Annals of Oncology 10:597-600, 1999
© 1999 European Society for Medical Oncology
brief-report |
High-dose paclitaxel plus G-CSF for malignant mesothelioma: CALGB phase II study 9234
1University of Chicago, Department of Medicine, Section of Hematology/Oncology Chicago, IL, USA
2CALGB Statistical Center, Duke University Medical Center Durham, NC, USA
3University of Tennessee Memphis, TN, USA
4Dana Farber Cancer Institute Boston, MA, USA
5University of Iowa, University of Iowa Iowa City, IA, USA
6University of Massachusetts Medical Center Worcester, MA, USA
7University of Maryland Baltimore, MD, USA
8Missouri Baptist Hospital St. Louis, MO, USA
9Bowman Gray School of Medicine Winston-Salem, NC, USA
10Mt. Sinai School of Medicine New York, NY, USA
11Medical University of South Carolina Charleston, SC, USA
Correspondence to: Genitourinary Oncology Department of Medicine Section of Hematology/Oncology University of Chicago, Medical Center 5841 S. Maryland Ave. MC 2115 Chicago, IL 60637 1470 USA E-mail: njvogelz{at}mcis.bsd.uchicago.edu
Background: New agents with activity in mesothelioma are sorely needed. The Cancer and Leukemia Group B (CALGB) therefore performed a phase II study of high-dose paclitaxel in patients with malignant mesothelioma who had no prior chemotherapy.
Patients and methods: Thirty-five patients accrued to this multi-institutional phase II study of paclitaxel given as a 24-hour infusion at 250 mg/m2 every three weeks plus filgrastim (G-CSF) 300 meg subcutaneously days 318.
Results: There were three (9%) regressions of evaluable disease. The median survival was five months (95% confidence interval (95% CI): 1.99.6 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 neutro-penia) 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 and 5-azacytidine. Future studies of of paclitaxel (at lower doses) in combination with synergistic agents could be considered.
mesothelioma, paclitaxel
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