Analysis of survival of mesothelioma cases in the Italian register (ReNaM)

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Abstract

The Italian National Mesothelioma Register (ReNaM) was set up at ISPESL (the National Institute for Occupational Safety and Prevention) in 1993. Five Italian regions (Piedmont, Liguria, Emilia-Romagna, Tuscany and Puglia, with a total of approximately 17 500 000 inhabitants) agreed to record mesothelioma cases according to guidelines established by ISPESL, to define exposure to asbestos and transmit the data to ISPESL. We describe an analysis of survival of 429 mesothelioma cases—392 pleural, 34 peritoneal and 3 in the pericardium—diagnosed during 1997, with variable follow-up from June 1999 to December 2001. The Kaplan–Meier method was used to estimate survival rates, the log rank non-parametric test and Cox proportional hazard model to assess the role of prognostic factors such as age, gender, morphology, level of diagnostic certainty and modality of exposure. Median survival was 275 days (95% confidence interval (CI) 241–309) for pleural mesotheliomas and 157 days (95% CI: 118–196) for peritoneal mesotheliomas. Survival after diagnosis of malignant pleural mesothelioma showed a statistically significant linear trend for age group at diagnosis, for males and females (P=0.006 and 0.008, respectively). The Cox proportional hazard model gave an adjusted relative risk (RRadj), for the fibrous histotype, of 2.96 (95% CI: 1.28–6.81; P=0.012) compared with cases with unspecified morphology; for epithelioid and biphasic morphologies, the risk was lower than unity. There was no significant difference in survival for cases with confirmed exposure (occupational, household or environmental) or without.

Introduction

Malignant mesothelioma (MM) is a highly lethal tumour with a low incidence, selectively induced by exposure to asbestos. It arises most frequently in the serous of the pleura and peritoneum, but cases have been reported in the pericardium and in the tunica vaginalis testicular. Incidence rates of mesothelioma, related to the large-scale use of asbestos in many industrial countries up until the 1980s, are rising and in view of the long latency of the disease—on average more than 30 years—this tendency can be expected to continue until at least 2020 1, 2.

In Italy, annual production of asbestos in the 1980s amounted to 100 000–130 000 tons and it was used in numerous industrial applications. Between 1988 and 1997, a total of 9094 deaths from tumours of the pleura were recorded, giving a standardised annual rate of 1.61 per 100 000 inhabitants. The incidence figures recorded by the Italian national tumour register show some parts of Italy, such as the provinces of Trieste and Genoa, where the rates are among the highest in the world (annual rates are 6.4 and 5.0, respectively for males, standardised to the world population) 3, 4.

The Italian National Mesothelioma Register (ReNaM) was set up in 1993 at the Istituto Superiore Prevenzione e Sicurezza Lavoro (National Institute for Occupational Safety and Prevention—ISPESL). Some Italian regions already had a system for active notification of cases and reconstruction of the exposure to asbestos. In 1988, Tuscany set up the Archivio Regionale Toscano dei Mesoteliomi Maligni (Tuscan Regional Archives of Malignant Mesotheliomas) which operates throughout that region [5]. In 1989, Puglia set up a regional register for cases of mesothelioma [6], and 1990 saw the start of the Piedmontese Mesothelioma Register [7]. In Liguria and Emilia-Romagna epidemiological surveillance started at municipal level; Genoa followed in 1994, after Reggio Emilia, in 1993, then in 1996 it was extended to the whole region 8, 9.

ReNaM published figures for incidence and asbestos exposure for the period from 1993 to 1996 and for the year 1997 for these five regions, which covers approximately 40% of the Italian population and 45% of the annual mortality from pleural tumours [10]. Since then Regional Operational Centers (COR) have been set up in Lombardy, Veneto, Sicily, Basilicata, the Marches and Campania, extending the ReNaM coverage to more than 80% of the resident population.

There is no absolute concordance between published studies of the prognostic factors in malignant pleural mesothelioma and opinions differ on how asbestos exposure influences survival 11, 12, 13. The aim of this study was therefore to present data on survival of incident cases of malignant mesothelioma in 1997 for the five Italian Regions listed, in order to add to the epidemiological picture obtained from clinical studies and to help establish the prognostic role of the main demographic factors (gender, age) and diagnostic and exposure variables (morphology, level of diagnostic certainty, modality of exposure).

Section snippets

Patients and methods

Cases are collected by the COR from health care institutions in each region that diagnose and treat cases of mesothelioma. These include pathology and histology units, lung disease and chest surgery wards. Hospital discharge records and death certificates are consulted to check that all available information has been collected. Reference diagnostic protocols are used to standardise the diagnostic criteria for mesothelioma, and cases are classified depending on the level of diagnostic certainty

Results

Median survival of incident cases in 1997 was 275 days (279 (95% CI: 245–313) for males and 263 (95% CI: 184–342) for females) for pleural mesothelioma (n=392) with 95% CI of 241–309; for peritoneal mesothelioma (n=34) it was 157 days (148 (95% CI: 84–212) for males and 252 (95% CI: 0–551) for females), with 95% CI of 118–196 (Table 2). The difference in the distribution of survival by gender adjusted for age was not significant for pleural mesothelioma (log rank test=0.01; P=0.91) and for

Discussion

The ReNaM survival figures give a good representation of the situation, based on an active system of seeking cases, with standard tools and methods, covering a good proportion of the country (approximately 17 514 000 residents in 1999). However, it does not allow a complete assessment of its determinants. No information is available on the stage of the disease at diagnosis, or its treatment, and these variables are obviously essential if one is to assess the efficacy of treatment and interpret

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