Background Pemetrexed is an expensive oncological drug, used in combination with platinum derivatives (cisplatin/carboplatin) in the first line treatment of unresectable malignant pleural mesothelioma. In Italy, this indication is no longer subject to web-based monitoring (Onco-AIFA Register) to ensure its use appropriateness.
Purpose To assess the effectiveness in patients treated at the Istituto Oncologico Veneto (IOV) compared to the pivotal trial.
Materials and Methods This observational analysis was performed on all patients with pleural mesothelioma treated at the IOV from 01/12/2006 to 30/04/2011; the data were extracted from both paper and computerised medical records. The median Overall Survival (OS) and Time To Progression (TTP) were calculated as updated on 31/05/2012 according to the intention to treat.
Results All 46 patients (32 males and 14 females) were evaluated in terms of OS. TTP was calculated only for the 41 evaluable patients (29 males and 12 females); 5 patients lost owing to lack of information at follow-up.
The median OS/TTP values were respectively 14.2/8.9 months (vs. pivotal trial 12.1/5.7 months).
The majority of patients received the less toxic protocol pemetrexed+carboplatin, which contributed to the better OS/TTP. Better OS/TTP might be related to the use in a neoadjuvant regimen (16 patients: 10 males and 6 females); a specific stratified analysis showed TTP/OS median of 27.8/18.6 months.
Conclusions To confirm the better effectiveness of the carboplatin+pemetrexed protocol, further data on a greater number of patients, neoadjuvant treatment, treatment toxicity and patient performance status are needed.
Since the effectiveness of this high-cost oncological drug is not monitored at the national level, local monitoring is required to ensure appropriateness.
The computerised medical record is a pre-requisite for protocol standardisation and a tool of information standardisation/updating.
This work represents an easy, versatile methodological model with significant health implications.
A widely shared computerised medical record is a powerful tool for epidemiological investigations; an established network allowing benchmarking is a valid and independent decision-making tool.
No conflict of interest.
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