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Originally published as JCO Early Release 10.1200/JCO.2005.02.0826 on December 19 2005 © 2006 American Society of Clinical Oncology. Postoperative Surveillance in Patients With Colorectal Cancer Who Have Undergone Curative Resection: A Prospective, Multicenter, Randomized, Controlled TrialFrom the Gastroenterology, Surgical and Oncology Departments, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, University of Barcelona (IDIBAPS), Barcelona; Oncology and Gastroenterology Departments, Hospital de Terrassa, Terrassa; and Gastroenterology and Oncology Department, Hospital General de Vic, Vic, Catalonia, Spain. Address reprint requests to Antoni Castells, MD, Department of Gastroenterology, Institut de Malalties Digestives, Hospital Clínic, Villarroel 170, 08036 Barcelona, Catalonia, Spain; e-mail: castells{at}clinic.ub.es Purpose Although systematic postoperative surveillance of patients with colorectal cancer has been demonstrated to improve survival, it remains unknown whether a more intensive strategy provides any significant advantage. This prospective, multicenter, randomized, controlled trial was aimed at comparing the efficacy of two different surveillance strategies in terms of both survival and recurrence resectability. Patients and Methods Patients with stage II or III colorectal cancer were allocated randomly to either a simple surveillance strategy including clinical evaluation and serum carcinoembryonic antigen monitoring, or an intensive strategy in which abdominal computed tomography or ultrasonography, chest radiograph, and colonoscopy were added. Results A total of 259 patients were included: 132 were observed according to the simple strategy and 127 were observed according to the intensive strategy. Both groups were similar with respect to baseline characteristics and rate and type of tumor recurrence. After a median follow-up of 48 months, there was no difference in the probability of overall survival in the whole series (hazard ratio [HR] = 0.87; 95% CI, 0.49 to 1.54; P = .62). However, the intensive strategy was associated with higher overall survival in patients with stage II tumors (HR = 0.34; 95% CI, 0.12 to 0.98; P = .045) and in those with rectal lesions (HR = 0.09; 95% CI, 0.01 to 0.81; P = .03), mainly due to higher rate of resectability for recurrent tumors. Colonoscopy was responsible for the detection of the highest proportion (44%) of resectable tumor recurrence in the intensive arm. Conclusion A more intensive surveillance strategy improves the prognosis of patients with stage II colorectal cancer or those with rectal tumors. Inclusion of regular performance of colonoscopy seems justified up to the fifth year of follow-up, at least. Supported by grants from the Agència d'Avaluació de Tecnologia Mèdica of the Generalitat de Catalunya (2/6/96), from the Instituto de Salud Carlos III (Grants No. RC03/02 and RC03/10), and from the Ministerio de Ciencia y Tecnología (Grant No. SAF 04-07190). F.R.-M. received a research grant from the Hospital Clínic and the Instituto de Salud Carlos III, and V.P. received a grant from the Institut d'Investigacions Biomèdiques August Pi i Sunyer. Presented in part at the Annual Meeting of the American Gastroenterological Association, Chicago, IL, May 16, 2005. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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