Long-term survival with paclitaxel and gemcitabine for germ cell tumors after progression following high-dose chemotherapy with tandem transplant.

OBJECTIVES: Germ cell tumor patients progressing after high-dose chemotherapy (HDCT) have a dismal prognosis. A prior retrospective study of paclitaxel and gemcitabine enrolled 32 patients. All failed first-line chemotherapy and salvage therapy with HDCT. We now present long-term results.

METHODS: Eligible patients received BEP or similar first-line chemotherapy and subsequent HDCT. They were treated with paclitaxel (100 mg/m) on days 1, 8, and 15 and gemcitabine (1000 mg/m) on days 1, 8, and 15 every 4 weeks for a maximum of 6 cycles.

RESULTS: Ten of 32 (31%) had an objective response (4 partial remissions and 6 complete responses). Four patients (12.5% of total) have enjoyed long-term survival; 3 are continuously disease free for 64, 94, and 122 months. None of these 3 received subsequent chemotherapy or surgery. A fourth patient relapsed after 72 months, and has now reachieved remission for 36+ months after treatment with the same regimen. These patients had 2, 2, 2, and 4 prior therapies, respectively, and a rising serum human chorionic gonadotropin (69 and 138 mIU/mL), α-fetoprotein (525 ng/mL), or increasing intrathoracic metastases. Longest prior response ranged from 5 to 24 months.

CONCLUSIONS: Paclitaxel and gemcitabine salvage chemotherapy can offer long-term survival and probable cure in relapsed/refractory germ cell tumor patients after HDCT. This is an appropriate regimen in a taxane-naive and gemcitabine-naive patient population. This is the first example of a nonplatinum curative chemotherapy regimen in patients progressing after HDCT.