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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

4867 - The Combination of TAS-102 and Bevacizumab as the third line chemotherapy for metastatic colorectal cancer (TAS-CC3 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

Hirohiko Kamiyama

Citation

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

Authors

H. Kamiyama1, Y. Yoshida2, H. Yoshida3, C. Kosugi4, K. Ishibashi5, K. Ihara6, M. Takahashi1, H. Kuramochi7, A. Fukazawa8, H. Sonoda9, K. Yoshimatsu10, A. Matsuda11, S. Yamaguchi6, H. Ishida5, S. Hasegawa2, T. Yamada3, K. Sakamoto1, K. Koda4

Author affiliations

  • 1 Coloproctological Surgery, Juntendo University School of Medicine, 113-0033 - Tokyo/JP
  • 2 Gastroenterological Surgery, Fukuoka University School of Medicine, 814-0180 - FUKUOKA/JP
  • 3 Gastroenterological Surgery, Nippon Medical School, 113-8603 - Tokyo/JP
  • 4 Surgery, Teikyo University Chiba Medical Center, 299-0111 - Ichihara/JP
  • 5 Digestive Tract And General Surgery, Saitama Medical University, 350-8550 - Saitama/JP
  • 6 Surgical oncology, Dokkyo Medical University, Tochigi/JP
  • 7 Department Of Chemotherapy, Tokyo Women's Medical University Yachiyo Medical Center, Yachiyo/JP
  • 8 Surgery, Iwata City Hospital, Shizuoka/JP
  • 9 Gastroenterological Surgery, Shiga Medical University, Shiga/JP
  • 10 Surgery, Tokyo Women’s Medical University, 162-8666 - Tokyo/JP
  • 11 Surgery, Nippon Medical School Chiba Hokusoh Hospital, 270-1694 - Inzai/JP
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Resources

Abstract 4867

Background

TAS-102 improved overall survival of refractory colorectal cancer patients with median progression free survival (PFS) of 2.0 months (RECOURSE trial). Subsequently, the combination of TAS-102 and Bevacizumab has been shown to extend median PFS with 3.7 months (C-TASK FORCE). However, this study included patients with 2nd line and 3rd line chemotherapy. Our study was planned exclusively for patients receiving this combination as the 3rd line chemotherapy to investigate clinical impact of this combination beyond cytotoxic doublet.

Methods

This phase II study was conducted in investigator-initiated, open-label, single-arm, multicentered manner in Japan. Eligible patients were 20-80 years old, and had to have an Eastern Cooperative Oncology Group performance status of 0 or 1; had confirmed unresectable metastatic colorectal cancer (mCRC) with histologically diagnosed adenocarcinoma; were refractory or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin in the 1st and the 2nd line chemotherapy; and had no previous treatment with regorafenib. TAS-102 (35 mg/ m²) was given orally twice daily on days 1–5 and 8–12 in a 4-weeks cycle, and bevacizumab (5 mg/ kg) was administered by intravenous infusion for 30 minutes in every 2 weeks. The primary endpoint was progression free survival (PFS), and the secondary endpoints were time to treatment failure (TTF), response rate (RR), overall survival (OS), and safety.

Results

Between June 1, 2016, and August 31, 2017, 32 patients with mCRC were enrolled in this study. The median PFS was 4.5 months. Partial response was observed in 2 patients. The most common adverse events above grade 3 were neutropenia (15 patients) followed by thrombocytopenia (4 patients). Treatment-related serious adverse events were reported in one patient. There were no non-hematologic adverse events above grade 3. No treatment-related deaths occurred.

Conclusions

This is the first study which involves the combination of TAS-102 and Bevacizumab as the 3rd line chemotherapy in the setting beyond cytotoxic doublet, and showed to improve PFS for the patients with mCRC. This combination has a potential to be one of therapeutic options of the 3rd line chemotherapy for mCRC.

Clinical trial identification

University Hospital Medical Information Network UMIN#000022438.

Legal entity responsible for the study

TAS-CC3 Study Group.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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