A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma

G. Rosati, G. Ambrosini, Sandro Barni, Bruno Andreoni, G. Corradini, Giovanna Luchena, B. Daniele, F. Gaion, Giovanni Oliverio, M. Duro, G. Martignoni, N. Pinna, Pietro Sozzi, Gianfranco Pancera, G. Solina, Gianfranco Pavia, Sandro Pignata, F. Johnson, R. Labianca, Giovanni ApoloneA. Zaniboni, Marta Monteforte, Eva Vanna Lorenza Negri, Valter Torri, Paola Mosconi, R. Fossati

Research output: Contribution to journalArticle

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. Patients and 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. Conclusion: Our findings support the conclusions of other randomized clinical trials, which show that early diagnosis of cancer recurrence is not associated with OS benefit.

Original languageEnglish
Article numbermdv541
Pages (from-to)274-280
Number of pages7
JournalAnnals of Oncology
Volume27
Issue number2
DOIs
Publication statusPublished - Feb 1 2016

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Colorectal Neoplasms
Survival
Adjuvant Chemoradiotherapy
Quality of Life
Recurrence
Bleeding Time
Health Resources
Carcinoembryonic Antigen
Diagnostic Imaging
Rectal Neoplasms
Early Detection of Cancer
Developed Countries
Colonic Neoplasms
Disease-Free Survival
Physical Examination
Appointments and Schedules
Therapeutics
Randomized Controlled Trials
Population
Neoplasms

Keywords

  • Colorectal carcinoma
  • Randomized clinical trial

ASJC Scopus subject areas

  • Oncology
  • Hematology

Cite this

Rosati, G., Ambrosini, G., Barni, S., Andreoni, B., Corradini, G., Luchena, G., ... Fossati, R. (2016). A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. Annals of Oncology, 27(2), 274-280. [mdv541]. https://doi.org/10.1093/annonc/mdv541

A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. / Rosati, G.; Ambrosini, G.; Barni, Sandro; Andreoni, Bruno; Corradini, G.; Luchena, Giovanna; Daniele, B.; Gaion, F.; Oliverio, Giovanni; Duro, M.; Martignoni, G.; Pinna, N.; Sozzi, Pietro; Pancera, Gianfranco; Solina, G.; Pavia, Gianfranco; Pignata, Sandro; Johnson, F.; Labianca, R.; Apolone, Giovanni; Zaniboni, A.; Monteforte, Marta; Negri, Eva Vanna Lorenza; Torri, Valter; Mosconi, Paola; Fossati, R.

In: Annals of Oncology, Vol. 27, No. 2, mdv541, 01.02.2016, p. 274-280.

Research output: Contribution to journalArticle

Rosati, G, Ambrosini, G, Barni, S, Andreoni, B, Corradini, G, Luchena, G, Daniele, B, Gaion, F, Oliverio, G, Duro, M, Martignoni, G, Pinna, N, Sozzi, P, Pancera, G, Solina, G, Pavia, G, Pignata, S, Johnson, F, Labianca, R, Apolone, G, Zaniboni, A, Monteforte, M, Negri, EVL, Torri, V, Mosconi, P & Fossati, R 2016, 'A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma', Annals of Oncology, vol. 27, no. 2, mdv541, pp. 274-280. https://doi.org/10.1093/annonc/mdv541
Rosati, G. ; Ambrosini, G. ; Barni, Sandro ; Andreoni, Bruno ; Corradini, G. ; Luchena, Giovanna ; Daniele, B. ; Gaion, F. ; Oliverio, Giovanni ; Duro, M. ; Martignoni, G. ; Pinna, N. ; Sozzi, Pietro ; Pancera, Gianfranco ; Solina, G. ; Pavia, Gianfranco ; Pignata, Sandro ; Johnson, F. ; Labianca, R. ; Apolone, Giovanni ; Zaniboni, A. ; Monteforte, Marta ; Negri, Eva Vanna Lorenza ; Torri, Valter ; Mosconi, Paola ; Fossati, R. / A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma. In: Annals of Oncology. 2016 ; Vol. 27, No. 2. pp. 274-280.
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T1 - A randomized trial of intensive versus minimal surveillance of patients with resected Dukes B2-C colorectal carcinoma

AU - Rosati, G.

AU - Ambrosini, G.

AU - Barni, Sandro

AU - Andreoni, Bruno

AU - Corradini, G.

AU - Luchena, Giovanna

AU - Daniele, B.

AU - Gaion, F.

AU - Oliverio, Giovanni

AU - Duro, M.

AU - Martignoni, G.

AU - Pinna, N.

AU - Sozzi, Pietro

AU - Pancera, Gianfranco

AU - Solina, G.

AU - Pavia, Gianfranco

AU - Pignata, Sandro

AU - Johnson, F.

AU - Labianca, R.

AU - Apolone, Giovanni

AU - Zaniboni, A.

AU - Monteforte, Marta

AU - Negri, Eva Vanna Lorenza

AU - Torri, Valter

AU - Mosconi, Paola

AU - Fossati, R.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - 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. Patients and 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. Conclusion: Our findings support the conclusions of other randomized clinical trials, which show that early diagnosis of cancer recurrence is not associated with OS benefit.

AB - 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. Patients and 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. Conclusion: Our findings support the conclusions of other randomized clinical trials, which show that early diagnosis of cancer recurrence is not associated with OS benefit.

KW - Colorectal carcinoma

KW - Randomized clinical trial

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DO - 10.1093/annonc/mdv541

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