title: Treosulfan in the Treatment of Advanced Ovarian Cancer - Results of a German Multicenter Non-interventional Study.
abstract: BACKGROUND
  Data on routine systemic treatment of patients with ovarian cancer are currently available only to a limited degree. The alkylating agent treosulfan is approved in oral (p.o.) and intravenous (i.v.) form for the treatment of ovarian carcinoma. The present non-interventional study analyzed the clinical use of treosulfan in Germany, evaluating the mode of application, toxicity, and response and survival rate.
  
  
  METHODS
  Two hundred and forty-eight ovarian cancer patients in 57 Centers, who received treosulfan mainly either i.v. (5,000-8,000 mg/m(2) d1, q21d or q28d) or p.o. (400-600 mg/m(2) d1-14 or 21, q28d) for at least one therapy cycle were evaluable and were included in the study.
  
  
  RESULTS
  With a median age of 70 years (range=36-92 years), predominantly elderly patients received treosulfan treatment. Most participants presented serous histology (131, 52.8%) and advanced-stage FIGO III (122, 49%) or IV (55, 22%) disease. Median ECOG status was 1 (range=0-2), whereas cardiac co-morbidity was common (31%). Treosulfan was usually administered as second- (26%), third- (21%) or fourth-line (17%) therapy. Two hundred and one patients received i.v. and 47 p.o.
  
  
  METHODS
  The most common reason for dose modifications was due to hematological toxicity (46%). The main reason for a therapy discontinuation was progressive disease (38.5%). Response was observed in 25.8% of participants, disease stabilization in 28.6 % and progress in 45.6%. The median progression-free and overall survival was 196 and 405 days, respectively.
  
  
  CONCLUSIONS
  In predominantly elderly and heavily pre-treated patients with recurrent ovarian cancer, treosulfan featured a clinical relevant efficacy and well-manageable, mostly hematological, toxicity, which resulted in a positive therapeutic index.
authors.affiliation: Department of Gynecology, European Competence Center for Ovarian Cancer, Campus Virchow Klinikum, Charité - Universitätsmedizin, Berlin, Germany radoslav.chekerov@charite.de.
authors.forename: Radoslav
authors.initials: R
authors.lastname: Chekerov
authors.affiliation: Department of Gynecology, Städtisches Klinikum Karlsruhe, Karlsruhe, Germany.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Kaltenecker
authors.affiliation: Onkologische Gemeinschaftspraxis, Westerstede, Germany.
authors.forename: Dietmar
authors.initials: D
authors.lastname: Reichert
authors.affiliation: Onkozentrum, Dresden, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Göhler
authors.affiliation: Praxiskliniken Krebsheilkunde für Frauen, Berlin, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.affiliation: Praxiskliniken Krebsheilkunde für Frauen, Berlin, Germany.
authors.forename: Gülten
authors.initials: G
authors.lastname: Oskay-Özcelik
authors.affiliation: Hämatologisch-Onkologische Gemeinschaftspraxis, Nordhorn, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Sauer
authors.affiliation: Department of Gynecology, Klinikum Augsburg, Augsburg, Germany.
authors.forename: Arthur
authors.initials: A
authors.lastname: Wischnik
authors.affiliation: H.O.T., Landshut, Germany.
authors.forename: Ursula
authors.initials: U
authors.lastname: Vehling-Kaiser
authors.affiliation: Onkologische Praxis, Minden, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Becker
authors.affiliation: Hämatologisch-Onkologische Gemeinschaftspraxis, Nordhorn, Germany.
authors.forename: Ulrich
authors.initials: U
authors.lastname: Hutzschenreuter
authors.affiliation: Hämatologisch-Onkologische Praxis, Göttingen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Ammon
authors.affiliation: Alcedis GmbH, Giessen, Germany.
authors.forename: Elke
authors.initials: E
authors.lastname: Heidrich-Lorsbach
authors.affiliation: Department of Gynecology, European Competence Center for Ovarian Cancer, Campus Virchow Klinikum, Charité - Universitätsmedizin, Berlin, Germany.
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D002066:Busulfan / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality
chemical_list: D018906:Antineoplastic Agents, Alkylating; C018404:treosulfan; D002066:Busulfan
keywords: Treosulfan; elderly; non-interventional study; ovarian cancer