Abstract 960P
Background
Cetuximab (Cmab), an anti-EGFR monoclonal antibody, was approved for the treatment of recurrent or metastatic squamous cell carcinoma of head and neck (RM-SCCHN). Cmab has been combined not just with platinum-based chemotherapy, but also with other chemotherapy regimens. The aims of this study are to evaluate the clinical outcomes and safety of first-line treatment with chemotherapy plus Cmab in the real-world patients with RM-SCCHN and to identify prognostic factors for overall survival (OS).
Methods
This is a prospective observation study involving 20 oncology institutions in Japan. All consecutive patients with RM-SCCHN treated with a first-line therapy consisting of any chemotherapy regimens plus Cmab between December 2013 and February 2017 were included. The primary objective of the study was 1-year OS. Secondary objectives included response rate and adverse events. This work is supported by Merck Biopharma.
Results
Of 120 patients recruited, 114 patients were analyzed. Patients characteristics were as follows: median age, 64 years; PS0/1/2, 48.2%/49.1%/2.6%; primary tumor sites, hypopharynx/oral cavity/oropharynx/larynx, 34.2%/27.2%/25.4%/13.2%; combined chemotherapy, FP/FU+CBDCA/PTX/S-1, 52.6%/22.8%/14.9%/5.3%. Of 78 patients who achieved disease control, 31 patients continued Cmab monotherapy as maintenance. The median OS was 1.0 year (95% confidence interval [CI] 0.8-1.2). A point estimate of 1-year survival rate was 51.1%. On multivariate analysis, independent unfavorable prognostic factors for OS were performance status ≥1, primary tumor site (oral cavity), nodal staging (≥2), presence of distant metastasis, no salvage chemotherapy, and lack of objective response. Overall response rate was 26.3% (95%CI 18.5 - 35.4). Grade 3 and 4 adverse events included neutropenia (22.8%), hypokalemia (9.6%), rash acneiform (7.0%), pneumonitis (1.8%), and infusion related reaction (0.9%).
Conclusions
Combination of chemotherapy and Cmab showed promising signs of efficacy and tolerability in patients with RM-SCCHN in the real-world. Several prognostic factors were identified for OS.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Merck Biopharma.
Disclosure
T. Yokota: Advisory/Consultancy, Research grant/Funding (institution): Merck Biopharma. Y. Ota, H. Fujii, T. Kodaira, M. Shimokawa, T. Nakashima, N. Monden, A. Homma, S. Ueda: T. Akimoto: Research grant/Funding (institution): Merck Biopharma.