A phase II trial of docetaxel, cisplatin and 5-fluorouracil in patients with recurrent squamous cell carcinoma of the head and neck (SCCHN).
BACKGROUND
In this phase II study, for the first time the efficacy and toxicity of triple chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with recurrent head and neck cancer was evaluated.


METHODS
Twenty-four patients with stage IV (UICC) recurrent squamous cell carcinoma of the head and neck (SCCHN), with different tumor sites, were treated with a polychemotherapy consisting of docetaxel 75 mg/m2 day 1, cisplatin 100 mg/m2 day 1 and 5-fluorouracil (5-FU) 1000 mg/m2 days 1 through 4 (total dose 4000 mg/m2) on days 1, 22 and 43, for a maximum of 3 cycles. The performance status of all patients at the start of the chemotherapy was 0-2, according to the Eastern Cooperative Oncology Group (ECOG).


RESULTS
Sixty-eight cycles were administered to 24 patients. The reversible major acute toxicities were afebrile neutropenia in 6 patients and emesis in 4 patients. One patient died, probably because of myocardial infarction related to treatment. A remission was observed in 10 patients. Six patients showed a complete remission and 4 patients a partial remission. The median time to progression was 10 months (range, 4-42 months), the median overall survival after treatment was 13 months (range, 6-48 months) and the median recurrence-free survival was 12 months (range, 10-18 months).


CONCLUSIONS
In terms of toxicity, TPF seems to be a feasible option for the treatment of recurrent SCCHN in patients with a compromised performance status. These results justify further investigations to evaluate the efficacy of this treatment.
Baghi
Mehran
M
Department for ENT-Surgery, University of Frankfurt am Main, Germany.
Hambek
Markus
M
Wagenblast
Jens
J
May
Angelika
A
Gstoettner
Wolfgang
W
Knecht
Rainald
R
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D043823:Taxoids; D002945:Cisplatin; D005472:Fluorouracil