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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

1616 - A phase II study of bevacizumab and irinotecan plus alternate-day S-1 as a second-line therapy for colorectal cancer. The AIRS study

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

Presenters

Michitaka Honda

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

M. Honda1, C. Matsuda2, C. Tanaka3, K. Kondo4, T. Takahashi5, C. Kosugi6, Y. Tokunaga7, H. Takemoto8, H.M. Kim9, J. Sakamoto10, K. Oba11, H. Mishima12

Author affiliations

  • 1 Minimally Invasive Surgical And Medical Oncology, Fukushima Medical University, 960-1295 - Fukushima/JP
  • 2 Gastroenterological Surgery, Osaka University, Osaka/JP
  • 3 Surgery, Gifu Prefectural General Medical Center, Gifu/JP
  • 4 Surgery, National Hospital Organization, Nagoya Medical Center, 460-0001 - Nagoya/JP
  • 5 Surgical oncology, Gifu University Graduate School of Medicine, Gifu/JP
  • 6 Department Of Surgery, Teikyo University Chiba Medical Center, 299-0111 - Ichihara/JP
  • 7 Surgery, Kyoto Japan Post Hospital, Kyoto/JP
  • 8 Surgery, Kinki Central Hospital, Osaka/JP
  • 9 Surgery, Rinku General Medical Center, Izumisano/JP
  • 10 Surgery, Tokai Central Hospital, 504 0816 - Kakamigahara/JP
  • 11 Biostatistics, The University of Tokyo School of Public Health, Tokyo/JP
  • 12 Surgery, Aichi Medical University, 480-1195 - Nagakute/JP
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Resources

Abstract 1616

Background

The aim of this single-arm phase II clinical trial was to evaluate whether the alternate-day administration of S-1 plus irinotecan would reduce the incidence of severe diarrhea in comparison to consecutive-day S-1 administration (standard IRIS regimen) in second-line treatment in patients with metastatic colorectal cancer.

Methods

Patients with metastatic colorectal cancer after failure with first-line treatment of oxaliplatin and fluoropyrimidine were enrolled. Irinotecan (150 mg/m2) and bevacizumab (5mg/kg) were given intravenously on day 1. Oral S-1 was administered on alternate-days at a dose of 40-60mg twice a day. Cycles were repeated every two weeks. The primary endpoint was the incidence of grade ≥3 diarrhea. Our hypothesis set the 21% as a threshold incidence and 10% as an expected incidence from previous studies with one-sided alpha = 0.05. The secondary endpoints included the relative dose intensity, progression free survival, overall survival and other adverse events.

Results

A total of 51 patients were enrolled. The incidence of grade ≥3 diarrhea was 15.7% (8/51). Other common grade ≥3 adverse events were neutropenia, anemia, thrombocytopenia and fatigue were 13.7% (7/51), 5.9% (3/51), 2.0% (1/51) and 5.9% (3/51), respectively. The relative dose intensities of irinotecan, bevacizumab, and S-1 were 80.0%, 86.8%, and 77.7%, respectively. The median progression free survival and overall survival were 8.4 months (5.8 - 9.8) and 17.1 months (11.8 - 22.3).

Conclusions

The alternate day S-1 administration doesn’t have significant effectiveness to reduce diarrhea in patients who received second line treatment for metastatic colorectal cancer.

Clinical trial identification

UMIN000008947.

Legal entity responsible for the study

Epidemiological and Clinical research Information Network (ECRIN).

Funding

Taiho Pharmaceutical Co., Ltd.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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