PMID- 24868024 OWN - NLM STAT- MEDLINE DCOM- 20140815 LR - 20221207 IS - 1527-7755 (Electronic) IS - 0732-183X (Linking) VI - 32 IP - 19 DP - 2014 Jul 1 TI - 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. PG - 2039-49 LID - 10.1200/JCO.2013.53.6136 [doi] AB - 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/m(2) 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. CI - (c) 2014 by American Society of Clinical Oncology. FAU - Satoh, Taroh AU - Satoh T AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Xu, Rui-Hua AU - Xu RH AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Chung, Hyun Cheol AU - Chung HC AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Sun, Guo-Ping AU - Sun GP AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Doi, Toshihiko AU - Doi T AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Xu, Jian-Ming AU - Xu JM AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Tsuji, Akihito AU - Tsuji A AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Omuro, Yasushi AU - Omuro Y AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Li, Jin AU - Li J AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Wang, Jin-Wan AU - Wang JW AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Miwa, Hiroto AU - Miwa H AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Qin, Shu-Kui AU - Qin SK AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Chung, Ik-Joo AU - Chung IJ AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Yeh, Kun-Huei AU - Yeh KH AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Feng, Ji-Feng AU - Feng JF AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Mukaiyama, Akihira AU - Mukaiyama A AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Kobayashi, Mikiro AU - Kobayashi M AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Ohtsu, Atsushi AU - Ohtsu A AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. FAU - Bang, Yung-Jue AU - Bang YJ AD - Taroh Satoh, Kinki University School of Medicine, Osaka; Toshihiko Doi and Atsushi Ohtsu, National Cancer Center Hospital East, Chiba; Akihito Tsuji, Kochi Health Sciences Center, Kochi; Yasushi Omuro, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital; Akihira Mukaiyama and Mikiro Kobayashi, GlaxoSmithKline, Tokyo; Hiroto Miwa, Hyogo College of Medicine, Hyogo, Japan; Rui-Hua Xu, Sun Yat-Sen University Cancer Center, Guangzhou; Guo-Ping Sun, First Affiliated Hospital of Anhui Medical University, Hefei; Jian-Ming Xu, 307 Hospital of the People's Liberation Army; Jin-Wan Wang, Cancer Hospital and Institute, Chinese Academy of Medical Sciences, Beijing; Jin Li, Fudan University Cancer Hospital, Shanghai; Shu-Kui Qin, People's Liberation Army 81 Hospital; Ji-Feng Feng, Cancer Hospital of Jiangsu Province, Nanjing, People's Republic of China; Hyun Cheol Chung, Yonsei Cancer Center, Yonsei University College of Medicine; Yung-Jue Bang, Seoul National University College of Medicine, Seoul; Ik-Joo Chung, Chonnam National University Hwasun Hospital, Jeollanamdo, South Korea; and Kun-Huei Yeh, National Taiwan University Hospital, Taipei, Taiwan. bangyj@snu.ac.kr. LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140527 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antineoplastic Agents, Phytogenic) RN - 0 (Biomarkers, Tumor) RN - 0 (Quinazolines) RN - 0VUA21238F (Lapatinib) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) RN - P88XT4IS4D (Paclitaxel) SB - IM MH - Adult MH - Aged MH - Antineoplastic Agents, Phytogenic/administration & dosage/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Area Under Curve MH - *Asian People/genetics/statistics & numerical data MH - Biomarkers, Tumor/*analysis/genetics MH - Drug Administration Schedule MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence MH - Kaplan-Meier Estimate MH - Lapatinib MH - Male MH - Middle Aged MH - Odds Ratio MH - Paclitaxel/administration & dosage/*therapeutic use MH - Pilot Projects MH - Quinazolines/administration & dosage MH - Receptor, ErbB-2/*analysis/genetics MH - Stomach Neoplasms/chemistry/*drug therapy/epidemiology/pathology MH - Treatment Outcome EDAT- 2014/05/29 06:00 MHDA- 2014/08/16 06:00 CRDT- 2014/05/29 06:00 PHST- 2014/05/29 06:00 [entrez] PHST- 2014/05/29 06:00 [pubmed] PHST- 2014/08/16 06:00 [medline] AID - JCO.2013.53.6136 [pii] AID - 10.1200/JCO.2013.53.6136 [doi] PST - ppublish SO - J Clin Oncol. 2014 Jul 1;32(19):2039-49. doi: 10.1200/JCO.2013.53.6136. Epub 2014 May 27.