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Connective Tissue Oncology Society |
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| 2001 CTOS Annual Meeting Posters— Medical Oncology SEQUENTIAL HIGH-DOSE
DOXORUBICIN (DX) AND HIGH-DOSE IFOSFAMIDE (IF) IN ADVANCED PREVIOUSLY
UNTREATED SOFT TISSUE SARCOMAS (STS). A MULTICENTER PHASE II STUDY
OF THE SPANISH GROUP FOR RESEARCH ON SARCOMAS (GEIS) OBJECTIVE: DX and IF the most active drugs in adult STS have a dose-response effect limited by its hematological toxicity when used in combination. We have designed a first-line sequential trial of high-dose DX followed by high dose IF to maximize dose-intensity and reduce toxicity. METHODS: Pts with advanced STS without prior exposure to chemotherapy were included. Prior radiotherapy was allowed if given to non-indicator lesions. Gastrointestinal sarcomas (GIST) and pts over 65 years were excluded. Treatment consisted of DX 90 mg/m2 q 14 days for 3 cycles followed by IF at 12.5 gr/m2 q 21 days for 3 cycles, both regimens with G-CSF support. RESULTS: From Dec’98 to May’01 we enrolled 56 STS pts, 53 were eligible (8 locally unresectable, 45 metastatic). Median age was 52 years (range 24-65). performance status (PS) was 0 in 20 pts, 1 in 29 and 2 in 4. Metastatic sites: lung 31 pts (only lung 11 pts), nodes 9, peritoneal 8, liver 7, bone 6. No. of sites: 1 in 32 pts, 2 or more in 13. 43 patients are already evaluate for toxicity and 41 for response (2 died without radiological assessment). Median DX dose was 43 mg/m2/w, 29 pts (68%) full dose, with grade III/IV toxicity: neutropenia 9 pts (21%), neutropenic fever 3 pts (7%), mucositis 12 pts (28%).There were 13 (32%) partial responses (PR). 8 pts did not received HDI (3 progressive disease and poor PS, 3 patients with severe no treatment-related infection and 2 refused). Dose-intensity HDI was 3.1 gr/m2/w, with grade III/IV neutropenia 15 pts (42%), neutropenic fever 8 pts (23%) and asthenia 10 pts (28%). After a full course of therapy 20 pts (48%) achieved a PR. Two pts with a PR to DX progressed under HDI, and 9 no responders to DX (8 SD and 1 PD) obtained a PR with HDI. There were no toxic death. CONCLUSION: This sequential dose-dense schedule is feasible, has an acceptable toxicity profile and has a response rate similar to concomitant high dose IF-DX regimens.
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