A phase II trial of prolonged, continuous infusion of low-dose gemcitabine plus cisplatin in patients with advanced malignant pleural mesothelioma
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Low-dose, prolonged infusion of gemcitabine has effects similar to standard doses in several cancers. We evaluated the toxicity and efficacy of low-dose gemcitabine in prolonged infusion plus cisplatin in patients with advanced pleural mesothelioma.
Patients with mesothelioma received gemcitabine (250 mg/m2) in a 6-h infusion plus cisplatin (35 mg/m2) on days 1 and 8 every three weeks. We used the modified response evaluation criteria in solid tumours. This study is registered in clinical trials (NCT01869023).
We included 39 patients; 82.1 % were low risk according to the European Organisation for Research and Treatment of Cancer prognostic group. Partial response was observed in 53.8 % (21/39), stable disease in 33.3 % (13/39) and progression in 12.8 % (5/39). The median progression-free survival was 6.9 months (95 % CI 3.2–10.6 months), and the associated factors were the EORTC risk and histology. The median overall survival was 20.7 months (95 % CI 10.7–30.8 months). The functional, physical and emotional roles and dyspnoea, insomnia and pain symptom scales improved. The most commonly graded 3/4 side effects were neutropenia (24.4 %), lymphopenia (14.6 %), thrombocytopenia (14.7 %) and anaemia (12.2 %).
Low-dose, prolonged gemcitabine infusion plus cisplatin has acceptable toxicity and high efficacy with improved quality of life, representing an affordable regimen for the low-income population.
KeywordsMesothelioma Prolonged infusion Gemcitabine Cisplatin
The study protocol was approved by the local Institutional Scientific and Bioethics Committee (INCAN/CC/458/01-INCAN/CB/516/01/CB/656) in accordance with the ethical standards laid down in the 1,964 Declaration of Helsinki and its later amendments and was registered in clinical trials (NCT01869023).
Conflict of interest
All patients signed written informed consent. The authors do not have any conflict of interest to declare.
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