@article{3087566,
    title = "Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial",
    author = "Pujade-Lauraine, E. and Hilpert, F. and Weber, B. and Reuss, A. and Poveda, A. and Kristensen, G. and Sorio, R. and Vergote, I. and Witteveen, P. and Bamias, A. and Pereira, D. and Wimberger, P. and Oaknin, A. and Mirza, M.R. and Follana, P. and Bollag, D. and Ray-Coquard, I.",
    journal = "Journal of Clinical Oncology",
    year = "2014",
    volume = "32",
    number = "13",
    pages = "1302-1308",
    publisher = "American Society of Clinical Oncology",
    issn = "0732-183X, 1527-7755",
    doi = "10.1200/JCO.2013.51.4489",
    keywords = "bevacizumab;  doxorubicin;  paclitaxel;  topotecan;  antineoplastic agent;  bevacizumab;  doxorubicin;  drug derivative;  macrogol derivative;  monoclonal antibody;  paclitaxel;  platinum complex;  topotecan, abdominal pain;  adult;  aged;  article;  cancer combination chemotherapy;  cancer growth;  cancer mortality;  cancer recurrence;  chemotherapy induced emesis;  congestive heart failure;  controlled study;  crossover procedure;  drug efficacy;  drug safety;  dyspnea;  fatigue;  female;  fistula;  hand foot syndrome;  heart disease;  human;  hypertension;  infarction;  major clinical study;  open study;  ovary cancer;  overall survival;  patient safety;  phase 3 clinical trial;  posterior reversible encephalopathy syndrome;  priority journal;  progression free survival;  proteinuria;  randomized controlled trial;  self report;  sensory neuropathy;  stomach perforation;  treatment duration;  treatment outcome;  tumor volume;  very elderly;  wound healing impairment;  controlled clinical trial;  disease free survival;  drug administration;  drug resistance;  middle aged;  multicenter study;  ovary tumor;  tumor recurrence, Adult;  Aged;  Aged, 80 and over;  Antibodies, Monoclonal, Humanized;  Antineoplastic Combined Chemotherapy Protocols;  Disease-Free Survival;  Doxorubicin;  Drug Administration Schedule;  Drug Resistance, Neoplasm;  Female;  Humans;  Middle Aged;  Neoplasm Recurrence, Local;  Organoplatinum Compounds;  Ovarian Neoplasms;  Paclitaxel;  Polyethylene Glycols;  Topotecan",
    abstract = "Purpose: In platinum-resistant ovarian cancer (OC), single-agent chemotherapy is standard. Bevacizumab is active alone and in combination. AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab with chemotherapy in platinum-resistant OC. Patients and Methods: Eligible patients had measurable/assessable OC that had progressed < 6 months after completing platinum-based therapy. Patients with refractory disease, history of bowel obstruction, or > two prior anticancer regimens were ineligible. After investigators selected chemotherapy (pegylated liposomal doxorubicin, weekly paclitaxel, or topotecan), patients were randomly assigned to single-agent chemotherapy alone or with bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until progression, unacceptable toxicity, or consent withdrawal. Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone. The primary end point was progression-free survival (PFS) by RECIST. Secondary end points included objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes. Results: The PFS hazard ratio (HR) after PFS events in 301 of 361 patients was 0.48 (95% CI, 0.38 to 0.60; unstratified log-rank P < .001). Median PFS was 3.4 months with chemotherapy alone versus 6.7 months with bevacizumab-containing therapy. RECIST ORR was 11.8% versus 27.3%, respectively (P = .001). The OS HR was 0.85 (95% CI, 0.66 to 1.08; P < .174; median OS, 13.3 v 16.6 months, respectively). Grade ≥ 2 hypertension and proteinuria were more common with bevacizumab. GI perforation occurred in 2.2% of bevacizumab-treated patients. Conclusion: Adding bevacizumab to chemotherapy statistically significantly improved PFS and ORR; the OS trend was not significant. No new safety signals were observed. © 2014 by American Society of Clinical Oncology."
}