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Old 06-09-2014, 05:12 PM   #1
Lani
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Join Date: Mar 2006
Posts: 4,778
Thumbs up Fabulous news-- adding Perjeta to herceptin+ taxane DELAYS brain metastasis in Stage4

her2+ patients-- result from Phase II CLEOPATRA: Not only were PFS and OS significantly increased but subset analysis showed although incidence of CNS mets the same, onset was delayed . Look forward to results of P+H+taxane given neoadjuvantly if some of those CNS mets can be prevented altogether!

Oxford JournalsMedicine Annals of Oncology Volume 25, Issue 6Pp. 1116-1121.
Incidence of central nervous system metastases in patients with HER2-positive metastatic breast cancer treated with pertuzumab, trastuzumab, and docetaxel: results from the randomized phase III study CLEOPATRA
S. M. Swain1,*, J. Baselga2, D. Miles3, Y.-H. Im4, C. Quah5, L. F. Lee5 and J. Cortés6
+ Author Affiliations

1Washington Cancer Institute, MedStar Washington Hospital Center, Washington
2Memorial Sloan-Kettering Cancer Center, Memorial Hospital, New York, USA
3Mount Vernon Cancer Centre, Middlesex, UK
4Division of Hematology and Medical Oncology, Department of Internal Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
5Genentech, Inc., South San Francisco, USA
6Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain
↵*Correspondence to: Dr Sandra M. Swain, Washington Cancer Institute, MedStar Washington Hospital Center, Washington, DC 20010, USA. Tel: +1-202-877-8112; Fax: +1-202-877-8113; E-mail: sandra.m.swain@medstar.net
Received January 24, 2014.
Revision received March 20, 2014.
Accepted March 24, 2014.
Abstract

Background Results from the phase III trial CLEOPATRA in human epidermal growth factor receptor 2-positive first-line metastatic breast cancer demonstrated significant improvements in progression-free and overall survival with pertuzumab, trastuzumab, and docetaxel over placebo, trastuzumab, and docetaxel. We carried out exploratory analyses of the incidence and time to development of central nervous system (CNS) metastases in patients from CLEOPATRA.

Patients and methods Patients received pertuzumab/placebo: 840 mg in cycle 1, then 420 mg; trastuzumab: 8 mg/kg in cycle 1, then 6 mg/kg; docetaxel: initiated at 75 mg/m2. Study drugs were administered i.v. every 3 weeks. The log-rank test was used for between-arm comparisons of time to CNS metastases as first site of disease progression and overall survival in patients with CNS metastases as first site of disease progression. The Kaplan–Meier approach was used to estimate median time to CNS metastases as first site of disease progression and median overall survival.

Results The incidence of CNS metastases as first site of disease progression was similar between arms; placebo arm: 51 of 406 (12.6%), pertuzumab arm: 55 of 402 (13.7%). Median time to development of CNS metastases as first site of disease progression was 11.9 months in the placebo arm and 15.0 months in the pertuzumab arm; hazard ratio (HR) = 0.58, 95% confidence interval (CI) 0.39–0.85, P = 0.0049. Overall survival in patients who developed CNS metastases as first site of disease progression showed a trend in favor of pertuzumab, trastuzumab, and docetaxel; HR = 0.66, 95% CI 0.39–1.11. Median overall survival was 26.3 versus 34.4 months in the placebo and pertuzumab arms, respectively. Treatment comparison of the survival curves was not statistically significant for the log-rank test (P = 0.1139), but significant for the Wilcoxon test (P = 0.0449).

Conclusions While the incidence of CNS metastases was similar between arms, our results suggest that pertuzumab, trastuzumab, and docetaxel delays the onset of CNS disease compared with placebo, trastuzumab, and docetaxel.

ClinicalTrials.gov NCT00567190.

Key words
central nervous system HER2 metastatic breast cancer pertuzumab trastuzumab
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
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