Hyperbaric oxygenation did not improve survival of patients with carcinoma of the urinary bladder treated with radiotherapy.

 

Clinical Bottom Line:

1. There was no survival advantage by the conduct of radiotherapy while in hyperbaric oxygen environment.

Appraised by: Mike Bennett, Dept. of Diving and Hyperbaric Oxygen, Prince of Wales Hospital, Sydney; Tuesday, 05 January, 1999

 

Clinical Scenario:  A patient with carcinoma of the urinary bladder considered suitable for attempted cure by radiotherapy.

Three-part Question: In treatment of bladder carcinoma with radiotherapy, does administration of hyperbaric oxygen during irradiation confer any benefit in terms of survival?

Search Terms: Hyperbaric oxygenation, radiotherapy, bladder neoplasms

 

The Study:

Non-blinded concealed randomised controlled trial without intention-to-treat.

Patients under 75 years with carcinoma of the urinary bladder without local spread to rectum or vagina and with lymphatic spread to external iliac nodes only.

Control group (N = 118; 118 analysed): Standard radiotherapy regime for each centre and grade of tumour.

Experimental group (N = 118; 118 analysed): As above, but radiotherapy while at 3ATA.

 

The Evidence:

Outcome

Time to Outcome

Control Rate

HBO Rate

Relative survival reduction

Absolute survival reduction

NNH

survival

1 year

0.644

0.636

1%

0.01

125

95% CI

 

 

 

-18% to 20%

-0.11 to 0.13

NNH= 8 to INF    NNT= 9 to INF

Survival

5 years

0.347

0.314

10%

0.033

30

95% CI

 

 

 

-25% to 44%

-0.09 to 0.15

NNH = 7 to INF    NNT = 12 to INF

 

 

 

Comments:

1. No standardisation of radiotherapy regime.

2. No suggestion of better survival for any stage or treatment regime with oxygen.

3. Cumulative radiation effect correlated with the incidence of high-dose complications.

 

Expiry date:  January 2004

References:

1.        Cade IS, Dische S, Watson ER, Wiernik G, Sutherland I. Hyperbaric oxygen and radiotherapy: a medical research council trial in carcinoma of the bladder. British Journal of Radiology 1978; 51:876-878.

2.        Kirk J, Wingate G, Watson E. High-dose effects in the treatment of carcinoma of the bladder under air and hyperbaric oxygen conditions. Clinical Radiology 1976; 27:137-144.

3.        Dische S. The hyperbaric oxygen chamber in the radiotherapy of carcinoma of the bladder. British Journal of Radiology 1973; 46:13-17.

4.        Wiernik G, Perrins D. Hyperbaric oxygen and radiotherapy in advanced carcinoma of the cervix and bladder. Fifth International Hyperbaric Congress Proceedings II 1974:820-829.

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