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2018-03-16T03:34:28Z

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'''Radiotherapy while administering both hyperbaric oxygen and misonidazole was associated with improved survival at 1 year in patients with locally advanced squamous cell carcinoma.''' 

{|
| '''Clinical Bottom Line:''' 
|-
| 1. A combination of hyperbaric oxygen and misonidazole during irradiation of locally advanced SCC was associated with improved survival at 1 year. 2. The incidence of toxic effects was higher in the hyperbaric /misonidazole group. 
|-
|}

'''Appraised by:''' Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital, Sydney; Friday, 22 January, 1999 

'''Clinical Scenario:''' A patient with locally advanced SCC of the mouth presented for radiotherapy. 
'''Three-part Question:''' In radiotherapeutic treatment of locally advanced squamous cell carcinoma, does the addition of hyperbaric oxygenation and misonidazole, compared to conventional air treatment, result in any improvement in tumour control or mortality? 
'''Search Terms:''' Hyperbaric oxygenation, misonidazole, radiotherapy. 

'''The Study:''' 
Non-blinded randomised controlled trial with intention-to-treat. 
Patients with primary presentation of locally advanced squamous cell carcinoma of the mouth or fixed neck nodes. 
Control group (N = 68; 66 analysed): Tumour dose of 63 Gy by external beam in 30 fractions over 38 days. 
Experimental group (N = 68; 64 analysed): Tumour dose of 36 Gy by external beam in six fractions over 17 days while breathing oxygen at 3ATA. Also given 2g/m2 misonidazole orally at time of each fraction.

'''The Evidence:''' 

{|
| '''Outcome''' || '''Time to Outcome''' || '''Air rate''' || '''Hyperbaric/ Misonidazole rate''' || '''Relative risk reduction''' || '''Absolute risk reduction''' || '''NNT''' 
|-
| '''Mortality''' || 1 year || 0.73 || 0.531 || 27% || 0.196 || 5 
|-
| '''95% CI:''' || || || || 5% to 49% || 0.03 to 0.36 || 3 to 30 
|-
| '''Mortality''' || 2 years || 0.87 || 0.75 || 13% || 0.114 || 9 
|-
| '''95% CI:''' || || || || -2% to 29% || -0.02 to 0.25 || NNT'''4 to INF NNH'''49 to INF 
|-
| '''Toxic events''' || 38 days || 0.11 || 0.469 || -342% || -0.363 || -3 
|-
| '''95% CI:''' || || || || -100% to -207% || -0.51 to -0.22 || -5 to -2 
|-
|}

'''Comments:'''
1. Different irradiation regimes may be important in considering the incidence of toxic effects.
2. Six patients were withdrawn after randomisation and not analysed, low follow-up rates at 2 yrs.
4. Some suggestion of greater benefit in tumours of greater mass.
5. Relative contribution of two agents remains unknown.

'''Expiry date:''' July 2020
'''References:'''
1. Sealy R, Cridland S, Barry L, Norris R. Irradiation with misonidazole and hyperbaric oxygen: final report on a randomised trial in advanced head and neck cancer. International Journal of Radiation Oncology and Biological Physics 1986; 12:1343-1346.
2. Sealy R. A preliminary clinical study in the use of misonidazole in cancer of the head and neck. British Journal of Cancer 1978; 37 (Suppl III):314-317.


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