161 O - Very high-dose chemotherapy (VHDCT) with ematologic support in previously untreated advanced ovarian cancer (OVCA): preliminary results of a phase I-II study

Two consecutive trials were conducted to evaluate a VHDCT programme with autologous bone marrow (ABM) or perlpheral stem cell (APSC) support in previously untreated OVCA patients (Pts) with macroscopic (0.5–2cm) residual tumor. Fifthy-one pts (median age 44; stage IIIC 78%) underwent: Induction chemotherapy (Indct) (2–4 cycles of a cisplatin and cyclophosphamide combination +/- G-CSF) with ABM and/or APSC hsrvestlng (H) foflowed by intensification (Int) CT (one course of a platinum, etoposide combination +/- L-PAM, +/-G-CSF&EPO) In the absence of clinical progression. 2nd-look laparotomy was performed in complete responders. 42 (82%) and 39 (76%) pts are evaluable for toxicity and pathological response (PR), respectively while 6 pts are still on treatment, 3 progressed when on treatment, 2 are awaiting 2nd look. One toxic death occurred due to systemic mycosis in a pt undergoing ABM transplantation (T). The number of leukaphereses required for adequate APSCH decreased after G-CSF Incorporation. Duration of BM aplasia progressively decressed lor pts receiving ABMT. APSCT and APSCT + G-cSF & EPO, respectively. 90% pR (CR 44%, PR 41% of which 36% microscopic) was revealed at 2nd-1ook. A median follow up of 28 (2–79) months has been reached from diagnosis. Only 2 of the 19 pathologically complete responders (6 with a > 5 year follow-up from 2nd-look) have so far relapsed without further therapy. Treatment proved to be feasible with acceptable toxicity when APSCT + G-CSF & EPO were used. The disease-free Interval would seem to be longer than expected in this pt subset. These data, if confirmed after a prolonged observation, warrants further investigation (in a randomized setting) on the possible therapeutic impact of this new approach on chemosensitive tumors.