title: Chemotherapy vs tamoxifen in platinum-resistant ovarian cancer: a phase III, randomised, multicentre trial (Ovaresist).
abstract: BACKGROUND
  Chemotherapy in platinum-resistant ovarian cancer (PROC) aims for palliation and prolonging of progression-free survival (PFS). This study compares Health-related Quality of Life (HRQoL) and efficacy between single-agent chemotherapy and tamoxifen in PROC.
  
  
  METHODS
  Patients with PROC were randomised (2 : 1) to chemotherapy (weekly paclitaxel 80 mg m-2or four weekly pegylated liposomal doxorubicin 40 mg m-2) or tamoxifen 40 mg daily. The primary end point was HRQoL. Secondary end points were PFS by RECIST and overall survival (OS).
  
  
  RESULTS
  Between March 2002 and December 2007, 156 and 82 patients were randomised to chemotherapy and tamoxifen, respectively. In the chemotherapy arm, a significantly larger proportion of patients experienced a worsening in their social functioning. There was no difference in the proportion of patients experiencing improvement of gastrointestinal symptoms. Median PFS on tamoxifen was 8.3 weeks (95% CI, 8.0-10.4) compared with 12.7 weeks (95% CI, 9.0-16.3) on chemotherapy (HR, 1.54; 95% CI, 1.16-2.05; log-rank P=0.003). There was no difference in OS between the treatment arms.
  
  
  CONCLUSIONS
  Patients on chemotherapy had longer PFS but experienced more toxicity and poorer HRQoL compared with tamoxifen. Control over gastrointestinal symptoms was not better on chemotherapy. These data are important for patient counselling and highlight the need to incorporate HRQoL end points in studies of PROC.
authors.affiliation: Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.|NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia.|Department of Medical Oncology, Westmead Hospital, Crown Princess Mary Cancer Centre, Wentworthville, NSW, Australia.
authors.forename: Kristina
authors.initials: K
authors.lastname: Lindemann
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW 2050, Australia.
authors.forename: Emma
authors.initials: E
authors.lastname: Gibbs
authors.affiliation: Department of Oncology and Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden.|Department of Oncology and Pathology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Åvall-Lundqvist
authors.affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
authors.forename: Rene
authors.initials: R
authors.lastname: dePont Christensen
authors.affiliation: Department of Gynecologic Oncology, Haukeland University Hospital, Bergen, Norway.
authors.forename: Kathrine
authors.initials: K
authors.lastname: Woie
authors.affiliation: Department of Gynecologic Oncology, Skane University Hospital, Lund, Sweden.
authors.forename: Marten
authors.initials: M
authors.lastname: Kalling
authors.affiliation: Department of Obstetrics and Gynecology, Tampere University Hospital, Tampere, Finland.
authors.forename: Annika
authors.initials: A
authors.lastname: Auranen
authors.affiliation: Department of Obstetrics and Gynecology, Turku University Hospital, Turku, Finland.|University of Turku, Turku, Finland.
authors.forename: Seija
authors.initials: S
authors.lastname: Grenman
authors.affiliation: Department of Cancer Epidemiology, Skane University Hospital Lund, Lund, Sweden.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hoegberg
authors.affiliation: Department of Oncology, Linköping University Hospital, Linköping, Sweden.
authors.forename: Per
authors.initials: P
authors.lastname: Rosenberg
authors.affiliation: Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
authors.forename: Tone
authors.initials: T
authors.lastname: Skeie-Jensen
authors.affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark, Odense, Denmark.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Hjerpe
authors.affiliation: Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
authors.forename: Anne
authors.initials: A
authors.lastname: Dørum
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW 2050, Australia.
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.affiliation: Department of Gynecologic Oncology, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.|Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo and University of Oslo, Oslo, Norway.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Kristensen
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D017671:Platinum Compounds / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000008:administration & dosage; D011788:Quality of Life; D013629:Tamoxifen / Q000627:therapeutic use*
chemical_list: D018931:Antineoplastic Agents, Hormonal; D017671:Platinum Compounds; C506643:liposomal doxorubicin; D013629:Tamoxifen; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel