Gemcitabine (2',2'-difluorodeoxycytidine) is a nucleoside analogue that inhibits DNA synthesis.48 Initial interest in this agent was partly stimulated by a report of a response in a female patient with cisplatin- and paclitaxel-refractory ovarian germ cell cancer.49
Two phase II trials evaluated this agent in patients with relapsed or refractory germ cell can-cer.50,51 Bokemeyer and colleagues50 reported a 19% partial reponse rate for patients with tumor progression after conventional salvage chemotherapy, cis-platin-refractory disease, or relapse after high-dose chemotherapy when treated with gemcitabine at 1,000 mg/m2 administered weekly for 3 consecutive weeks and repeated in a 4-week cycle. Similar activity was seen in patients relapsing after high-dose therapy (17%), patients who had previously undergone salvage therapy with a paclitaxel-containing regimen (16%), and patients with mediastinal germ cell tumors (25%). No patient with absolute cis-platin-refractory disease responded. The median progression-free survival was 4 months. Investigators at Indiana University51 reported 1 complete response and 2 partial responses among 20 evaluable similar patients (15%) treated with gemcitabine at 1,200 mg/m2 on a similar schedule. In both trials, gemcitabine was generally well tolerated and demonstrated an important level of activity in a population of patients who are typically unresponsive to treatment, suggesting that this agent may be an excellent candidate for incorporation into multiagent salvage regimens.52
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