Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

2068 - A phase II study of Trastuzumab with S-1 plus Oxaliplatin for HER2-positive advanced gastric cancer (HIGHSOX).


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology



Tumour Site

Gastric Cancer


Keisho Chin


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


K. Chin1, A. Takashima2, K. Minashi3, S. Kadowaki4, T. Nishina5, T.E. Nakajima6, K. Amagai7, N. Machida8, M. Gotoh9, K. Taku10, N. Ishizuka11, D. Takahari1

Author affiliations

  • 1 Department Of Gastroenterology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 2 Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 104-0045 - Tokyo/JP
  • 3 Clinical Trial Promotion Department, Chiba Cancer Center, Chiba/JP
  • 4 Department Of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya/JP
  • 5 Department Of Gastroenterology, Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 6 Department Of Clinical Oncology, St Marianna University School of Medicine, 216-8511 - Kawasaki city/JP
  • 7 Division Of Gastroenterology, Ibaraki Prefectural Central Hospital, 309-1793 - Kasama/JP
  • 8 Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 4118777 - Shizuoka/JP
  • 9 Cancer Chemotherapy Center, Osaka Medical College, 569-8686 - Takatsuki/JP
  • 10 Department Of Medical Oncology, Shizuoka General Hospital, Shizuoka/JP
  • 11 Clinical Trial Planning And Management, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 2068


Trastuzumab with cisplatin and fluoropyrimidines(FUs) improved the overall survival of patients with human epidermal growth factor receptor type 2 (HER2)-positive advanced gastric cancer (AGC). S-1 plus oxaliplatin (SOX) is a one of the standard regimen for HER2-negative AGC especially in Japan. However, to date, few studies have evaluated the efficacy and safety of trastuzumab combined with SOX in patients with HER2-positive AGC.


This is the multi-central, phase II study that is conducted in 10 Japanese institutions. Patients with HER2-positive AGC received S-1 (80mg/m2) twice a day orally on days 1–14, oxaliplatin (130mg/m2) intravenously on day 1, and trastuzumab (course 1, 8mg /kg; course 2-, 6mg/kg) intravenously on day 1 of a 21-day cycle. The primary end point was confirmed response rate (cRR); secondary end points included overall survival (OS), progression-free survival(PFS), and adverse events.The sample size was determined to be 75cases based on a hypothesis of threshold RR of 50% and an expected RR of 65%, 90% power, with an alpha value of 0.1 (one-sided) using the binomial test.


From June 2015 to January 2018, a total of 78 patients were screened, of whom 75 were enrolled and eligible. The median age was 64 years. ECOG PS(0/1);57/18, unresectable/recurrence; 66/9, Gastric/EGJ; 64/11, pathology(tub1/tub2/por/sig); 13/33/24/5, metastatic sites(LNs/liver/peritoneum/lung/bone/others); 40/35/20/9/3/8. The proportion of IHC 3+ was 73.3%. In the full analysis set of 75 patients as of March 2018, cRR was 65.2% (95% confidence interval (CI).52.4–76.5); n = 66: excluding unconfirmed 9 cases; and the disease control rate was 89.4% (95% CI.79.4-95.6). Median OS, PFS, were estimated as 20.6 (95% CI.14.8–30.6) and 9.4(95% CI.7.4-14.7) months, respectively. Major grade 3 or 4 adverse events included sensory neuropathy (14.7%), neutropenia (9.3%), diarrhea (6.7%), and anemia (6.7%). There were no treatment-related deaths.


Trastuzumab in combination with SOX showed promising activity with well-tolerated toxicities in patients with HER2-positive AGC as well as other platinum and FUs. Final analysis based on confirmed response will be reported at the conference.

Clinical trial identification


Legal entity responsible for the study

The authors.


Japanese Foundation for Multidisciplinary Treatment of Cancer.

Editorial Acknowledgement


A. Takashima: Grants: Gilead Sciences, Takeda Pharmaceutical Company; Personal fees: Takeda Pharmaceutical Company, Taiho Pharmaceutical Co., Ltd, Merck, Chugai Pharmaceutical Company P, Sanofi K.K., outside the submitted work. S. Kadowaki: Grants: Boehringer Ingelheim, Taiho Pharmaceutical, Ono Pharmaceutical, Bristol-Myers Squibb, Eli Lilly Japan. T. Nishina: Grants, Honoraria: Taiho Pharmaceutical, Chugai Pharmaceutical. T.E. Nakajima: Personal financial interests: Eli Lilly, Sanofi, Chugai, Sawai, Bayer, Bristol, Taiho, Merck, Ono, Takeda, Mochida, MSD; Institutional financial interests: Ono, Taiho, A2 Health Care, JCRO, Daiichi-Sankyo, Mediscience Planning. D. Takahari: Honoraria: Taiho Pharmaceutical, Eli Lilly Japan, Chugai Pharmaceutical, Yakult Honsha. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.