UFT (uracil and tegafur), an active agent against advanced head and
neck squamous cell carcinoma (HNSCC), is widely used in Japan. Its
efficacy for adjuvant chemotherapy has been proved in randomized
studies. In the first of two retrospective studies, we examined
the efficacy of UFT as adjuvant chemotherapy in patients with
maxillary cancer. The next study developed the UFT and carboplatin
(Paraplatin) regimen as a modification of cisplatin (Platinol) plus
fluorouracil (5-FU) to determine its activity and evaluate toxicity
in advanced HNSCC patients.
This study included 48 patients with maxillary sinus squamous cell
carcinoma who proved disease-free after definitive treatment with
surgery or chemoradiotherapy. UFT (200 mg/m²/day) was
continuously administered for more than 1 year. In all, 15 patients
were successfully administered UFT; nine patients did not complete
the schedule due to toxicity, and 24 did not receive UFT (Table
1). Survival rates were retrospectively compared between
patients treated with and without UFT.
The 5-year survival rate in 39 evaluable patients was 41.5% in T3
patients and 20.2% in T4 patients (Figure
1). The 5-year survival rate in patients treated with UFT or
without UFT was 76.6% and 22.6%, respectively. This indicates a
significantly higher survival in the UFT patients (P = .001) (Figure
2). Comparison was made in 23 patients with or without UFT and
five discontinued patients at T3. The 5-year survival rate was 71.4%
in the UFT group, 23.8% in the group without UFT, and 40.0% in the
UFT-discontinued group. These results indicate a favorable prognosis
for the UFT group compared with the group without UFT (P =
.033) and the UFT-discontinued group (P = .731) (Figure
Patients with evaluable and unresectable HNSCC were enrolled in this
study (Table 1). All the
patients had normal bone marrow, renal, pulmonary functions and
performance status of 0 or 1 (ECOG). UFT (400 mg/day) was
administered from day 1 to day 14 and from day 28 to day 42.
Carboplatin (350 mg/m²) was administered at day 7 and day 35.
Two complete responses and 15 partial responses were observed, for an
overall response rate of 53.1% (95% confidence interval, 35.8% to
70.4%). The antitumor efficacy in terms of lesion site is shown in Table
Toxicities greater than grade 3 were rare. Two patients experienced
grade 3 leukopenia; one patient, grade 4 anemia; two patients, grade
3 thrombocytopenia. There were no grade 3 or higher gastrointestinal
tract toxicities, fever, or stomatitis (Table
Adjuvant chemotherapy with UFT achieved longer survival duration for
patients with maxillary cancer compared with patients not receiving
UFT. UFT plus carboplatin was proved to have efficacy for advanced
HNSCC with mild toxicity. This regimen will be applied as adjuvant
chemotherapy in the outpatient setting. To avoid grade 3 and 4
hematologic toxicity with this regimen, a dose-finding study for
carboplatin is required.
1. Ota K, Taguchi T, Kimura K: Report on nationwide pooled data and
cohort investigation in UFT phase II study. Cancer Chemother
Pharmacol 22:333-338, 1988.
2. Jacobs S, Makuch R: Efficacy of adjuvant chemotherapy for patients
with resectable head and neck cancer: A subset analysis of Head and
Neck Contracts Program. J Clin Oncol 8:838-847, 1990.
3. Fujii M, Kanzaki J: Combination with carboplatin and UFT for head
and neck cancer. Head and Neck Cancer 19:235-238, 1993.
4. Benasso M, Numico G, Merlano M: Carboplatin and 5-fluorouracil in
squamous cell carcinoma of the head and neck previously responding to
cisplatin and 5-fluorouracil. Eur J Cancer 33:318-319, 1997.