High-dose Ifosfamide (HDIFX) as a 14-day continuous infusion (ci) in advanced adult soft tissue sarcoma (STS): A single- institution retrospective case series analysis
10067 Background: High-dose IFX (≥12 g/sqm) is active even in STS patients pretreated with standard-dose IFX, though with substantial toxicity. Prolonged continuous infusion, through a portable pump, may be an alternative way of administration. A Phase II study thereof is ongoing in Italy, but some pts have been treated off the study, either prior to its start or for practical reasons. Such consecutive pts seen at a single institution have been retrospectively reviewed. Methods: Between July 2001 and September 2006, 45 adult patients (M:F = 25:20; mean age 47 yrs; PS 0–1) with progressing advanced/metastatic STS, all previously treated with anthracyclines and standard-dose IFX, were given ciHDIFX, at the dose of 14 g/sqm as a 14-day continuous infusion every 4 weeks, using two portable infusional devices, with equidose Mesna, lasting 7 days each. Diagnosis was leyomiosarcoma in 12 patients, synovial sarcoma in 9, liposarcoma in 5, and other histological types in 19. Disease was advanced inoperable in 6 pts, and metastatic in 39. The total number of cycles was 176 (median number per pt: 4). Results: A PR was seen in 5 pts (synovial sarcoma, 2; leyomiosarcoma, 1, liposarcoma, 1; chondrosarcoma, 1), and SD in 22 (>6 mos in 12), for a clinical benefit rate = 37%. PFS at 6 months was 35%. Median PFS was 11 mos in pts with PR and 6 in those with SD. Median PFS was 8 months in 9 patients undergoing complete tumor resection. Most common side effects were nausea (G1–2 in 14 pts) and asthenia (G1–2 in 15 pts). G2 anemia was seen in 8 pts, G2 neutropenia in 6. One pt with a single kidney had a reversible G2 hypercreatininemia. No grade 3–4 toxicity were recorded. Conclusions: In this series, ciHDIFX was associated with a PR and 6-mos PFS rate in the range of active second-line agents in advanced STS. This regimen was exceedingly well tolerated. No significant financial relationships to disclose.