Abstract
The evidence of a dose-response effect to anthracyclines in advanced STS prompted us to begin a clinical trial with HD-EPI. We have already reported (Proc ASCO II:414, 1992) a 14% response rate with EPI 120 mg/m2 iv q 3 weeks in 36 sarcoma pts. Since April 1991,48 pts were treated with EPI 160 mg/m2 iv q 3 weeks. Clinical characteristics of pts are the following: M/F = 26/22, median age = 52 years (14–72), median (WHO) PS = 1 (0–2). Pre-treatment: surgery 34/48, chemotherapy 1/48, radiotherapy 15/48, stage of disease IIIB = 17%, IV = 83%. Median number of cycles (in 43 pts evaluable for response) = 6 (range 2–8), median cumulative EPI dose = 740 mg/m2 (range 290–1280 mg/m2). We observed 3 CR and 13 PR (37%) [95% CI, 23%-51%] 14 NC (33%); 13 PD (30%). Responses were observed in 6/IIIiposarcoma, 2/6 leiomyosarcoma, 1/5 MFH, 2(8 synovial sarcoma, 1/3 malignant schwannoma, 1/3 fibrosarcoma, 1/2 stromal sarcoma, 2/4 other types. Median duration of response was 10 months (range 4–38+). Median time to progression was 9 months (range 3–42+). Median overall survival was 14 months (range 3–42+) with a significant difference between responding (17 months) and progressive pts (6.5 months). The most important side effect was myelotoxicity with leukopenia occurring in all patients (G4 38%), thrombocytopenia in 36% (G1–G2 18%) and anemia in 72% (G1–G2 53%) of the pts. In 11/43 pts (26%) EPI dose was reduced because of myelotoxicity. Neutropenic fever occurred in 28% of the pts. Stomatitis was recorded in 36% of the pts and N/V (G3) in 6% of the pts. Cardiotoxicity was monitored in 24 pts by radionuclide angiography. Only 3/24 pts experienced a ≥20% decrease in left ventricular ejection fraction at cumulative doses of 880 mg/m2, 960 mg/m2 and 1280 mg/m2, Clinical cardiotoxicity was not observed. HD–EPI is an effective and reasonably well tolerated treatment in advanced STS. In comparison to our previous study a dose–response effect has been observed at EPI doses of 160 mg/m3. The accrual of pts continues to better define the effectiveness and the toxicity of this treatment.
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