Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer

Richard M. Goldberg, Isabelle Tabah-Fisch, Harry Bleiberg, Aimery De Gramont, Christophe Tournigand, Thierry Andre, Mace L. Rothenberg, Erin Green, Daniel J. Sargent

Research output: Contribution to journalArticle

382 Scopus citations

Abstract

Purpose: Oxaliplatin, fluorouracil, and leucovorin are commonly used to treat advanced and resected colorectal cancer. This analysis compares the safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly (FOLFOX4) in patients age younger than and at least 70 years. Patients and Methods: This retrospective analysis included 3,742 colorectal cancer patients (614 age ≥ 70) from four clinical trials testing FOLFOX4 in the adjuvant, first-, and second-line settings. End points included grade ≥ 3 adverse events, response rate (in advanced disease), progression or relapse-free survival, dose-intensity, and overall survival in the studies with mature survival data. Results: Grade ≥ 3 hematologic toxicity (neutropenia [43% v 49%; P = .04] and thrombocytopenia [2% v 5%; P = .04]) were significantly higher in older patients. Older age was not associated with increased rates of severe neurologic adverse events, diarrhea, nausea/vomiting, infection, overall incidence of grade ≥ 3 toxicity (63% v 67%; P = .15), or 60-day mortality (1.1% v 2.3%; P = .20). The relative benefit of FOLFOX4 versus control did not differ by age for response rate, progression or recurrence free-survival (hazard ratio, 0.70 for FOLFOX4 v control for age < 70, 0.65 for age ≥ 70; P = .42), or overall survival (hazard ratio, 0.77 age < 70, 0.82 age ≥ 70; P = .79). Dose-intensity did not differ by age at cycles 1, 3, 6, or 12. Conclusion: FOLFOX4 maintains its efficacy and safety ratio in selected elderly patients with colorectal cancer. Its judicious use should be considered without regard to patient age, although scant data are available among patients older than 80 years.

Original languageEnglish (US)
Pages (from-to)4085-4091
Number of pages7
JournalJournal of Clinical Oncology
Volume24
Issue number25
DOIs
StatePublished - Sep 1 2006

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Goldberg, R. M., Tabah-Fisch, I., Bleiberg, H., De Gramont, A., Tournigand, C., Andre, T., Rothenberg, M. L., Green, E., & Sargent, D. J. (2006). Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer. Journal of Clinical Oncology, 24(25), 4085-4091. https://doi.org/10.1200/JCO.2006.06.9039