title: A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis.
abstract: BACKGROUND
  Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens.
  
  
  METHODS
  Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1-28 of a 56-day cycle) for a maximum of 12 cycles (i.v.) or 12 months (p.o.). Indecisive patients were randomized. Toxicity was evaluated according to the NCI-CTC version 2.0.
  
  
  RESULTS
  Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70-82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1-12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %).
  
  
  CONCLUSIONS
  Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued.
authors.affiliation: Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Sven.Mahner@gmx.de
authors.forename: Sven
authors.initials: S
authors.lastname: Mahner
authors.forename: Gülten
authors.initials: G
authors.lastname: Oskay-Özcelik
authors.forename: Elke
authors.initials: E
authors.lastname: Heidrich-Lorsbach
authors.forename: Stefan
authors.initials: S
authors.lastname: Fuxius
authors.forename: Harald
authors.initials: H
authors.lastname: Sommer
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.forename: Antje
authors.initials: A
authors.lastname: Belau
authors.forename: Birgit
authors.initials: B
authors.lastname: Ruhmland
authors.forename: Thomas
authors.initials: T
authors.lastname: Heuser
authors.forename: Heinz
authors.initials: H
authors.lastname: Kölbl
authors.forename: Susanne
authors.initials: S
authors.lastname: Markmann
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000505:Alopecia / Q000139:chemically induced; D000740:Anemia / Q000139:chemically induced; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use; D002066:Busulfan / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003248:Constipation / Q000139:chemically induced; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D011788:Quality of Life; D012008:Recurrence; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; C018404:treosulfan; D002066:Busulfan