A Phase 1 Study of Afatinib in Combination with Postoperative Radiation Therapy with and Without Weekly Docetaxel in Intermediate- and High-Risk Patients with Resected Squamous Cell Carcinoma of the Head and Neck

Abstract

Regeneron; and serving as a consultant/advisory board member for AstraZeneca, BMS, Debiopharm, Nanobiotix, and Tilos. G.J.H. reports research support to institution from BMS and EMD Serono. R.B.T. reports serving on the data safety monitoring board for Intrexon/PSI and on the advisory board for EMD Serono and Regeneron. N.G.C. reports research funding from Merck, Pfizer, and GlaxoSmithKline. G.R. reports consulting for EMD Serono, Pfizer, Merck, Regeneron, Sanofi, and Castle; and owning stocks in Regeneron and Syros pharmaceuticals.

Systematic review of postoperative therapy for resected squamous cell carcinoma of the head and neck: Executive summary of the American Radium Society appropriate use criteria

“…After limitation to the eligibility criteria, 96 studies were identified. An additional five eligible studies were added, including four that were published after the cut‐off date of 01/10/2019 15‐18 and one randomized trial that was not identified through the literature search 19 …”

“…An additional five eligible studies were added, including four that were published after the cut-off date of 01/10/2019 [15][16][17][18] and one randomized trial that was not identified through the literature search. 19 Studies with primary oncologic endpoints are shown in Table S1 and included 11 systematic reviews, [20][21][22][23][24][25][26][27][28][29][30] 24 randomized trials with four long-term updates, 19,31-57 29 nonrandomized clinical trials, [15][16][17][18] and nine post hoc analyses of randomized trials. [83][84][85][86][87][88][89][90][91] The randomized trials are presented in Table 4.…”

“…The combination of PORT with panitumumab and weekly cisplatin 30 mg/m 2 was feasible in a stage III/IV high‐risk resected cohort 60 . PORT combined with the irreversible EGFR/HER inhibitor, afatinib, with or without docetaxel was not tolerated in an oral cavity cancer population 17 . PORT with weekly cisplatin will be directly compared to PORT with docetaxel and PORT with docetaxel/cetuximab in the first phase of RTOG 1216.…”

“…Studies with primary oncologic endpoints are shown in the Table S1 and included 11 systematic reviews, 20‐30 24 randomized trials with four long‐term updates, 19,31‐57 29 non‐randomized clinical trials, 15‐18,58‐82 and nine post hoc analyses of randomized trials 83‐91 . The randomized trials are presented in Table 4.…”

“…60 PORT combined with the irreversible EGFR/HER inhibitor, afatinib, with or without docetaxel was not tolerated in an oral cavity cancer population. 17 PORT with weekly cisplatin will be directly compared to PORT with docetaxel and PORT with docetaxel/cetuximab in the first phase of RTOG 1216. The trial will reopen and include an arm of PORT and weekly cisplatin with the checkpoint inhibitor, atezolizumab, to be compared to PORT and cisplatin, and PORT and docetaxel/cetuximab (NCT01810913).…”