000 03784nam a22005177a 4500
008 150603s20142014 xxu||||| |||| 00| 0 eng d
022 _a1083-7159
040 _aOvid MEDLINE(R)
099 _a24869931
245 _aSafety 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.
251 _aOncologist. 19(7):693-701, 2014 Jul.
252 _aOncologist. 19(7):693-701, 2014 Jul.
253 _aThe oncologist
260 _c2014
260 _fFY2015
266 _d2015-06-03
501 _aAvailable online from MWHC library: 1996 - present
520 _aCONCLUSION: 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.Copyright ©AlphaMed Press.
520 _aINTRODUCTION: 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.
520 _aPATIENTS 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/m(2). All study drugs were given intravenously, 3 times weekly.
520 _aRESULTS: Docetaxel dose reductions below 75 mg/m(2) were more common in patients from Asia (47.0%) than other regions (13.4%); docetaxel dose escalations to 100 mg/m(2) 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).
546 _aEnglish
650 _a*Antineoplastic Combined Chemotherapy Protocols/ae [Adverse Effects]
650 _a*Antineoplastic Combined Chemotherapy Protocols/tu [Therapeutic Use]
650 _a*Breast Neoplasms/dt [Drug Therapy]
650 _a*Receptor, ErbB-2/me [Metabolism]
650 _aAdult
650 _aAged
650 _aAged, 80 and over
650 _aAntibodies, Monoclonal, Humanized/ad [Administration & Dosage]
650 _aAntibodies, Monoclonal, Humanized/ae [Adverse Effects]
650 _aBiomarkers, Pharmacological
650 _aBreast Neoplasms/en [Enzymology]
650 _aDouble-Blind Method
650 _aFemale
650 _aHumans
650 _aMiddle Aged
650 _aTaxoids/ad [Administration & Dosage]
650 _aTaxoids/ae [Adverse Effects]
650 _aTreatment Outcome
651 _aWashington Cancer Institute
700 _aSwain, Sandra M
790 _aBaselga J, Chan V, Clark E, Im SA, Im YH, Knott A, Miles D, Ross G, Swain SM
856 _uhttp://dx.doi.org/10.1634/theoncologist.2014-0033
_zhttp://dx.doi.org/10.1634/theoncologist.2014-0033
942 _cART
_dArticle
999 _c1581
_d1581