Summary. This study is supported by grants from the Province of Gorizia, Italy, and the Compagnia di San Paolo, Turin, Italy.

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1 Low-dose spiral CT screening in asbestos-exposed workers: an Alpe Adria Thoracic Oncology Multidisciplinary group study (ATOM 002) a Screening con TC spirale a bassa dose di radiazioni in lavoratori esposti ad amianto: studio dell Alpe Adria Thoracic Oncology Multidisciplinary group (ATOM 002) Gianpiero Fasola*, Fabio Barbone**, Tina Zanin***, Stefano Meduri*, Paolo Cassetti***, Giusto Pignata***, Mauro Melato***, Claudio Rieppi***, Anna Troilo***, Giovanni Pilati***, Danilo Spazzapan***, Vincenzo de Pangher***, Marianna Aita**, Ciro Rossetto**, Alessandro Follador**, Adriana Scogna**, Oriana Delicati***, Tino Ceschia*, Angelo Morelli*, Francesco Grossi****, Ornella Belvedere** * S.M. Misericordia Hospital, Udine, Italy ** University Hospital, Udine, Italy *** Isontina Health Unit, S. Polo Hospital, Monfalcone, Italy **** National Institute for Research on Cancer, Genoa, Italy Summary Aim. To evaluate baseline and annual repeat screening with low-dose spiral computed tomography (LDCT) in asbestos-exposed workers, at high risk for both lung cancer and pleural mesothelioma. Subjects and methods. Enrollment of 1,000 asymptomatic volunteers was initiated in February Main inclusion criteria are: exposure to asbestos, age 40 to 75, no prior cancer or concomitant disease, no chest CT in the last 2 years. Eligible subjects undergo an interview, chest-x-ray (CXR) and LDCT. If baseline examinations are negative, LDCT is repeated annually; otherwise, high resolution CT (HRCT) and additional diagnostic workup are performed. Results. Up till February 12 th, 2003, 546 subjects had been enrolled. Among the first 309 evaluated participants, LDCT has identified 231 non calcified nodules (NCN). On CXR, 22 nodules have been detected. Pleural abnormalities have been identified in 97% and 64% of subjects by LDCT and CXR, respectively. Conclusions. These preliminary results confirm that LDCT is much more sensitive than CXR for the detection of lung nodules and pleural abnormalities, suggesting Address/Indirizzo: Dr. Gianpiero Fasola, Dipartimento di Oncologia Medica, Azienda Ospedaliera S. M. Misericordia, P.le S. M. Misericordia 15, Udine, Italia; - Tel. 0039/0432/ Fax 0039/0432/ a This study is supported by grants from the Province of Gorizia, Italy, and the Compagnia di San Paolo, Turin, Italy. 65

2 Eur. J. Oncol. Library, vol. 3 that LDCT may play a rôle in the early detection of lung cancer and pleural mesothelioma in asbestos-exposed workers. Key words: lung cancer, pleural mesothelioma, screening, asbestos, low-dose spiral computed tomography Riassunto Finalità. Valutare lo screening con tomografia computerizzata spirale a bassa dose di radiazioni (LDCT) in una popolazione di lavoratori esposti all amianto, ad alto rischio di neoplasie polmonari e mesotelioma della pleura. Soggetti e metodi. L arruolamento di 1000 volontari asintomatici è iniziato nel febbraio Principali criteri di inclusione sono: esposizione ad amianto, età compresa tra 40 e 75 anni, non gravi malattie o pregresso tumore, non TC del torace nei due anni precedenti. I soggetti eleggibili vengono sottoposti a colloquio, Rx torace (CXR) e LDCT. In caso di valutazione basale negativa, si avvia screening annuale con LDCT; altrimenti, è prevista l esecuzione di TC ad alta risoluzione (HRCT) e di eventuali ulteriori accertamenti. Risultati. Fino al 12 febbraio 2003, sono stati arruolati 546 soggetti. Tra i primi 309 pazienti valutati, la LDCT ha evidenziato 231 noduli non calcifici (NCN); la CXR ha individuato 22 noduli. Anomalie pleuriche sono state riscontrate nel 97% e nel 64% dei partecipanti mediante rispettivamente LDCT e CXR. Conclusioni. Questi risultati preliminari confermano che la LDCT è molto più sensibile della CXR nell individuare noduli polmonari ed anomalie pleuriche, suggerendo che la LDCT potrebbe avere un ruolo importante nell identificazione di tumori polmonari e del mesotelioma della pleura in stadio precoce in soggetti con storia di esposizione ad amianto. Parole chiave: tumore del polmone, mesotelioma, screening, amianto, TC spirale a bassa dose di radiazioni Introduction Lung cancer is the leading cause of death due to malignant disease in developed countries, causing about one third of all cancer-related deaths 1. Most cases are diagnosed in subjects over 60 years of age. Approximately 35,000 new cases are observed annually in Italy. Cigarette-smoking is the main risk factor, being responsible for approximately 85-90% of cases. Other risk factors include environmental and professional exposures, some of them being direct carcinogenic agents for the respiratory system. The combination of smoking and asbestos exposure significantly increases the risk of developing lung cancer 1. Furthermore, experimental, epidemiological and clinical studies have demonstrated the strong causal relationship of asbestos exposure with pleural mesothelioma 2. Subjects who are exposed to asbestos fibres, like shipyard workers, are particularly at risk: about 10% of them will eventually die of mesothelioma 3, 4. Pleural mesothelioma incidence and mortality are increasing all over the world. In Italy, the mortality rate for mesothelioma has increased three times from 1970 to 1995, but the highest mortality is expected in , 6. In the Friuli Venezia Giulia Region, the mortality rate for mesothelioma is double that in the rest of Italy (standardized mortality ratio for 100,000 inhabitants = 4.1). In the area of Venezia Giulia, 66

3 G. Fasola, F. Barbone, T. Zanin, et al: Screening for lung cancer and mesothelioma with LDCT the standardized mortality ratio for 100,000 inhabitants is 13.5: most of these cases are observed among shipyard workers in Monfalcone and their wives 7-9. The most important prognostic factor in lung cancer and mesothelioma is the stage of disease. Unfortunately, lung cancer is usually diagnosed at advanced stages, when the prognosis is poor. However, when early diagnosis occurs, radical surgery may be performed, resulting in a 5 year-survival rate of up to 70%. Therefore, physicians have long evaluated screening methods to identify early stage lung cancer. Three large randomized trials were undertaken in the 1970s, to evaluate chest radiography (CXR) and sputum cytology in lung cancer screening: these were shown to improve long-term survival rates but had no impact on disease-specific mortality rate, which is considered the best indicator of screening efficacy Recent, uncontrolled studies have reported encouraging results for lung cancer screening with low-dose computed tomography (LDCT) These studies have shown that LDCT is much more sensitive than CXR in the detection of lung cancer, increasing the probability of detecting the disease at an early stage, when it can be possibly cured. While waiting for the results of large randomized controlled trials, currently ongoing, evaluating LDCT screening, the possible survival benefit from an early diagnosis justifies further studies, especially in high-risk populations, such as asbestos-exposed subjects, at high risk for both lung cancer and pleural mesothelioma. Accordingly, we have designed and started a prospective, nonrandomized trial to evaluate baseline and annually repeated screening with LDCT in asbestos-exposed workers. Herein, we report the preliminary results of the baseline screening. Subjects and methods People enrolled in the Surveillance Programme for asbestos-exposed workers and/or former workers at the Unit of Occupational Health in Monfalcone, are considered candidates for this study. Eligibility criteria also include age 40 to 75, no prior cancer (other than nonmelanoma skin cancer) or severe concomitant conditions, no chest CT scan in the last 2 years, written informed consent. At the time of enrollment, after written informed consent, eligible subjects undergo a structured interview, including questions on smoking habits, and occupational and medical history. Blood samples are collected from each participant and stored for future analysis. Respiratory function tests are also performed at baseline. Subjects then undergo CXR and LDCT. Scans are obtained from the level of the apex to the diaphragm, with a 20-second breath hold after one minute of hyperventilation. Image reconstruction is performed with a standard algorithm at intervals of 5 mm. All LDCT images are reviewed by two radiologists separately. Subjects with negative baseline examinations are scheduled for annually repeated LDCT screening. Subjects with positive baseline examinations (i.e. non calcified nodules -NCN, calcified nodules >20 mm or with a malignant pattern, pleural thickening >10 mm or with scissural or circumferential involvement) undergo high resolution CT (HRCT) and additional diagnostic workup. The study protocol was approved by the local ethical committee. Results From February 16 th, 2002, to February 12 th, 2003, 546 subjects were enrolled. The median age of participants is 58, ranging from 45 to 75. The median time of asbestos exposure 67

4 Eur. J. Oncol. Library, vol. 3 is 12 years, ranging from 1 to 50. The majority of the subjects are males (99%), retired (84%), and former smokers (51%). With LDCT, 231 NCN have been identified in 75% of the first 309 evaluated participants; 25 calcified nodules were discovered. In contrast, CXR detected 22 nodules, all of them calcified. Pleural abnormalities were observed in 64% and 97% of participants, by CXR and LDCT, respectively. No pleural effusion was identified. So far, 51% of the participants had negative basal examination and have been scheduled for annual screening, whereas 49% of the subjects, who had positive basal examination, have undergone HRCT. Based on HRCT results and according to the diagnostic workup in the study protocol, these subjects have undergone either repeated HRCT after 3 months or immediate invasive diagnostic procedures (i.e. videoassisted thoracoscopic biopsy (VATS), percutaneous transthoracic CT-guided fine-needle aspiration), or have been scheduled for LDCT annual screening. Discussion Our preliminary data suggest that LDCT may play a rôle in the early detection of lung cancer in asbestos-exposed workers, at high risk for both lung cancer and pleural mesothelioma. These results are consistent with previously published studies, evaluating screening with LDCT in heavy smokers So far, we have been facing several issues that must be taken into account in the overall evaluation of lung cancer screening with LDCT. First, false positive results may lead to unnecessary, invasive diagnostic procedures, such as percutaneous CT-guided fine-needle aspiration or VATS or thoracotomy. Second, false positive findings raise anxiety among subjects undergoing screening, that may significantly affect their quality of life. Third, the risk of overdiagnosis (i.e. the diagnosis of slow-growing cancers that may not cause the patient s death) may be associated with morbidity and mortality for invasive diagnostic procedures and treatment. Fourth, cumulative radiation exposure must be calculated, mostly when repeated HRCT are required to follow-up nodules detected at baseline LDCT. Finally, other concerns include cost-effectiveness. The currently ongoing, large, randomized controlled trial promoted by the National Cancer Institute will address the issue whether LDCT screening decreases mortality for lung cancer. Even if the efficacy of LDCT screening is eventually proven, the question of whether the above-mentioned drawbacks offset the mortality benefit must be carefully evaluated. References 1. Ginsberg RJ, Vokes EE, Rosenzweig K. Cancer of the lung. In DeVita VT, Hellman S, Rosenberg SA. Cancer. Principles and practice of oncology, VI Ed. Philadelphia: JB Lippincott, 2001, Antman KH, Schiff PB, Pass HI. Benign and malignant mesothelioma. In DeVita VT, Hellman S, Rosenberg SA. Cancer. Principles and practice of oncology, VI Ed. Philadelphia: JB Lippincott, 2001, Damhuis RA, van Gelder T. Malignant mesothelioma in the Rotterdam area, Eur J Cancer 1993; 29A: Magnani C, Agudo A, Gonzalez CA, et al. Multicentric study on malignant pleural mesothelioma and non-occupational exposure to asbestos. Br J Cancer 2000; 83:

5 G. Fasola, F. Barbone, T. Zanin, et al: Screening for lung cancer and mesothelioma with LDCT 5. WHO Databank. Available on 6. Merler E, Lagazio C, Biggeri A. Trends in mortality from primary pleural tumor and incidence of pleural mesothelioma in Italy: a particularly serious situation. Epidemiol Prev 1999; 23: Giarelli L, Grandi G, Bianchi C. Malignant mesothelioma of the pleura in the Trieste-Monfalcone area, with particular regard to shipyard workers. Med Lav 1997; 88: Bianchi C, Brollo A, Ramani L, et al. Asbestos-related mesothelioma in Monfalcone, Italy. Am J Ind Med 1993; 24: De Pangher Manzini V, Brollo A, Franceschi S, et al. Prognostic factors of malignant mesothelioma of the pleura. Cancer 1993; 72: Fontana RS, Sanderson DR, Taylor WF, et al. Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Mayo Clinic study. Am Rev Respir Dis 1984; 130: Frost JK, Ball WC Jr, Levin ML, et al. Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Johns Hopkins study. Am Rev Respir Dis 1984; 130: Flehinger BJ, Melamed MR, Zaman MB, et al. Early lung cancer detection: results of the initial (prevalence) radiologic and cytologic screening in the Memorial Sloan-Kettering study. Am Rev Respir Dis 1984; 130: Kaneko M, Eguchi K, Ohmatsu H, et al. Peripheral lung cancer: screening and detection with low-dose spiral CT versus radiography. Radiology 1996; 201: Sone S, Takashima S, Li F, et al. Mass screening for lung cancer with mobile spiral computed tomography scanner. Lancet 1998; 351: Henschke CI, McCauley DI, Yankelevitz DF, et al. Early Lung Cancer Action Project: overall design and findings from baseline screening. Lancet 1999; 354:

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