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Prospective Dutch colorectal cancer cohort: an infrastructure for long-term observational, prognostic, predictive and (randomized) intervention research25 augustus 2016
Nationwide comprehensive gastro-intestinal cancer cohorts: the 3P initiative19 juli 2017
Background: The increasing sub-classification of cancer patients due to more detailed molecular classification of tumors, and limitations of current trial designs, require innovative research designs. We present the design, governance and current standing of three comprehensive nationwide cohorts including pancreatic, esophageal/gastric, and colorectal cancer patients (NCT02070146). Multidisciplinary collection of clinical data, tumor tissue, blood samples, and patient-reported outcome (PRO) measures with a nationwide coverage, provides the infrastructure for future and novel trial designs and facilitates research to improve outcomes of gastrointestinal cancer patients.
Material and methods: All patients aged 18 years with pancreatic, esophageal/gastric or colorectal cancer are eligible. Patients provide informed consent for: (1) reuse of clinical data; (2) biobanking of primary tumor tissue; (3) collection of blood samples; (4) to be informed about relevant newly identified genomic aberrations; (5) collection of longitudinal PROs; and (6) to receive information on new interventional studies and possible participation in cohort multiple randomized controlled trials (cmRCT) in the future.
Results: In 2015, clinical data of 21,758 newly diagnosed patients were collected in the Netherlands Cancer Registry. Additional clinical data on the surgical procedures were registered in surgical audits for 13,845 patients. Within the first two years, tumor tissue and blood samples were obtained from 1507 patients; during this period, 1180 patients were included in the PRO registry. Response rate for PROs was 90%. The consent rate to receive information on new interventional studies and possible participation in cmRCTs in the future was >85%. The number of hospitals participating in the cohorts is steadily increasing.
Conclusion: A comprehensive nationwide multidisciplinary gastrointestinal cancer cohort is feasible and surpasses the limitations of classical study designs. With this initiative, novel and innovative studies
can be performed in an efficient, safe, and comprehensive setting.Bekijk deze publicatie
The impact of postoperative complications on health-related quality of life in older patients with rectal cancer; a prospective cohort study10 oktober 2017
Objectives: As result of the aging population and increasing rectal cancer incidence, more older patients undergo treatment for rectal cancer. This study compares treatment course, postoperative complications, and quality of life (QOL) between older and younger patientswith rectal cancer and evaluates the impact of postoperative complications on QOL in the elderly.
Materials and Methods: Patients with rectal cancer participating in a prospective colorectal cancer cohort and referred for radiotherapy between 2013 and 2016 were included. QOL was assessed with the cancer questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30) before treatment and at three, six, and twelve months. Outcomes were compared between older patients (≥70 years) and younger patients (b70 years) and stratified by presence of postoperative complications.
Results: In total, 115 (33%) older patients and 230 (67%) younger patients were included. Compared to younger patients, older patients underwent significantly more often short-course radiation with delayed surgery (6.1% and 19.1% respectively) and less often chemoradiation (62.6% and 39.1% respectively), and were more likely to undergo a Hartmann procedure with permanent stoma (3.5% and 13.0% respectively) instead of sphincter-sparing surgery (43.9% and 29.6% respectively). Postoperative complication rates were similar (38.5% in older patients versus 34.7% in younger patients). Older patients had worse physical functioning at six and twelve months after diagnosis compared to younger patients. Presence of postoperative complications had a significant stronger impact on physical- and role functioning in older patients.
Conclusion: Older patients undergo more often a tailored treatment approach for rectal cancer than younger patients.With this tailored approach, similar postoperative complication rates and QOL are achieved. However, postoperative complications have a larger negative impact on physical- and role functioning in older patients
which indicates a need for better prediction of postoperative complications in the elderly.Bekijk deze publicatie