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Neoadjuvant Docetaxel Regimen Improves Survival in Head and Neck Cancer Patients: Presented at ASCO

By Charlene Laino

NEW ORLEANS, LA -- June 6, 2004 -- Neoadjuvant therapy with cisplatin, fluorouracil (5-FU), and docetaxel significantly extends survival in patients with nonresectable, locally advanced squamous cell carcinoma of the head and neck, compared with standard therapy with cisplatin and 5-FU alone, a phase 3 trial shows.

Previous studies have not shown any survival benefit with other neoadjuvant chemotherapy regimens, said Jan Baptist Vermorken, MD, PhD, professor of oncology and head, department of medical oncology, University Hospital of the University of Antwerp, in Antwerp, Belgium. Dr. Vermorken presented the findings here on June 5th at the American Society of Clinical Oncology 40th Annual Meeting.

The trial, conducted by the European Organization for Research and Treatment of Cancer Head and Neck Cooperative Group, also demonstrated that the neoadjuvant docetaxel regimen was associated with significantly improved progression-free survival and cancer response rates, compared with standard therapy, Dr. Vermorken reported.

The phase 3 study was conducted after data from 5 phase 2 studies suggested that the addition of docetaxel to standard cisplatin and 5-FU regimens may improve efficacy in patients with nonresectable locally advanced squamous cell carcinoma of the head and neck (Posner et al. ASCO 20: 203b, 2001), he said.

In the new study, 358 patients were randomized to receive an infusion of 75 mg/m² of docetaxel plus 75 mg/m² of cisplatin on day 1 and a 5-day continuous infusion of 750 mg/m² of 5-FU, or 100 mg/m² of cisplatin on day 1 followed by a 5-day continuous infusion of 1000 mg/m² of 5-FU. Treatment was repeated every 3 weeks for a total of 4 cycles, unless the patients progressed, experienced unacceptable toxicity, or refused to continue. All the patients also received radiation therapy -- 5 days a week for up to 7 weeks -- within 4 to 7 weeks of completing the last cycle of chemotherapy.

The 2 arms were balanced in terms of age, sex, performance status, primary site, tumor stage, and nodal involvement, Dr. Vermorken said.

At a median follow-up of 32 months, progression-free survival, the trial's primary end point was 12.7 months in the docetaxel arm and 8.4 months in the standard therapy arm (P =.006), the study showed.

The docetaxel combination was also associated with significantly improved overall survival -- 18.6 months and 14.5 months (P =.016). Overall response rates were 67.8% and 53.6%, respectively (P =.007).

The docetaxel regimen was well tolerated, with patients in the standard treatment arm experiencing more grade 3-4 nausea (7.3% vs 0.6%), vomiting (5.05 vs 0.6%), and stomatitis (11.2% vs 4.6%). Also, 5.5% of patients in the standard treatment arm died due to treatment-related toxicity, compared with 2.3% in the docetaxel arm, Dr. Vermorken said.

"Nonresectable, locally advanced head and neck cancer has a very poor prognosis, with a 5-year survival of less than 10%," Dr. Vermorken said. "This data is quite compelling. I think it will change the standard of care."

Head and neck cancer is the 7th most frequently occurring cancer worldwide, with 390,000 new cases annually. In the United States alone, more than 38,000 cases will be diagnosed in 2004.


[Presentation title: Standard Cisplatin/Infusional 5-Fourouracil (5-FU) (PF) Vs Docetaxel (T) Plus PF (TPF) as Neoadjuvant Chemotherapy for Nonresectable Locally Advanced Squamous Cell Carcinoma of the Head and Neck (LA-SCCHN): a Phase III Trial of the EIRTC Head and Neck Cancer Group (EORTC #24971)." Abstract 5508]

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