus < 1%) were more common with XELOX. Conclusion: XELOX is noninferior to FOLFOX-4 when administered as second-line treatment in patients with metastatic colorectal cancer.

AB - Background: To demonstrate the noninferiority of capecitabine plus oxaliplatin (XELOX) versus 5-fluorouracil/folinic acid and oxaliplatin (FOLFOX-4) as second-line therapy in patients with metastatic colorectal cancer after prior irinotecan-based chemotherapy. Patients and methods: A total of 627 patients were randomly assigned to receive XELOX (n = 313) or FOLFOX-4 (n = 314) following disease progression/recurrence or intolerance to irinotecan-based chemotherapy. The primary end point was progression-free survival (PFS). Results: PFS for XELOX was noninferior to FOLFOX-4 [hazard ratio (HR) = 0.97; 95% confidence interval (CI) 0.83-1.14] in the intention-to-treat (ITT) population. Median PFS was 4.7 months with XELOX versus 4.8 months with FOLFOX-4. The robustness of the primary analysis was supported by multivariate and subgroup analyses. Median overall survival in the ITT population was 11.9 months with XELOX versus 12.5 months with FOLFOX-4 (HR = 1.02; 95% CI 0.86-1.21). Treatment-related grade 3/4 adverse events occurred in 50% of XELOX- and 65% of FOLFOX-4-treated patients. Whereas grade 3/4 neutropenia (35% versus 5% with XELOX) and febrile neutropenia (4% versus < 1%) were more common with FOLFOX-4, grade 3/4 diarrhea (19% versus 5% with FOLFOX-4) and grade 3 hand-foot syndrome (4% versus < 1%) were more common with XELOX. Conclusion: XELOX is noninferior to FOLFOX-4 when administered as second-line treatment in patients with metastatic colorectal cancer.

KW - 5-fluorouracil/folinic acid

KW - Capecitabine

KW - FOLFOX-4

KW - Metastatic colorectal cancer

KW - Oxaliplatin

KW - XELOX

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DO - 10.1093/annonc/mdn370

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