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 G, Taguchi T, Takahashi M, Shiono O, Komatsu M, Sano D, Yabuki K, Arai Y, Takahashi H, Hata M, and Oridate N
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Antineoplastic Combined Chemotherapy Protocols adverse effects, Carcinoma, Squamous Cell mortality, Carcinoma, Squamous Cell pathology, Cetuximab administration & dosage, Cetuximab adverse effects, Cisplatin administration & dosage, Cisplatin adverse effects, Disease-Free Survival, Docetaxel, Early Termination of Clinical Trials, Head and Neck Neoplasms mortality, Head and Neck Neoplasms pathology, Humans, Leukopenia chemically induced, Male, Middle Aged, Neoplasm Staging, Neutropenia chemically induced, Radiation Dosage, Severity of Illness Index, Taxoids administration & dosage, Taxoids adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell therapy, Cetuximab therapeutic use, Chemoradiotherapy methods, Cisplatin therapeutic use, Head and Neck Neoplasms therapy, Taxoids therapeutic use
- 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.
- Published
- 2016
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