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dc.contributor.authorWardley, Andrew M
dc.contributor.authorPivot, Xavier
dc.contributor.authorMorales-Vasquez, Flavia
dc.contributor.authorZetina, Luis M
dc.contributor.authorDe Fátima Dias Gaui, Maria
dc.contributor.authorReyes, Douglas Otero
dc.contributor.authorJassem, Jacek
dc.contributor.authorBarton, Claire
dc.contributor.authorButton, Peter
dc.contributor.authorHersberger, Veronica
dc.contributor.authorTorres, Antonio Antón
dc.date.accessioned2010-08-04T11:56:14Z
dc.date.available2010-08-04T11:56:14Z
dc.date.issued2010-02-20
dc.identifier.citationRandomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer. 2010, 28 (6):976-83 J Clin Oncolen
dc.identifier.issn1527-7755
dc.identifier.pmid20038734
dc.identifier.doi10.1200/JCO.2008.21.6531
dc.identifier.urihttp://hdl.handle.net/10541/109046
dc.description.abstractPURPOSE To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. PATIENTS AND METHODS Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m(2) in HTX arm, 100 mg/m(2) in HT arm, every 3 weeks) with or without X (950 mg/m(2) twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. CONCLUSION HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.
dc.language.isoenen
dc.subjectBone Canceren
dc.subjectBreast Canceren
dc.subjectLiver Canceren
dc.subjectCancer Stagingen
dc.subjectSoft Tissue Canceren
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAged, 80 and over
dc.subject.meshAntibodies, Monoclonal
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols
dc.subject.meshBone Neoplasms
dc.subject.meshBreast Neoplasms
dc.subject.meshDeoxycytidine
dc.subject.meshFeasibility Studies
dc.subject.meshFemale
dc.subject.meshFluorouracil
dc.subject.meshHumans
dc.subject.meshIn Situ Hybridization, Fluorescence
dc.subject.meshInternational Agencies
dc.subject.meshLiver Neoplasms
dc.subject.meshMiddle Aged
dc.subject.meshNeoplasm Staging
dc.subject.meshPrognosis
dc.subject.meshReceptor, erbB-2
dc.subject.meshSoft Tissue Neoplasms
dc.subject.meshSurvival Rate
dc.subject.meshTaxoids
dc.subject.meshTreatment Outcome
dc.subject.meshYoung Adult
dc.titleRandomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer.en
dc.typeArticleen
dc.contributor.departmentCancer Research UK Department of Medical Oncology, The Christie, 550 Wilmslow Rd, Manchester, M20 4BX, United Kingdom. andrew.wardley@christie.nhs.uken
dc.identifier.journalJournal of Clinical Oncologyen
html.description.abstractPURPOSE To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. PATIENTS AND METHODS Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m(2) in HTX arm, 100 mg/m(2) in HT arm, every 3 weeks) with or without X (950 mg/m(2) twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. CONCLUSION HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.


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