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.

MedStar author(s):
Citation: Oncologist. 18(3):257-64, 2013.PMID: 23475636Institution: Washington Cancer InstituteForm of publication: Journal ArticleMedline article type(s): Clinical Trial, Phase III | Journal Article | Multicenter Study | Randomized Controlled Trial | Research Support, Non-U.S. Gov'tSubject headings: *Antibodies, Monoclonal, Humanized/ae [Adverse Effects] | *Antibodies, Monoclonal, Humanized/tu [Therapeutic Use] | *Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects] | *Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use] | *Breast Neoplasms/dt [Drug Therapy] | *Receptor, erbB-2/bi [Biosynthesis] | *Ventricular Dysfunction, Left/ci [Chemically Induced] | Antibodies, Monoclonal, Humanized/ad [Administration & Dosage] | Breast Neoplasms/pa [Pathology] | Double-Blind Method | Female | Humans | Neoplasm Metastasis | Stroke Volume/de [Drug Effects] | Taxoids/ad [Administration & Dosage] | Taxoids/ae [Adverse Effects]Year: 2013Local holdings: Available online from MWHC library: 1996 - presentISSN:
  • 1083-7159
Name of journal: The oncologistAbstract: 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.All authors: Amadori D, Baselga J, Benyunes MC, Clark E, Cortes J, Ewer MS, Knott A, Miles D, Ross G, Swain SMFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2013-12-24
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Journal Article MedStar Authors Catalog Article 23475636 Available 23475636

Available online from MWHC library: 1996 - present

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.

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