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

Abstract

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.

Surgical Treatment Is Recommended for Advanced Oral Squamous Cell Carcinoma

“…Although the results of the outcomes in this study support the findings of previous reports (Shaha et al 1984;Hicks et al 1997;Sessions et al 2000), we emphasize that the patient outcome for surgery in our patients was almost equal to, or better than those of previous reports (Hicks et al 1997;Sessions et al 2000;Diaz et al 2003) and this study contained some intensive CRT patients, such as iaCDDP (Doweck et al 2008), CF (Giralt et al 2000), and DCF (Tsukuda et al 2010).…”

Predictive markers, including total lesion glycolysis, for the response of lymph node(s) metastasis from head and neck squamous cell carcinoma treated by chemoradiotherapy

“…Due to the anatomical features of the head and neck, organ preservation is important to maintain functions and to minimize aesthetic changes. To preserve function, some authors have described the efficacy of chemoradiotherapy (CRT) and neo-adjuvant (induction) chemotherapy followed by definitive radiotherapy for advanced HNSCC patients [1][2][3][4][5][6][7][8][9][10][11]. Until recently, planned neck dissection (PND) after CRT was a common treatment method for lymph node(s) metastatic advanced HNSCC.…”

Phase II trial of concurrent bio-chemoradiotherapy using docetaxel, cisplatin, and cetuximab for locally advanced head and neck squamous cell carcinoma

“…Posner et al [6] reported that TPF after carboplatin-CRT provided significantly better 2-year overall survival for resectable and We have performed phase I and II studies of TPF-CRT and observed a CR rate of 90 % and a 3-year survival rate of 95.8 %, although the incidences of grades 3-4 mucositis, leukocytopenia, and neutropenia were 79, 53, and 42 %, respectively [7,8]. These severe adverse events could lead to treatment discontinuation, which indicates that a more tolerable alternative is needed.…”

“…Based on our results for TPF-CRT [7,8], and the substitution of Cmab for 5-FU, we expected that B-CRT using DTX and CDDP plus Cmab would produce a <50 % incidence of grades 3-4 neutropenia. Therefore, we defined the expected incidence of neutropenia as 50 %, the threshold incidence of neutropenia as 77 %, the alpha error as 0.1, and the beta error as 0.1.…”

“…Docetaxel (DTX) has been using in induction chemotherapy (IC) for patients with advanced head and neck squamous cell carcinoma (HNSCC), and the TPF regimen (DTX + CDDP + 5-FU) is the standard regimen for IC, based on the TAX324 report [6]. We have previously evaluated the safety and efficacy of CRT using TPF [7,8], although some patients were unable to complete the treatment because of severe adverse events (especially neutropenia). Cetuximab (Cmab) is a monoclonal antibody that targets epidermal growth factor receptor, and Bonner et al [9] have reported that bio-radiotherapy using Cmab was effective for patients with advanced HNSCC.…”