Abstract
9020 Background: High dose MTX in adult patients (pts) with LO is highly toxic. We have designed in 1995 an intensive protracted regimen without MTX (API-AI regimen) in LO Methods:. Preliminary results were reported at ASCO 2001. The 3-yr event-free survival (EFS) compared favorably with those obtained with HDMTX CT regimen in pediatric population (Le Cesne, ECCO 11). Briefly good responders (≥95% necrosis) (GR) received 2 other API courses (c) and poor responders (PR) a salvage regimen of etoposide and ifosfamide. Results: from March 1993 to March 2000, 32 adult pts with LO (male/female : 19/13) with a median age of 21 yrs, [range 15–49], were included in the study. 126 c (API-AI) of CT were administered (median 3,94 c/pt, range 3 to 5). The planned protocol was given in 75% of pts, 16% received only 3 c for hematologic toxicity (T), and 10% received 5 c due to delay surgery. The median delay between each c of CT was 15 days (range 12–32). All pts received the fixed dose. All but 3 pts had a limb sparing surgery performed 10.3 weeks (median) after the first CT c (range 8–15). T was mainly haematological with febrile neutropenia, grade 4 neutropenia and thrombocytopenia observed in 34%, 69% and 35% of pts respectively. There were no renal and cardiac T. There were 15 GR (47%) and 17 PR (53%). The median follow-up was now 64 months [30–115]. The 5-yr EFS and overall survival (OS) were 65% [48–79%] and 69% [50–83%]. Two pts developed hemopathy: 1 AML5 in a PR with concomitant relapse and 1 MDS in a GR. Until december 2003, two pts with GR exhibited a distant relapse and one died from secondary hemopathy. The 5-yr EFS and OS for pts with GR were 79% [54–93%] and 85% [59–96%]. Eight of the pts with PR experienced relapse. The 5-yr EFS and OS for pts with PR were 52% [30–74%] and 56% [32–77%]. Conclusions: despite the haematological T, these results compare favorably with those observed with previous induction CT containing MTX in adult pts treated in our institution (Le Cesne, ASCO 98). These promising results had to be corroborated by an ongoing national multicenter coordinated by the French Sarcoma Group. No significant financial relationships to disclose.
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