Abstract 2072
Background
Recurrent or metastatic squamous cell carcinoma of the head and neck have a poor prognosis. The PFE (Platinum, 5-FU and Cetuximab) regimen is established as the first-line standard therapy in the world, as per a Phase III study conducted in Europe. A phase II study conducted in China suggested that lower dose of cisplatin and 5-FU achieve similar outcome than PFE in an Asian population with an acceptable toxicity profile. In a phase II study, TPEx (Docetaxel, Platinum and Cetuximab) regimen showed favorable overall survival and response rate when indirectly compared to the PFE regimen. Administration of the TPEx regimen in Asian population is likely to be more toxic than in Caucasian patients. Therefore, we considered to compare the modified TPEx regimen and the modified PFE regimen to assess the efficacy and safety of this regimen.
Trial design
TEMPER is open-label, randomized, a multicenter phase II study comparing modified TPEx regimen vs. modified PFE regimen as the first-line treatment with recurrent or metastatic squamous cell carcinoma of the head and neck. Patients will be allocated randomly (1:1) to the two treatment groups with dynamic allocation method. Treatment will be stratified by ECOG PS, p16-positive oropharynx carcinoma and history of chemotherapy. The primary endpoint is progression-free survival. Secondary endpoints are response rate, adverse events and overall survival. A median progression-free survival of 6.0 months is assumed for the modified PFE, and 148 events are deemed necessary to detect a hazard ratio of 0.71 in modified TPEx, with 80% power and a two-sided significance level of 20%. The target sample size is set at 180 patients (90 patients in both groups), allowing for dropouts. Clinical trial information: UMIN000025436. This study is supported by Merck KGaA.
Clinical trial identification
Legal entity responsible for the study
Clinical research Support Center Kyushu.
Funding
Clinical research Support Center Kyushu.
Editorial Acknowledgement
Disclosure
M. Shimokawa: Consulting: Sysmex, T. Satoh: Honoraria: Chugai Pharma, Merck Serono, Bristol-Myers Squibb, Takeda, Yakult Honsha, Lilly, Bayer Yakuhin, Ono Pharmaceutical, Merck; Consulting or advisory role: Bayer Yakuhin, Lilly, Ono Pharmaceutical, Takara Bio, Merck Serono; Research funding: Yakult Honsha, Chugai Pharma, Ono Pharmaceutical, Sanofi, Lilly, Daiichi Sankyo, Merck, Merck Serono, Gilead Sciences, Dainihon Sumitomo. H. Inohara: Consulting or advisory role: Merck; Speakers' bureau: Merck, Ono, Eisai, Meiji, TaihoM; Travel expenses: MSD, Nippon Kayaku. All other authors have declared no conflicts of interest.
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