G Rosati1, G Ambrosini2, S Barni3, B Andreoni4, G Corradini5, G Luchena6, B Daniele7, F Gaion8, G Oliverio9, M Duro10, G Martignoni11, N Pinna12, P Sozzi13, G Pancera14, G Solina15, G Pavia12, S Pignata16, F Johnson17, R Labianca18, G Apolone19, A Zaniboni20, M Monteforte21, E Negri21, V Torri21, P Mosconi21, R Fossati22. 1. Department of Oncology, Ospedale San Carlo, Potenza. 2. Department of Oncology, Ospedale Santa Chiara, Trento. 3. Department of Oncology, Az. Osp. Treviglio-Caravaggio, Treviglio. 4. Department of Oncology, Istituto Europeo di Oncologia, Milan. 5. Department of Oncology, Ospedale Civile, Rho. 6. Department of Oncology, Ospedale Sant'Anna, Como. 7. Department of Oncology, Az. Osp. G. Rummo, Benevento. 8. Department of Oncology, Ospedale Civile, Camposampiero. 9. Department of Oncology, Ospedale Infermi, Rimini. 10. Department of Oncology, Ospedale Valduce, Como. 11. Department of Oncology, Ospedale S. Carlo Borromeo, Milan. 12. Department of Oncology, Casa di Cura San Carlo, Paderno Dugnano. 13. Department of Oncology, Ospedale degli Infermi, Biella. 14. Department of Oncology, Casa di Cura IGEA, Milan. 15. Department of Oncology, Az. Osp. Ospedali Riuniti Villa Sofia-Cervello, Palermo. 16. Department of Oncology, Istituto Nazionale dei Tumori, Napoli, Italy. 17. Department of Surgery, St Louis University Hospital, St Louis, USA. 18. Department of Oncology, Ospedali Riuniti, Bergamo. 19. Department of Oncology, IRCCS Arcispedale S. Maria Nuova, Reggio Emilia. 20. Department of Oncology, Fondazione Poliambulanza, Brescia. 21. Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy. 22. Department of Oncology, IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy roldano.fossati@marionegri.it.
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. CLINICALTRIALSGOV: NCT02409472.
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. CLINICALTRIALSGOV: NCT02409472.
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