title: Patient-reported outcome results from the open-label phase III AURELIA trial evaluating bevacizumab-containing therapy for platinum-resistant ovarian cancer.
abstract: OBJECTIVE
  To determine the effects of bevacizumab on patient-reported outcomes (PROs; secondary end point) in the AURELIA trial.
  
  
  METHODS
  Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone (CT) or with bevacizumab (BEV-CT). PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 (EORTC QLQ-OV28) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index (FOSI) at baseline and every two or three cycles (8/9 weeks) until disease progression. The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15% (≥ 15-point) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale (items 31-36) at week 8/9. Patients with missing week 8/9 questionnaires were included as unimproved. Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures (MMRM) analysis. Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data.
  
  
  RESULTS
  Baseline questionnaires were available from 89% of 361 randomly assigned patients. More BEV-CT than CT patients achieved a ≥ 15% improvement in abdominal/GI symptoms at week 8/9 (primary PRO end point, 21.9% v 9.3%; difference, 12.7%; 95% CI, 4.4 to 20.9; P = .002). MMRM analysis covering all time points also favored BEV-CT (difference, 6.4 points; 95% CI, 1.3 to 11.6; P = .015). More BEV-CT than CT patients achieved ≥ 15% improvement in FOSI at week 8/9 (12.2% v 3.1%; difference, 9.0%; 95% CI, 2.9% to 15.2%; P = .003). Sensitivity analyses gave similar results and conclusions.
  
  
  CONCLUSIONS
  Bevacizumab increased the proportion of patients achieving a 15% improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer.
authors.affiliation: Martin R. Stockler, Madeleine T. King, Chee Khoon Lee, The University of Sydney; Michael Friedlander, Prince of Wales Clinical School, University of New South Wales, Sydney, Australia; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Nikolaus de Gregorio, AGO and University of Ulm Medical Center, Ulm, Germany; Lari Wenzel, University of California Irvine, Irvine, CA; Florence Joly, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Centre François Baclesse, Caen; Eric Pujade-Lauraine, GINECO and Centre Hospitalier Universitaire Hotel Dieu, Paris, France; José Angel Arranz, Grupo Español de Investigación en Cáncer de Ovario and Hospital General Universitario Gregorio Marañón, Madrid, Spain; Mansoor Raza Mirza, Nordic Society of Gynaecological Oncology and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Roberto Sorio, Multicenter Italian Trials in Ovarian Cancer and Centro di Riferimento Oncologico-Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Italy; and Ulrich Freudensprung, Vesna Sneller, Gill Hales, F. Hoffmann-La Roche, Basel, Switzerland.
authors.forename: Martin R
authors.initials: MR
authors.lastname: Stockler
authors.forename: Felix
authors.initials: F
authors.lastname: Hilpert
authors.forename: Michael
authors.initials: M
authors.lastname: Friedlander
authors.forename: Madeleine T
authors.initials: MT
authors.lastname: King
authors.forename: Lari
authors.initials: L
authors.lastname: Wenzel
authors.forename: Chee Khoon
authors.initials: CK
authors.lastname: Lee
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
authors.forename: Nikolaus
authors.initials: N
authors.lastname: de Gregorio
authors.forename: José Angel
authors.initials: JA
authors.lastname: Arranz
authors.forename: Mansoor Raza
authors.initials: MR
authors.lastname: Mirza
authors.forename: Roberto
authors.initials: R
authors.lastname: Sorio
authors.forename: Ulrich
authors.initials: U
authors.lastname: Freudensprung
authors.forename: Vesna
authors.initials: V
authors.lastname: Sneller
authors.forename: Gill
authors.initials: G
authors.lastname: Hales
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D057566:Self Report; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D000068258:Bevacizumab; D011092:Polyethylene Glycols; D019772:Topotecan; D004317:Doxorubicin; D017239:Paclitaxel