Abstract
4585 Background: Patients (pts) with cisplatin-refractory or multiply relapsed germ cell tumors (GCT) have a poor prognosis and rarely achieve long term survival. Different combination chemotherapy regimens (CTX) including gemcitabine, oxaliplatin and paclitaxel have shown efficacy in these pts with resonse rates of 20-40 % and complete responses in 5-15%. However, long term survival appears to be rare and most studies have only been reported with short follow up. We here report long-term outcome from two previously reported trials. Methods: Two phase II trials have previously evaluated CTX with gemcitabine and oxaliplatin (GO) or GO plus paclitaxel (GOP) including a total of 76 pts (GO 35 pts / GOP 41 pts) (Kollmannsberger 2004; Bokemeyer 2008). A total of 26 patients were alive at the time of reporting of the studies, with 9 pts (12%) being in free of disease after CTX ± surgery and 17 alive with disease. Of the 9 pts free of disease 3 (3/35; 9%) and 6 (6/41; 15%) had received GO and GOP, respectively. Results: After a median follow up of 16 months (2 – 64+) for the 26 pts still alive, 8 (8/76; 11%) pts remain disease free with a median progression free and overall survival time of 32 months (11 – 64+) and 35 months [11-64+], respectively: 1/35 pts (3%) after GO and 7/41 pts (17%) after GOP. Another 3 pts, one after GO and 2 after GOP, who had relapsed after one, two and 6 months, achieved a complete remission after salvage treatment with CTX + surgery resulting in an overall long term survival rate of 13% (10/76 pts): 6% (2/35) after GO and 20% (8/41) after GOP. 2/10 pts had been absolutely refractory to previous cisplatin-based CTX. Eight pts have been now disease free for > 2 years after GO/GOP treatment, indicating potential long term cure in these heavily pretreated pts. Conclusions: Long term survival can be achieved with GO or GOP CTX in about 15% of pts with cisplatin-refractory or multiply relapsed GCT. Based on this retrospective analysis, the triple CTX combination GOP appears to achieve higher long term survival rates than two drug combinations. This finding requires confirmation in a randomized trial. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly, sanofi-aventis
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