https://scholars.lib.ntu.edu.tw/handle/123456789/477730
標題: | Adjuvant lapatinib and trastuzumab for early human epidermal growth factor receptor 2-positive breast cancer: Results From the randomized phase III adjuvant lapatinib and/or trastuzumab treatment optimization trial | 作者: | Piccart-Gebhart M. Holmes E. Baselga J. De Azambuja E. Dueck A.C. Viale G. Zujewski J.A. Goldhirsch A. Armour A. Pritchard K.I. McCullough A.E. Dolci S. McFadden E. Holmes A.P. Tonghua L. Eidtmann H. Dinh P. Di Cosimo S. Harbeck N. Tjulandin S. Im Y.-H. CHIUN-SHENG HUANG Diéras V. Hillman D.W. Wolff A.C. Jackisch C. Lang I. Untch M. Smith I. Boyle F. Xu B. Gomez H. Suter T. Gelber R.D. Perez E.A. |
公開日期: | 2016 | 出版社: | American Society of Clinical Oncology | 卷: | 34 | 期: | 10 | 起(迄)頁: | 1034-1042 | 來源出版物: | Journal of Clinical Oncology | 摘要: | Background Lapatinib (L) plus trastuzumab (T) improves outcomes for metastatic human epidermal growth factor 2-positive breast cancer and increases the pathologic complete response in the neoadjuvant setting, but their role as adjuvant therapy remains uncertain. Methods In the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization trial, patients with centrally confirmed human epidermal growth factor 2-positive early breast cancer were randomly assigned to 1 year of adjuvant therapy with T, L, their sequence (T→L), or their combination (L+T). The primary end point was disease-free survival (DFS), with 850 events required for 80% power to detect a hazard ratio (HR) of 0.8 for L+T versus T. Results Between June 2007 and July 2011, 8,381 patients were enrolled. In 2011, due to futility to demonstrate noninferiority of L versus T, the L arm was closed, and patients free of disease were offered adjuvant T. A protocol modification required P # .025 for the two remaining pairwise comparisons. At a protocol-specified analysis with a median follow-up of 4.5 years, a 16% reduction in the DFS hazard rate was observed with L+T compared with T (555 DFS events; HR, 0.84; 97.5% CI, 0.70 to 1.02; P = .048), and a 4%reduction was observed with T→L compared with T (HR, 0.96; 97.5%CI, 0.80 to 1.15; P = .61). L-treated patients experienced more diarrhea, cutaneous rash, and hepatic toxicity compared with T-treated patients. The incidence of cardiac toxicity was low in all treatment arms. Conclusion Adjuvant treatment that includes L did not significantly improve DFS compared with T alone and added toxicity. One year of adjuvant T remains standard of care. ?2015 by American Society of Clinical Oncology. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84963612956&doi=10.1200%2fJCO.2015.62.1797&partnerID=40&md5=f5d59ae82e311182f1e74c010f8c4d63 https://scholars.lib.ntu.edu.tw/handle/123456789/477730 |
ISSN: | 0732-183X | DOI: | 10.1200/JCO.2015.62.1797 | SDG/關鍵字: | carboplatin; docetaxel; lapatinib; paclitaxel; trastuzumab; antineoplastic agent; epidermal growth factor receptor 2; ERBB2 protein, human; lapatinib; quinazoline derivative; trastuzumab; tumor marker; adult; aged; Article; breast cancer; cancer adjuvant therapy; cardiotoxicity; clinical protocol; controlled study; diarrhea; disease free survival; drug fatality; drug safety; drug withdrawal; epidermal growth factor receptor 2 positive breast cancer; epidermal growth factor receptor 2 positive breast cancer; febrile neutropenia; female; hepatobiliary disease; human; incidence; interstitial pneumonia; liver toxicity; loading drug dose; major clinical study; multicenter study; multiple cycle treatment; neutropenia; phase 3 clinical trial; priority journal; randomized controlled trial; rash; skin toxicity; treatment outcome; treatment response; adjuvant chemotherapy; Breast Neoplasms; cancer staging; chemistry; clinical trial; drug administration; follow up; Kaplan Meier method; middle aged; pathology; patient selection; Adult; Aged; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Biomarkers, Tumor; Breast Neoplasms; Chemotherapy, Adjuvant; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Kaplan-Meier Estimate; Middle Aged; Neoplasm Staging; Patient Selection; Quinazolines; Receptor, ErbB-2; Trastuzumab; Treatment Outcome |
顯示於: | 醫學系 |
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