Posters— Medical Oncology

FEASIBILITY OF PRE OR POST-OPERATIVE COMBINED CHEMOTHERAPY AND RADIATION-THERAPY IN ADULT SOFT TISSUE SARCOMAS OF EXTREMITIES

S.Frustaci, A.Buonadonna, G.Boz, M.Berretta, M.Rupolo, G.Bertola, R.Innocente, *F.Gherlinzoni, A.De Paoli. CRO-IRCCS, National Cancer Institute, Aviano. *Orthopedic Div. General Hospital, Gorizia

Adjuvant chemotherapy(CT) impacts favorably on DFS and OS. Pre or post-operative radiation-therapy(pre-, post-op RT) and wide excision allow limb preservation with local control success comparable to radical(ablative) surgery. However, the long interval between diagnosis and start of CT could be responsible for the appearance of resistant cellular clones and possibly micro-metastases. Therefore, the anticipation and combination of CT with RT could be worthwhile in terms of prognosis. Based on this hypothesis, we started a pilot study to evaluate the feasibility and toxicity of this integration.

METHODS: eligibility: high grade (Grade 3-4 Broder), polymorphous, sub-fascial spindle cell sarcomas of extremities and/or girdles, size > 5 cm or any dimension if a relapse; age>16<65 years; PS< 2 ECOG; no previous CT or RT. Chemotherapy: Epirubicin 60 mg/m2, day 1-2; Ifosfamide 3g/m2, day 1-2-3, with fractionated equivalent dose of Mesna ; G-CSF 300mg/die s.c. from day +9 to day +16. Treatment was given every 21 days. Radiation-therapy: Conventional treatment divided in two phases in pre-operative setting: 22Gy/11Fr between cycle 1 and 2 of CT; 22Gy/11Fr between cycle 2 and 3 of CT and a third phase of 16Gy/Fr between cycles 4 and in post-operative setting.

RESULTS: From 9/96 14 pts have been enrolled, 7 as neo-adjuvant therapy, 7 as adjuvant therapy. Toxicity: on 41 evaluable cycles of CT: leucopenia Grade 3-4= 51%; thrombocytopenia Gr3-4=14%; anemia Grade 3-4=9%; non hematological toxicity Gr3-4=32% (stomatitis 4%), cutaneous (erithema 21%), mucositis (proctitis 7%). All 7 pts treated in pre-op setting underwent conservative surgery; 1 pt had major complication (infected seroma). No complications were noted in post-op group.

FEASIBILITY: The average median dose intensity of CT was 84% ( 60-100%). The RT was performed in foreseen doses and time interval in 13 on 14 pts. In 1 pt RT was delayed due to thrombocytopenia ( field of RT included great vessels). The median time-interval between biopsy and start of chemotherapy in our adjuvant previous study was 92 days (17-288), while in this experience it was 9 days (5-34).

PRELIMINARY CONCLUSIONS: Integration of CT with RT allowed a preservation of dose intensity of 84% with a compliant toxic profile. The accrual is ongoing in order to obtain sufficient data on toxicity to define a new neo-adjuvant cooperative randomized trial.