دورية أكاديمية
Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE.
| العنوان: | Phase III, Randomized Study of Dual Human Epidermal Growth Factor Receptor 2 (HER2) Blockade With Lapatinib Plus Trastuzumab in Combination With an Aromatase Inhibitor in Postmenopausal Women With HER2-Positive, Hormone Receptor-Positive Metastatic Breast Cancer: ALTERNATIVE. |
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| المؤلفون: | Johnston, SRD, Hegg, R, Im, S-A, Park, IH, Burdaeva, O, Kurteva, G, Press, MF, Tjulandin, S, Iwata, H, Simon, SD, Kenny, S, Sarp, S, Izquierdo, MA, Williams, LS, Gradishar, WJ |
| المساهمون: | Johnston, Stephen, Marsden |
| سنة النشر: | 2018 |
| المجموعة: | The Institute of Cancer Research (ICR): Publications Repository |
| مصطلحات موضوعية: | Humans, Breast Neoplasms, Receptor, erbB-2, Antineoplastic Agents, Aromatase Inhibitors, Postmenopause, Adult, Aged, 80 and over, Middle Aged, Female, Trastuzumab, Lapatinib |
| الوصف: | Purpose Human epidermal growth factor receptor 2 (HER2) targeting plus endocrine therapy (ET) improved clinical benefit in HER2-positive, hormone receptor (HR)-positive metastatic breast cancer (MBC) versus ET alone. Dual HER2 blockade enhances clinical benefit versus single HER2 blockade. The ALTERNATIVE study evaluated the efficacy and safety of dual HER2 blockade plus aromatase inhibitor (AI) in postmenopausal women with HER2-positive/HR-positive MBC who received prior ET and prior neo(adjuvant)/first-line trastuzumab (TRAS) plus chemotherapy. Methods Patients were randomly assigned (1:1:1) to receive lapatinib (LAP) + TRAS + AI, TRAS + AI, or LAP + AI. Patients for whom chemotherapy was intended were excluded. The primary end point was progression-free survival (PFS; investigator assessed) with LAP + TRAS + AI versus TRAS + AI. Secondary end points were PFS (comparison of other arms), overall survival, overall response rate, clinical benefit rate, and safety. Results Three hundred fifty-five patients were included in this analysis: LAP + TRAS + AI (n = 120), TRAS + AI (n = 117), and LAP + AI (n = 118). Baseline characteristics were balanced. The study met its primary end point; superior PFS was observed with LAP + TRAS + AI versus TRAS + AI (median PFS, 11 v 5.7 months; hazard ratio, 0.62; 95% CI, 0.45 to 0.88; P = .0064). Consistent PFS benefit was observed in predefined subgroups. Overall response rate, clinical benefit rate, and overall survival also favored LAP + TRAS + AI. The median PFS with LAP + AI versus TRAS + AI was 8.3 versus 5.7 months (hazard ratio, 0.71; 95% CI, 0.51 to 0.98; P = .0361). Common adverse events (AEs; ≥ 15%) with LAP + TRAS + AI, TRAS + AI, and LAP + AI were diarrhea (69%, 9%, and 51%, respectively), rash (36%, 2%, and 28%, respectively), nausea (22%, 9%, and 22%, respectively), and paronychia (30%, 0%, and 15%, respectively), mostly grade 1 or 2. Serious AEs were reported similarly across the three groups, and AEs leading to discontinuation were lower with LAP + TRAS + AI. ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | Print-Electronic; 748; image/png |
| اللغة: | English |
| تدمد: | 0732-183X 1527-7755 |
| العلاقة: | Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2018, 36 (8), pp. 741 - 748; https://repository.icr.ac.uk/handle/internal/1293Test |
| DOI: | 10.1200/jco.2017.74.7824 |
| الإتاحة: | https://doi.org/10.1200/jco.2017.74.7824Test https://repository.icr.ac.uk/handle/internal/1293Test |
| رقم الانضمام: | edsbas.FF0B67F5 |
| قاعدة البيانات: | BASE |
| تدمد: | 0732183X 15277755 |
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| DOI: | 10.1200/jco.2017.74.7824 |