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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

5820 - Phase II Study of Cetuximab Rechallenge in Patients with RAS Wild-Type metastatic Colorectal Cancer: E-Rechallenge Trial

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

Hiroshi Osawa

Citation

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

Authors

H. Osawa1, E. Shinozaki2, M. Nakamura3, Y. Ohhara4, Y. Shindo5, M. Shiozawa6, H. Uetake7, H. Matsumoto8, N. Ureshino9, H. Satake10, T. Kobayashi11, T. Suto12, S. Kitano13, Y. Ohashi14, K. Uemura15, K. Yamaguchi16

Author affiliations

  • 1 Department Of Oncology And Hematology, Edogawa Hospital, 133-0052 - Tokyo/JP
  • 2 Gastrointestinal Oncology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 3 Aizawa Comprehensive Cancer Center, Aizawa Hospital, 390-8510 - Matsumoto/JP
  • 4 Department Of Gastroenterology, Sapporo Medical Center, Sapporo/JP
  • 5 Gastroenterological Surgery, Nakadori General Hospital, 010-8577 - Akita/JP
  • 6 Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama/JP
  • 7 Specialized Surgeries, Tokyo Medical and Dental University, Tokyo/JP
  • 8 Department Of Surgery, Cancer And Infectious Diseases Center, Tokyo Metropolitan Komagome Hospital, Tokyo/JP
  • 9 Medical Oncology, Saga-Ken Medical Center Koseikan, Saga/JP
  • 10 Department Of Medical Oncology, Kobe City Medical Center General Hospital, 650-0047 - Kobe/JP
  • 11 Department Of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka/JP
  • 12 Department Of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, Yamagata/JP
  • 13 Graduate School Of Engineering, Osaka University, Osaka/JP
  • 14 Integrated Science And Engineering For Sustainable Society, Chuo University, Tokyo/JP
  • 15 Division Of Biostatistics And Bioinformatics, Interfacluty Initiative In Information Studies, The University of Tokyo, Tokyo/JP
  • 16 Department Of Gastroenterology, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
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Resources

Abstract 5820

Background

Several previous reports indicated that cetuximab (Cmab) rechallenge may be efficacious in patients for whom Cmab was previously effective. On the other hand, some reports did not support this. Considering the plasticity of sensitive clone, we assumed that an anti-EGFR antibody-free interval (aEFI) and efficacy may be correlated. This current study investigates the efficacy and safety of Cmab rechallenge as a salvage chemotherapy.

Methods

The E-Rechallenge tiral is a multicenter phase II study in mCRC patients who have become refractory to fluoropyrimidines, L-OHP, CPT-11, Cmab and bevacizumab, and in whom previous treatment with Cmab was effective in any earlier line (achieving CR, PR, or SD that persisted for ≥6 months). The other main eligibility criteria are; RAS wild-type, measurable disease, aEFI ≥16 weeks between the last dose of Cmab during previous treatment and the start of Cmab rechallenge. Protocol treatment is the combination of weekly Cmab with biweekly CPT-11. The primary endpoint is response rate (RR). Secondary endpoints are progression free survival (PFS), overall survival (OS), association between the aEFI and efficacy, and safety. Using a single-stage binominal design, 45 patients were required; a RR of ≥ 20% was considered promising, and a RR of ≤ 5% unacceptable (one-sided α = 2.5%, β = 10%). Additional research of ctDNA was conducted optionally.

Results

Between Dec 2014 and Oct 2017, 33 patients were enrolled. Patients’ characteristics were as follows; mean age 64.4, male/female 84.8%/15.2%, primary location right/left 12.1%/87.9% and the efficacy in previous Cmab, CR/PR/SD ≥6 months 3%/78.8%/18.2%, respectively. The primary endpoint; the rates of PR/SD/PD (95%CI) were PR 15.6% (5.3-32.7%)/SD 40.6% (23.6-57.6%)/ PD 43.8% (26.4-62.3%). Secondary endpoint; median PFS and OS (95%CI) were 88 days (62-113days) and 262 days (195-307days). There were no statistical significant difference of PFS stratified by median aEFI. New signals of adverse events were not identified.

Conclusions

Cmab rechallenge showed some activity in the salvage setting, in patients for whom Cmab was previously effective. The additional research of ctDNA may contribute to identify patients with benefit from Cmab rechallenge.

Clinical trial identification

UMIN 000016439.

Legal entity responsible for the study

Comprehensive Support Project for Oncological Research.

Funding

Merck Serono.

Editorial Acknowledgement

Disclosure

E. Shinozaki, H. Satake: Honoraria: Merck Serono. All other authors have declared no conflicts of interest.

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