Department of Clinical Oral Oncology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8588, Japan.
Department of Oral and Maxillofacial Surgery, Yokohama City University Graduate School of Medicine, 3-9 Fukuura, Kanazawa-ku, Yokohama, Japan.
Cancer Chemother Pharmacol. 2018 Mar;81(3):549-554. doi: 10.1007/s00280-018-3531-x. Epub 2018 Jan 30.
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).
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/m; subsequent weeks, 250 mg/m) plus a maximum of six 3-weekly cycles of cisplatin (80 or 100 mg/m, 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/m/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.
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.
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.
本研究旨在评估西妥昔单抗联合铂类化疗治疗复发性或转移性口腔鳞状细胞癌（OSCC）患者的疗效和安全性。
我们进行了一项多中心回顾性观察研究，纳入 2012 年 12 月至 2015 年 6 月期间接受一线西妥昔单抗联合铂类化疗的患者。65 例患者接受每周西妥昔单抗（第 1 周，400mg/m；随后每周，250mg/m）联合最多 6 个 3 周周期的顺铂（80 或 100mg/m，第 1 天）或卡铂（曲线下面积 5mg/mL/min，第 1 天 1 小时静脉输注）和氟尿嘧啶（800 或 1000mg/m/天，第 1-4 天）。疾病稳定且接受西妥昔单抗联合铂类化疗的患者继续接受西妥昔单抗治疗，直至疾病进展或出现不可耐受的毒性，以先发生者为准。
中位随访时间为 10.5 个月（范围 1.2-34.2 个月）。最佳总缓解率和疾病控制率分别为 46.2%和 67.7%。中位总生存期和无进展生存期分别为 12.1 和 7.8 个月。最常见的 3-4 级不良事件是皮疹（9.2%），其次是白细胞减少（6.2%）。无不良事件致死。
我们的多中心回顾性研究结果，是迄今为止规模最大的研究，表明一线西妥昔单抗联合铂类化疗适合且耐受良好，可用于复发性或转移性 OSCC 的全身治疗。
