Originally published as JCO Early Release 10.1200/JCO.2008.19.5362 on January 5 2009

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Evidence for Cure by Adjuvant Therapy in Colon Cancer: Observations Based on Individual Patient Data From 20,898 Patients on 18 Randomized Trials

From the Divisions of Biostatistics and Medical Oncology, Mayo Clinic, Rochester, MN; Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA; National Surgical Adjuvant Breast and Bowel Project Operations Office and Biostatistical Center, Pittsburgh; Abramson Cancer Center at the University of Pennsylvania, Philadelphia, PA; University of North Carolina, Chapel Hill, NC; Medical Oncology, Ospedale S. Martino, Genova; Ospedali Riuniti, Bergamo; University of Siena, Siena, Italy; International Drug Development Institute, Louvain-la-Neuve, Belgium; Hopital Pitie-Salpetiere, Paris; University of the Mediterranean, Marseilles; Hopital Saint Antoine, Paris, France; and National Cancer Institute of Canada Clinical Trials Group, Queens University, Kingston, Ontario, Canada.

Corresponding author: Daniel Sargent, PhD, Professor of Biostatistics and Oncology, Division of Biomedical Statistics and Informatics, Mayo Clinic, 200 1st St SW, Rochester, MN 55905; e-mail: sargent.daniel{at}mayo.edu.

Purpose Limited data are available on the time course of treatment failures (recurrence and/or death), the nature and duration of adjuvant treatment benefit, and long-term recurrence rates in patients with resected stage II and III colon cancer.

Methods The data set assembled by the Adjuvant Colon Cancer Endpoints Group, a collection of individual patient data from 18 trials and more than 20,800 patients testing fluorouracil-based adjuvant therapy in patients with stage II or III colon cancer, was analyzed.

Results A significant overall survival (OS) benefit of adjuvant therapy was consistent over the 8-year follow-up period. The risk of recurrence in patients treated with adjuvant chemotherapy never exceeds that of control patients, signifying that adjuvant therapy cures some patients, as opposed to delaying recurrence. After 5 years, recurrence rates were less than 1.5% per year, and after 8 years, they were less than 0.5% per year. Significant disease-free survival (DFS) benefit from adjuvant chemotherapy was observed in the first 2 years. After 2 years, DFS rates in treated and control patients were not significantly different, and after 4 years, no trend toward benefit was demonstrated. This benefit was primarily driven by patients with stage III disease.

Conclusion Adjuvant chemotherapy provides significant DFS benefit, primarily by reducing the recurrence rate, within the first 2 years of adjuvant therapy with some benefit in years 3 to 4, translating into long-term OS benefit. This reflects the curative role of chemotherapy in the adjuvant setting. After 5 years, recurrence rates in patients treated on clinical trials are low, and after 8 years, they are minimal; thus, long-term follow-up for recurrence is of little value.

Written on behalf of the Adjuvant Colon Cancer Endpoints Group.

Supported by National Cancer Institute Grants No. CA 25224, CA 12027, CA 69974, CA 37377, and CA 69651.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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