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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

2221 - Updated analysis of a phase II study of SOX plus trastuzumab for the patients with HER2 positive advanced or recurrent gastric cancer: KSCC/HGCSG/CCOG/PerSeUS1501B

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

Satoshi Yuki

Citation

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

Authors

S. Yuki1, K. Shinozaki2, T. Kashiwada3, T. Kusumoto4, M. Iwatsuki5, H. Satake6, S. Tokunaga7, Y. Emi8, A. Makiyama9, Y. Kawamoto1, Y. Komatsu10, M. Shimokawa11, H. Saeki12, E. Oki12, H. Baba5, Y. Maehara12

Author affiliations

  • 1 Department Of Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Department Of Medical Oncology, Hiroshima Prefectural Hospital, Hiroshima/JP
  • 3 Division Of Hematology, Respiratory Medicine And Oncology, Department Of Internal Medicine, Faculty of Medicine, Saga University, 849-8501 - Saga/JP
  • 4 Department Of Gastroenterological Surgery / Clinical research Institute Cancer Research Division, National Kyushu Medical Center, Fukuoka/JP
  • 5 Department Of Gastroenterological Surgery, Graduate School Of Medical Sciences, Kumamoto University, Kumamoto/JP
  • 6 Department Of Medical Oncology, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 7 Medical Information Center, Kyushu University Hospital, Fukuoka/JP
  • 8 Department Of Surgery, Saiseikai Fukuoka General Hospital, 810 0001 - FUKUOKA/JP
  • 9 Department Of Hematology / Oncology, Japan Community Health care Organization Kyushu Hospital, 811-1395 - Kita-Kyusyu/JP
  • 10 Division Of Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 11 Clinical research Institute, Cancer Biostatistics Laboratory, National Kyushu Cancer Center, 811-1395 - FUKUOKA/JP
  • 12 Department Of Surgery And Science, Graduate School Of Medical Sciences, Kyushu University, Fukuoka/JP
More

Resources

Abstract 2221

Background

Trastuzumab (T-mab) combined with cisplatin and fluoropyrimidines is the standard first line treatment for the patients with HER2-positive advanced gastric cancer (AGC). We conducted first phase II trial to assess the efficacy and safety of T-mab combined with S-1 and oxaliplatin (HER-SOX130) for HER2-positive AGC or recurrent gastric cancer.

Methods

Patients with IHC 3+ or IHC 2+/FISH positive received 80 mg/m2 (80-120 mg/body) S-1 per day orally on days 1–14, 130 mg/m2 oxaliplatin intravenously on day 1, and T-mab (8-mg/kg loading dose and 6 mg/kg thereafter) intravenously on day 1 of a 21-day cycle until one of the criteria for withdrawal of the study treatment occurred. The primary end-point was the response rate (RR). The secondary end-points were adverse events, progression-free survival (PFS), overall survival (OS), time-to-treatment failure (TTF), duration of treatment, time to failure of strategy (TFS) and dose intensity. Adverse events were recorded based on the CTCAE Ver.4.0.

Results

42 patients were enrolled from June 2015 to May 2016. Efficacy and safety analyses were conducted in the full analysis set of 39 patients. The data cut off specific to the survival status was February 19, 2018. The proportion of patients with IHC 3+ was 87%. The incidence of grade 3 or 4 adverse events (>10%) were platelet count decreased (17.9%), anorexia (17.9%), neutrophil count decreased (12.8%), anemia (10.3%), and hyponatremia (10.3%). The confirmed RR assessed by the independent review committee was 82.1%(32/39) (95%C.I.: 67.3–91.0), and the disease control rate was 87.2%(34/39) (95%C.I.: 73.3–94.4). 9 cases underwent curative surgery after HER-SOX130. Median PFS, TTF and OS was 7.0 (95%C.I.: 5.5–14.1), 5.7 (95%C.I.: 4.6–7.0) and 27.7 (95%C.I.: 15.6–) months, respectively.

Conclusions

HER-SOX130 demonstrates promising response and survival with avourable safety profile. HER-SOX130 should be considered for the patients with HER2-positive AGC.

Clinical trial identification

UMIN000017552, 2015/05/29.

Legal entity responsible for the study

Kyushu Study group of Clinical Cancer.

Funding

Kyushu Study group of Clinical Cancer.

Editorial Acknowledgement

Disclosure

S. Yuki, K. Shinozaki, Y. Maehara: Honoraria: Yakult Honsha. Y. Komatsu: Research funding: Yakult Honsha. H. Baba: Donation Yakult Honsha. All other authors have declared no conflicts of interest.

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