Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, Japan.
Jpn J Clin Oncol. 2012 Oct;42(10):927-33. doi: 10.1093/jjco/hys128. Epub 2012 Aug 23.
The current standard of care for post-operative high-risk squamous cell carcinoma of the head and neck is concurrent chemoradiotherapy with a 3-weekly cycle of cisplatin (3W-CDDP/RT). In previous pivotal trials, the complete delivery rate of three cycles of cisplatin and radiation therapy was only ~60%. Here, we evaluated the feasibility and safety of 3W-CDDP/RT in a Japanese population.
The study enrolled post-operative high-risk squamous cell carcinoma of the head and neck patients. High-risk factors were a microscopically incomplete resection, extracapsular extension and two or more lymph node metastases. Subjects received three cycles of cisplatin at a dose of 100 mg/m(2) concomitant with radiation therapy (66 Gy/33 Fr).
From August 2006 to May 2009, 25 eligible subjects were accrued, including 13 males, with a median age of 59 years, Eastern Cooperative Oncology Group performance status 0/1 (18/7), Stage III/IVA/IVB/recurrent (1/18/1/5) and oral cavity/oropharynx/hypopharynx/larynx (17/4/3/1). Protocol completion rate was 80%. The lower limit of the one-sided 90% confidence interval was 66%, which met the predefined statistical criteria. Grade 3/4 acute and late toxicities were almost identical to those in previous pivotal trials. No treatment-related deaths were observed. With a median follow-up of 39 months, 14 have had progression and 10 have died. Estimated 3-year locoregional control rate, relapse-free survival and overall survival were 74, 43 and 60%, respectively. On univariate analysis, oral cavity cancer and a cumulative cisplatin dose below 240 mg/m(2) appeared to be poor prognostic factors.
This is the first Phase II feasibility trial of adjuvant chemoradiotherapy with 3-weekly cisplatin for post-operative high-risk squamous cell carcinoma of the head and neck in a Japanese population. This treatment was feasible and the safety profile was identical to those in pivotal Phase III trials.
术后高危头颈部鳞状细胞癌的现行标准治疗方法是每周 3 次给予顺铂的同期放化疗（3W-CDDP/RT）。在以前的关键性试验中，仅约 60%的患者能够完全完成三个周期的顺铂和放疗。在此，我们评估了每周 3 次给予顺铂的方案在日本人群中的可行性和安全性。
本研究纳入了术后高危头颈部鳞状细胞癌患者。高危因素包括显微镜下不完全切除、包膜外侵犯和两个或更多淋巴结转移。患者接受三个周期的顺铂治疗，剂量为 100mg/m2，同时给予放疗（66Gy/33Fr）。
从 2006 年 8 月至 2009 年 5 月，共纳入 25 例符合条件的患者，包括 13 名男性，中位年龄为 59 岁，东部肿瘤协作组体能状态 0/1（18/7），Ⅲ期/IVA/IVB/复发性（1/18/1/5）和口腔/口咽/下咽/喉（17/4/3/1）。方案完成率为 80%。单侧 90%置信区间的下限为 66%，符合预定的统计学标准。3/4 级急性和迟发性毒性与以前的关键性试验几乎相同。未观察到与治疗相关的死亡。中位随访 39 个月时，14 例患者发生进展，10 例患者死亡。估计 3 年局部区域控制率、无复发生存率和总生存率分别为 74%、43%和 60%。单因素分析显示，口腔癌和累积顺铂剂量低于 240mg/m2 似乎是预后不良的因素。
这是日本人群中术后高危头颈部鳞状细胞癌每周 3 次给予顺铂辅助放化疗的首个Ⅱ期可行性试验。该治疗方案是可行的，安全性与关键性Ⅲ期试验一致。
