Souichi Yanamoto1, Masahiro Umeda2, Mitomu Kioi3, Tadaaki Kirita4, Tetsuro Yamashita5, Hiroyoshi Hiratsuka6, Satoshi Yokoo7, Hideki Tanzawa8, Narikazu Uzawa9, Takahiko Shibahara10, Yoshihide Ota11, Hiroshi Kurita12, Masaya Okura13, Hiroyuki Hamakawa14, Jingo Kusukawa15, Iwai Tohnai3. 1. Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan. syana@nagasaki-u.ac.jp. 2. Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan. 3. Department of Oral and Maxillofacial Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan. 4. Department of Oral and Maxillofacial Surgery, Nara Medical University, 840 Shijo-Cho, Kashihara, Nara, Japan. 5. Department of Oral and Maxillofacial Surgery, Keiyukai Sapporo Hospital, 1-1-14 Hondori, Shiroishi-ku, Sapporo, Japan. 6. Department of Oral Surgery, Sapporo Medical University School of Medicine, S1 W17, Chuo-ku, Sapporo, Japan. 7. Department of Stomatology and Maxillofacial Surgery, Gunma University Graduate School of Medicine, 3-39-22 Showa-machi, Maebashi, Gunma, Japan. 8. Department of Oral Science, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba, Japan. 9. Department of Maxillofacial Surgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan. 10. Oral Cancer Center, Tokyo Dental College, 5-11-13 Sugano, Ichikawa, Chiba, Japan. 11. Department of Oral and Maxillofacial Surgery, Tokai University School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, Japan. 12. Department of Dentistry and Oral Surgery, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, Japan. 13. First Department of Oral and Maxillofacial Surgery, Graduate School of Dentistry, Osaka University, 1-8 Yamada-Oka, Suita, Osaka, Japan. 14. Department of Oral and Maxillofacial Surgery, Ehime University Graduate School of Medicine, Shitukawa, Toon, Ehime, Japan. 15. Dental and Oral Medical Center, Kurume University School of Medicine, 67 Asahi-machi, Kurume, Fukuoka, Japan.
Abstract
PURPOSE: The purpose of this study was to assess the efficacy and safety of cetuximab plus platinum-based chemotherapy for patients specifically diagnosed with recurrent or metastatic oral squamous cell carcinoma (OSCC). METHODS: We conducted a multicenter retrospective observational study of patients who underwent first-line cetuximab plus platinum-based chemotherapy between December 2012 and June 2015. 65 patients received weekly cetuximab (week 1, 400 mg/m2; subsequent weeks, 250 mg/m2) plus a maximum of six 3-weekly cycles of cisplatin (80 or 100 mg/m2, day 1) or carboplatin (at an area under the curve of 5 mg/mL/min as a 1-h intravenous infusion on day 1) and 5-fluorouracil (800 or 1000 mg/m2/day, days 1-4). Patients with stable disease who received cetuximab plus platinum-based chemotherapy continued to receive cetuximab until disease progression or unacceptable toxicities, whichever occurred first. RESULTS: The median follow-up was 10.5 (range 1.2-34.2) months. The best overall response and the disease control rates were 46.2 and 67.7%, respectively. The median overall survival and progression-free survival rates were 12.1 and 7.8 months, respectively. The most common grades 3-4 adverse events were skin rash (9.2%) followed by leukopenia (6.2%). None of the adverse events were fatal. CONCLUSION: The results of our multicenter retrospective study, which was the largest of its kind to date, suggest that first-line cetuximab plus platinum-based chemotherapy is suitable and well-tolerated for the systemic therapy of recurrent or metastatic OSCC.
PURPOSE: The purpose of this study was to assess the efficacy and safety of cetuximab plus platinum-based chemotherapy for patients specifically diagnosed with recurrent or metastatic oral squamous cell carcinoma (OSCC). METHODS: We conducted a multicenter retrospective observational study of patients who underwent first-line cetuximab plus platinum-based chemotherapy between December 2012 and June 2015. 65 patients received weekly cetuximab (week 1, 400 mg/m2; subsequent weeks, 250 mg/m2) plus a maximum of six 3-weekly cycles of cisplatin (80 or 100 mg/m2, day 1) or carboplatin (at an area under the curve of 5 mg/mL/min as a 1-h intravenous infusion on day 1) and 5-fluorouracil (800 or 1000 mg/m2/day, days 1-4). Patients with stable disease who received cetuximab plus platinum-based chemotherapy continued to receive cetuximab until disease progression or unacceptable toxicities, whichever occurred first. RESULTS: The median follow-up was 10.5 (range 1.2-34.2) months. The best overall response and the disease control rates were 46.2 and 67.7%, respectively. The median overall survival and progression-free survival rates were 12.1 and 7.8 months, respectively. The most common grades 3-4 adverse events were skin rash (9.2%) followed by leukopenia (6.2%). None of the adverse events were fatal. CONCLUSION: The results of our multicenter retrospective study, which was the largest of its kind to date, suggest that first-line cetuximab plus platinum-based chemotherapy is suitable and well-tolerated for the systemic therapy of recurrent or metastatic OSCC.
Entities:
Keywords:
Cetuximab; Metastasis; Oral cancer; Recurrence; Retrospective study