Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2007 Oct 22;97(8):1021-7.
doi: 10.1038/sj.bjc.6604011. Epub 2007 Sep 25.

A Prospective Randomised Phase III Trial of Adjuvant Chemotherapy With 5-fluorouracil and Leucovorin in Patients With Stage II Colon Cancer

Affiliations
Free PMC article
Clinical Trial

A Prospective Randomised Phase III Trial of Adjuvant Chemotherapy With 5-fluorouracil and Leucovorin in Patients With Stage II Colon Cancer

W Schippinger et al. Br J Cancer. .
Free PMC article

Abstract

The purpose of this trial was to investigate the efficacy of adjuvant chemotherapy with 5-fluorouracil (5-FU) and leucovorin (LV) in stage II colon cancer. Patients with stage II colon cancer were randomised to either adjuvant chemotherapy with 5-FU/LV (100 mg m(-2) LV+450 mg m(-2) 5-FU weekly, weeks 1-6, in 8 weeks cycles x 7) or surveillance only. Five hundred patients were evaluable for analyses. After a median follow-up of 95.6 months, 55 of 252 patients (21.8%) have died in the 5-FU/LV arm and 58 of 248 patients (23.4%) in the surveillance arm. There was no statistically significant difference in overall survival (OS) between the two treatment arms (hazard ratios, HR 0.88, 95% CI 0.61-1.27, P=0.49). The relative risk for tumour relapse was higher for patients on the surveillance arm than for those on the 5-FU/LV arm; however, this difference was not statistically significant (HR 0.69, 95% CI 0.45-1.06, P=0.09). Consequently, disease-free survival (DFS) was not significantly different between the two trial arms. In conclusion, results of this trial demonstrate a trend to a lower risk for relapse in patients treated with adjuvant 5-FU/LV for stage II colon cancer. However, in this study with limited power to detect small differences between the study arms, adjuvant chemotherapy failed to significantly improve DFS and OS.

Figures

Figure 1
Figure 1
Relapse-free survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.
Figure 2
Figure 2
Overall survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.
Figure 3
Figure 3
Cancer-specific survival: adjuvant chemotherapy with 5-fluorouracil (5-FU)/leucovorin (LV) vs surveillance.

Similar articles

See all similar articles

Cited by 24 articles

See all "Cited by" articles

References

    1. Andre T, Boni C, Mounedji-Boudiaf L, Navarro M, Tabernero J, Hickish T, Topham C, Zaninelli M, Clingan P, Bridgewater J, Tabah-Fisch I, de Gramont A, Multicenter International Study of Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon Cancer (MOSAIC) investigators Oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment for colon cancer. N Engl J Med. 2004;350:2343–2351. - PubMed
    1. Benson AB, III, Schrag D, Somerfield MR, Cohen AM, Figueredo AT, Flynn PJ, Krzyzanowska MK, Maroun J, McAllister P, Van Cutsem E, Brouwers M, Charette M, Haller DG. American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol. 2004;22:3408–3419. - PubMed
    1. Chen SL, Bilchik AJ. More extensive nodal dissection improves survival for stages I to III of colon cancer: a population-based study. Ann Surg. 2006;244:602–610. - PMC - PubMed
    1. Cox DR. Regression models and life-tables. J R Stat Soc (B) 1972;34:187–220.
    1. Figueredo A, Charette ML, Maroun J, Brouwers MC, Zuraw L. Adjuvant therapy for stage II colon cancer: a systematic review from the Cancer Care Ontario Program in evidence-based care's gastrointestinal cancer disease site. J Clin Oncol. 2004;22:3395–3407. - PubMed

Publication types

MeSH terms

Feedback