OP28PRELIMINARY RESULTS OF THE PROSPECTIVE FEASIBILITY CNS GCT-4 CONSORTIUM TRIAL FOR PATIENTS WITH REFRACTORY/RECURRENT CNS GERM CELL TUMORS (GCT)

Abstract

INTRODUCTION: We present updated findings on the response rate, toxicity and early outcomes of a re-induction regimen of gemcitabine, oxaliplatin and paclitaxel (GemPOx) administered, in responsive patients, prior to myeloablative chemotherapy and autologous hematopoietic cell rescue (HDCx + AuHCR). METHOD: Since December 2004, 14 recurrent or refractory patients (12 MMGCT, 2 germinoma; 12 males; mean age 16.5 years, range 7-34 years) have been treated with up to 4 cycles of gemcitabine (800mg/m2), oxaliplatin (100mg/m2) and paclitaxel (170 mg/m2), administered on one day at 14 days intervals. RESULTS: Of 14 patients, five were treated on a preceding feasibility pilot with 1-3 cycles of GemPOx, and nine have been formally enrolled on an ongoing prospective multi-center trial. Seven patients achieved complete remissions (tumor marker and/or imaging studies), five achieved partial remissions and two developed progressive disease (PD) while on GemPOx. Twelve of the 14 patents subsequently underwent HDCx + AuHCR; 6 subsequently received irradiation. Transient hepatotoxicity and pancytopenia were the most prevalent toxicities. Five patients continue alive and disease-free for 9 + , 20 + , 22 + , 26+ and 28+ months since end of therapy. CONCLUSION: GemPOx appears to be an effective re-induction regimen for patients with recurrent CNS MMGCT, with acceptable toxicities. The ongoing multi-center, international trial should confirm this and demonstrate the contribution of GemPOx towards improved survival when followed by HDCx + AuHCR with or without further irradiation, in the setting of minimal residual disease.