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Department of Head and Neck Medical Oncology

Makoto Tahara, Susumu Okano, Tomoko Yamazaki, Tomohiro Enokida, Tetsuro Wakasugi


The Department of Head and Neck Medical Oncology is engaged in the clinical management of patients with head and neck cancer (HNC), and research into anticancer drugs for the treatment of HNC.

Our missions are to:

  1. provide the best evidence-based treatment
  2. promote the importance of supportive care in the treatment of patients with HNC
  3. facilitate the timely approval of new drugs by active participation in global clinical trials to eliminate the drug lag
  4. develop cutting-edge treatments
  5. train experts in head and neck medical oncology

Routine activities

Our department consists of three physicians, one senior resident and one resident. We manage the treatment of HNC patients who receive anticancer drugs. An estimated 60% of HNC patients require a multidisciplinary approach, including surgery, radiotherapy, and chemotherapy. Furthermore, HNC patients are at risk of injury and impairment of vital organs both from the cancer itself and from the series of treatments provided to cure it. In treating patients, we therefore, carefully assess both the curability of the condition and possible subsequent complications, such as swallowing dysfunction and cosmetic changes. Given the increasing complexity of the management of HNC, the recommended treatment for patients who are referred to our institution is decided at weekly tumor board meetings attended by a multidisciplinary team.

A total of 276 patients were referred to our department from January 2015 to December 2015 (Table 1). The outpatient service of our department is available from Monday to Friday. We carefully follow patients during and after treatment and provide palliative chemotherapy as an outpatient service.

Research activities

Our research activity has focused on two areas: the development of new treatments in clinical trials for HNC and biomarker analysis in HNC.

Development of new treatments

Based on the results of our previously reported feasibility study (Kiyota N, Tahara M, et. al, The Japanese Journal of Clinical Oncology 2012), a multicenter phase II/III trial of postoperative concurrent chemoradiotherapy with weekly CDDP compared with postoperative concurrent chemoradiotherapy with 3-weekly CDDP for high risk squamous cell carcinoma of the head and neck (SCCHN) (The Japan Clinical Oncology Group (JCOG) 1008) is now ongoing. In phase II, the safety of both treatment arms has been confirmed.

After the approval of cetuximab for HNC in Japan, the following multicenter clinical trials that we planned as the primary investigator are ongoing: 1) CSPOR-HN01: The phase II study of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab with concurrent radiotherapy in patients with local advanced SCCHN, 2) CSPORHN02: Phase II trial of a combination with paclitaxel, carboplatin and cetuximab (PCE) as a first line treatment in patients with recurrent and/or metastatic SCCHN. Patient enrollments of both trials have been completed and the results will be open soon.

Biomarker analysis

An analysis of gene expression profiles in tongue squamous cell carcinoma (TSCC) is being carried out to determine the biomarker that can predict treatment outcomes. We then identified 27 genes with the most predictive value for recurrence, five genes highly expressed in the low-risk group and 22 highly expressed in the high-risk group. Clustering into high- and low-risk groups based on this 27-gene expression in a validation study also showed a significant association with recurrence. Clinicopathological and biomarker analyses of early stage (T1/2) TSCC are also ongoing.

A prospective study to compare the miRNA expression patterns in head and neck cancer patients revealed that an extreme change of expression was observed in 6 miRNAs before and after completion of surgery and 20 miRNAs between healthy volunteers and head and neck cancer patients. These results suggest that these miRNAs will be good candidates for biomarkers to predict either incidence or recurrence for HNC.

Clinical trials

A feasibility study of a combination with docetaxel, cisplatin and 5-FU (TPF) as an induction chemotherapy (IC) for locally advanced SCCHN has been completed. A total of 48 patients were accrued. 41 patients (85.4%) received the full course of IC and 33 patients (82.5%) received the planned cardiac resynchronization therapy (CRT). To evaluate the feasibility of a combination with paclitaxel, carboplatin and cetuximab (PCE) as IC, a feasibility study for unresectable locally advanced SCCHN is now ongoing.

To facilitate the timely approval of new drugs and eliminate the drug lag, we have also participated in the global phase trials including immune-checkpoint inhibitors.


We educate not only medical staff in our institute but also outside of our institute by conducting the following education program: 1) Seminar of Japan society of supportive care for patients with HNC and 2) Preceptorship in HNC. A number of Asian physicians participated in preceptorship in HNC this year. Furthermore, our department is accepting trainees all the time.

Future prospects

We hope that ongoing or planned clinical trials will change the standard of care for HNC and our biomarker analysis will lead to the development of new treatment strategies. Our education program will increase the number of medical oncologists who take charge of treatment for HNC, leading to improving patient's quality of life.

Table 1. Number of patients according to sites Table 2. Number of patients according to procedure

List of papers published in 2015


  1. Tahara M, Kiyota N, Mizusawa J, Nakamura K, Hayashi R, Akimoto T, Hasegawa Y, Iwae S, Monden N, Matsuura K, Fujii H, Onozawa Y, Homma A, Kubota A, Fukuda H, Fujii M. Phase II trial of chemoradiotherapy with S-1 plus cisplatin for unresectable locally advanced head and neck cancer (JCOG0706). Cancer Sci, 106:726-733, 2015
  2. Zenda S, Ishi S, Akimoto T, Arahira S, Motegi A, Tahara M, Hayashi R, Asanuma C. DeCoP, a Dermatitis Control Program using a moderately absorbent surgical pad for head and neck cancer patients receiving radiotherapy: a retrospective analysis. Jpn J Clin Oncol, 45:433-438, 2015
  3. Zenda S, Kawashima M, Arahira S, Kohno R, Nishio T, Tahara M, Hayashi R, Akimoto T. Late toxicity of proton beam therapy for patients with the nasal cavity, para-nasal sinuses, or involving the skull base malignancy: importance of long-term follow-up. Int J Clin Oncol, 20:447-454, 2015
  4. Schlumberger M, Tahara M, Wirth LJ, Robinson B, Brose MS, Elisei R, Habra MA, Newbold K, Shah MH, Hoff AO, Gianoukakis AG, Kiyota N, Taylor MH, Kim SB, Krzyzanowska MK, Dutcus CE, de las Heras B, Zhu J, Sherman SI. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med, 372:621-630, 2015
  5. Kiyota N, Tahara M, Fujii M. Adjuvant treatment for post-operative head and neck squamous cell carcinoma. Jpn J Clin Oncol, 45:2-6, 2015
  6. Machiels JP, Haddad RI, Fayette J, Licitra LF, Tahara M, Vermorken JB, Clement PM, Gauler T, Cupissol D, Grau JJ, Guigay J, Caponigro F, de Castro G, de Souza Viana L, Keilholz U, Del Campo JM, Cong XJ, Ehrnrooth E, Cohen EE, LUX-H&N 1 investigators. Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial. Lancet Oncol, 16:583-594, 2015
  7. Schlumberger M, Tahara M, Wirth LJ. Lenvatinib in radioiodine-refractory thyroid cancer. N Engl J Med, 372:1868, 2015
  8. Kiyota N, Schlumberger M, Muro K, Ando Y, Takahashi S, Kawai Y, Wirth L, Robinson B, Sherman S, Suzuki T, Fujino K, Gupta A, Hayato S, Tahara M. Subgroup analysis of Japanese patients in a phase 3 study of lenvatinib in radioiodine-refractory differentiated thyroid cancer. Cancer Sci, 106:1714-1721, 2015
  9. Tahara M, Fuse N, Mizusawa J, Sato A, Nihei K, Kanato K, Kato K, Yamazaki K, Muro K, Takaishi H, Boku N, Ohtsu A. Phase I/II trial of chemoradiotherapy with concurrent S-1 and cisplatin for clinical stage II/III esophageal carcinoma (JCOG 0604). Cancer Sci, 106:1414-1420, 2015


  1. Tahara M. Systemic chemotherapy. In: Kirita T, Omura K (eds), Oral Cancer - Diagnosis and Therapy, Japan, Springer Japan, pp 307-318, 2015