Cisplatin, tegafur, and leucovorin: a moderately effective and minimally toxic outpatient neoadjuvant chemotherapy for locally advanced squamous cell carcinoma of the head and neck.

BACKGROUND

To evaluate the efficacy and toxicity of cisplatin, tegafur, and leucovorin as neoadjuvant chemotherapy (CT) for patients with advanced, nonmetastatic squamous cell carcinoma of the head and neck (SCCHN).

METHODS

Patients with SCCHN according to World Health Organization (WHO) performance status of 2 or less and adequate organ function were enrolled. The CT regimen (PTL) was 50 mg/m(2) cisplatin (P) on Day 1, 800 mg per day oral tegafur (T), and 60 mg per day oral leucovorin (L) for 14 days. The CT was administered at outpatient clinics for 14-day cycles. PTL was initiated with the intent of organ preservation and it was continued for a maximum of six cycles before locoregional therapy. Reevaluation after three cycles led to the termination of CT when the response was less than a partial response. CT was discontinued immediately upon evidence of tumor progression or excessive toxicity.

RESULTS

From March 1996 through July 1999, 97 patients were enrolled consecutively. All participants were men with a median age of 56 years (range, 37-70 years). The primary tumor sites were the tongue base, 14, and the hypopharynx, 83. Sixteen percent of the tumors were Stage III, 84% were Stage IV, 62% were Stage T4, and 44% were Stage N2-3. The median number of CT cycles was six. On an intent-to-treat basis, 26 patients (27%) achieved complete responses and 32 patients (33%) achieved partial responses. The overall response rate was 60% (95% confidence interval, 50-70%). The most common toxicities of WHO Grade 3 or higher included (percent of patients): anemia, 8.3%; stomatitis, 6.3%; thrombocytopenia, 3.1%; and vomiting, 3.1%. With a median follow-up period of 3 years, the overall survival and disease-free survival rates were 40% and 38%, respectively. Organ preservation was achieved in 70% (29 of 37) of the surviving patients.

CONCLUSION

The outpatient PTL regimen was a moderately effective and minimally toxic CT for SCCHN. PTL should be studied further in combination with other active agents or radiotherapy for patients with SCCHN.