Phase II study of bendamustine in patients with relapsed or cisplatin-refractory germ cell cancer

Despite generally high cure rates in patients with metastatic germ cell can cer, patients with incomplete response to first-line cisplatin-based chemot herapy or with relapsed disease following high-dose salvage therapy exhibit a very poor prognosis. We investigated the efficacy and toxicity of bendam ustine, a bifunctional alkylating benzimidol derivative with only partial c ross-resistance to other alkylating agents such as ifosfamide or cyclophosp hamide. Nineteen patients with cisplatin-refractory germ cell tumors (GCT) or relapse after high-dose chemotherapy plus autologous stem cell support w ere treated with bendamustine at a dose of 120 mg/m(2) on 2 consecutive day s at 3 week intervals. Patients had received a median of 9 (range 4-20) pla tinum-containing treatment cycles prior to bendamustine and 13 patients (68 %) had previously received carboplatin/etoposide-based high-dose chemothera py. One patient achieved a partial remission of only 6 weeks duration. No o ther responses were seen. Toxicity was low with one patient developing WHO grade 3 thromboyctopenia as the only WHO grade 3/4 toxicity observed. Hemat ologic toxicity was similar in patients pretreated with and without high-do se chemotherapy plus autologous stem cell support. We conclude that bendamu stine has little or no clinically relevant activity in after high-dose chem otherapy. [(C) 2000 Lippincott Williams & Wilkins].