The Chinese subgroup from a randomized phase III study of lapatinib in combination with weekly paclitaxel versus weekly paclitaxel alone as second-line treatment of HER2-amplified advanced gastric cancer (AGC) in Asian countries.

Authors

null

Guo-ping Sun

Department of Oncology, The First Affiliated Hospital of An Hui Medical University, Hefei, China

Guo-ping Sun , Yan Sun , Rui-hua Xu , Jian-Ming Xu , Jin Li , Jin-Wan Wang , Shukui Qin , Ji Feng Feng , Yi Ba , Lin Shen , Yu-Xian Bai , Yihong Sun , Hongming Pan , Ying Cheng , Shiying Yu , Haijun Zhong , Li Bai , Rongcheng Luo , Mikiro Kobayashi , Atsushi Ohtsu

Organizations

Department of Oncology, The First Affiliated Hospital of An Hui Medical University, Hefei, China, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China, Department of Medical Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China, Cancer Center, 307 Hospital, Academy of Military Medical Science, Beijing, China, Fudan University Shanghai Cancer Center, Shanghai, China, Cancer Institute and Hospital, Chinese Academy of Medical Science, Beijing, China, PLA Cancer Center of Nanjing Bayi Hospital, Nanjing, China, Jiangsu Cancer Hospital, Nanjing, China, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China, Department of Gastrointestinal Oncology, Key laboratory of Carcinogenesis & Translational Research under Ministry of Education, Peking University Cancer Hospital, Beijing, China, Tumor Hospital of Harbin Medical University, Harbin, China, Zhongshan Hospital, Fudan University, Shanghai, China, Shao Yifu Hospital, Hangzhou, China, Jilin Provincial Cancer Hospital, Changchun, China, Oncology Center Tongji Hospital, Wuhan, China, Zhejiang Cancer Hospital, Hangzhou, China, Beijing 301 PLA Hospital, Beijing, China, Guangzhou Nanfang Hospital, Guangzhou, China, GSK Japan Tokyo Head Office, Tokyo, Japan, National Cancer Center Hospital East, Kashiwa, Japan

Research Funding

Pharmaceutical/Biotech Company

Background: TyTAN is a randomized phase III study to evaluate lapatinib (L) plus paclitaxel (P) in pretreated HER2 amplified (HER2+) advanced gastric cancer (AGC). The disease characteristics and GC treatment pattern differed in Japan and in China, so a subgroup analysis was done for subjects recruited in mainland China. Methods: AGC subjects with prior 5-FU and/or cisplatin and HER2 amplification by fluorescence in situ hybridization (FISH) in tumor tissue were randomized 1:1 to L (1500mg QD) and P (80mg/m2, Day 1, 8, 15 q4w) or P alone (80mg/m2, Day 1, 8, 15 q4w). 1st endpoint was overall survival (OS). 2nd endpoints included progression free survival (PFS), overall response rate (ORR) and safety. A total of 95 subjects recruited from mainland China. Results: TyTAN was not significant in OS (HR0.84), but 2 months OS improvement was observed in L+P arm. The results from Chinese subgroup are shown in the Table. The most common adverse events in Chinese subjects were similar as in whole population (neutropenia, diarrhea, rash, leukopenia, anemia, fatigue). Compare to the overall results, less Chinese subjects reported nausea and vomiting. Conclusions: This analysis showed that there were clear regional differences as observed between subjects in China and Japan. The addition of L to P was associated with a clinically meaningful benefit in subjects recruited from mainland China. These data warrants further prospective evaluations on the impact of regional differences in the outcome of HER+ GC in East Asian patients. Clinical trial information: NCT00486954.

Overall (n=261) Mainland Chinese (n=95)
Disease
Type of gastric cancer
Diffuse/intestinal/mixed (%)
34/43/23 51/13/37
PS 0/1 (%) 41/59 21/79
Gastrectomy pylorus removed (%) 49 37
HER2 FISH+ and IHC +++ (%) 53 65
Treatment
 Median treatment duration (weeks) 16.6 18
 Post-study chemotherapy (treatment
vs control arm; %)
58 vs 64 42 vs 42
Efficacy
 OS (HR; 95%CI); median 0.84 (0.64-1.11)
11.0 vs 8.9 months
0.62 (0.39-0.98)
9.7 vs 7.6 months
 PFS (HR; 95%CI); median 0.85(0.63-1.13)
5.4 vs 4.4 months
0.52(0.32-0.86)
7.2 vs 4.7 months
 ORR (treatment vs control) 27% vs 9% 42% vs 8%

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Abstract Details

Meeting

2013 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Esophageal or Gastric Cancer

Clinical Trial Registration Number

NCT00486954

Citation

J Clin Oncol 31, 2013 (suppl; abstr 4109)

DOI

10.1200/jco.2013.31.15_suppl.4109

Abstract #

4109

Poster Bd #

24G

Abstract Disclosures