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Poster Display

2699 - Phase II study of third-line cetuximab rechallenge in patients with metastatic wild-type K-RAS colorectal cancer who achieved a clinical benefit in response to first-line cetuximab plus chemotherapy (JACCRO CC-08)


08 Oct 2016


Poster Display


Akihito Tsuji


Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370


A. Tsuji1, T. Eto2, T. Masuishi3, H. Satake4, Y. Segawa5, H. Tanioka6, H. Hara7, M. Kotaka8, T. Sagawa9, T. Watanabe10, M. Nakamura11, T. Takahashi12, Y. Negoro13, D. Manaka14, H. Fujita15, T. Suto16, W. Ichikawa17, M. Fujii18, M. Takeuchi19, T. Nakajima20

Author affiliations

  • 1 Clinical Oncology, Kagawa University Faculty of Medicine/Graduate School of Medicine, 761-0793 - Kagawa/JP
  • 2 Department Of Gastroenterology, Tsuchiura Kyodo General Hospital, Ibaraki/JP
  • 3 Department Of Clinical Oncology, Aichi Cancer Center Hospital, Aichi/JP
  • 4 Department Of Medical Oncology, Kobe City Medical Center General Hospital, Kobe/JP
  • 5 Department Of Medical Oncology, Saitama Medical University Internatl Medical Centre, Saitama/JP
  • 6 Department Of Medical Oncology, Japan Labour Health and Welfare Organization Okayama Rosai Hospital, Okayama/JP
  • 7 Department Of Gastroenterology, Saitama Cancer Center, Saitama/JP
  • 8 Gastrointestinal Cancer Center, Sano Hospital, Kobe/JP
  • 9 Department Of Gastroenterology, Hokkaido Cancer Center, Sapporo/JP
  • 10 Department Of Surgery, Himeji Red Cross Hospital, Himeji/JP
  • 11 Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto/JP
  • 12 Department Of Surgical Oncology, Gifu University Hospital, Gifu/JP
  • 13 Department Of Gastroenterology, Kochi Health Sciences Center, Kochi/JP
  • 14 Gastrointestinal Center, Department Of Surgery, Kyoto-Katsura Hospital, Kyoto/JP
  • 15 Department Of General And Digestive Surgery, Kanazawa Medical University, Kanazawa/JP
  • 16 Department Of Gastroenterological Surgery, Yamagata Prefectural Central Hospital, Yamagata/JP
  • 17 Division Of Medical Oncology, Showa University Fujigaoka Hospital, Yokohama/JP
  • 18 Department Of Digestive Surgery, Nihon University School of Medicine, Tokyo/JP
  • 19 Department Of Clinical Medicine (biostatistics), Kitasato University School of Pharmacy, Tokyo/JP
  • 20 Gastroenterology, Japan Clinical Cancer Research Organization, Tokyo/JP


Abstract 2699


Cetuximab rechallenge has been reported to be promising (Santini D et al. Ann Oncol 2012). We performed a multicenter phase II prospective study in Japan.


The study cohort comprised patients with metastatic wild-type K-RAS colorectal cancer who achieved a clinical benefit (confirmed stable disease for at least 6 months or clinical response) in response to first-line cetuximab plus chemotherapy, then had disease progression and received second-line chemotherapy, and finally had a clear new progression of disease. Patients received bi-weekly irinotecan (150 mg/m2) combined with cetuximab (400 mg/m2 as an initial dose followed by 250 mg/m2 weekly). The primary endpoint was the 3-month progression-free rate. The required sample size was estimated to be at least 30 patients, assuming a 3-month progression-free rate of less than 15% as the null hypothesis versus a 3-month progression-free rate of higher than 35% as the alternative hypothesis, a power of 80%, and an alpha value of 0.05.


A total of 36 patients were recruited. Two patients were excluded: one met the ineligibility criteria, and the other did not receive the study treatment because of poor condition at the time scheduled for treatment. The 3-month progression-free rate of 44.1% (95% confidence interval: 27.4-60.8) met the primary endpoint, with a median progression-free survival time of 2.4 months and an overall survival time of 8.1 months. The overall response rate and disease-control rate were 2.9% and 55.9%, respectively. The most frequent grade 3 to 4 adverse event was neutropenia (28.6%), and skin toxicities occurred in 80% of all patients, as expected.


Third-line cetuximab rechallenge may be clinically beneficial comparable to regorafenib and TAS102, with manageable toxicity.

Clinical trial identification

Trial protocol number: UMIN000010638 UMIN release date: 2013/5/7

Legal entity responsible for the study

Akihito Tsuji


Japan Clinical Cancer Research Organization


A. Tsuji: Horonaria : Merck Serono, Daiichi Sankyo. H. Hara: Horonaria : Merck Serono, Yakult Honsha Research Funding : Merck Serono, Daiichi Sankyo. M. Kotaka: Horonaria : Merck Serono, Yakult Honsha. W. Ichikawa: Consulting fees : Merck Serono, Daiichi Sankyo. All other authors have declared no conflicts of interest.

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