Abstract
BackgroundSmoking is a strong risk factor for cancer and atherosclerosis. Cancer mortality, especially from lung cancer, overtakes cardiovascular (CV) death rate in patients with peripheral arterial disease (PAD). Only a few patients with lung cancer after PAD management may benefit from surgical excision. Circulating tumor cells (CTC) associated with low-dose chest CT (LDCT) may improve early cancer detection. This study focuses on a screening strategy that can address not only lung cancer but all tobacco-related cancers in this high-risk population.MethodsDETECTOR Project is a prospective cohort study in two French University hospitals. Participants are smokers or former smokers (≥30 pack-years, quitted ≤15 years), aged ≥55 to 80 years, with atherosclerotic PAD or abdominal aortic aneurysm. After the first screening round combining LDCT and CTC search on a blood sample, two other screening rounds will be performed at one-year interval. Incidental lung nodule volume, volume doubling time and presence of CTC will be taken into consideration for adapted diagnostic management. In case of negative LDCT and presence of CTC, a contrast enhanced whole-body PET/CT will be performed for extra-pulmonary malignancy screening. Psychological impact of this screening strategy will be evaluated in population study using a qualitative methodology. Assuming 10% prevalence of smoking-associated cancer in the studied population, a total of at least 300 participants will be enrolled.DiscussionEpidemiological data underline an increase incidence in cancer and related death in the follow-up of patients with PAD, compared with the general population, particularly for tobacco-related cancers. The clinical benefit of a special workup for neoplasms in patients with PAD and a history of cigarette smoking has never been investigated. By considering CTCs detection in this very high-risk selected PAD population for tobacco-induced cancer, we expect to detect earlier pulmonary and extra-pulmonary malignancies, at a potentially curable stage.Trial registrationThe study was registered in the French National Agency for Medicines and Health Products Safety (No N° EUDRACT_ID RCB: 2016-A00657–44) and was approved by the ethics Committee for Persons Protection (IRB number 1072 and n° initial agreement 2016-08-02; ClinicalTrials.gov identifier NCT02849041).
Highlights
Smoking is a strong risk factor for cancer and atherosclerosis
Peripheral arterial disease is defined according to the following criteria: asymptomatic patients with ankle-brachial pressure index value less than 0.90 or pulse abolition with imaging-documented atherosclerotic vascular disease; symptomatic patients with intermittent claudication or chronic ischemic rest pain with or without tissue loss; acute limb ischemia; presence of abdominal aortic aneurysm (AAA), defined as a localized dilation of the aorta of at least 50% in relation to the normal adjacent aorta measured by duplex-ultrasound or Positron emission tomography–computed tomography (CT)-scan.; previous arterial revascularization procedure of lower limb or amputation due to peripheral arterial disease (PAD)
Exclusion criteria are treatment for, or evidence of, any cancer within 5 years before enrollment, except non-melanoma skin cancer and in situ carcinomas, previous lung resection surgery, acute respiratory tract infection treated with antibiotics in the previous 12 weeks, contraindication to any invasive thoracic procedure, any sign suggestive of prevalent malignancy, renal insufficiency not allowing - if appropriate - injection of contrast medium, psychiatric comorbidities or limited life expectancy due to concomitant disease, Eastern cooperative oncology group (ECOG) Performance Status ≥2
Summary
Smoking is a strong risk factor for cancer and atherosclerosis. Especially from lung cancer, overtakes cardiovascular (CV) death rate in patients with peripheral arterial disease (PAD). In European countries, cancer has overtaken cardiovascular disease as the main cause of death [1]. Smoking is considered as a major risk factor for atherosclerosis and cancer and remains the predominant risk factor for premature death in Europe [2]. In patients with peripheral arterial disease (PAD), mortality rate from cancer is currently exceeding that of cardiovascular diseases [3]. Lung cancer is considered as the most frequent cause of death from cancer in Europe [4]. Most patients with tobacco related cancer present with advanced disease, not yet curable with currently available therapies. Early detection might be a valuable approach to detect the disease at an asymptomatic and potentially curable stage
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