TY  - BOOK
AU  - Swain, Sandra M
TI  - 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
SN  - 1083-7159
PY  - 2013///
KW  - *Antibodies, Monoclonal, Humanized/ae [Adverse Effects]
KW  - *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use]
KW  - *Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects]
KW  - *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use]
KW  - *Breast Neoplasms/dt [Drug Therapy]
KW  - *Receptor, erbB-2/bi [Biosynthesis]
KW  - *Ventricular Dysfunction, Left/ci [Chemically Induced]
KW  - Antibodies, Monoclonal, Humanized/ad [Administration & Dosage]
KW  - Breast Neoplasms/pa [Pathology]
KW  - Double-Blind Method
KW  - Female
KW  - Humans
KW  - Neoplasm Metastasis
KW  - Stroke Volume/de [Drug Effects]
KW  - Taxoids/ad [Administration & Dosage]
KW  - Taxoids/ae [Adverse Effects]
KW  - Washington Cancer Institute
KW  - Clinical Trial, Phase III
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1996 - present
N2  - 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; 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); 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; 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
UR  - http://dx.doi.org/10.1634/theoncologist.2012-0448
ER  -