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J Clin Oncol. 2015 Jan 10;33(2):141-8. doi: 10.1200/JCO.2014.57.1513. Epub 2014 Sep 2.

Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer.

Author information

1
John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ. john.mackey@trioncology.org.
2
John R. Mackey, Cross Cancer Institute; Francois Thireau and Helena Fung, Translational Research in Oncology, Edmonton; Marc Webster, Tom Baker Cancer Centre, Calgary, Alberta; Karen A. Gelmon, British Columbia Cancer Agency, Vancouver, British Columbia; Sunil Verma, Sunnybrook Health Sciences Center; Lorinda Simms, Eli Lilly, Toronto, Ontario, Canada; Manuel Ramos-Vazquez, Centro Oncológico de Galicia "José Antonio Quiroga y Piñeiro," A Coruña; Miguel Martin, Instituto de Investigación Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain; Oleg Lipatov, Republican Clinical Oncology Dispensary, Bashkortostan Republic Ministry of Health, Ufa; Dmitriy Krasnozhon, Leningrad Regional Oncology Dispensary, Leningrad; Vladimir Semiglazov, Institute of Oncology N.N. Petrov; Alexey Manikhas, City Clinical Oncology Dispensary, St Petersburg; Vera Gorbunova, N.N. Blokhin Russian Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russia; Nicole McCarthy, ICON Cancer Care Wesley, Brisbane, Queensland, Australia; Gottfried E. Konecny, University of California Los Angeles, Los Angeles, CA; Roberto Hegg, Hospital Pérola Byigton Centro de Referência da Saúde da Mulher, Sao Paulo, Brazil; Dany Abi Gerges, Middle East Institute of Health, Bsalim, Lebanon; Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium; and Ayman Ibrahim, ImClone Systems, Bridgewater, NJ.

Abstract

PURPOSE:

Currently, antiangiogenic strategies in metastatic breast cancer have demonstrated modest improvements in progression-free survival (PFS) but not improved quality or duration of survival, warranting evaluation of new agents in a placebo-controlled setting. Ramucirumab is a human immunoglobulin G1 antibody that binds vascular endothelial growth factor receptor-2 and blocks ligand-stimulated activation. The ROSE/TRIO-012 trial evaluated ramucirumab with docetaxel in unresectable, locally recurrent, or metastatic breast cancer.

PATIENTS AND METHODS:

In this double-blind, placebo-controlled, randomized, multinational phase III trial, 1,144 patients with human epidermal growth factor receptor 2 (HER2) -negative breast cancer who had not received cytotoxic chemotherapy in the advanced setting were randomly assigned at a two-to-one ratio to receive docetaxel 75 mg/m(2) plus ramucirumab 10 mg/kg or docetaxel 75 mg/m(2) plus placebo once every 3 weeks. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria. Patients were stratified by previous taxane therapy, visceral metastasis, hormone receptor status, and geographic region. An independent data monitoring committee oversaw the trial. The primary end point was investigator-assessed PFS.

RESULTS:

Median PFS in patients treated with ramucirumab plus docetaxel was 9.5 months, compared with 8.2 months in patients who received placebo plus docetaxel (hazard ratio [HR], 0.88; P = .077). Median overall survival was 27.3 months in patients who received ramucirumab plus docetaxel, compared with 27.2 months in patients who received placebo plus docetaxel (HR, 1.01; P = .915). Toxicities seen at significantly higher rates in patients receiving ramucirumab included fatigue, hypertension, febrile neutropenia, palmar-plantar erythrodysesthesia syndrome, and stomatitis.

CONCLUSION:

Addition of ramucirumab to docetaxel in HER2-negative advanced breast cancer did not meaningfully improve important clinical outcomes.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00703326.

PMID:
25185099
DOI:
10.1200/JCO.2014.57.1513
[Indexed for MEDLINE]
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