Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III study. (Record no. 1373)

MARC details
000 -LEADER
fixed length control field 03796nam a22005537a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 131223s20132013 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1083-7159
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 23475636
245 ## - TITLE STATEMENT
Title Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III study.
251 ## - Source
Source Oncologist. 18(3):257-64, 2013.
252 ## - Abbreviated Source
Abbreviated source Oncologist. 18(3):257-64, 2013.
253 ## - Journal Name
Journal name The oncologist
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2013
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2014
266 ## - Date added to catalog
Date added to catalog 2013-12-24
501 ## - WITH NOTE
Local holdings Available online from MWHC library: 1996 - present
520 ## - SUMMARY, ETC.
Abstract CONCLUSION: The combination of pertuzumab plus trastuzumab plus docetaxel did not increase the incidence of cardiac adverse events, including LVSD, compared with the control arm in HER2-positive MBC. The majority of cardiac adverse events were reversible.
520 ## - SUMMARY, ETC.
Abstract INTRODUCTION: We report cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel observed in the phase III study CLEOPATRA in patients with HER2-positive first-line metastatic breast cancer (MBC).
520 ## - SUMMARY, ETC.
Abstract PATIENTS AND METHODS: Left ventricular ejection fraction (LVEF) >= 50% and ECOG performance status of 0 or 1 were required for study entry. During the study, LVEF assessments took place every 9 weeks. Pertuzumab/placebo was given at 840 mg, then 420 mg q3w; trastuzumab was administered at 8 mg/kg, then 6 mg/kg q3w, and docetaxel was initiated at 75 mg/m(2) q3w.
520 ## - SUMMARY, ETC.
Abstract RESULTS: The incidence of cardiac adverse events (all grades) was 16.4% in the placebo arm and 14.5% in the pertuzumab arm, with left ventricular systolic dysfunction (LVSD, all grades) being the most frequently reported event (8.3% versus 4.4% in the placebo and pertuzumab arm). Declines in LVEF by >= 10% points from baseline and to <50% were reported in 6.6% and 3.8% of patients in the placebo and pertuzumab arm, respectively. Seventy-two percent (placebo arm) and 86.7% (pertuzumab arm) of those patients recovered to a value >= 50%. The incidence of symptomatic LVSD was low, occurring in 1.8% (n = 7) versus 1.0% (n = 4) of patients in the placebo and pertuzumab arm. In 8/11 patients, the symptomatic LVSD had resolved at data cutoff.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antibodies, Monoclonal, Humanized/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Breast Neoplasms/dt [Drug Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Receptor, erbB-2/bi [Biosynthesis]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Ventricular Dysfunction, Left/ci [Chemically Induced]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Antibodies, Monoclonal, Humanized/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Breast Neoplasms/pa [Pathology]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Double-Blind Method
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Female
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Neoplasm Metastasis
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Stroke Volume/de [Drug Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Taxoids/ad [Administration & Dosage]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Taxoids/ae [Adverse Effects]
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution Washington Cancer Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Clinical Trial, Phase III
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
657 ## - INDEX TERM--FUNCTION
Medline publication type Multicenter Study
657 ## - INDEX TERM--FUNCTION
Medline publication type Randomized Controlled Trial
657 ## - INDEX TERM--FUNCTION
Medline publication type Research Support, Non-U.S. Gov't
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Swain, Sandra M
790 ## - Authors
All authors Amadori D, Baselga J, Benyunes MC, Clark E, Cortes J, Ewer MS, Knott A, Miles D, Ross G, Swain SM
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="http://dx.doi.org/10.1634/theoncologist.2012-0448">http://dx.doi.org/10.1634/theoncologist.2012-0448</a>
Public note http://dx.doi.org/10.1634/theoncologist.2012-0448
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 12/24/2013   23475636 23475636 12/24/2013 12/24/2013 Journal Article

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