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Poster display session

3326 - A phase II study of combination chemotherapy with cetuximab/S-1/low dose cisplatin as neoadjuvant manner for oral squamous cell carcinoma patients.


10 Sep 2017


Poster display session


Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Head and Neck Cancers


Mitsuhiro Nakazawa


Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374


M. Nakazawa1, T. Imai1, Y. Matsumiya1, M. Suematsu2, Y. Ohta3, T. Ohnishi4, M. Ohmae5, H. Chisoku6, I. Kato1, S. Tada2, A. Takeshita1

Author affiliations

  • 1 Oral & Maxillofacial Surgery 2, Osaka University Graduate School of Dentistry, 5650871 - Suita/JP
  • 2 Oral & Maxillofacial Surgery, Meiwa Hospital, 6638186 - Nishinomiya/JP
  • 3 Oral & Maxillofacial Surgery, Itami City Hospital, 6648540 - Itami/JP
  • 4 Oral & Maxillofacial Surgery, Ikeda Municipal Hospital, 5638510 - Ikeda/JP
  • 5 Oral & Maxillofacial Surgery, Rinku General Medical Center, 5988577 - Izumisano/JP
  • 6 Oral & Maxillofacial Surgery, Higashiosaka City Medical Center, 5788588 - Higashiosaka/JP


Abstract 3326


In oral cancer therapy, functional preservation, as well as survival, is a very important matter to consider. One of the methods for organ preservation is an effective preoperative (neoadjuvant) chemotherapy. We previously reported the good antitumor effect and good tolerance of low dose cisplatin/S-1 at ESMO 2004 and 2006. Cetuximab enhances the antitumor effect of cisplatin/5-Fluorouracil . We investigated the feasibility of combining cetuximab/low dose cisplatin/S-1 chemotherapy as a neoadjuvant regimen for patients with oral squamous cell carcinoma.


Consecutive patients (n = 14) with newly diagnosed stage II-IV oral squamous cell carcinoma were enrolled in this study from July 2014 to June 2016. Patients were administered S-1 80mg/m2/day (day 1-14), cisplatin 5 mg/m2/day (day 1-5,8-12) and cetuximab 400mg/m2/day on day 1 and 250mg m2/day on day 8. This was followed by definitive surgery. Clinical response was assessed by clinical findings and/or CT according to RECIST and histopathological effects were evaluated with surgical specimens.


The rate of clinical response, including complete response (CR) and partial response (PR), was 85.7%: CR 21.8%, PR 64.3%, SD (stable disease) 14.3%. The rate of histological response was 71.4%: CR 21.4%, PR 50%, no change 28.6%. Toxicities above grade 3 were neutropenia (7.1%), hypokalaemia (7.1%), leukocytopenia (7.1%), thrombocytopenia (7.1%), anorexia (21.4%), diarrhoea (7.1%) and nausea (7.1%). Most toxicities disappeared within 8 weeks after chemotherapy. No serious adverse effects were observed in the majority of patients. Conservative surgery was applied to 12 patients, except 2 patients with SD and 5 of 9 patients who needed reconstruction were able to avoid reconstructive surgery.


Combination chemotherapy with cetuximab/low dose cisplatin/S-1 represents an effective antitumor therapy with mild to moderate toxicities. It is suggested that this regimen is superior to low dose cisplatin/S-1 and can promote function preserving surgery.

Clinical trial identification


Legal entity responsible for the study

Individual person




All authors have declared no conflicts of interest.

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