title: A phase II study of bendamustine chemotherapy as second-line treatment in metastatic uveal melanoma.
abstract: Uveal melanoma is the most frequent primary malignant neoplasm of the eye and has a poor prognosis in metastatic stage. Fotemustine or a combination of gemcitabine and treosulfan has demonstrated some efficacy in metastatic disease. We conducted a phase II trial to assess the second-line activity and toxicity of bendamustine hydrochloride, a nucleoside analogue with alkylating activity. Inclusion criteria were a Karnofsky performance status of > or = 60% and progressive disease during or after first-line chemotherapy. Bendamustine was administered at a dose of 120 mg/m2 on days 1 and 2. Cycles were repeated on day 22. The primary endpoint of the study was the determination of the number of patients achieving an objective response or stable disease. The secondary endpoint was toxicity. Eleven patients were enrolled into the trial. Grade III and IV toxicity consisted of anaemia, thrombocytopenia and leucocytopenia in two, one and two patients, respectively. No grade III or IV non-haematological toxicity was observed. According to Response Evaluation Criteria in Solid Tumours (RECIST), all patients showed progressive disease. We conclude that bendamustine is ineffective as second-line chemotherapy for metastatic uveal melanoma.
authors.affiliation: Medizinische Klinik III (Haematology, Oncology and Transfusion Medicine), University Medicine Berlin, Charité Campus Benjamin Franklin, Berlin, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Schmidt-Hieber
authors.forename: Alexander
authors.initials: A
authors.lastname: Schmittel
authors.forename: Eckhard
authors.initials: E
authors.lastname: Thiel
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholz
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016879:Salvage Therapy; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D016896:Treatment Outcome; D014604:Uveal Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000970:Antineoplastic Agents; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride