• Cancer Chemother. Pharmacol. · Sep 2010

    Randomized Controlled Trial

    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.

    • Mamoru Tsukuda, Junichi Ishitoya, Hideki Matsuda, Choichi Horiuchi, Takahide Taguchi, Masahiro Takahashi, Goshi Nishimura, Mariko Kawakami, Makiko Watanabe, Tatsuo Niho, Toshiro Kawano, Yoichi Ikeda, Yasunori Sakuma, Osamu Shiono, and Masanori Komatsu.
    • 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
    • Cancer Chemother. Pharmacol. 2010 Sep 1; 66 (4): 729-36.

    AbstractWe 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.

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