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Combination of Raltitrexed and Oxaliplatin Is an Active Regimen in Malignant Mesothelioma: Results of a Phase II Study

From the Department of Medicine, Institut Gustave Roussy, Villejuif; Centre François Baclesse, Caen; AstraZeneca, Rueil-Malmaison, France; and AstraZeneca, Macclesfield, United Kingdom.

Address reprint requests to Karim Fizazi, MD, Department of Medicine, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94800 Villejuif, France, email: fizazi{at}igr.fr.

Purpose: The aim of this open-label phase II study was to evaluate the activity of raltitrexed (Tomudex; AstraZeneca, Cergy, France) and oxaliplatin combination therapy in patients with diffuse malignant pleural mesothelioma.

Patients and Methods: Fifteen pretreated and 55 chemotherapy-naive patients (median age, 60 years; World Health Organization performance status of 2) were enrolled. Most patients (66%) had advanced disease. Patients received raltitrexed 3 mg/m² followed by oxaliplatin 130 mg/m² every 3 weeks.

Results: Twenty-four patients (34%) were classified as having a poor prognosis. In the overall study population, 14 patients (20%) had a partial response, and 32 patients (46%) had stable disease. The symptomatic response rates were as follows: shortness of breath, 36%; pain, 30%; activity, 23%; appetite, 21%; and asthenia, 20%. Median time to disease progression was 18 weeks (95% confidence interval [CI], 13 to 22 weeks). In chemotherapy-naive patients, median survival was 31 weeks (95% CI, 23 to 40 weeks) from the start of treatment and 49 weeks (95% CI, 40 to 52 weeks) from diagnosis of mesothelioma. In pretreated patients, median survival was 44 weeks (95% CI, 24 to 40 weeks) from the start of treatment and 226 weeks (95% CI, 63 to 292 weeks) from the diagnosis of mesothelioma. Overall 1-year survival was 26% (95% CI, 15.5% to 36.4%), survival was 22% (95% CI, 10.9% to 33.2%) in chemotherapy-naive patients and 40% (95% CI, 15.2% to 64.8%) in pretreated patients. Hematologic toxicity was mild, and there was no alopecia. The most common adverse events were asthenia, nausea/vomiting, and paraesthesia, and no treatment-related deaths were reported.

Conclusion: The raltitrexed and oxaliplatin combination is an active outpatient regimen in malignant mesothelioma and has an acceptable tolerability profile.

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