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… Show more
“…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 …”
Section: Resultsmentioning
confidence: 99%
“…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.…”
Section: Characteristics Of Studies Identified In the Literature Sementioning
confidence: 99%
“…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.…”
Section: Topic 1: Summary Of Studies With Oncologic Endpointsmentioning
confidence: 99%
“…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).…”
Section: Port Combined With Egfrinhibitionmentioning
Background: The aims of this systematic review are to (a) evaluate the current literature on the impact of postoperative therapy for resected squamous cell carcinoma of the head and neck (SCCHN) on oncologic and non-oncologic outcomes and (b) identify the optimal evidence-based postoperative therapy recommendations for commonly encountered clinical scenarios. Methods: An analysis of the medical literature from peer-reviewed journals was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline. Prospective studies and methodologybased systematic reviews and meta-analyses of postoperative therapy for SCCHN were identified by searching Medline (OVID) and EMBASE (Elsevier)
“…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 …”
Section: Resultsmentioning
confidence: 99%
“…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.…”
Section: Characteristics Of Studies Identified In the Literature Sementioning
confidence: 99%
“…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.…”
Section: Topic 1: Summary Of Studies With Oncologic Endpointsmentioning
confidence: 99%
“…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).…”
Section: Port Combined With Egfrinhibitionmentioning
Background: The aims of this systematic review are to (a) evaluate the current literature on the impact of postoperative therapy for resected squamous cell carcinoma of the head and neck (SCCHN) on oncologic and non-oncologic outcomes and (b) identify the optimal evidence-based postoperative therapy recommendations for commonly encountered clinical scenarios. Methods: An analysis of the medical literature from peer-reviewed journals was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guideline. Prospective studies and methodologybased systematic reviews and meta-analyses of postoperative therapy for SCCHN were identified by searching Medline (OVID) and EMBASE (Elsevier)
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