Phase II Feasibility Trial of Adjuvant Chemoradiotherapy with 3-weekly Cisplatin for Japanese Patients with Post-operative High-risk Squamous Cell Carcinoma of the Head and Neck
Phase II Feasibility Trial of Adjuvant Chemoradiotherapy with 3-weekly Cisplatin for Japanese Patients with Post-operative High-risk Squamous Cell Carcinoma of the Head and Neck
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DOI：
10.1093/jjco/hys128
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发表时间：
2012-10-01
影响因子：
2.4
通讯作者：
Ohtsu, Atsushi
中科院分区：
文献类型：
--
作者：
Kiyota, Naomi;Tahara, Makoto;Ohtsu, Atsushi
目前，头颈部高危鳞状细胞癌术后的标准治疗是同步放化疗联合顺铂（3 W-CDDP/RT），每3周1次。在以前的关键性试验中，顺铂和放射治疗的三个周期的完全递送率仅约为60。在此，我们评估了3 W-CDDP/RT在日本人群中的可行性和安全性。该研究纳入了头颈部高危鳞状细胞癌术后患者。高风险因素是显微镜下不完全切除，囊外扩张和两个或更多的淋巴结转移。受试者接受三个周期的顺铂治疗，剂量为100 mg/m2，同时接受放射治疗（66戈伊/33 Fr）。从2006年8月至2009年5月，累积了25名合格受试者，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（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，符合预定义的统计标准。3/4级急性和晚期毒性几乎与既往关键性试验相同。未观察到给药相关死亡。中位随访时间为39个月，其中14例进展，10例死亡。估计3年局部控制率、无复发生存率和总生存率分别为74、43和60。单变量分析显示，口腔癌和顺铂累积剂量低于240 mg/m2似乎是不良预后因素。这是首次在日本人群中进行的关于术后高危头颈部鳞状细胞癌患者使用顺铂辅助放化疗（3周一次）的II期可行性试验。这种治疗是可行的，安全性特征与关键III期试验相同。
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 approximate to 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.