1. Phase II trial of concurrent bio-chemoradiotherapy using docetaxel, cisplatin, and cetuximab for locally advanced head and neck squamous cell carcinoma.
- Author
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Nishimura, Goshi, Taguchi, Takahide, Takahashi, Masahiro, Shiono, Osamu, Komatsu, Masanori, Sano, Daisuke, Yabuki, Kenichiro, Arai, Yasuhiro, Takahashi, Hideaki, Hata, Masaharu, and Oridate, Nobuhiko
- Subjects
CHEMORADIOTHERAPY ,DOCETAXEL ,CISPLATIN ,CETUXIMAB ,HEAD & neck cancer treatment ,MEDICATION safety ,DRUG efficacy ,THERAPEUTICS - Abstract
Purpose: Although locally advanced head and neck squamous cell carcinoma (HNSCC) can be effectively treated using chemoradiotherapy (CRT) with docetaxel (DTX), and cisplatin (CDDP) plus 5-fluorouracil (TPF-CRT), severe adverse events (especially neutropenia) can limit treatment adherence. Therefore, we evaluated the safety and efficacy of a new chemotherapy regimen that consisted of DTX and CDDP plus cetuximab (Cmab) with concurrent radiotherapy.Methods: Bio-chemoradiotherapy (B-CRT) using DTX, CDDP, and Cmab was administrated to patients with locally advanced HNSCC, and its safety and efficacy were evaluated.Results: Interim analysis of nine patients revealed severe neutropenia in five patients (56 %) and leukopenia in seven patients (78 %); hence, the study was terminated. One patient experienced disease-free survival using only B-CRT.Conclusions: Neutropenia was equally severe for B-CRT, compared to TPF-CRT. Based on the limited sample size, it is impossible to conclude that B-CRT has non-inferior efficacy, compared to TPF-CRT. [ABSTRACT FROM AUTHOR]- Published
- 2016
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