Safety profile of pertuzumab with trastuzumab and docetaxel in patients from Asia with human epidermal growth factor receptor 2-positive metastatic breast cancer: Results from the phase III trial CLEOPATRA Journal Article


Authors: Swain, S. M.; Im, Y. H.; Im, S. A.; Chan, V.; Miles, D.; Knott, A.; Clark, E.; Ross, G.; Baselga, J.
Article Title: Safety profile of pertuzumab with trastuzumab and docetaxel in patients from Asia with human epidermal growth factor receptor 2-positive metastatic breast cancer: Results from the phase III trial CLEOPATRA
Abstract: Introduction. We report detailed safety analyses by geographic region from the phase III study CLEOPATRA with pertuzumab, trastuzumab, and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive first-line metastatic breast cancer. Patients and Methods. Patients received pertuzumab/placebo at 840 mg in cycle 1 and 420 mg in subsequent cycles, and trastuzumab at 8 mg/kg in cycle 1 and 6 mg/kg in subsequent cycles; docetaxel was initiated at 75 mg/m2. All study drugs were given intravenously, 3 times weekly. Results. Docetaxel dose reductions below 75 mg/m2 were more common in patients from Asia (47.0%) than other regions (13.4%); docetaxel dose escalations to 100 mg/m2 were less frequent in Asia (2.4%) than other regions (18.7%). Rates of edema (26.1% and 5.4% for Asia and other regions, respectively), myalgia (42.3%, 14.7%), nail disorder (39.9%, 15.1%), febrile neutropenia (18.6%, 7.1%), upper respiratory tract infection (25.7%, 10.2%), decreased appetite (47.0%, 19.1%), and rash (44.3%, 22.0%) were at least twice as high in Asia as in other regions. Adverse events did not result in a reduction in the median number of study treatment cycles administered in patients from Asia. Efficacy analyses per region showed hazard ratios similar to those of the whole intention-to-treat (ITT) population for progression-free survival (ITT: 0.63; Asia: 0.68; other regions: 0.61) and overall survival (ITT: 0.66; Asia: 0.64; other regions: 0.66). Conclusion. Despite a higher proportion of docetaxel dose reductions in patients from Asia, survival benefits were comparable between regions. The benefit-risk profile of pertuzumab, trastuzumab, and docetaxel supports this regimen as the first-line therapy for patients with HER2-positive metastatic breast cancer from all geographic regions. © Alpha Med Press 2014.
Keywords: adult; cancer survival; controlled study; aged; major clinical study; overall survival; constipation; fatigue; neutropenia; doxorubicin; placebo; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; cancer incidence; edema; progression free survival; multiple cycle treatment; mucosa inflammation; nausea; vomiting; myalgia; peripheral neuropathy; epidermal growth factor receptor 2; risk assessment; docetaxel; drug dose escalation; febrile neutropenia; nail disease; rash; peripheral edema; drug clearance; asia; trastuzumab; drug dose increase; breast metastasis; double blind procedure; alopecia; granulocyte colony stimulating factor; upper respiratory tract infection; pertuzumab; decreased appetite; phase 3 clinical trial (topic); left ventricular systolic dysfunction; human; female; priority journal; article; her2-positive metastatic breast cancer
Journal Title: The Oncologist
Volume: 19
Issue: 7
ISSN: 1083-7159
Publisher: Oxford University Press  
Date Published: 2014-07-01
Start Page: 693
End Page: 701
Language: English
DOI: 10.1634/theoncologist.2014-0033
PROVIDER: scopus
PMCID: PMC4077449
PUBMED: 24869931
DOI/URL:
Notes: Export Date: 1 August 2014 -- CODEN: OCOLF -- Source: Scopus
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  1. Jose T Baselga
    484 Baselga