دورية أكاديمية
An open-label safety study of lapatinib plus trastuzumab plus paclitaxel in first-line HER2-positive metastatic breast cancer.
| العنوان: | An open-label safety study of lapatinib plus trastuzumab plus paclitaxel in first-line HER2-positive metastatic breast cancer. |
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| المؤلفون: | Esteva FJ; Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, USA. fjesteva@mdanderson.org, Franco SX, Hagan MK, Brewster AM, Somer RA, Williams W, Florance AM, Turner S, Stein S, Perez A |
| المصدر: | The oncologist [Oncologist] 2013 Jun; Vol. 18 (6), pp. 661-6. Date of Electronic Publication: 2013 May 22. |
| نوع المنشور: | Clinical Trial; Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| مواضيع طبية MeSH: | Antibodies, Monoclonal, Humanized/*administration & dosage , Breast Neoplasms/*drug therapy , Neoplasm Metastasis/*drug therapy , Paclitaxel/*administration & dosage , Quinazolines/*administration & dosage, Adult ; Antineoplastic Combined Chemotherapy Protocols ; Breast Neoplasms/genetics ; Breast Neoplasms/pathology ; Drug Administration Schedule ; Drug-Related Side Effects and Adverse Reactions/pathology ; Female ; Humans ; Lapatinib ; Middle Aged ; Neoplasm Metastasis/pathology ; Receptor, ErbB-2/genetics ; Trastuzumab |
| مستخلص: | Background: Recent data support the hypothesis that combining lapatinib and trastuzumab with taxane chemotherapy may offer added clinical benefit to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). This study examined the safety of the triplet combination in first-line HER2-positive MBC. Patients and Methods: Patients were enrolled into three sequential cohorts; the last two cohorts were added by protocol amendment following review of safety data from cohort 1. Patients in cohort 1 received lapatinib (1000 mg/day) plus paclitaxel (80 mg/m(2) per week, 3 of every 4 weeks); cohort 2 received lapatinib (1000 mg/day) plus paclitaxel (70 mg/m(2) per week, 3 of every 4 weeks); and cohort 3 received lapatinib (750 mg/day) plus paclitaxel (80 mg/m(2) per week, 3 of every 4 weeks). All received standard trastuzumab dosing. The primary objective was assessment of dose-limiting toxicities, safety, and tolerability of this combination. Results: The most frequent adverse events (AEs) for all cohorts were diarrhea (89%), rash (79%), fatigue (73%), alopecia (63%), nausea (63%), and vomiting (40%). In cohorts 1 and 2, the incidence of grade 3 diarrhea was 62% and 50%, respectively; in cohort 3, the incidence was 25% (with prophylactic loperamide). Dehydration was the most frequent serious AE (10%). Across cohorts, overall response rate was 75%. Conclusions: The dose-limiting toxicity of paclitaxel, trastuzumab, and lapatinib in first-line HER2-positive MBC was diarrhea. Of the triplet combinations tested, the cohort receiving 750 mg/day dose of lapatinib had the lowest incidence of diarrhea; therefore, this dose should be used in further studies on the treatment of MBC. |
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| فهرسة مساهمة: | Keywords: Breast cancer; HER2; Lapatinib; Paclitaxel; Trastuzumab |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00272987 |
| المشرفين على المادة: | 0 (Antibodies, Monoclonal, Humanized) 0 (Quinazolines) 0VUA21238F (Lapatinib) EC 2.7.10.1 (ERBB2 protein, human) EC 2.7.10.1 (Receptor, ErbB-2) P188ANX8CK (Trastuzumab) P88XT4IS4D (Paclitaxel) |
| تواريخ الأحداث: | Date Created: 20130524 Date Completed: 20140213 Latest Revision: 20211021 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC4063391 |
| DOI: | 10.1634/theoncologist.2012-0129 |
| PMID: | 23697602 |
| قاعدة البيانات: | MEDLINE |
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