A phase II trial of prolonged, continuous infusion of low-dose gemcitabine plus cisplatin in patients with advanced malignant pleural mesothelioma.

Cancer Chemotherapy Pharmacology. 2014 April 1.[Epub ahead of print][Link]

Arrieta O, Bacon-Fonseca L, Blake-Cerda M, Corona-Cruz J.F., Lopez-Macias D, Macedo-Perez E.O., Mendoza-Garcia V.O., Muniz-Hernandez S, Munoz-Montano W

Abstract

PURPOSE:

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.

METHODS:

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).

RESULTS:

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 %).

CONCLUSIONS:

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.