Combination Chemotherapy With Docetaxel, Cisplatin, and 5-Fluorouracil in Previously Treated Patients With Advanced/Recurrent Head and Neck Cancer

Abstract

The purpose of this phase II feasibility trial was to determine the efficacy and toxicity of docetaxel combined with cisplatin and 5-fluorouracil in patients with locally advanced and/or recurrent squamous cell carcinoma of the head and neck. Nineteen patients entered the study. The majority had received prior radiotherapy but were chemotherapy naive. Treatment consisted of docetaxel 80 mg/m2 day 1, cisplatin 40 mg/m2 days 2 and 3, and 5-fluorouracil 1,000 mg/m2 by continuous infusion days 1 to 3. The cycle was repeated every 28 days. Most patients received granulocyte colony-stimulating factor, 150 microg/m2/day subcutaneously between days 4 and 8. The median number of chemotherapy cycles per patient was four. Dose reduction was done in three patients with no treatment delays. Of the 16 evaluable for response, seven patients (44%) demonstrated an objective response, including two complete and five partial ones; eight patients (50%) had stable disease; and one patient had progressive disease. The median time to progression was 7.5 months (range: 4-17.5 months). The median survival was 11 months (range: 1-18 months) and 1-year survival was 49%. Febrile neutropenia was recorded in 15% of courses. There were no toxic deaths. In conclusion, the combination of docetaxel, cisplatin, and 5-fluorouracil is an active regimen against previously treated squamous cell carcinoma of the head and neck with acceptable toxicity.

Phase I and Pharmacokinetic Study of Weekly Docetaxel, Cisplatin, and Daily Capecitabine in Patients with Advanced Solid Tumors

“…Five percent of patients developed grade 3 to 4 renal toxicity. The combination of docetaxel, 5-FU, and cisplatin has also been evaluated in patients with recurrent head and neck cancer after definitive radiation or chemoradiation therapy (24). Nineteen patients were entered on this phase II trial.…”

“…Of particular importance is a high rate febrile neutropenia in the range of 15% to 20% (22,24,28). Furthermore, the application of this regimen is hindered by the protracted i.v.…”

New approaches to EGFR inhibition for locally advanced or metastatic squamous cell carcinoma of the head and neck (SCCHN)

“…2a), and a variety may be utilized in clinical practice [29]. The addition of a third cytotoxic agent in this patient population may improve outcomes in some cases, but this option is generally limited by increased toxicity [35–37]. The EXTREME trial was the first study in over 25 years to demonstrate a survival advantage in the metastatic/recurrent SCCHN setting, with significant improvements for cetuximab plus 5-FU and platinum-based chemotherapy versus chemotherapy alone (Fig.…”

Management and palliative chemotherapy for metastatic or recurrent squamous cell carcinoma of the head and neck

“…Several Phase II trials have attempted to improve outcomes by testing triplet combinations [108][109][110][111]. They combined a platinum compound with a taxane and either 5-FU or ifosfamide.…”