Abstract
9035 Background. Results of CT in MSTS remain disappointing. Only 3 agents are active (Adriamycin, Ifosfamide, Deticene) with RR of 16–25% as single agent and 20–40% in poliCT. The 2nd line is more frustrating. The same drugs at different doses or schedules therapy offer 10–15% objective responses, TTP of 3–4 months and MS of 10–12 months. HDI (12–16 g/m2) on continuous intravenous infusion has demonstrated significant antitumor activity. Two different schedules have been published: 4 days c.i. (Le Cesne, JCO 1995) and 14 days c.i. (Frustaci & Comandone Proc ASCO 1998) with the same total dose of 14 g/m2. Methods. We treated from 1996 to 2003 90 pts with pretreated MSTS using both schedules. We report the results of the two protocols as perspective phase II trials independently analyzed. 90 pts with measurable MSTS previously treated with Antracyclines entered the study. Both sexes, age from 18 to 70 years, histological demonstration, PS 0–2 ECOG, good renal and hematological function, informed consent were requested. Protocol A): 54 pts treated with HDIFO in 4 days c.i. (3,5 g/m2/d + Mesna equidose). Protocol B): 36 pts received IFO 1 g/m2/d c.i. for 14 days + Mesna equidose). The two schedules were repeated every 21–28 days following the complete recovery from toxicities. Leiomiosarcomas, MFH, Synovialsarcomas and Liposarcomas were the most represented histological types. Lung and local failure were the two most common sites of relapse. Results. In protocol A Neutropenia G3/G4 (100%), Thrombocytopenia G3/G4 (30%), Anemia (28%), Alopecia G3 (100%), N&V G3 (28,4%) and Ipokaliemia (17%) were the most common toxicities. In protocol B Neutropenia G3/G4 (7%), N&V G3 (5%) were the most serious adverse effects. In protocol A 6 RR (12%, 1 CR) and 11 SD (22,4%) were recorded; TTP 6,7 mo, MS 12 mo. In protocol B 4 RR (12%, 1CR) and 9 SD (27%) were seen, TTP 4,2 mo, MS 10,4 mo. Conclusions. The activity of HDI in pretreated MSTS suggests a dose response relationship. Both protocols guarantee a percentage of RR not exceeding 12%. Maintained SD in about 25% of the pts must be considered a positive result in 2nd line CT for MSTS. HDI in 4 days c.i. seems to be more toxic. No significant financial relationships to disclose.
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