Five compared with six fractions per week of conventional radiotherapy of squamous-cell carcinoma of head and neck: DAHANCA 6&7 randomized controlled trial

Danish Head and Neck Cancer Study Group The Lancet, Volume 362, Issue 9388, Pages 933 - 940, 20 September 2003

Background

Although head and neck cancer can be cured by radiotherapy, the optimum treatment time for locoregional control is unclear. We aimed to find out whether shortening of treatment time by use of six instead of five radiotherapy fractions per week improves the tumour response in squamous-cell carcinoma.

Methods

We did a multicentre, controlled, randomised trial. Between January, 1992, and December, 1999, of 1485 patients treated with primary radiotherapy alone, 1476 eligible patients were randomly assigned five (n=726) or six (n=750) fractions per week at the same total dose and fraction number (66—68 Gy in 33—34 fractions to all tumour sites except well-differentiated T1 glottic tumours, which were treated with 62 Gy). All patients, except those with glottic cancers, also received the hypoxic radiosensitiser nimorazole. Analysis was by intention to treat.

Findings

More than 97% of the patients received the planned total dose. Median overall treatment times were 39 days (sixfraction group) and 46 days (five-fraction group). Overall 5-year locoregional control rates were 70% and 60% for the six-fraction and five-fraction groups, respectively (p=0·0005). The whole benefit of shortening of treatment time was seen for primary tumour control (76 vs 64% for six and five fractions, p=0·0001), but was non-significant for neck-node control. Six compared with five fractions per week improved preservation of the voice among patients with laryngeal cancer (80 vs 68%, p=0·007). Disease-specific survival improved (73 vs 66% for six and five fractions, p=0·01) but not overall survival. Acute morbidity was significantly more frequent with six than with five fractions, but was transient.

Interpretation

The shortening of overall treatment time by increase of the weekly number of fractions is beneficial in patients with head and neck cancer. The six-fractions-weekly regimen has become the standard treatment in Denmark.

 

Hyperfractionated or accelerated radiotherapy in head and neck cancer: a meta-analysis

Meta-Analysis of Radiotherapy in Carcinomas of Head and neck (MARCH) Collaborative Group The Lancet, Volume 368, Issue 9538, Pages 843 - 854, 2 September 2006

Background

Several trials have studied the role of unconventional fractionated radiotherapy in head and neck squamous cell carcinoma, but the effect of such treatment on survival is not clear. The aim of this meta-analysis was to assess whether this type of radiotherapy could improve survival.

Methods

Randomised trials comparing conventional radiotherapy with hyperfractionated or accelerated radiotherapy, or both, in patients with non-metastatic HNSCC were identified and updated individual patient data were obtained. Overall survival was the main endpoint. Trials were grouped in three pre-specified categories: hyperfractionated, accelerated, and accelerated with total dose reduction.

Findings

15 trials with 6515 patients were included. The median follow-up was 6 years. Tumours sites were mostly oropharynx and larynx; 5221 (74%) patients had stage III—IV disease (International Union Against Cancer, 1987). There was a significant survival benefit with altered fractionated radiotherapy, corresponding to an absolute benefit of 3·4% at 5 years (hazard ratio 0·92, 95% CI 0·86—0·97; p=0·003). The benefit was significantly higher with hyperfractionated radiotherapy (8% at 5 years) than with accelerated radiotherapy (2% with accelerated fractionation without total dose reduction and 1·7% with total dose reduction at 5 years, p=0·02). There was a benefit on locoregional control in favor of altered fractionation versus conventional radiotherapy (6·4% at 5 years; p<0·0001), which was particularly efficient in reducing local failure, whereas the benefit on nodal control was less pronounced. The benefit was significantly higher in the youngest patients (hazard ratio 0·78 [0·65—0·94] for under 50 year olds, 0·95 [0·83—1·09] for 51—60 year olds, 0·92 [0·81—1·06] for 61—70 year olds, and 1·08 [0·89—1·30] for over 70 year olds; test for trends p=0·007).

Interpretation

Altered fractionated radiotherapy improves survival in patients with head and neck squamous cell carcinoma. Comparison of the different types of altered radiotherapy suggests that hyperfractionation has the greatest benefit.