[Adjuvant chemotherapy (nedaplatin/UFT) after concurrent chemoradiotherapy for locally advanced head and neck squamous cell carcinoma].

To evaluate the efficacy of adjuvant chemotherapy after concurrent chemoradiotherapy, 41 previously untreated patients with locally advanced and resectable head and neck squamous cancer were enrolled in a study to compare adjuvant chemotherapy (Nedaplatin/UFT) after concurrent chemoradiotherapy (CDDP/5-FU) and concurrent chemoradiation alone. Nine of the patients had stage III tumors and 32 had stage IV tumors. The primary tumor site was the hypopharynx in 14 patients, the larynx in 12 patients, the oral cavity in 9 patients, and the oropharynx in 6 patients. Treatment consisted of 6 courses of Nedaplatin (80 mg/m2) repeated at 4-week intervals and one year of the oral administration of UFTE (400 mg/day) after concurrent chemoradiotherapy at an outpatient clinic. Toxicities included leukopenia (grade 3, 15.4%) and thrombocytopenia (grade 3, 7.7%). One death from a gastric ulcer occurred. The median overall survival time was 30.1 months (5.5-50.1 months) for the adjuvant chemotherapy group and 21.7 months (4.0-48.8 months) for the control group. The progression-free survival period was 22.8 months (5.6-33.9 months) for the adjuvant chemotherapy group and 26.5 months (5.6-33.9 months) for the control group. The two-year overall survival rate was 73.3% for the adjuvant chemotherapy group and 55.7% for the control group. A significant difference was observed in the two-year progression-free survival rates: 66.9% for the adjuvant chemotherapy group and 27.8% for the control group (p = 0.03290). Among the patients with a partial response to concurrent chemoradiotherapy, in particular, a significant difference in the two-year progression-free survival rates was seen : 59.3% for the adjuvant chemotherapy group and 15.3% for the control group (p = 0.01102). The rate of loco-regional failure was 29.6% for the adjuvant chemotherapy group and 64.3% for the control group (p = 0.0716). Distant metastasis was not detected in either group. The rate of organ preservation was 66.7% for the adjuvant chemotherapy group and 35.7% for the control group (p = 0.1183). This adjuvant chemotherapy regimen might improve the loco-regional control rates after concurrent chemoradiotherapy.