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Chemoradiotherapy for locally advanced head and neck cancer: 10-year follow-up of the UK Head and Neck (UKHAN1) trial
The Lancet Oncology - Online First, 10/30/09

Tobias JS et al. – Concurrent non-platinum chemoradiotherapy reduces recurrences, new tumours, and deaths in patients who have not undergone previous surgery, even 10 years after starting treatment. Chemotherapy given after radiotherapy (with or without concurrent chemotherapy) is ineffective. Patients who have undergone previous surgery for head and neck cancer do not benefit from non-platinum chemotherapy.

Methods

966 patients
Patients with locally advanced head and neck cancer, and who had not previously undergone surgery, randomly assigned to 1 of 4 groups in 3:2:2:2 ratio
Stratified by centre and chemotherapy regimen: radical radiotherapy alone ; radiotherapy with two courses of chemotherapy given simultaneously on days 1 and 14 of radiotherapy ; or 14 and 28 days after completing radiotherapy ; or both
Chemotherapy either methotrexate alone, or vincristine, bleomycin, methotrexate, and fluorouracil
Patients who had previously undergone radical surgery to remove their tumour randomised to radiotherapy alone or SIM alone , in 3:2 ratio
Primary endpoints were overall survival (from randomisation), and event-free survival (EFS; recurrence, new tumour, or death; whichever occurred first) among patients who were disease-free 6 months after randomisation. Analyses by intention to treat

Results

966 patients included in analyses
Among patients who did not undergo surgery, the median overall survival was 2·6 years (99% CI 1·9—4·2) in radiotherapy alone group, 4·7 (2·6—7·8) years in SIM alone group, 2·3 (1·6—3·5) years in SUB alone group, and 2·7 (1·6—4·7) years in SIM+SUB group
The corresponding median EFS were 1·0 (0·7—1·4), 2·2 (1·1—6·0), 1·0 (0·6—1·5), and 1·0 (0·6—2·0) years
For every 100 patients given SIM alone, 11 fewer EFS events (99% CI 1—21), compared with 100 given radiotherapy, 10 years after treatment
Among patients who had previously undergone surgery, median overall survival was 5·0 (99% CI 1·8—8·0) and 4·6 (2·2—7·6) years in the radiotherapy alone and SIM alone groups , respectively, with corresponding median EFS of 3·7 (99% CI 1·1—5·9) and 3·0 (1·2—5·6) years , respectively
Percentage of patients who had significant toxicity during treatment were: 11% (radiotherapy alone, n=25), 28% (SIM alone, n=47), 12% (SUB alone, n=19), and 36% (SIM+SUB, n=55) among patients without previous surgery; and 9% (radiotherapy alone, n=12) and 20% (SIM alone, n=24) among those who had undergone previous surgery
Most common toxicity during treatment mucositis
Percentage of patients who had significant toxicity at least 6 months months after randomisation were: 6% (radiotherapy alone, n=13), 6% (SIM alone, n=10), 4% (SUB alone, n=7), and 6% (SIM+SUB, n=9) among patients who had no previous surgery; and 7% (radiotherapy alone, n=10) and 11% (SIM alone, n=13) among those who had undergone previous surgery
Most common toxicity 6 months after treatment was xerostomia, but this occurred in 3% or less of patients in each group