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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

1742 - A phase 1 study of IRISOX (irinotecan/S-1/oxaliplatin) in the second-line treatment for gemcitabine-refractory pancreatic cancer.

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

Clinical Research

Tumour Site

Pancreatic Cancer

Presenters

EIJI MIYATA

Citation

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

Authors

E. MIYATA1, K. Okuwaki2, H. Imaizumi3, M. Kida2, T. Iwai2, H. Yamauchi2, T. Kaneko2, R. Hasegawa2, K. Adachi2, M. Tadehara2, W. Koizumi1

Author affiliations

  • 1 Gastroenterology, Kitasato University School of Medicine, 2520329 - Sagamihara/JP
  • 2 Gastroenterology, Kitasato University School of Medicine, 252-0329 - Sagamihara/JP
  • 3 Gastroenterology, Japan Community Health care Organization, Sagamino Hospital, 252-0206 - Sagamihara/JP
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Resources

Abstract 1742

Background

In Japan, gemcitabine based chemotherapy has been a standard regimen as one of the first-line treatment for unresectable pancreatic cancer. FOLFIRINOX was introduced in the second-line treatment for the gemcitabine-refractory pancreatic cancer of patients with an ECOG performance status score of 0 or 1. However, FOLFIRINOX requires close monitoring and must be limited to patients with good performance status because of significant toxicity. Further FOLFIRINOX requires a central veins port, and a trouble such as the port infection may occur. Therefore, it is difficult to administer FOLFIRINOX as second-line treatment. The first time in the world, we introduced IRISOX which substituted S-1 for fluorouracil and leucovorin in the second-line treatment. We aimed to evaluate the tolerance, safety, and clinical efficacy of IRISOX in the second-line treatment for the gemcitabine-refractory pancreatic cancer in a phase 1 study.

Methods

The primary objective was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of IRISOX. The study was designed in accordance with a standard 3 + 3 method. Patients received 2-week cycles of treatment. Irinotecan was administered as an intravenous infusion at 100, 120, or 150 mg/m2 on day 1, S-1 was administered orally at 80 mg/m2 twice daily for 7 days, and oxaliplatin was administered as an intravenous infusion at 85 mg/m2 on day 1.

Results

Among the 12 patients enrolled, dose-limiting toxicity was observed in a patient at level 1 (irinotecan 100 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1) , and in two patients at level 2 (irinotecan 120 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1). The MTD was established as level 2. The RD was established as level 1. The most common grade 3-4 toxicity was neutropenia (33.3 %). The overall response rate was 9.0 %. The overall disease control rate was 45.4 %.

Conclusions

Based on the present results, the RD was determined as level 1 (irinotecan 100 mg/ m2 on day 1, S-1 80 mg/m2 twice daily, and oxaliplatin 85 mg/m2 on day 1). IRISOX was well tolerated and showed antitumor efficacy in the second-line treatment for the gemcitabine-refractory pancreatic cancer in a phase 1 study.

Clinical trial identification

UMIN000022964.

Legal entity responsible for the study

Kitasato University School of Medicine, Japan.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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