title: Phase II study of bendamustine in patients with relapsed or cisplatin-refractory germ cell cancer.
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.
authors.affiliation: Department of Hematology/Oncology, University of Tübingen Medical Center, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Kollmannsberger
authors.forename: A
authors.initials: A
authors.lastname: Gerl
authors.forename: N
authors.initials: N
authors.lastname: Schleucher
authors.forename: J
authors.initials: J
authors.lastname: Beyer
authors.forename: M
authors.initials: M
authors.lastname: Kuczyk
authors.forename: O
authors.initials: O
authors.lastname: Rick
authors.forename: J
authors.initials: J
authors.lastname: Casper
authors.forename: M
authors.initials: M
authors.lastname: Sosada
authors.forename: C
authors.initials: C
authors.lastname: Rie
authors.forename: L
authors.initials: L
authors.lastname: Kanz
authors.forename: C
authors.initials: C
authors.lastname: Bokemeyer
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000069461:Bendamustine Hydrochloride; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D003432:Cross-Linking Reagents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005240:Feasibility Studies; D018237:Germinoma / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009588:Nitrogen Mustard Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D003432:Cross-Linking Reagents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride; D002945:Cisplatin