000 | 03784nam a22005177a 4500 | ||
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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 |
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942 |
_cART _dArticle |
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999 |
_c1581 _d1581 |