Abstract
4557 Background: GCTs patients (pts) relapsing after conventional-dose salvage chemotherapy (CDCT) are candidates to receive HDCT with hematopoietic stem cell (SC) support. We have previously reported (Ann Oncol 2014; 25:1775-82) that non-refractory pts can benefit from HDCT. We here analyzed the efficacy of the induction regimen EPI-TAX. Methods: All male GCTs pts treated by EPI-TAX between 1998 and 2015 were identified from clinical records at Tenon Hospital. Primary aim was response rate after EPI-TAX. Secondary aims were efficacy of SC harvest, Beyer score, toxicities and overall survival (OS) after HDCT. Kaplan-Meier methods were used for analysis. Results: Of the 170 pts treated (EPI 100 mg/m2, TAX 250 mg/m2, days 1-15), 142 (83.5%) had received > 2 previous lines of CDCT. 79 (46.5%) had disease progression at the time of treatment and 44 were absolutely refractory to cisplatin. The other pts were in remission (65) or had stable disease (SD, 26). Most of pts (75.3%) had Beyer score > 1. Following EPI-TAX, favorable responses were achieved in 140 pts (82.4%,CI95% 79.8-85.0; 21 complete responses, 68 partial responses and 51 SD). EPI-TAX was able to control disease in 56 (70.9%, CI95% 61.0-80.8) out of 79 pts who were in progression. Beyer score after EPI-TAX resulted 0 in 70.6% of pts. Successful harvested of SC was achieved in 146 (85.8%, CI95% 80.5-91.1) pts. EPI-TAX was well tolerated with peripheral neuropathy as the main non-hematopoietic toxicity. Treatment discontinuation was needed in 3 (1.8%) pts and 2 (1.2%) related deaths were observed. Following EPI-TAX, 155 (91.2%) pts received HDCT. HDCT was given in consolidation, once progressive disease was controlled by EPI-TAX or for progressive pts. With a median follow-up of 31 months (0.5-223) the 2- and 10-years OS for the subgroup consolidation were 78.2% (95%CI 69.1-87.4) and 66.9% (95%CI 55.4-78.6). Disease control by EPI-TAX resulted in 55.8% (95%CI 42.4-69.2) and 38.2% (95%CI 24.9-51.4) 2- and 10-y OS compared to 14.6% (95%CI 0-33.2, logrank p = 0.006) 2-y OS for progressive pts. Conclusions: EPI-TAX is effective to collect SC and to control disease of pts who were in progression after CDCT allowing them to receive HDCT.
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