Background: New agents with activity in mesothelioma are sorely needed. The
Cancer and Leukemia Group B (CALGB) therefore performed a phase II study o
f high-dose paclitaxel in patients with malignant mesothelioma who had no p
rior chemotherapy.
Patients and methods: Thirty-five patients accrued to this multi-institutio
nal phase II study of paclitaxel given as a 24-hour infusion at 250 mg/m(2)
every three weeks plus filgrastim (G-CSF) 300 mcg subcutaneously days 3-18
.
Results: There were three (9%) regressions of evaluable disease. The median
survival was five months (95% confidence interval (95% CI): 1.9-9.6 months
), the one-year survival rate was 14% and the two-year survival rate was 6%
. Toxicity was tolerable with one death from pneumonia (without neutropenia
) on day 18 and a 23% rate of grade 4 granulocytopenia.
Conclusions: The level of activity seen with paclitaxel is similar to that
seen in other CALGB trials of the single agents carboplatin, trimetrexate a
nd 5-azacytidine. Future studies of of paclitaxel (at lower doses) in combi
nation with synergistic agents could be considered.