Ad. Colevas et al., A phase II trial of palliative docetaxel plus 5-fluorouracil for squamous-cell cancer of the head and neck, ANN ONCOL, 11(5), 2000, pp. 535-539
Purpose: A phase II study to determine the response rate and toxicity of do
cetaxel and 5-fluorouracil (5-FU) every four weeks ('TF'), in patients with
incurable SCCHN.
Patients and methods: Patients with metastatic or recurrent SCCHN with an E
COG PS < 3 were enrolled in an institutional review board approved trial. P
rior induction or adjuvant chemotherapy was permitted provided six months h
ad elapsed.
The regimen was docetaxel 70 mg/m(2) i.v., day 1 and 5-FU 800 mg/m(2)/d x 5
days, days 1-5, as a continuous intravenous infusion, repeated every 28 da
ys. Planned intra-patient dose modifications were based on hematological, c
utaneous, and gastrointestinal toxicities. Patients were removed from the s
tudy for progression of disease or unacceptable toxicity.
Results: Seventeen patients were enrolled. Fourty-six cycles of TF were adm
inistered. Reasons for discontinuance of TF included: progressive disease,
12 patients; toxicity, 3 patients; concomitant illness, 1 patient; death, 1
patient.
The most common toxicities were neutropenia, mucositis, anemia, fatigue, al
opecia, pain, diarrhea and nausea. Evaluation of responses to TF showed tha
t there were four patients of seventeen (24%, 95% exact CI: 6.8-49.9) who a
chieved a PR or CR. Accrual was terminated after interim analysis of the re
sponse rate of the first 17 patients failed to exceed 4 of 17.
Conclusions: The response rate to TF in patients with SCCHN was lower than
expected. Trials of other regimens should take precedence over further expl
oration of the TF regimen.