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.
CONCLUSIONS
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.


OBJECTIVE
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).
Department of Hematology and Medical Oncology, Mackay Memorial Hospital, Taipei, Taiwan, ROC. medicine_su@hotmail.com
Nai-Wen
NW
Su
Yi-Shing
YS
Leu
Jehn-Chuan
JC
Lee
Yu-Jen
YJ
Chen
Hong-Wen
HW
Chen
Chung-Ji
CJ
Liu
Yi-Fang
YF
Chang
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage*; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D011879:Radiotherapy Dosage; D012189:Retrospective Studies
D002945:Cisplatin; D005472:Fluorouracil