Randomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer.
Authors
Wardley, Andrew MPivot, Xavier
Morales-Vasquez, Flavia
Zetina, Luis M
De Fátima Dias Gaui, Maria
Reyes, Douglas Otero
Jassem, Jacek
Barton, Claire
Button, Peter
Hersberger, Veronica
Torres, Antonio Antón
Affiliation
Cancer Research UK Department of Medical Oncology, The Christie, 550 Wilmslow Rd, Manchester, M20 4BX, United Kingdom. andrew.wardley@christie.nhs.ukIssue Date
2010-02-20
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PURPOSE 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.Citation
Randomized 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 OncolJournal
Journal of Clinical OncologyDOI
10.1200/JCO.2008.21.6531PubMed ID
20038734Type
ArticleLanguage
enISSN
1527-7755ae974a485f413a2113503eed53cd6c53
10.1200/JCO.2008.21.6531
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