https://scholars.lib.ntu.edu.tw/handle/123456789/543481
標題: | Lapatinib plus paclitaxel versus paclitaxel alone in the second-line treatment of HER2-amplified advanced gastric cancer in Asian populations: TyTAN - A randomized, phase III study | 作者: | Satoh T. Doi T. Ohtsu A. Tsuji A. Omuro Y. Mukaiyama A. Kobayashi M. Miwa H. Xu R.-H. Sun G.-P. Xu J.-M. Wang J.-W. Li J. Qin S.-K. Feng J.-F. Chung H.C. Bang Y.-J. Chung I.-J. KUN-HUEI YEH |
公開日期: | 2014 | 出版社: | American Society of Clinical Oncology | 卷: | 32 | 期: | 19 | 起(迄)頁: | 2039-2049 | 來源出版物: | Journal of Clinical Oncology | 摘要: | Purpose: In Asian countries, paclitaxel once per week is used as second-line treatment in advanced gastric cancer, including human epidermal growth factor receptor 2 (HER2) -positive tumors. The role of anti-HER2 agents, including lapatinib, in this setting and population is unclear. Patients and Methods: TyTAN was a two-part, parallel-group, phase III study in Asian patients. An open-label, dose-optimization phase (n = 12) was followed by a randomized phase (n = 261), in which patients who were HER2 positive by fluorescence in situ hybridization (FISH) received lapatinib 1,500 mg once per day plus once-per-week paclitaxel 80 mg/m2 or paclitaxel alone. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), time to progression (TTP), overall response rate (ORR), time to response, response duration, and safety. Analyses were based on immunohistochemistry (IHC) and gastrectomy status, prior trastuzumab therapy, and regional subpopulations. Results: Median OS was 11.0 months with lapatinib plus paclitaxel versus 8.9 months with paclitaxel alone (P = .1044), with no significant difference in median PFS (5.4 v 4.4 months) or TTP (5.5 v 4.4 months). ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone (odds ratio, 3.85; P < .001). Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC3+ compared with IHC0/1+ and 2+ patients and in Chinese compared with Japanese patients. A similar proportion of patients experienced adverse events with each treatment (lapatinib plus paclitaxel, 100% v paclitaxel alone, 98%). Conclusion: Lapatinib plus paclitaxel demonstrated activity in the second-line treatment of patients with HER2 FISH-positive IHC3+ advanced gastric cancer but did not significantly improve OS in the intent-to-treat population. ? 2014 by American Society of Clinical Oncology. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84905566147&doi=10.1200%2fJCO.2013.53.6136&partnerID=40&md5=cd918276d5a9373b75f90d05b2413d9a https://scholars.lib.ntu.edu.tw/handle/123456789/543481 |
ISSN: | 0732-183X | DOI: | 10.1200/JCO.2013.53.6136 | SDG/關鍵字: | alanine aminotransferase; aspartate aminotransferase; lapatinib; paclitaxel; trastuzumab; abdominal pain; acute heart infarction; adult; advanced cancer; alopecia; anemia; area under the curve; arthralgia; article; Asian; asthenia; backache; body weight disorder; cancer combination chemotherapy; cancer growth; cancer immunotherapy; cancer surgery; cancer survival; cardiotoxicity; constipation; controlled study; decreased appetite; diarrhea; drug fever; drug response; drug safety; drug tolerability; drug withdrawal; fatigue; febrile neutropenia; female; fluorescence in situ hybridization; gastrectomy; heart arrest; heart left ventricle failure; human; interstitial lung disease; leukocyte; lymphocytopenia; major clinical study; male; maximum plasma concentration; monotherapy; myalgia; nausea; neutropenia; neutrophil count; optimal drug dose; overall survival; peripheral neuropathy; phase 3 clinical trial (topic); plasma concentration-time curve; pneumonia; priority journal; progression free survival; pruritus; randomized controlled trial; randomized controlled trial (topic); rash; sensory neuropathy; stomach cancer; stomatitis; time to maximum plasma concentration; vomiting; Adult; Aged; Antineoplastic Agents, Phytogenic; Antineoplastic Combined Chemotherapy Protocols; Area Under Curve; Asian Continental Ancestry Group; Drug Administration Schedule; Female; Humans; In Situ Hybridization, Fluorescence; Kaplan-Meier Estimate; Male; Middle Aged; Odds Ratio; Paclitaxel; Pilot Projects; Quinazolines; Receptor, erbB-2; Stomach Neoplasms; Treatment Outcome; Tumor Markers, Biological |
顯示於: | 腫瘤醫學研究所 |
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