High-dose paclitaxel plus G-CSF for malignant mesothelioma: CALGB phase II study 9234.
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.


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 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 and 5-azacytidine. Future studies of of paclitaxel (at lower doses) in combination with synergistic agents could be considered.
Vogelzang
N J
NJ
University of Chicago, Department of Medicine, IL, USA. njvogelz@mcis.bsd.uchicago.edu
Herndon
J E
JE
Miller
A
A
Strauss
G
G
Clamon
G
G
Stewart
F M
FM
Aisner
J
J
Lyss
A
A
Cooper
M R
MR
Suzuki
Y
Y
Green
M R
MR
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008654:Mesothelioma / Q000188:drug therapy* / Q000401:mortality; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate
D016179:Granulocyte Colony-Stimulating Factor; D017239:Paclitaxel