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

Anticancer Drugs. 2000 Aug;11(7):535-9. doi: 10.1097/00001813-200008000-00003.

Abstract

Despite generally high cure rates in patients with metastatic germ cell cancer, patients with incomplete response to first-line cisplatin-based chemotherapy or with relapsed disease following high-dose salvage therapy exhibit a very poor prognosis. We investigated the efficacy and toxicity of bendamustine, a bifunctional alkylating benzimidol derivative with only partial cross-resistance to other alkylating agents such as ifosfamide or cyclophosphamide. Nineteen patients with cisplatin-refractory germ cell tumors (GCT) or relapse after high-dose chemotherapy plus autologous stem cell support were treated with bendamustine at a dose of 120 mg/m2 on 2 consecutive days at 3 week intervals. Patients had received a median of 9 (range 4-20) platinum-containing treatment cycles prior to bendamustine and 13 patients (68%) had previously received carboplatin/etoposide-based high-dose chemotherapy. One patient achieved a partial remission of only 6 weeks duration. No other responses were seen. Toxicity was low with one patient developing WHO grade 3 thrombocytopenia as the only WHO grade 3/4 toxicity observed. Hematologic toxicity was similar in patients pretreated with and without high-dose chemotherapy plus autologous stem cell support. We conclude that bendamustine has little or no clinically relevant activity in patients with cisplatin-refractory GCT or relapsed disease after high-dose chemotherapy.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bendamustine Hydrochloride
  • Cisplatin / administration & dosage
  • Cisplatin / adverse effects
  • Cisplatin / therapeutic use
  • Cross-Linking Reagents / administration & dosage
  • Cross-Linking Reagents / adverse effects
  • Cross-Linking Reagents / therapeutic use
  • Drug Administration Schedule
  • Drug Resistance, Neoplasm
  • Feasibility Studies
  • Germinoma / drug therapy*
  • Humans
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local / drug therapy
  • Nitrogen Mustard Compounds / administration & dosage
  • Nitrogen Mustard Compounds / adverse effects
  • Nitrogen Mustard Compounds / therapeutic use*

Substances

  • Cross-Linking Reagents
  • Nitrogen Mustard Compounds
  • Bendamustine Hydrochloride
  • Cisplatin