TY - JOUR
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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U2 - 10.1093/annonc/mdv541
DO - 10.1093/annonc/mdv541
M3 - Article
VL - 27
SP - 274
EP - 280
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 2
M1 - mdv541
ER -