The
addition of hyperbaric oxygen to radiotherapy for the treatment of maxillary
antrum carcinoma was not associated with improved local tumour control or
survival.
Clinical Bottom Line:
1.
There was no improvement in survival with maxillary antrum carcinoma by the
addition of hyperbaric oxygen therapy.
2.
There was no evidence of a significant reduction in local tumour recurrence
with hyperbaric oxygen.
Appraised
by: Mike Bennett, Dept of Diving and
Hyperbaric Medicine, Prince of Wales Hospital
Sydney; Saturday, 27 March 1999
Clinical
Scenario: A patient presented with
squamous cell carcinoma of the maxillary antrum for radiotherapy.
Three-part
Question: For patients with carcinoma of
the maxillary antrum, does the addition of hyperbaric oxygen to a course of
radiotherapy result in an improvement in local control or survival?
Search
Terms: Radiotherapy, carcinoma/head and
neck.
The
Study:
Non-blinded pseudo-randomised
controlled trial with intention-to-treat.
Patients under 70 years with
maxillary antrum carcinoma without evidence of metastases or nodal disease.
Control group (N = 21; 21
analysed): 8 to 10 fractions of radiotherapy on a twice weekly schedule to a
total dose of 6,000 to 7,000 R, modified by judgement of treating staff.
Experimental group (N = 21; 21
analysed): 8 to 10 fractions of radiotherapy on the same schedule to a total
dose of 4,000 to 5,000 R, modified by judgement of the staff.
The
Evidence:
|
Outcome |
Time
to Outcome |
Air
group |
HBO
group |
Relative
risk reduction |
Absolute
risk reduction |
NNT |
|
Survival |
1
year |
0.476 |
0.476 |
0% |
0.0 |
0 |
|
95%
CI: |
|
|
|
-63%
to 63% |
-0.30
to 0.30 |
NNT=3
to INF NNH=3 to
INF |
|
Recurrence
|
1
year |
0.76 |
0.67 |
12% |
0.09 |
11 |
|
95%
CI: |
|
|
|
-24%
to 48% |
-0.18
to 0.36 |
NNT=3
to INF NNH=6 to
INF |
|
Primary
not cleared |
3
months |
0.29 |
0.24 |
17% |
0.05 |
21 |
|
95%
CI: |
|
|
|
-70%
to 100% |
-0.22
to 0.32 |
NNT=3
to INF NNH=5 to
INF |
Comments:
1. The report indicates
considerable variation in treatment regimen, but does not report actual
treatments given.
2. Pseudo-randomisation by
admission order may be problematic.
3. Comparisons made with
different groups from outside the study are confusing.
Expiry
date:
January 2004
References:
1. Shigematsu Y, Fuchihata H,
Makino T, Inoue T. Radiotherapy with reduced fraction in head and neck cancer,
with special reference to hyperbaric oxygen radiotherapy in maxillary sinus
carcinoma (a controlled study). In: Radiobiology and Radiotherapy, Sugahara T,
Rivesz I, Scott O eds, Tokyo 1973:180-187.
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