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Randomized controlled phase II comparison study of concurrent chemoradiotherapy with docetaxel, cisplatin, and 5-fluorouracil versus CCRT with cisplatin, 5-fluorouracil, methotrexate and leucovorin in patients with locally advanced squamous cell carcinoma of the head and neck.

Author(s): Tsukuda M, Ishitoya J, Matsuda H, Horiuchi C, Taguchi T, Takahashi M, Nishimura G, Kawakami M, Watanabe M, Niho T, Kawano T, Ikeda Y, Sakuma Y, Shiono O, Komatsu M

Affiliation(s): Department of Otorhinolaryngology, Head and Neck Surgery, Yokohama City University School of Medicine, 9-3 Fukuura, Kanazawa-Ku, Yokohama, Japan. mtsukuda@med.yokohama-cu.ac.jp

Publication date & source: 2010-09, Cancer Chemother Pharmacol., 66(4):729-36. Epub 2009 Dec 24.

Publication type: Clinical Trial, Phase II; Randomized Controlled Trial

We compared concurrent chemoradiotherapy (CCRT) with docetaxel, cisplatin (CDDP), and 5-fluorouracil (5-FU) (TPF) with CCRT with CDDP, 5-FU, methotrexate and leucovorin (PFML) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) in terms of safety and efficacy on survival. A total of 100 patients were enrolled. The TPF group received CCRT with the TPF regimen [docetaxel (50 mg/m(2): day 1), CDDP (60 mg/m(2): day 4), and continuous 5-FU infusion (600 mg/m(2)/day: days 1-5)]. In the PFML group, patients received CCRT with the PFML regimen [CDDP (60 mg/m(2): day 4)], continuous 5-FU infusion (600 mg/m(2)/day: days 1-5), methotrexate (30 mg/m(2): day 1) and leucovorin (20 mg/m(2)/day: days 1-5)]. Both groups received 2 cycles of chemotherapy during definitive radiotherapy. The total radiation dose was between 66.6 and 70.2 Gray. The overall response rates after CCRT were 98 with 90% of a pathologically complete response (pCR) in the TPF group and 94 with 77% in the PFML group. For grade 3/4 adverse events, mucositis was more frequent in the PMFL group, and the TPF group showed a higher incidence of hematological toxicity. CCRT with TPF or PMFL for advanced SCCHN was tolerable and produced excellent survival rates.

Page last updated: 2010-10-05

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