TARGeted Intra-operative radioTherapy (TARGIT) for breast cancer - a randomised trial Jayant Vaidya, Michael Baum, Jeff Tobias, Joan Houghton,Mo Keshtgar, Irving Taylor, Richard Sainsbury, Derek D’Souza,
Download ReportTranscript TARGeted Intra-operative radioTherapy (TARGIT) for breast cancer - a randomised trial Jayant Vaidya, Michael Baum, Jeff Tobias, Joan Houghton,Mo Keshtgar, Irving Taylor, Richard Sainsbury, Derek D’Souza,
Slide 1
TARGeted Intra-operative radioTherapy
(TARGIT)
for breast cancer - a randomised trial
Jayant Vaidya, Michael Baum, Jeff Tobias,
Joan Houghton,Mo Keshtgar, Irving Taylor,
Richard Sainsbury,
Derek D’Souza, S Morgan, M Metaxas,
K Harte, A Sliski, E Thomson
Slide 2
Local treatment of breast cancer
Have the principles really changed?
Halsted’s Radical Mastectomy
Limited Surgery plus Radical
Radiotherapy
Slide 3
Are there any problems with
current approach?
Radiotherapy typically takes 6wks to deliver
Patients don’t like these 30 daily visits
Geography prevents many women from
receiving conservative breast surgery
Breast cancer = 1/3rd of RT work-load
Long waiting lists in many centres
Slide 4
The Solution
A novel radiotherapy technique that will
accurately deliver all the necessary
radiotherapy in ONE sitting
Treat only the index quadrant of breast
Slide 5
The Rationale
Whole organ analysis of
mastectomy specimens*
3-D analysis
63% harbour
*Vaidya et al, Br. J. Cancer; 1996
occult cancer
80% of these
are in other
quadrants
Slide 6
The Rationale
but, in trials of conservative surgery:
>90% recurrences occur in the index
quadrant
- whether radiotherapy is given or not
The occult cancers in other quadrants of
the breast are probably not the cause of
local recurrence.
Radiation to the index quadrant alone
might be sufficient
Slide 7
Targeted Intra-operative
Radiotherapy: (Targit)
A Novel Approach
Slide 8
The Technique
PRS400 (Intrabeam)
A miniature electron generator and accelerator
Accurately delivers radiotherapy
from within the breast
in about 25 minutes.
Slide 9
•Soft X-rays
•Small ‘very-high-dose’ region
•Quick attenuation (1/r3)– distance protects normal
tissues
•Shielding is easy
0
5
1
10
15
20
20 Gy at 2mm
5
9
13
17
Physical radiation
dose
21
25
1 Gy at 27mm
Slide 10
Slide 11
Applicator is inserted and purse string is tied
Slide 12
Rather than the complicated
conformation of the source
to the target...
the target - the pliable
breast tissue is conformed to the source
Slide 13
Estimated Biologically equivalent
radiation dose (BED)
Distance from
applicator
External
Boost
/
Targit
with PRS
=10
/
=1.5
2mm e.g. breast
12 Gy
53 Gy
121 Gy
10mm e.g. skin
12 Gy
7 Gy
21 Gy
Slide 14
1. To test the the TARGIT technique
-its feasibility and safety
2. To test the approach
of treating only the index quadrant
Slide 15
Phase I/II study
July 1998-Jan 2000
Early operable breast cancer: <4cm in size
Wide Local excision + axillary surgery
Boost radiation with Photon Radio
Surgery (PRS) intra-operatively
Whole breast radiotherapy post-op
Slide 16
Results – the pilot study
25 patients treated
With tumours ranging from 0.42 -4 cm
Median follow up 30 m
No major complications
No recurrences
Cosmetic results are good
Slide 17
Complications
Our 3rd patient had radionecrosis of skin near
the scar- skin was too close to the applicator
9 months
28 months
Slide 18
Cosmetic Results
1) Photographs
2) Patient’s own assessment of the cosmetic
result – appearance and texture:
a) What would be your expected score
(out of 10)?
b) What is the actual score (out of 10)
Satisfaction index = Actual / Expected
Slide 19
Cosmetic Results
Satisfaction index (observed/expected)
Appearance
Texture
Mean
95% CI
1.2
1.2
(1.1-1.4)
(1.0-1.4)
In only 4 out of the 25 patients in the pilot
study, was the observed less than expected.
Slide 20
Slide 21
Breast cancer - breast conserving therapy
Randomisation
Study Arm
Control Arm
Wide local excision of
primary tumour +
SNB/ axillary dissection
+
Targeted Intraoperative
Radiotherapy
Wide local excision of
primary tumour +
SNB/ axillary
dissection +
6 wks of Postoperative
Radiotherapy
(If histopathology is
Lobular or EIC, add
5wks of postoperative
radiotherapy)
Slide 22
1st patient randomised on 29 March 2000
- 29 patients randomised until June 2001
No complications in the IORT arm
1 wound infection in the post-op RT arm
Median follow up is 15 months
Cosmetic appearance is good
No recurrences to date
Slide 23
If proven, Targit could
Save up to 1/3rd of the
workload of radiotherapy
units world-wide
Allow women from remote
areas to avail of breast
conserving therapy
TARGeted Intra-operative radioTherapy
(TARGIT)
for breast cancer - a randomised trial
Jayant Vaidya, Michael Baum, Jeff Tobias,
Joan Houghton,Mo Keshtgar, Irving Taylor,
Richard Sainsbury,
Derek D’Souza, S Morgan, M Metaxas,
K Harte, A Sliski, E Thomson
Slide 2
Local treatment of breast cancer
Have the principles really changed?
Halsted’s Radical Mastectomy
Limited Surgery plus Radical
Radiotherapy
Slide 3
Are there any problems with
current approach?
Radiotherapy typically takes 6wks to deliver
Patients don’t like these 30 daily visits
Geography prevents many women from
receiving conservative breast surgery
Breast cancer = 1/3rd of RT work-load
Long waiting lists in many centres
Slide 4
The Solution
A novel radiotherapy technique that will
accurately deliver all the necessary
radiotherapy in ONE sitting
Treat only the index quadrant of breast
Slide 5
The Rationale
Whole organ analysis of
mastectomy specimens*
3-D analysis
63% harbour
*Vaidya et al, Br. J. Cancer; 1996
occult cancer
80% of these
are in other
quadrants
Slide 6
The Rationale
but, in trials of conservative surgery:
>90% recurrences occur in the index
quadrant
- whether radiotherapy is given or not
The occult cancers in other quadrants of
the breast are probably not the cause of
local recurrence.
Radiation to the index quadrant alone
might be sufficient
Slide 7
Targeted Intra-operative
Radiotherapy: (Targit)
A Novel Approach
Slide 8
The Technique
PRS400 (Intrabeam)
A miniature electron generator and accelerator
Accurately delivers radiotherapy
from within the breast
in about 25 minutes.
Slide 9
•Soft X-rays
•Small ‘very-high-dose’ region
•Quick attenuation (1/r3)– distance protects normal
tissues
•Shielding is easy
0
5
1
10
15
20
20 Gy at 2mm
5
9
13
17
Physical radiation
dose
21
25
1 Gy at 27mm
Slide 10
Slide 11
Applicator is inserted and purse string is tied
Slide 12
Rather than the complicated
conformation of the source
to the target...
the target - the pliable
breast tissue is conformed to the source
Slide 13
Estimated Biologically equivalent
radiation dose (BED)
Distance from
applicator
External
Boost
/
Targit
with PRS
=10
/
=1.5
2mm e.g. breast
12 Gy
53 Gy
121 Gy
10mm e.g. skin
12 Gy
7 Gy
21 Gy
Slide 14
1. To test the the TARGIT technique
-its feasibility and safety
2. To test the approach
of treating only the index quadrant
Slide 15
Phase I/II study
July 1998-Jan 2000
Early operable breast cancer: <4cm in size
Wide Local excision + axillary surgery
Boost radiation with Photon Radio
Surgery (PRS) intra-operatively
Whole breast radiotherapy post-op
Slide 16
Results – the pilot study
25 patients treated
With tumours ranging from 0.42 -4 cm
Median follow up 30 m
No major complications
No recurrences
Cosmetic results are good
Slide 17
Complications
Our 3rd patient had radionecrosis of skin near
the scar- skin was too close to the applicator
9 months
28 months
Slide 18
Cosmetic Results
1) Photographs
2) Patient’s own assessment of the cosmetic
result – appearance and texture:
a) What would be your expected score
(out of 10)?
b) What is the actual score (out of 10)
Satisfaction index = Actual / Expected
Slide 19
Cosmetic Results
Satisfaction index (observed/expected)
Appearance
Texture
Mean
95% CI
1.2
1.2
(1.1-1.4)
(1.0-1.4)
In only 4 out of the 25 patients in the pilot
study, was the observed less than expected.
Slide 20
Slide 21
Breast cancer - breast conserving therapy
Randomisation
Study Arm
Control Arm
Wide local excision of
primary tumour +
SNB/ axillary dissection
+
Targeted Intraoperative
Radiotherapy
Wide local excision of
primary tumour +
SNB/ axillary
dissection +
6 wks of Postoperative
Radiotherapy
(If histopathology is
Lobular or EIC, add
5wks of postoperative
radiotherapy)
Slide 22
1st patient randomised on 29 March 2000
- 29 patients randomised until June 2001
No complications in the IORT arm
1 wound infection in the post-op RT arm
Median follow up is 15 months
Cosmetic appearance is good
No recurrences to date
Slide 23
If proven, Targit could
Save up to 1/3rd of the
workload of radiotherapy
units world-wide
Allow women from remote
areas to avail of breast
conserving therapy