Τίτλος:
Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Pujade-Lauraine, E.
Hilpert, F.
Weber, B.
Reuss, A.
Poveda, A.
Kristensen, G.
Sorio, R.
Vergote, I.
Witteveen, P.
Bamias, A.
Pereira, D.
Wimberger, P.
Oaknin, A.
Mirza, M.R.
Follana, P.
Bollag, D.
Ray-Coquard, I.
Περιοδικό:
Journal of Clinical Oncology
Εκδότης:
American Society of Clinical Oncology
Λέξεις-κλειδιά:
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
DOI:
10.1200/JCO.2013.51.4489
