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Selected Publication:
SHR Neuro Cancer Cardio Lipid Metab Microb
Schippinger, W; Samonigg, H; Schaberl-Moser, R; Greil, R; Thödtmann, R; Tschmelitsch, J; Jagoditsch, M; Steger, GG; Jakesz, R; Herbst, F; Hofbauer, F; Rabl, H; Wohlmuth, P; Gnant, M; Thaler, J; Austrian Breast and Colorectal Cancer Study Group.
A prospective randomised phase III trial of adjuvant chemotherapy with 5-fluorouracil and leucovorin in patients with stage II colon cancer.
BRIT J CANCER. 2007; 97(8): 1021-1027.
Doi: 10.1038/sj.bjc.6604011
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- Leading authors Med Uni Graz
- Schippinger Walter
- Co-authors Med Uni Graz
- Samonigg Hellmut
- Schaberl-Moser Renate
- Study Group Members Med Uni Graz:
- Hofmann Guenter
- Kronberger Leo
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Adenocarcinoma - drug therapy Adenocarcinoma - mortality Adenocarcinoma - pathology
- Adult -
- Aged -
- Antineoplastic Combined Chemotherapy Protocols - therapeutic use
- Chemotherapy, Adjuvant -
- Colonic Neoplasms - drug therapy Colonic Neoplasms - mortality Colonic Neoplasms - pathology
- Disease-Free Survival -
- Female -
- Fluorouracil - administration and dosage
- Humans -
- Kaplan-Meier Estimate -
- Leucovorin - administration and dosage
- Male -
- Middle Aged -
- Neoplasm Recurrence, Local - prevention and control
- Neoplasm Staging -
- Find related publications in this database (Keywords)
- adjuvant chemotherapy
- colon cancer
- stage II