頭頸部癌に対するcetuximabの使用経験

Clinical application of cetuximab for head and neck cancer

Ⅰ．はじめに

　近年，乳癌に対するtrastuzumabや悪性リンパ腫に対するrituximabなどの分子標的治療が抗癌薬治療の標準治療として取り入れられるようになり，その予後が著しく改善している^1,2）。頭頸部領域においても海外ではEGF-receptor阻害剤であるcetuximabの臨床試験が盛んに行われており，放射線との併用においてはevidence level Ⅰbに該当するrandomized controlled studyが行われ^3）るなど進行癌に対する効果が広く認められている。一方，国内では大腸癌に対する治験は既に行われている^4）ものの頭頸部癌に対してはこれから開始されようとしている段階である。今回われわれは，わが国で初めて頭頸部癌の進行再発例に対して本剤を個人輸入して使用したので，その使用経験について報告する。

　Cetuximab is an inhibitor directed against the EGF receptor. A randomized controlled study which is applicable to evidence level Ⅰb（according to Oxford Centre for Evidence-based Medicine Levels of Evidence 2001）, enrolled advanced head and neck cancer patients to receive radiation with or without concomitant cetuximab was already performed recently. In US the efficacy of cetuximab is generally recognized but in Japan we have not been approved of the use of the agent for head and neck cancer. We report the first case in Japan that we used cetuximab obtained by the private importation from abroad for the advanced recurrent head and neck cancer.

　A 63-year-old patient visited a hospital due to epistaxis and tooth pain. in December 2001. In May 2002, he was diagnosed of maxillary cancer, and treated with concurrent chemotherapy（5-FU, intra artery）and radiotherapy（50Gy）. In November 2002, recurrence of orbital floor occurred and it was surgically excised. In April 2003, because of the local recurrence, subtotal maxillectomy and free rectus abdominis M. C. flap transfer was performed. In October 2003, because of the local recurrence and metastasis to the parotid gland, additional irradiation（50Gy）to the orbit was performed and it was surgically excised. After that additional operation of neck dissection was performed three times until July 2006. Though he was given TS-1, CDDP＋DOC and administered lymphocyte-activated killer cells therapy, lung and liver metastasis was increased and progression to brain was seen. In this condition he came to our hospital. Because he was anxious to be given cetuximab, we gave him cetuximab of 200mg/body basically every week on basis of sufficient informed consent by the private importation from abroad. Because of poor state of the patient, we reduced the amount of cetuximab as compared with other literatures. After given cetuximab, the clinical data was dramatically improved, and the trend of increasing of tumor was suppressed, and the pain was weakened. We considered that this agent has a possibility for the treatment of advanced recurrent head and neck cancer.