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SLIDES
& TRANSCRIPTS
Tuesday,
June 18
Breakout
Group C Summary and Recomendations with Group Discussion: Improving
Therapy and Reducing Morbidity of Primary Therapy for Localized
Disease
Robert
S. Bell, MD
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| Slide
1: |
 DR.
BELL: The next issue that we addressed was the issue of morbidity
in the local management of extremity soft tissue sarcoma.
We felt that the recognition that we have acceptable local control
rates in soft tissue sarcoma management at present means that
trials should not be driven off the endpoint of local control.
We need alternative questions and alternative end points to generate
local management trials.
It is, however, critical in devising the next generation of treatments
that we not lose sight of the fact that local control is good
at present -- we should not compromise that local control by addressing
issues related to morbidity.
Some examples of alternative endpoints that were discussed - wound
healing, disability, impairment of fractures, fibrosis, joint
impairment, the cost to both the payer and the total cost to the
patient in terms of opportunity costs, and some surrogate markers,
such as R0 resection rates, were a variety of endpoints that we
looked at.
TOP
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| Slide
2: |
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 We
looked at a variety of questions, interventions that we might test
in terms of improving morbidity in local management. Some of the
options discussed were decreasing post-operative radiation dose,
decreasing volumes for both pre-op and post-op radiation management
with external beam, potential for concurrent chemotherapy to facilitate
dose reduction in radiotherapy.
We thought that most of those were yesterday's technologies, yesterday's
questions, and that what we should be doing in devising something
that looks to the future is to look at the potential for future
technologies in impacting on improved patient outcomes with respect
to morbidity.
We thought that the availability of Intensity Modulated Radiotherapy
in several institutions around this continent offers a timely opportunity
for leapfrogging forward and determining before this technology
has been introduced, what potential benefits in extremity soft tissue
sarcoma are.
We think that we have got a timely opportunity. We are in a situation
where, if we seize this opportunity, we can prevent potential harm
to our patients and we can look at this in a scientific fashion,
rather than seeing IMRT roll out in a haphazard fashion across North
America.
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| Slide
3: |
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 Currently,
there is a lot of theory that suggests that IMRT methods will substantially
reduce morbidity. We are in the unique situation that few centers
have any experience at the present time in IMRT in extremity lesions.
The benefit of IMRT is uncertain for extremity patients, extremity
soft tissue sarcoma patients. There is a cost to doing IMRT -- a
cost to the institution in terms of the time taken in planning,
the costly technology necessary to provide treatment.
We thought, at this point, it is a unique opportunity for a coordinated
research program, that has a strategy that implements IMRT in an
investigative fashion, with a rational implementation that looks
-- as well as at the improvements in local morbidity -- also looks
that we don't compromise local control of these patients by introducing
this new technology of radiation.
TOP
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| Slide
4: |
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 The
research strategy that we agree upon and present for your discussion
is to look at a pilot study in several centers that have the technology
available -- to evaluate, first of all, feasibility issues in terms
of target identification in the extremity, and in terms of the types
of plans that are necessary to provide treatment; to move forward
immediately, however, from a planned phase I study or pilot study,
into a planned phase III study if the pilot study suggests that
IMRT on the extremity is both feasible and potentially less morbid.
So, we have the phase III study being designed as we are doing the
pilot work.
The target group for the pilot study would most likely be that group
of patients where there is the most potential for benefit from reduced
morbidity, that would be in low extremity tumors that require combined
management. The primary endpoint would likely be reduction in wound complications
and morbidity while importantly, maintaining local control as a
secondary endpoint. So, again, perhaps I will stop there.
TOP
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