Paclitaxel in extensively pretreated nonseminomatous germ cell tumors

Paclitaxel was given as a single agent to previously treated, cisplatin-refractory, and relapsed patients with metastatic nonseminomatous germ cell tumors (GCT). Fifteen patients received paclitaxel at 250 mg/m² as a 24-hour continuous intravenous infusion, repeated every 21 days. The regimen was premedicated to prevent hypersensitivity reactions. Patients were supported with granulocyte-colony stimulating factor until resolution of the neutropenia. Of 15 patients, I I patients had received at least three previous chemotherapy regimens; 80% of the patients were cisplatin-refractory at study entry. A total of 34 courses of paclitaxel were delivered. A serologic partial response and a partial remission for an overall response rate of 13.3% (95% C.I. 2-39%), with a median duration of 9.5 weeks, were achieved. Thirteen (86.6%) patients developed progressive disease. The toxicity of the regimen consisted of grade 3 4 neutropenia, with only one infectious complication and no life-threatening events. Nonhematologic toxicity was significant for progressive peripheral neuropathy in 8 patients. No hypersensitivity reactions or symptomatic cardiac toxicity occurred. In conclusion, paclitaxel in the dose and schedule given has minimal activity in this extensively treated, cisplatin-refractory group of patients with nonseminomatous GCT. Further investigation is warranted to find the role of paclitaxel in GCT by either selecting a better patient population and/or combining it with cisplatin, which would use the synergistic cytotoxicity that has been reported.