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Multicenter Randomized Trial of Adjuvant Fluorouracil and Folinic Acid Compared With Surgery Alone After Resection of Colorectal Liver Metastases: FFCD ACHBTH AURC 9002 Trial

Guillaume Portier, Dominique Elias, Olivier Bouche, Philippe Rougier, Jean-François Bosset, Jean Saric, Jacques Belghiti, Pascal Piedbois, Rosine Guimbaud, Bernard Nordlinger, Roland Bugat, Franck Lazorthes, Laurent Bedenne

From the Centre Hospitals-Universitaire (CHU) Purpan; Institut Claudius Régaud, Toulouse; Institut Gustave Roussy, Villejuif; CHU de Reims, Reims; Hôpital Ambroise Paré, Boulogne; CHU de Besançon, Besançon; Hôpital Saint André, Bordeaux; CHU Beaujon, Clichy; CHU Henri Mondor, Créteil; and the CHU Dijon, France

Address reprint requests to Guillaume Portier, MD, Chirurgie Digestive, CHU Purpan, place du Dr. Baylac, 31059 Toulouse, France; portier.g{at}chu-toulouse.fr

Purpose Complete resection of liver metastases of colorectal origin is the only potentially curative treatment. In order to decrease recurrences, the use of adjuvant systemic chemotherapy after liver resection is controversial because no randomized study demonstrated its benefit.

Patients and Methods In a multicenter trial, we randomly assigned 173 patients with completely resected (R0) hepatic metastases from colorectal cancer to surgery alone and observation (87 patients) or to surgery followed by 6 months of systemic adjuvant chemotherapy with a fluorouracil and folinic acid monthly regimen (86 patients). The main outcome criterion was disease-free survival. Secondary outcome measures were overall survival and treatment-related toxicity.

Results The intention-to-treat analysis was based on 171 patients, after a median follow-up of 87 months (SE = 5.8). The 5-year disease-free survival rate, after adjustment for major prognostic factors, was 33.5% for patients in the chemotherapy group and 26.7% for patients in the control group (Cox multivariate analysis: odds ratio for recurrence or death = 0.66; 95% CI, 0.46 to 0.96; P = .028). With regard to secondary outcome measures, a trend towards increased overall survival was observed but did not reach statistical significance (5-year overall survival: chemotherapy group, 51.1% v control group, 41.1%; odds ratio for death, 0.73; 95% CI, 0.48 to 1.10; P = .13).

Conclusion Despite a suboptimal regimen, which was the standard at the beginning of the study, adjuvant intravenous systemic chemotherapy provided a significant disease-free survival benefit for patients with resected liver metastases from colorectal cancer.

Supported in part by grants from the Association pour la Recherche Contre le Cancer and from the Ligue Nationale Contre le Cancer.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002, and at the Annual Meeting of the Société Nationale Française de Gastro-Entérologie, Paris, France, March 22, 2006.

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

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Related Correspondence

• Control Arm for Surgery Alone Is Needed but Difficult to Obtain in Randomized Trials for Adjuvant Chemotherapy After Liver Resection for Colorectal Metastases
  Norihiro Kokudo, Kiyoshi Hasegawa, and Masatoshi Makuuchi
  JCO 2007 25: 1299-1300 [Full Text]

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