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Poster display session

3055 - Multicenter prospective cohort study to evaluate of eye disorder induced by chemotherapy including S-1 (EyeDropS study/HGCSG1604)

Date

10 Sep 2017

Session

Poster display session

Presenters

Masataka Yagisawa

Citation

Annals of Oncology (2017) 28 (suppl_5): v543-v567. 10.1093/annonc/mdx388

Authors

M. Yagisawa1, M. Nakamura2, T. Muranaka1, Y. Kawamoto1, H. Nakatsumi1, S. Yuki3, T. Sasaki4, T. Meguro4, M. Dazai5, A. Ishiguro6, K. Eto7, K. Harada8, Y. Kobayashi9, T. Miyagishima10, I. Iwanaga11, M. Uebayashi11, K. Hatanaka12, N. Sakamoto3, Y. Sakata13, Y. Komatsu14

Author affiliations

  • 1 Cancer Center, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 2 Gastroenterology, Sapporo City General Hospital, 060-8604 - Sapporo/JP
  • 3 Gastroenterology And Hepatology, Hokkaido University Hospital, 060-8638 - Sapporo/JP
  • 4 Internal Medicine, Hokkaido Gastroenterology Hospital, Sapporo/JP
  • 5 Gastroenterology, Sapporo Medical Center NTT EC, 060-0061 - Sapporo/JP
  • 6 Medical Oncology, Teine Keijinkai Hospital, Sapporo/JP
  • 7 Gastroenterology, Tomakomai City Hospital, Tomakomai/JP
  • 8 Medical Oncology, Kushiro Rosai Hospital, Kushiro/JP
  • 9 Medical Oncology, Kushiro Rosai Hospital, 085-8533 - Kushiro/JP
  • 10 Internal Medicine, Kushiro Rosai Hospital, Kushiro/JP
  • 11 Medical Oncology, Japanese Red Cross Kitami Hospital, 090-0026 - Kitami/JP
  • 12 Gastroenterology, Hakodate Municipal Hospital, 041-8680 - Hakodate/JP
  • 13 Ceo, Misawa City Hospital, 033-0022 - Misawa/JP
  • 14 Cancer Center, Hokkaido University Hospital Cancer Centre, 060-8638 - Sapporo/JP
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Resources

Abstract 3055

Background

We previously reported that S-1 chemotherapy for gastrointestinal cancer (GI cancer) induced the high incidence of eye disorders (EDs), regardless of primary cancer site, treatment regimen and administration schedule (Yagisawa M, et al. 2017 Gastrointestinal Cancers Symposium). However, because this report showed a retrospective data from single institutional small cohort by reviewing medical records, we might have underestimated the incidence of EDs. So, we have conducted this prospective cohort study to confirm the incidence of EDs induced by S-1 more precisely.

Trial design

This is a multicenter prospective cohort study to evaluate the incidence of EDs and ophthalmologic changes in GI cancer patients received S-1 chemotherapy. The key eligibility criteria are as follows: 1) Histologically confirmed carcinoma in GI cancer, including esophageal, gastric, colorectal, pancreatic, and biliary tract cancer.; 2) The patient who receives chemotherapy including S-1.; 3) No prior medication of S-1.; 4) No lachrymal duct obstruction and less than three points of corner conjunctiva epithelium disorder score. All participants receive four times of ophthalmological examinations. The primary endpoint is cumulative incidence of epiphora in periods from start of S-1 chemotherapy to 12 weeks after induction S-1. The secondary endpoints are cumulative incidence of epiphora in overall S-1 chemotherapy periods, the time of onset and severity of epiphora, the situation of ophthalmological intervention, ophthalmological changes, risk factors of epiphora, and QOL. Because we supposed that incidence of epiphora at 12 weeks after induction S-1 is 10% as already reported, we calculated the sample size as 160 based on precision of the 95% confidence interval and aimed to recruit 180 patients considering the possibility of 10% dropouts. This study is sponsored by Non Profit Organization Hokkaido Gastrointestinal Cancer Study Group.

Clinical trial identification

UMIN 000027192 24, June, 2017

Legal entity responsible for the study

Hokkaido Gastrointestinal Cancer Study Group

Funding

None

Disclosure

S. Yuki: Honoraria: Taiho Pharmaceutical Y. Sakata: Consultant fee from Taiho Pharmaceutical Co., Ltd., Y. Komatsu: Grants for research and donations: Taiho Pharmaceutical Co., Ltd., All other authors have declared no conflicts of interest.

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