作者
Lori J Wirth, Shaker Dakhil, Gabriela Kornek, Rita Axelrod, Douglas Adkins, Shubham Pant, Paul O’Brien, Philip R Debruyne, Kelly S Oliner, Jun Dong, Swami Murugappan
发表日期
2016/10/1
期刊
Oral oncology
卷号
61
页码范围
31-40
出版商
Pergamon
简介
Objective
This phase 2 estimation study evaluated docetaxel/cisplatin with/without panitumumab, an anti–epidermal growth factor receptor monoclonal antibody, as first-line therapy for recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).
Patients and methods
Randomized patients received docetaxel/cisplatin (75 mg/m2 each) with/without panitumumab (9 mg/kg) in 21-day cycles. Patients randomized to panitumumab + chemotherapy could continue panitumumab monotherapy after completing six chemotherapy cycles without progression; patients randomized to chemotherapy alone could receive second-line panitumumab after progression. Progression-free survival (PFS) was the primary endpoint. Secondary endpoints included overall survival (OS), overall response rate (ORR), time to response (TTR), duration of response (DOR), and safety. A protocol amendment limited enrollment to …
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LJ Wirth, S Dakhil, G Kornek, R Axelrod, D Adkins… - Oral oncology, 2016