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J Clin Oncol. 2014 Jul 1;32(19):2039-49. doi: 10.1200/JCO.2013.53.6136. Epub 2014 May 27.

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.

Author information

1
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.
2
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.

Abstract

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.

PMID:
24868024
DOI:
10.1200/JCO.2013.53.6136
[Indexed for MEDLINE]
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