Phase II trial of combination treatment with S-1/cetuximab in patients with platinum-ineligible recurrent and/or metastatic squamous cell carcinoma of the head and neck
Phase II trial of combination treatment with S-1/cetuximab in patients with platinum-ineligible recurrent and/or metastatic squamous cell carcinoma of the head and neck
复制标题
S-1/西妥昔单抗联合治疗不适合接受铂类治疗的复发性和/或转移性头颈部鳞状细胞癌患者的 II 期试验
DOI：
10.1007/s10147-020-01788-6
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发表时间：
2021
期刊：
影响因子：
3.3
通讯作者：
Hirotoshi Dosaka-Akita
中科院分区：
文献类型：
--
作者：
Jun Taguchi;Yasushi Shimizu;Shin Ariga;Tomohiro Goda;Yoshihito Ohhara;Rio Honma;Takuro Noguchi;Satoshi Takeuchi;Ichiro Kinoshita;Toraji Amano;Takatsugu Mizumachi;Satoshi Kano;Miki Takahara;Takahisa Abe;Akihiro Homma;Hirotoshi Dosaka-Akita
对于不能耐受铂类药物治疗方案的复发和/或转移性头颈部鳞状细胞癌（R/M SCCHN）患者，一线治疗的标准治疗尚未明确。我们的目的是开发一种新的治疗方案与R/M SCCHN患者谁是不符合铂为基础的治疗，通过评估的效果和安全性替加氟/吉美拉西/奥替拉西（S-1）和cetuximab.MethodsPlatinum-ineligibility被定义为：老年人（年龄≥ 75岁），PS差，合并症，铂耐药和拒绝接受铂为基础的治疗。患者接受S-1（80 mg/m2/天，持续14天，随后停药7天）和西妥昔单抗（初始剂量，400 mg/m2，随后每周250 mg/m2）治疗，直至疾病进展或出现不可接受的毒性。主要终点为总缓解率（ORR）。结果2014年9月至2018年9月，共纳入23例患者。在21例可评价患者中，20例为男性[中位年龄69岁（范围49-82）]。ORR为9/21例患者（43%）[95%置信区间（CI）22-66]。分别有1例和8例患者达到完全缓解（CR）和部分缓解（PR）。中位总生存期（OS）为13.7个月（95% CI 9.0-18.3），无进展生存期（PFS）为5.7个月（95% CI 3.1-8.2）。3/4级不良事件包括痤疮样皮疹和皮肤反应（33%）、低镁血症（19%）、手足综合征（14%）、疲劳（14%）、粘膜炎（10%）和厌食（10%）。结论S-1和西妥昔单抗联合治疗对不符合铂类治疗条件的R/M SCCHN患者有效且耐受性良好。
BackgroundThe standard of care for first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) in patients who cannot tolerate platinum-based regimens has not been clarified. We aimed to develop a new treatment regimen for patients with R/M SCCHN who are ineligible for platinum-based therapy, by evaluating the effects and safety of tegafur/gimeracil/oteracil (S-1) and cetuximab.MethodsPlatinum-ineligibility was defined as: elderly (aged ≥ 75 years), poor PS, comorbidity, platinum resistance and refusal to undergo platinum-based therapy. Patients received S-1 (80 mg/m2/day for 14 days followed by a seven-day break) and cetuximab (initial dose, 400 mg/m2, followed by 250 mg/m2weekly) until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR).ResultsBetween September 2014 and September 2018, we enrolled 23 patients. Among the 21 patients who were evaluable, 20 were male [median age, 69 years (range 49–82)]. The ORR was 9 (43%) of 21 patients [95% confidence interval (CI) 22–66]. One and eight patients achieved complete response (CR) and partial response (PR), respectively. The median overall survival (OS) was 13.7 months (95% CI 9.0–18.3) and progression-free survival (PFS) was 5.7 months (95% CI 3.1–8.2). Grade 3/4 adverse events included acneiform rash and skin reactions (33%), hypomagnesemia (19%), hand-foot syndrome (14%), fatigue (14%), mucositis (10%), and anorexia (10%).ConclusionsCombination treatment with S-1 and cetuximab was effective and tolerated well by patients with platinum-ineligible R/M SCCHN.Registered clinical trial number: UMIN000015123