title: A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma.
abstract: BACKGROUND
  Colorectal cancer is the third most common and the third most lethal cancer in both men and women in developed countries. About 75% of cases are first diagnosed when the disease is classified as localized or regional, undergo potentially curative treatment and enter a post-treatment surveillance program. Although such programs drain significant resources from health systems, empirical evidence of their efficacy is scanty.
  
  
  METHODS
  Dukes B2-C colorectal cancer patients who had no evidence of disease at the end of their front-line treatment (surgery and adjuvant radiochemotherapy, if indicated) were eligible for the trial and randomized to two different surveillance programs. These programs differed greatly in the frequency of diagnostic imaging. They had similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments. Patients received baseline and yearly health-related quality-of-life (HR-QoL) questionnaires. Primary outcomes were overall survival (OS) and QoL.
  
  
  RESULTS
  From 1998 to 2006, 1228 assessable patients were randomized, 933 with colon cancer and 295 with rectal cancer. More than 90% of patients had the expected number of diagnostic procedures. Median follow-up duration was 62 months [interquartile range (IQR) 51-86] in the minimal surveillance group and 62 months (IQR 50-85) in the intensive group. At primary analysis, 250 patients had recurred and 218 had died. Intensive surveillance anticipated recurrence, as shown by a significant difference in mean disease-free survival of 5.9 months. Comparison of OS curves of the whole intention-to-treat population showed no statistically significant differences. HR-QoL of life scores did not differ between regimens.
  
  
  CONCLUSIONS
  Our findings support the conclusions of other randomized clinical trials, which show that early diagnosis of cancer recurrence is not associated with OS benefit.
  
  
  BACKGROUND
  NCT02409472.
authors.affiliation: Department of Oncology, Ospedale San Carlo, Potenza.
authors.forename: G
authors.initials: G
authors.lastname: Rosati
authors.affiliation: Department of Oncology, Ospedale Santa Chiara, Trento.
authors.forename: G
authors.initials: G
authors.lastname: Ambrosini
authors.affiliation: Department of Oncology, Az. Osp. Treviglio-Caravaggio, Treviglio.
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.affiliation: Department of Oncology, Istituto Europeo di Oncologia, Milan.
authors.forename: B
authors.initials: B
authors.lastname: Andreoni
authors.affiliation: Department of Oncology, Ospedale Civile, Rho.
authors.forename: G
authors.initials: G
authors.lastname: Corradini
authors.affiliation: Department of Oncology, Ospedale Sant'Anna, Como.
authors.forename: G
authors.initials: G
authors.lastname: Luchena
authors.affiliation: Department of Oncology, Az. Osp. G. Rummo, Benevento.
authors.forename: B
authors.initials: B
authors.lastname: Daniele
authors.affiliation: Department of Oncology, Ospedale Civile, Camposampiero.
authors.forename: F
authors.initials: F
authors.lastname: Gaion
authors.affiliation: Department of Oncology, Ospedale Infermi, Rimini.
authors.forename: G
authors.initials: G
authors.lastname: Oliverio
authors.affiliation: Department of Oncology, Ospedale Valduce, Como.
authors.forename: M
authors.initials: M
authors.lastname: Duro
authors.affiliation: Department of Oncology, Ospedale S. Carlo Borromeo, Milan.
authors.forename: G
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authors.lastname: Martignoni
authors.affiliation: Department of Oncology, Casa di Cura San Carlo, Paderno Dugnano.
authors.forename: N
authors.initials: N
authors.lastname: Pinna
authors.affiliation: Department of Oncology, Ospedale degli Infermi, Biella.
authors.forename: P
authors.initials: P
authors.lastname: Sozzi
authors.affiliation: Department of Oncology, Casa di Cura IGEA, Milan.
authors.forename: G
authors.initials: G
authors.lastname: Pancera
authors.affiliation: Department of Oncology, Az. Osp. Ospedali Riuniti Villa Sofia-Cervello, Palermo.
authors.forename: G
authors.initials: G
authors.lastname: Solina
authors.affiliation: Department of Oncology, Casa di Cura San Carlo, Paderno Dugnano.
authors.forename: G
authors.initials: G
authors.lastname: Pavia
authors.affiliation: Department of Oncology, Istituto Nazionale dei Tumori, Napoli, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Pignata
authors.affiliation: Department of Surgery, St Louis University Hospital, St Louis, USA.
authors.forename: F
authors.initials: F
authors.lastname: Johnson
authors.affiliation: Department of Oncology, Ospedali Riuniti, Bergamo.
authors.forename: R
authors.initials: R
authors.lastname: Labianca
authors.affiliation: Department of Oncology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia.
authors.forename: G
authors.initials: G
authors.lastname: Apolone
authors.affiliation: Department of Oncology, Fondazione Poliambulanza, Brescia.
authors.forename: A
authors.initials: A
authors.lastname: Zaniboni
authors.affiliation: Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Monteforte
authors.affiliation: Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: E
authors.initials: E
authors.lastname: Negri
authors.affiliation: Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Torri
authors.affiliation: Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Mosconi
authors.affiliation: Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy roldano.fossati@marionegri.it.
authors.forename: R
authors.initials: R
authors.lastname: Fossati
mesh_terms: D002272:Carcinoembryonic Antigen / Q000097:blood; D059186:Chemoradiotherapy, Adjuvant; D003110:Colonic Neoplasms / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy; D003113:Colonoscopy / Q000379:methods*; D003952:Diagnostic Imaging; D018572:Disease-Free Survival; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000517:prevention & control*; D063868:Patient Outcome Assessment; D011788:Quality of Life; D012004:Rectal Neoplasms / Q000175:diagnosis* / Q000401:mortality / Q000628:therapy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D002272:Carcinoembryonic Antigen
keywords: colorectal carcinoma; randomized clinical trial