title: Preference of elderly patients' to oral or intravenous chemotherapy in heavily pre-treated recurrent ovarian cancer: final results of a prospective multicenter trial.
abstract: BACKGROUND
  Palliative systemic treatment in elderly gynaecological cancer patients remains a major challenge. In recurrent ovarian cancer (ROC), treosulfan an active alkylating drug showed similar cytotoxicity whether as oral (p.o.) or intravenous (i.v.) application. The aim of this innovative trial was to evaluate the preference of elderly patients (≥65 years) for p.o. or i.v. chemotherapy focusing compliance, outcome, toxicities, and geriatric aspects as secondary endpoints.
  
  
  METHODS
  Patients with ROC had the free choice between treosulfan i.v. (7000 mg/m2d1, q29d) or p.o. (600 mg/m2daily d1-28, q57d). Only indecisive participants were randomized.
  
  
  RESULTS
  Overall 123 patients with 2ndto 5threcurrence were registered and 119 received at least one cycle of chemotherapy. 85.7% preferred treosulfan i.v. and 14.3% oral, where only three patients were randomized. Main reasons for i.v. preference associated with individual expectations of lower rate of gastrointestinal disorders, higher activity and tolerability of treatment. Median of applied chemotherapies was three (range 1-12 cycles), with most common grade 3/4 toxicities thrombopenia (18.7%), leukopenia (15.7%), ascites (7.6%), bowel obstruction (6.7%), and abdominal pain (4.2%). Median time until progression/overall survival was 5.2/7.8 months (i.v.), and 5.6/10.4 months (p.o.), respectively, without significant differences in efficacy.
  
  
  CONCLUSIONS
  Elderly patients with recurrent ovarian cancer asked and demonstrated active participation in the decision-making process of their oncological treatment and favoured predominantly the i.v. application. Treosulfan was generally well-tolerated despite comorbidities and heavy pre-treatment. Our study demonstrates that patients' preference did not influence prognosis negatively and remains important in gynaecologic oncology decision practice.
  2004-000719-25; NCT 00170690.
authors.affiliation: Department of Gynaecology, European Competence Centre for Ovarian Cancer, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: Radoslav
authors.identifier: 0000-0001-9535-3033
authors.initials: R
authors.lastname: Chekerov
authors.affiliation: Department of Gynaecology and Gynaecologic Oncology, Kliniken Essen Mitte, Essen, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Harter
authors.affiliation: Onkologische Schwerpunktpraxis Heidelberg, Heidelberg, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Fuxius
authors.affiliation: Department of Gynaecology and Obstetrics, Gynaecological Cancer Center of the University Schleswig-Holstein, Campus Lübeck, Lübeck, Germany.
authors.forename: Lars Christian
authors.initials: LC
authors.lastname: Hanker
authors.affiliation: Department of Gynaecology and Gynaecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
authors.forename: Linn
authors.initials: L
authors.lastname: Woelber
authors.affiliation: Onkologische Schwerpunktpraxis Leer, Leer, Germany.
authors.forename: Lothar
authors.initials: L
authors.lastname: Müller
authors.affiliation: Praxisklinik Krebsheilkunde für Frauen, Berlin, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.affiliation: Onkologische Schwerpunktpraxis im Elisenhof, Munich, Germany.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Abenhardt
authors.affiliation: Department of Gynaecology, European Competence Centre for Ovarian Cancer, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: Yoana
authors.initials: Y
authors.lastname: Nedkova
authors.affiliation: Department of Gynaecology, European Competence Centre for Ovarian Cancer, Charité Universitätsmedizin, Berlin, Germany.
authors.forename: Isil
authors.initials: I
authors.lastname: Yalcinkaya
authors.affiliation: Gynäkologisch-onkologische Schwerpunktpraxis, Fürstenwalde, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Heinrich
authors.affiliation: Department of Gynaecology and Obstetrics and Comprehensive Cancer Center, University of Munich, Munich, Germany.
authors.forename: Harald
authors.initials: H
authors.lastname: Sommer
authors.affiliation: Department of Gynaecology and Obstetrics and Comprehensive Cancer Center, University of Munich, Munich, Germany.
authors.forename: Sven
authors.initials: S
authors.lastname: Mahner
authors.affiliation: Department of Gynecology and Obstetrics, Technische Universität Dresden, Dresden, Germany.
authors.forename: Pauline
authors.initials: P
authors.lastname: Wimberger
authors.affiliation: Department of Gynaecology and Obstetrics, University Medicine Greifswald, Greifswald, Germany.
authors.forename: Dominique
authors.initials: D
authors.lastname: Koensgen-Mustea
authors.affiliation: North-Eastern German Society for Gynaecologic Oncology, Ovarian Cancer Study Group, Berlin, Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Richter
authors.affiliation: Praxisklinik Krebsheilkunde für Frauen, Berlin, Germany.|North-Eastern German Society for Gynaecologic Oncology, Ovarian Cancer Study Group, Berlin, Germany.
authors.forename: Gülten
authors.initials: G
authors.lastname: Oskay-Oezcelik
authors.affiliation: Department of Gynaecology, European Competence Centre for Ovarian Cancer, Charité Universitätsmedizin, Berlin, Germany.|North-Eastern German Society for Gynaecologic Oncology, Ovarian Cancer Study Group, Berlin, Germany.
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
keywords: Elderly; Patient preference; Recurrent ovarian cancer; Treosulfan