Background The standard of care for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is combination treatment with platinum, 5-FU and cetuximab (PFE). However, this regimen requires hospitalization to ensure proper hydration and continuous infusion of 5-FU, and causes severe nausea and anorexia. We evaluated the efficacy and safety of paclitaxel, carboplatin and cetuximab (PCE) as first-line treatment in patients with R/M SCCHN. Patients and methods Eligibility criteria included recurrent and/or metastatic, histologically proven SCC of the oropharynx, oral cavity, hypopharynx or larynx; PS 0-1; adequate organ function; no suitable local therapy for R/M SCCHN; and no prior systemic chemotherapy for R/M SCCHN. Chemotherapy consisted of paclitaxel 100 mg/m2 on days 1, 8; carboplatin area under the blood concentration-time curve 2.5 on days 1, 8, repeated every 3 weeks for up to 6 cycles; and cetuximab at an initial dose of 400 mg/m2, followed by 250 mg/m2 weekly until disease progression or unacceptable toxicities. Primary end point was overall response rate. Secondary end points were safety, treatment completion rate, progression-free survival, overall survival, and clinical benefit rate. Planned sample size was 45 patients. Results Forty-seven subjects were accrued from July 2013 to October 2014. Of 45 evaluable, 40 were male; median age was 63 years; Eastern Cooperative Oncology Group Performance Status was 0/1 in 23/22 cases; site was the hypopharynx/oropharynx/oral cavity/larynx in 17/11/10/7 cases; and 36/9 cases were smokers/nonsmokers, respectively. Overall response rate, the primary end point, was 40%. Median overall survival was 14.7 months and progression-free survival was 5.2 months. Grade 3/4 adverse events included neutropenia (68%), skin reaction (15%), fatigue (9%) and febrile neutropenia (9%). A potentially treatment-related death occurred in one patient with intestinal pneumonia. Conclusions The PCE regimen shows promising activity with acceptable toxicity in the outpatient clinic. Further studies are needed to compare PCE with PFE in this population. Registered clinical trial number UMIN000010507.

中文翻译：

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紫杉醇，卡铂和西妥昔单抗（PCE）联合治疗头颈部复发和/或转移性鳞状细胞癌（CSPOR-HN02）患者的一线治疗的II期临床试验。

背景技术一线治疗复发性和/或转移性头颈部鳞状细胞癌（R / M SCCHN）的护理标准是铂，5-FU和西妥昔单抗（PFE）的联合治疗。然而，该方案需要住院以确保适当的水合作用和持续输注5-FU，并引起严重的恶心和厌食症。我们评估了紫杉醇，卡铂和西妥昔单抗（PCE）作为R / M SCCHN患者的一线治疗的疗效和安全性。患者和方法入选标准包括复发性和/或转移性，经组织学证实的口咽，口腔，下咽或喉癌。PS 0-1; 适当的器官功能；没有适用于R / M SCCHN的局部治疗；且之前未进行过R / M SCCHN的全身化疗。第1、8天化疗药物为100 mg / m2紫杉醇；在第1、8天的血药浓度-时间曲线下的卡铂面积2.5，每3周重复一次，最多进行6个周期；和西妥昔单抗的初始剂量为400 mg / m2，然后每周250 mg / m2，直至疾病进展或出现不可接受的毒性。主要终点是总体缓解率。次要终点是安全性，治疗完成率，无进展生存期，总体生存期和临床受益率。计划的样本量为45名患者。结果从2013年7月至2014年10月，共有47名受试者入选。在45位可评估的受试者中，有40位是男性。中位年龄为63岁；东部合作肿瘤小组表现状态在23/22例中为0/1。17/11/10/7例为下咽/口咽/口腔/喉部位。吸烟者/不吸烟者分别为36/9。主要终点是总体回应率为40％。中位总生存期为14.7个月，无进展生存期为5.2个月。3/4级不良事件包括中性粒细胞减少症（68％），皮肤反应（15％），疲劳（9％）和发热性中性粒细胞减少症（9％）。一名患有肠肺炎的患者可能发生了与治疗相关的死亡。结论PCE方案在门诊中显示出令人鼓舞的活性和可接受的毒性。需要进一步研究以比较该人群中PCE和PFE。注册的临床试验号为UMIN000010507。结论PCE方案在门诊中显示出令人鼓舞的活性和可接受的毒性。需要进一步研究以比较该人群中PCE和PFE。注册的临床试验号为UMIN000010507。结论PCE方案在门诊中显示出令人鼓舞的活性和可接受的毒性。需要进一步研究以比较该人群中PCE和PFE。注册的临床试验号为UMIN000010507。