title: Phase II Study Evaluating PegLiposomal Doxorubicin and Carboplatin Combination Chemotherapy in Gynecologic Sarcomas and Mixed Epithelial-Mesenchymal Tumors A Phase II Protocol of the Arbeitsgemeinschaft Gynaekologische Onkologie Study Group (AGO-GYN 7).
abstract: Gynecologic sarcomas are rare diseases with still undefined optimal treatment. Platinum and anthracyclines were reported as active agents in gynecologic sarcoma and carcinosarcoma. So far, data regarding the combination of carboplatin and pegylated liposomal doxorubicin for this patient population are missing.
  
  
  
  This prospective single-arm multicenter phase II trial evaluated the efficacy of carboplatin AUC 6 in combination with pegylated liposomal doxorubicin 40 mg/m q28 in 40 patients with newly diagnosed or recurrent gynecologic sarcoma or carcinosarcoma.
  
  
  
  Twenty patients with carcinosarcoma and 20 patients with leiomyosarcoma or endometrial stromal sarcoma were included. The percentage of patients with grade 3/4 neutropenia was 50%, but we did not observe any febrile neutropenia. The rates of grade 1 and 2 palmo-plantar erythema were moderate with 25% and 10%, respectively. Response rate was 33.3%. The 12-month progression-free and overall survival times were 32.5% and 77.0%, respectively.
  
  
  
  The combination of carboplatin and pegylated liposomal doxorubicin is feasible and has activity within the investigated study cohort.
authors.affiliation: *Department of Gynecology & Gynecologic Oncology, Kliniken Essen-Mitte, Essen; †Department of Gynecology, Charité Medical University of Berlin, Berlin; ‡Coordinating Center for Clinical Trials, University Marburg; §Department of Gynecology, Gynecologic Endocrinology and Oncology, Philipps University Marburg, Marburg; ∥Department of Obstetrics and Gynecology, Johann Wolfgang Goethe-University, Frankfurt; ¶Department of Obstetrics and Gynecology, University Hospital Schleswig-Holstein, Campus Lübeck, Lübeck; #Department of Obstetrics and Gynecology, University of Duisburg-Essen, Essen; **Department of Gynecologic Oncology and Gynecology, Gynaekologicum Bremen, Bremen; ††Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Munich, München; ‡‡Department of Obstetrics and Gynecology, Oberschwabenklinik Hospital St. Elisabeth Ravensburg, Ravensburg; §§Department of Obstetrics and Gynecology, University Hospital Ulm, Ulm; ∥∥Department of Gynecology and Gynecologic Oncology, University Medical Center Hamburg-Eppendorf, Hamburg; ¶¶Department of Obstetrics and Gynecology, Carl Gustav Carus Technische University Dresden, Dresden; ##Gynecology Hannover, Hannover; ***Department of Obstetrics and Gynecology, Ev. Hospital Düsseldorf, Düsseldorf; †††Department of Obstetrics and Gynecology, University of Tübingen, Tübingen; and ‡‡‡Department of Obstetrics and Gynecology, University of Düsseldorf, Düsseldorf, Germany.
authors.forename: Philipp
authors.initials: P
authors.lastname: Harter
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
authors.forename: Alexander
authors.initials: A
authors.lastname: Reuss
authors.forename: Klaus
authors.initials: K
authors.lastname: Baumann
authors.forename: Lars
authors.initials: L
authors.lastname: Hanker
authors.forename: Rainer
authors.initials: R
authors.lastname: Kimmig
authors.forename: Willibald
authors.initials: W
authors.lastname: Schröder
authors.forename: Alexander
authors.initials: A
authors.lastname: Burges
authors.forename: Martina
authors.initials: M
authors.lastname: Gropp-Meier
authors.forename: Christian
authors.initials: C
authors.lastname: Kurzeder
authors.forename: Sven
authors.initials: S
authors.lastname: Mahner
authors.forename: Ulrich
authors.initials: U
authors.lastname: Canzler
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.forename: Werner
authors.initials: W
authors.lastname: Meier
authors.forename: Tanja
authors.initials: T
authors.lastname: Fehm
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols; D016190:Carboplatin / Q000627:therapeutic use*; D002296:Carcinosarcoma / Q000188:drug therapy*; D004317:Doxorubicin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D006801:Humans; D007890:Leiomyosarcoma / Q000188:drug therapy*; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011446:Prospective Studies
chemical_list: D000903:Antibiotics, Antineoplastic; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin