Phase II Study of Gemcitabine Plus Docetaxel as Second-Line Treatment in Malignant Pleural Mesothelioma

Abstract

OBJECTIVE: The combinations of cisplatin-pemetrexed and cisplatin-gemcitabine are considered the standard systemic therapy for malignant pleural mesothelioma (MPM), which is a rapidly progressive tumor. The purpose of the present study is to evaluate the efficacy, safety, and clinical benefit of the gemcitabine plus docetaxel regimen in the second-line treatment of this disease. PATIENTS AND METHODS: A total of 37 patients with MPM were treated with the combination of docetaxel (80 mg/m) and gemcitabine (1000 mg/m) on day 1 and 14 of a 28-day cycle. The regimen was repeated for a maximum of 6 cycles or until disease progression or unacceptable toxicity. RESULTS: There was partial response of the disease in 7 patients (18.9%), whereas it remained stable in 23 patients (62.2%) and progressed in 7 patients (18.9%). The median time to disease progression was 7 months (range: 5.8-8.2 months) with a mean survival of 16.2 months (range: 13-19.3 months). CONCLUSION: The biweekly administration of docetaxel and gemcitabine, along with granulocyte colony-stimulating factor support, constitutes a safe, tolerable, and convenient regimen for the treatment of MPM, suggesting that this combination may be a viable option, especially in previously treated patients.