title: Safety and efficacy of single-agent bevacizumab-containing therapy in elderly patients with platinum-resistant recurrent ovarian cancer: Subgroup analysis of the randomised phase III AURELIA trial.
abstract: BACKGROUND
  The AURELIA trial demonstrated significantly improved progression-free survival (PFS) with bevacizumab added to chemotherapy for platinum-resistant ovarian cancer (PROC).
  
  
  METHODS
  Patients with PROC were randomised to receive investigator-selected single-agent chemotherapy alone or with bevacizumab. Post-hoc exploratory analyses assessed efficacy, safety and patient-reported outcomes according to age <65 versus ≥65years.
  
  
  RESULTS
  In the 133 patients (37%) aged ≥65years, baseline hypertension was more frequent and ascites was less common than in patients <65years. The magnitude of PFS benefit from bevacizumab was similar in patients ≥65 versus <65years (hazard ratio 0.44 [95% CI, 0.31-0.64] versus 0.49 [95% CI, 0.37-0.64], respectively, treatment-age interaction p=0.58), with similar improvements in response rates. Grade≥3 hypertension was more common with bevacizumab than chemotherapy alone in both subgroups, and more common in older than younger patients irrespective of treatment. However, there was no excess of other adverse events of specific interest for bevacizumab, including venous thromboembolic events, in older patients. More patients receiving bevacizumab in the younger but not the older subgroup showed improved gastrointestinal/abdominal symptoms.
  
  
  CONCLUSIONS
  In exploratory analyses, PFS and response rate improvement with bevacizumab were consistent in older and younger patients. Grade≥3 hypertension was more common in elderly bevacizumab-treated patients; careful monitoring is recommended. Overall, bevacizumab-containing therapy was well tolerated in a selected population aged ≥65years, suggesting a favourable benefit:risk profile. However, geriatric assessments are needed to improve selection of elderly patients potentially gaining symptom and quality of life improvements from bevacizumab-containing therapy.
  
  
  BACKGROUND
  ClinicalTrials.govNCT00976911.
authors.affiliation: MITO and Centro di Riferimento Oncologico, CRO-IRCCS, Via F. Gallini, 2 - 33081 Aviano, PN, Italy. Electronic address: rsorio@cro.it.
authors.forename: Roberto
authors.initials: R
authors.lastname: Sorio
authors.affiliation: GINECO and Centre d'Oncologie de Gentilly, 2 rue Marie Marvingt, 54000 Nancy, France.
authors.forename: Célia
authors.initials: C
authors.lastname: Roemer-Becuwe
authors.affiliation: AGO and Onkologisches Therapiezentrum am Krankenhaus Jerusalem Hamburg, Moorkamp 2-6, 20357 Hamburg, Germany.
authors.forename: Felix
authors.initials: F
authors.lastname: Hilpert
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.
authors.forename: Emma
authors.initials: E
authors.lastname: Gibbs
authors.affiliation: GEICO and Hospital Universitari Parc Taulí, Parc Taulí 1, 08208 Sabadell, Barcelona, Spain.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: García
authors.affiliation: NSGO and Oslo University Hospital HF, Radiumhospitalet, Postboks 4950, Nydalen, N-0424 Oslo, Norway.
authors.forename: Janne
authors.initials: J
authors.lastname: Kaern
authors.affiliation: BGOG and Universitair Ziekenhuis Antwerpen, Wilrijkstraat 10, 2650 Edegem, Belgium.
authors.forename: Manon
authors.initials: M
authors.lastname: Huizing
authors.affiliation: DGOG and University Medical Center Utrecht, F02.126, PO Box 85500, 3508 GA Utrecht, The Netherlands.
authors.forename: Petronella
authors.initials: P
authors.lastname: Witteveen
authors.affiliation: HECOG and Department of Clinical Therapeutics, Medical School, University of Athens, 133, Vas Sofias Av, 11528 Athens, Greece.
authors.forename: Flora
authors.initials: F
authors.lastname: Zagouri
authors.affiliation: GINECO and Polyclinique Courlancy, 38 rue de Courlancy, 51100 Reims, France.
authors.forename: David
authors.initials: D
authors.lastname: Coeffic
authors.affiliation: AGO and Gynäkologisch-Onkologische Praxis am Pelikanplatz, Pelikanplatz 23, D30177 Hannover, Germany.
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.affiliation: GEICO and MD Anderson Cancer Center Spain, C/Arturo Soria 270, 28033 Madrid, Spain.
authors.forename: Antonio
authors.initials: A
authors.lastname: González-Martín
authors.affiliation: NSGO and Department of Gynecological Cancer and Institute for Cancer Genetics and Informatics, The Norwegian Radium Hospital, Oslo University Hospital and Institute for Clinical Medicine, Oslo University, Postboks 4950, Nydalen, N-0424 Oslo, Norway.
authors.forename: Gunnar
authors.initials: G
authors.lastname: Kristensen
authors.affiliation: GINECO and Clinique Francheville, 38 Boulevard de Vésone, BP 4063, 24000 Périgueux, France.
authors.forename: Charles-Briac
authors.initials: CB
authors.lastname: Levaché
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.
authors.forename: Chee Khoon
authors.initials: CK
authors.lastname: Lee
authors.affiliation: National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, Sydney, NSW 1450, Australia.
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.affiliation: GINECO and Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu - Oncologie, 1 Place du Parvis Notre-Dame - Place Jean-Paul II, 75004 Paris, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000503:physiopathology; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D018579:Patient Selection; D017671:Platinum Compounds; D011092:Polyethylene Glycols / Q000008:administration & dosage; D019772:Topotecan / Q000008:administration & dosage
chemical_list: D017671:Platinum Compounds; C506643:liposomal doxorubicin; D000068258:Bevacizumab; D011092:Polyethylene Glycols; D019772:Topotecan; D004317:Doxorubicin; D017239:Paclitaxel
keywords: Bevacizumab; Elderly; Ovarian cancer; Patient-reported outcomes; Platinum resistant