Salvage chemotherapy with paclitaxel and gemcitabine plus nedaplatin (TGN) as part of multidisciplinary therapy in patients with heavily pretreated cisplatin-refractory germ cell tumors

We investigated the efficacy and toxicity of a regimen consisting of paclitaxel and gemcitabine plus nedaplatin, a derivative of cisplatin (TGN) in patients with heavily pretreated cisplatin-refractory germ cell tumors (GCTs). Fifteen patients with advanced GCTs were treated with the TGN regimen. The combination chemotherapy consisted of paclitaxel (210 mg/m(2)) on day 1 and gemcitabine (1000 mg/m(2)) on days 1 and 8 in combination with nedaplatin (100 mg/m(2)) on day 2 every 3 weeks. Patients enrolled in this study had been heavily pretreated with a median of 12 platinum-containing cycles (range, 7 to 26 cycles). Most of the regimens had included paclitaxel and ifosfamide plus cisplatin or nedaplatin (TIP/TIN) chemotherapy. The median follow-up period of the present study was 15 months. Patients received 2-11 cycles of the TGN combination chemotherapy. Six patients received the treatment combined with other therapeutic modalities; 2 patients received radiation therapy for retroperitoneal lymph node metastasis, 1 patient had cyber-knife radiosurgery for brain metastasis and 3 patients had radiofrequency ablation for liver and lung metastasis. Seven (46.7%) of the 15 patients achieved an objective response; 6 had marker-negative partial responses (PRs) and 1 had a marker-positive PR. Two (13%) of the 7 patients with PRs achieved a disease-free status after chemotherapy combined with RT and followed by surgical resection. However, 10 patients died of the disease and 3 patients are still alive with the disease. The TGN regimen alone had limited efficacy in this patient population, with severe but manageable toxicities. However, TGN chemotherapy may offer a chance of cure for some heavily pretreated cisplatin-refractory (TIP/TIN-refractory) patients as part of multidisciplinary therapy.