Comparison of the efficacy and toxicity of two dose levels of cisplatin/5-fluorouracil as the chemoradiotherapy regimen for the treatment of locally advanced squamous cell carcinoma of the head and neck.

CONCLUSION

The low-dose regimen brought less grade 3?4 neutropenia and mucositis with similar treatment efficacy. It should be further investigated in prospective randomized clinical trials to confirm its effectiveness and tolerability.

OBJECTIVES

This nonrandomized study compared the efficacy and toxicity profiles of two dose levels of cisplatin/5-fluorouracil (5-FU) as the chemoradiotherapy regimen for the treatment of locally advanced squamous cell carcinoma of the head and neck.

METHODS

Concurrent chemotherapy consisted of two dose levels: a low dose (cisplatin 12 mg/m(2) + 5-FU 600 mg/m(2) per day) or a high dose (cisplatin 15 mg/m(2) + 5-FU 750 mg/m(2) per day). Both were administered as a 5-day continuous infusion in week 1 and week 5 during radiotherapy.

RESULTS

With a median follow-up of 44 months, the overall survival and disease-free survival were 35 months and 22 months (n = 67) for the low-dose group and 36 months and 33 months for the high-dose group (n = 96). The 2-year locoregional control rate was 67.2% for the low-dose and 66.8% for the high-dose group. No statistically significant differences were demonstrated in the treatment efficacy end points. The high-dose regimen resulted in significantly more grade 3?4 neutropenia (31.5% vs 10.9%, p = 0.003) and a trend towards more mucositis (62.1% vs 49.3%, p = 0.066).