在不适合顺铂联合治疗的复发或转移性（R/M）头颈部鳞状细胞癌（SCCHN）人群中，作为一线治疗，甲氨蝶呤联合或不联合西妥昔单抗，一项 Ib 期随机 II 期研究开始。
Methotrexate plus or minus cetuximab as first-line treatment in a recurrent or metastatic (R/M) squamous cell carcinoma population of the head and neck (SCCHN), unfit for cisplatin combination treatment, a phase Ib-randomized phase II study Commence.
机构信息
Department of Medical Oncology, Radboud University Medical Center, Nijmegen, HB, The Netherlands.
Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, GD, The Netherlands.
出版信息
Head Neck. 2020 May;42(5):828-838. doi: 10.1002/hed.26053. Epub 2020 Jan 6.
BACKGROUND
Methotrexate in recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) has limited progression-free survival (PFS) benefit. We hypothesized that adding cetuximab to methotrexate improves PFS.
METHODS
In the phase-Ib-study, patients with R/M SCCHN received methotrexate and cetuximab as first-line treatment. The primary objective was feasibility. In the phase-II-study patients were randomized to this combination or methotrexate alone (2:1). The primary endpoint was PFS. Secondary endpoints were overall survival (OS), toxicity, and quality of life (QoL).
RESULTS
In six patients in the phase-Ib-study, no dose limiting toxicities were observed. In the phase II study, 30 patients received the combination and 15 patients methotrexate. In the phase-II-study median PFS was 4.5 months in the combination group vs 2.0 months in the methotrexate group (HR 0.37; P = .002). OS, toxicity, and QoL were not significantly different.
CONCLUSION
Cetuximab with methotrexate improved PFS without increased toxicity in R/M SCCHN-patients.
背景
甲氨蝶呤在复发性或转移性（R/M）头颈部鳞状细胞癌（SCCHN）中的无进展生存期（PFS）获益有限。我们假设在甲氨蝶呤中加入西妥昔单抗可以改善 PFS。
方法
在 Ib 期研究中，R/M SCCHN 患者接受甲氨蝶呤和西妥昔单抗作为一线治疗。主要目的是可行性。在 II 期研究中，患者被随机分为联合治疗组或甲氨蝶呤单药治疗组（2:1）。主要终点是 PFS。次要终点是总生存期（OS）、毒性和生活质量（QoL）。
结果
在 Ib 期研究的 6 名患者中，未观察到剂量限制毒性。在 II 期研究中，30 名患者接受了联合治疗，15 名患者接受了甲氨蝶呤单药治疗。在 II 期研究中，联合治疗组的中位 PFS 为 4.5 个月，而甲氨蝶呤组为 2.0 个月（HR 0.37；P=0.002）。OS、毒性和 QoL 无显著差异。
结论
在 R/M SCCHN 患者中，西妥昔单抗联合甲氨蝶呤可改善 PFS，且毒性未增加。
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