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

被引：11

作者：

Ham, Janneke C. ^{[1
]}

van Meerten, Esther ^{[2
]}

Fiets, W. Edward ^{[3
]}

Beerepoot, Laurens V. ^{[4
]}

Jeurissen, Frank J. F. ^{[5
]}

Slingerland, Marije ^{[6
]}

Jonker, Marianne A. ^{[7
]}

Husson, Olga ^{[8
,9
]}

van der Graaf, Winette T. A. ^{[1
,10
]}

van Herpen, Carla M. L. ^{[1
]}

机构：

[1] Radboud Univ Nijmegen, Dept Med Oncol, Med Ctr, Nijmegen HB, Netherlands

[2] Erasmus MC, Dept Med Oncol, Inst Canc, Rotterdam GD, Netherlands

[3] Med Ctr Leeuwarden, Dept Internal Med, Leeuwarden AD, Netherlands

[4] Elisabeth TweeSteden Hosp, Dept Internal Med, Tilburg AD, Netherlands

[5] Med Ctr Haaglanden, Dept Internal Med, The Hague VA, Netherlands

[6] Leiden Univ, Dept Med Oncol, Med Ctr, Leiden ZA, Netherlands

[7] Radboud Univ Nijmegen, Radboud Inst Hlth Sci, Biostat, Med Ctr, Nijmegen HB, Netherlands

[8] Netherlands Canc Inst, Dept Psychosocial Res & Epidemiol, Amsterdam CX, Netherlands

[9] Inst Canc Res, Div Clin Studies, London, England

[10] Netherlands Canc Inst, Dept Med Oncol, Amsterdam CX, Netherlands

来源：

HEAD AND NECK-JOURNAL FOR THE SCIENCES AND SPECIALTIES OF THE HEAD AND NECK | 2020年 / 42卷 / 05期

关键词：

cetuximab; first-line; methotrexate; palliative treatment; recurrent or metastatic squamous cell carcinoma of the head and neck; QUALITY-OF-LIFE; EUROPEAN-ORGANIZATION; OPEN-LABEL; CANCER; TRIAL; FLUOROURACIL; GEFITINIB;

D O I：

10.1002/hed.26053

中图分类号：

R76 [耳鼻咽喉科学];

学科分类号：

100213 ;

摘要：

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.

引用

页码：828 / 838

页数：11

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