Annals of Surgical Oncology

, Volume 21, Issue 8, pp 2636–2641

Toxicity of Oxaliplatin Plus Fluorouracil/Leucovorin Adjuvant Chemotherapy in Elderly Patients with Stage III Colon Cancer: A Population-Based Study

  • Samia Hamza
  • Anne-Marie Bouvier
  • Fabien Rollot
  • Côme Lepage
  • Jean Faivre
  • Laurent Bedenne
Colorectal Cancer



Results concerning the side effects of oxaliplatin associated with fluorouracil and leucovorin (FOLFOX) in older patients are controversial. The objective of this study was to assess the use and the toxicity of FOLFOX in patients aged 70 years and older as administered in current practice.


Among 305 stage III colon cancers registered in a well-defined population in Burgundy between 2004 and 2009, 210 had adjuvant chemotherapy, including 156 with FOLFOX. The cumulated rates of toxicity were calculated by using the Kaplan–Meier method. The risks of overall toxicity and of severe toxicity (grade 3 or 4) in patients less than 70 years and in older patients were compared by using a Cox model.


There was no difference between the group of the patients less than 70 years and the older age group for the cumulative incidence of hematologic, neurologic, digestive, and general toxicity. There was also no difference between the two groups for the severity of side effects (grade 3 or 4, 31.4 vs. 39.0 %; p = 0.576). The multivariate analysis indicated after adjustment on sex and the Charlson comorbidity score that there was no difference between the two age groups for toxicity (hazard ratio = 1.28; 95 % CI 0.68–2.41; p = 0.439).


Cancer registries can be used to evaluate the toxicity of chemotherapy at the population level. Tolerance to the FOLFOX regimen among elderly patients did not significantly differ from that in younger patients. This treatment should be considered regardless of patients’ age alone, but consideration should be given to the capacity of patients to tolerate adverse events.


  1. 1.
    Colonna M, Bossard N, Remontet L, Grosclaude P. Changes in the risk of death from cancer up to five years after diagnosis in elderly patients: a study of five common cancers. Int J Cancer. 2010;127:924–931.PubMedGoogle Scholar
  2. 2.
    Laurie JA, Moertel CG, Fleming TR, Wieand HS, Leigh JE, Rubin J, et al. Surgical adjuvant therapy of large-bowel carcinoma: an evaluation of levamisole and the combination of levamisole and fluorouracil. The North Central Cancer Treatment Group and the Mayo Clinic. J Clin Oncol. 1989;7:1447–1456.PubMedGoogle Scholar
  3. 3.
    Moertel CG, Fleming TR, Macdonald JS, Haller DG, Laurie JA, Goodman PJ, et al. Levamisole and fluorouracil for adjuvant therapy of resected colon carcinoma. N Engl J Med. 1990;322:352–358.PubMedCrossRefGoogle Scholar
  4. 4.
    Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, et al. Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–2351.PubMedCrossRefGoogle Scholar
  5. 5.
    Sargent DJ, Goldberg RM, Jacobson SD, Macdonald JS, Labianca R, Haller DG, et al. A pooled analysis of adjuvant chemotherapy for resected colon cancer in elderly patients. N Engl J Med. 2001;345:1091–1097.PubMedCrossRefGoogle Scholar
  6. 6.
    Allegra CJ, Yothers G, O’Connell MJ, Sharif S, Colangelo LH, Lopa SH, et al. Initial safety report of NSABP C-08: a randomized phase III study of modified FOLFOX6 with or without bevacizumab for the adjuvant treatment of patients with stage II or III colon cancer. J Clin Oncol. 2009;27:3385–3390.PubMedCentralPubMedCrossRefGoogle Scholar
  7. 7.
    McCleary NJ, Meyerhardt JA, Green E, Yothers G, de Gramont A, Van Cutsem E, et al. Impact of age on the efficacy of newer adjuvant therapies in patients with stage II/III colon cancer: findings from the ACCENT database (abstract). J Clin Oncol. 2009;27:170 s.CrossRefGoogle Scholar
  8. 8.
    Goldberg RM, Tabah-Fisch I, Bleiberg H, de Gramont A, Tournigand C, Andre T, et al. Pooled analysis of safety and efficacy of oxaliplatin plus fluorouracil/leucovorin administered bimonthly in elderly patients with colorectal cancer. J Clin Oncol. 2006;24:4085–4091.PubMedCrossRefGoogle Scholar
  9. 9.
    Sanoff HK, Carpenter WR, Sturmer T, Goldberg RM, Martin CF, Fine JP, et al. Effect of adjuvant chemotherapy on survival of patients with stage III colon cancer diagnosed after age 75 years. J Clin Oncol. 2012;30:2624–2634.PubMedCentralPubMedCrossRefGoogle Scholar
  10. 10.
    Muss HB, Bynum DL. Adjuvant chemotherapy in older patients with stage III colon cancer: an underused lifesaving treatment. J Clin Oncol. 2012;30:2576–2578.PubMedCrossRefGoogle Scholar
  11. 11.
    World Health Organization. International classification of disease for oncology. 3rd ed. Geneva: World Health Organization; 2000.Google Scholar
  12. 12.
    Sobin L, Wittekin Ch, eds. TNM classification of malignant tumours. 6th ed. New York: Wiley; 2002.Google Scholar
  13. 13.
    Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373–383.PubMedCrossRefGoogle Scholar
  14. 14.
    Bouvier AM, Launoy G, Lepage C, Faivre J. Trends in the management and survival of digestive tract cancers among patients aged over 80 years. Aliment Pharmacol Ther. 2005;22: 233–241.PubMedCrossRefGoogle Scholar
  15. 15.
    Ayanian JZ, Zaslavsky AM, Fuchs CS, Guadagnoli E, Creech CM, Cress RD, et al. Use of adjuvant chemotherapy and radiation therapy for colorectal cancer in a population-based cohort. J Clin Oncol. 2003;21:1293–1300.PubMedCrossRefGoogle Scholar
  16. 16.
    Sundararajan V, Grann VR, Jacobson JS, Ahsan H, Neugut AI. Variations in the use of adjuvant chemotherapy for node-positive colon cancer in the elderly: a population-based study. Cancer J. 2001;7:213–218.PubMedGoogle Scholar
  17. 17.
    Kohne CH, Grothey A, Bokemeyer C, Bontke N, Aapro M. Chemotherapy in elderly patients with colorectal cancer. Ann Oncol. 2001;12:435–442.PubMedCrossRefGoogle Scholar
  18. 18.
    Bouvier AM, Jooste V, Bonnetain F, Cottet V, Bizollon MH, Bernard MP, et al. Adjuvant treatments do not alter the quality of life in elderly patients with colorectal cancer: a population-based study. Cancer. 2008;113:879–886.PubMedCrossRefGoogle Scholar
  19. 19.
    Newcomb PA, Carbone PP. Cancer treatment and age: patient perspectives. J Natl Cancer Inst. 1993;85:1580–1584.PubMedCrossRefGoogle Scholar
  20. 20.
    Yothers G, O’Connell MJ, Allegra CJ, Kuebler JP, Colangelo LH, Petrelli NJ, et al. Oxaliplatin as adjuvant therapy for colon cancer: updated results of NSABP C-07 trial, including survival and subset analyses. J Clin Oncol. 2011;29:3768–3774.PubMedCentralPubMedCrossRefGoogle Scholar

Copyright information

© Society of Surgical Oncology 2014

Authors and Affiliations

  • Samia Hamza
    • 1
  • Anne-Marie Bouvier
    • 1
  • Fabien Rollot
    • 1
  • Côme Lepage
    • 1
  • Jean Faivre
    • 1
  • Laurent Bedenne
    • 1
  1. 1.Digestive Cancer Registry of Burgundy, INSERM U866, University HospitalUniversity of BurgundyDijonFrance

Personalised recommendations