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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).

Date

21 Oct 2018

Session

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

Topics

Immunotherapy

Tumour Site

Gastric Cancer

Presenters

Keisho Chin

Citation

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

Authors

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
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Abstract 2068

Background

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.

Methods

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.

Results

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.

Conclusions

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

UMIN000017602,18/5/2015.

Legal entity responsible for the study

The authors.

Funding

Japanese Foundation for Multidisciplinary Treatment of Cancer.

Editorial Acknowledgement

Disclosure

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.

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