A phase II study of gemcitabine in patients with malignant pleural mesothelioma

BACKGROUND, Gemcitabine has shown activity in patients with less chemosensi tive solid tumors. Phase II screening of novel drugs is an accepted method with which to investigate new therapies in malignant mesothelioma. The Euro pean Organization for Research and Treatment of Cancer-Lung Cancer Cooperat ive Group has performed several sequential Phase II trials of new agents fo r the treatment of mesothelioma over the last 10 years. METHODS. Twenty-seven chemotherapy-naive patients with histologically prove n malignant mesothelioma were treated with gemcitabine as a 30-minute intra venous administration of 1250 mg/m(2) on Days 1, 8, and 15 of a 28-day cycl e. Therapy continued for up to ten cycles unless disease progression or exc essive toxicity mandated discontinuation. RESULTS, With a median relative dose intensity of 96%, toxicity was mild an d neutropenia of greater than or equal to Grade 3 (according to National Ca ncer Institute criteria) occurred in 30% of patients, without episodes of f ebrile neutropenia. One case of hemolytic-uremic syndrome, most likely rela ted to gemcitabine use, was observed. Overall, 2 objective responses were o bserved (response rate of 7%; 95% confidence interval, 1-24%). The median s urvival was 8 months. CONCLUSIONS. At the prescribed dosage and schedule, single agent gemcitabin e appears to have limited activity in chemotherapy-naive patients with mali gnant pleural mesothelioma. Cancer 1999;85:2577-82. (C) 1999 American Cance r Society.