Docetaxel has activity in a wide variety of solid tumors. To evaluate its efficacy in malignant mesothelioma, previously untreated patients (pts.) were treated with docetaxel 100 mg/m[Superscript 2], 1-hour infusion administered every 21 days.
Dexamethasone 8 mg twice daily was also administered for five days starting 24 hours prior to docetaxel infusion. A total of 20 pts. Were accrued to the first stage of the study between December 1996 and April 1997. Nineteen of the 20 pts. Had histological confirmation of mesothelioma and the tumors were carcinoembryonic antigen and mucin negative. In one patient (pt.) the histology could not be confirmed and he was considered ineligible. Characteristics of the remaining 19 pts. Include: 5% ECOG Performance Status (PS) 0; 68% PS 1; 26% PS 2; median age 69 years (range 57--81); 89% male. Only one pt. Had a partial response, with an overall response rate of 5% (95% CI 0.16--26.4). Three pts. (16%) had stable disease, 11 (58%) progressed on treatment and 4 (21%) were not evaluable for response. One pt. With stable disease has not relapsed so far after 16 months of follow-up.
There were three deaths during the treatment phase: One died of gastrointestinal hemorrhage, one from rapidly progressive disease with brain metastasis and one definite treatment related septic death with multi-organ failure.
The major toxicity seen was myelosuppression with grade 4 leucopenia in 17 pts. (90%) and grade 4 granulocytopenia in 8 (42%) pts. Other rare grade 4 non-hematologic toxicities included: Vomiting (1 pt.), diarrhea (1 pt.), hypersensitivity reaction (1 pt.) and cardiac toxicity (1 pt.). The study was terminated after the first accrual stage due to insufficient responses. In conclusion: Docetaxel is not an effective agent in malignant mesothelioma and does not warrant further investigation. (Conducted by ECOG and supported in part by PHS grants CA18653, CA23318, CA52743, CA13650, CA49957, CA66636, CA21115 from the NCI, NIH and the DHHS.)
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