Marc Carrier1, Alejandro Lazo-Langner, Sudeep Shivakumar, Vicky Tagalakis, Ryan Zarychanski, Susan Solymoss, Nathalie Routhier, James Douketis, Kim Danovitch, Agnes Y Lee, Gregoire Le Gal, Philip S Wells, Daniel J Corsi, Timothy Ramsay, Doug Coyle, Isabelle Chagnon, Zahra Kassam, Hardy Tao, Marc A Rodger. 1. From the Department of Medicine (M.C., K.D., G.L.G., P.S.W., M.A.R.) and the Clinical Epidemiology Program (D.J.C., T.R., D.C.), Ottawa Hospital Research Institute, and Department of Diagnostic Imaging (H.T.), University of Ottawa, Ottawa, Departments of Medicine (A.L.-L.), Oncology (A.L.-L.), Epidemiology and Biostatistics (A.L.-L.), and Medical Imaging (Z.K.), University of Western Ontario, London, Department of Medicine, Dalhousie University, Halifax, NS (S. Shivakumar), Department of Medicine, Jewish General Hospital (V.T.), and Department of Medicine, Montreal General Hospital (S. Solymoss), McGill University, and Department of Medicine, Sacre Coeur Hospital, Université de Montréal (N.R., I.C.), Montreal, Department of Medicine, University of Manitoba, Winnipeg (R.Z.), Department of Medicine, McMaster University, Hamilton, ON (J.D.), and the Department of Medicine, University of British Columbia, Vancouver (A.Y.L.) - all in Canada.
Abstract
BACKGROUND:Venous thromboembolism may be the earliest sign of cancer. Currently, there is a great diversity in practices regarding screening for occult cancer in a person who has an unprovoked venous thromboembolism. We sought to assess the efficacy of a screening strategy for occult cancer that included comprehensive computed tomography (CT) of the abdomen and pelvis in patients who had a first unprovoked venous thromboembolism. METHODS: We conducted a multicenter, open-label, randomized, controlled trial in Canada. Patients were randomly assigned to undergo limited occult-cancer screening (basic blood testing, chest radiography, and screening for breast, cervical, and prostate cancer) or limited occult-cancer screening in combination with CT. The primary outcome measure was confirmed cancer that was missed by the screening strategy and detected by the end of the 1-year follow-up period. RESULTS: Of the 854 patients who underwent randomization, 33 (3.9%) had a new diagnosis of occult cancer between randomization and the 1-year follow-up: 14 of the 431 patients (3.2%) in the limited-screening group and 19 of the 423 patients (4.5%) in the limited-screening-plus-CT group (P=0.28). In the primary outcome analysis, 4 occult cancers (29%) were missed by the limited screening strategy, whereas 5 (26%) were missed by the strategy of limited screening plus CT (P=1.0). There was no significant difference between the two study groups in the mean time to a cancer diagnosis (4.2 months in the limited-screening group and 4.0 months in the limited-screening-plus-CT group, P=0.88) or in cancer-related mortality (1.4% and 0.9%, P=0.75). CONCLUSIONS: The prevalence of occult cancer was low among patients with a first unprovoked venous thromboembolism. Routine screening with CT of the abdomen and pelvis did not provide a clinically significant benefit. (Funded by the Heart and Stroke Foundation of Canada; SOME ClinicalTrials.gov number, NCT00773448.).
RCT Entities:
BACKGROUND:Venous thromboembolism may be the earliest sign of cancer. Currently, there is a great diversity in practices regarding screening for occult cancer in a person who has an unprovoked venous thromboembolism. We sought to assess the efficacy of a screening strategy for occult cancer that included comprehensive computed tomography (CT) of the abdomen and pelvis in patients who had a first unprovoked venous thromboembolism. METHODS: We conducted a multicenter, open-label, randomized, controlled trial in Canada. Patients were randomly assigned to undergo limited occult-cancer screening (basic blood testing, chest radiography, and screening for breast, cervical, and prostate cancer) or limited occult-cancer screening in combination with CT. The primary outcome measure was confirmed cancer that was missed by the screening strategy and detected by the end of the 1-year follow-up period. RESULTS: Of the 854 patients who underwent randomization, 33 (3.9%) had a new diagnosis of occult cancer between randomization and the 1-year follow-up: 14 of the 431 patients (3.2%) in the limited-screening group and 19 of the 423 patients (4.5%) in the limited-screening-plus-CT group (P=0.28). In the primary outcome analysis, 4 occult cancers (29%) were missed by the limited screening strategy, whereas 5 (26%) were missed by the strategy of limited screening plus CT (P=1.0). There was no significant difference between the two study groups in the mean time to a cancer diagnosis (4.2 months in the limited-screening group and 4.0 months in the limited-screening-plus-CT group, P=0.88) or in cancer-related mortality (1.4% and 0.9%, P=0.75). CONCLUSIONS: The prevalence of occult cancer was low among patients with a first unprovoked venous thromboembolism. Routine screening with CT of the abdomen and pelvis did not provide a clinically significant benefit. (Funded by the Heart and Stroke Foundation of Canada; SOME ClinicalTrials.gov number, NCT00773448.).
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