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S759
ESTRO 36
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Science Centre- The Christie NHS Foundation Trust,
Manchester, United Kingdom
10
University of Rochester, Medical Center, Rochester,
USA
11
University of Manchester, Translational Radiobiology
Group I Institute of Cancer Sciences- The Christie NHS
Foundation Trust, Manchester, United Kingdom
Purpose or Objective
To define the optimal design and patient selection for
interventional trials in radiogenomics, as radiogenomics
do not give binary information like in e.g. targetable
mutation biomarkers. Here, the risk to develop severe side
effects is continuous, with increasing incidences of side
effects with higher doses and/or volumes.
Material and Methods
The most appropriate interventions, endpoints, trial
designs, model performance, identification of patient
groups that could benefit most from a radio-genomic
biomarker, and patient considerations were identified.
Patients’ advocacy representatives were part of this work.
Results
Interventions that can be considered are: alternative
treatment, dose modification, altered radiotherapy,
mitigation / amelioration and the omission of
postoperative radiotherapy in patients with a low risk for
tumour recurrence. The optimal intervention is dependent
on pre-defined risk factors, which were identified. There
is clearly no simple endpoint or time point that can be
selected when designing a clinical trial. Composite
endpoints should be considered.
Randomised clinical trials and retrospective observational
studies have pros and cons in radiogenomics, which will be
discussed. As model precision improves, thresholds can be
relaxed, e.g., a very precise model could select patients
for receiving a higher radiation dose with no risk of undue
toxicity. Although more precise models will typically
result in more benefit, less precise models might be
informative to some degree.
The consequences of the incidence of toxicity/toxicities
on the number of patients needed for prospective
validation as a function of the prevalence of a genetic
profile must be considered. A polygenic risk score will
likely be needed as individual genetic variants each
contribute only modestly to risk of developing toxicity.
Decreasing the standard radiation dose in the most
susceptible patients is highly dependent on the dose-
effect relationship.. These relations are highly dependent
on the endpoint, e.g. radiation pneumonitis vs. fibrosis.
An in-depth knowledge of the dose-volume relation for a
specific endpoint taking into account the clinical
usefulness of the dose reduction is needed in order to
select the correct patient for this strategy. For the results
of a study to be of value for patients, there should be a
therapeutic alternative for the standard of care
radiotherapy and the quantitative gain should be
measurable and relevant. The incidence of peak reactions
after radiotherapy is not the only parameter that should
be taken into account. It is their severity, reversibility,
the possible salvage treatments and the overall influence
on quality of life that is also crucial to take into account.
Conclusion
The REQUITE and radiogenomics consortium has defined
recommendations for the optimal design and patient
selection for interventional trials using radiogenomic
biomarkers, which will be presented in detail.
Funding: EU 601826
SK: K07CA187546 NCI USA
EP-1420 Effects of Japanese traditional Kampo
medicines “Goreisan” for acute radiation enteritis
H. Matsutani
1
, T. Shimbo
1
, H. Yoshioka
1
, N. Yoshikawa
1
,
K. Yoshida
1
, M. Nakata
1
, T. Hamada
1
, T. Komori
1
, Y.
Narumi
1
, Y. Uesugi
2
1
Osaka Medical College, Radiation Oncology, Osaka,
Japan
2
Kansai University of Welfare Sciences, Medical
treatment for health, Kashihara, Japan
Purpose or Objective
Goreisan
（
TJ-17
）
is one of Japanese traditional Kampo
medicine which is composed of five kinds of herbal
medicines. TJ-17 has been found to suppress the abnormal
water movement through the aquaporin inhibitory effect
and an anti-inflammatory effect. Recently, TJ-17 has been
indicated for cerebral edema and chronic subdural
hematoma, and appears its effects soon. We have
investigated whether the TJ-17 is effective in radiation
enteritis.
Material and Methods
TJ-17 (7.5g/day) was administered 68 patients who
received radiation therapy for the whole pelvis. The
median age was 64 years old (range; 50-88). Fifty cases
were male and eighteen cases were female. Sixty cases
(92.6%) were combined chemotherapy (cisplatin and/or
gemcitabine), eight cases received radiation alone. When
patients showed the diarrhea grade 2 or more in the CTCAE
v4.0, we administered TJ-17 without stopping radiation
therapy. After prescription, we examined the number of
defecation and stool property using a Bristol stool scale.
Results
All patients showed grade 2 or more diarrhea during
radiation therapy.
At the time of prescription, the median irradiation dose
was 23Gy (range; 12-44). Before the administration, the
median stool frequency was eight times (range; 4-20).
Eighteen cases was type 6 (mushy stool), and fifteen cases
was type 7 (watery) in the Bristol stool scale, the median
scale was type 7 (average; 6.7). Bloody stools were
observed in six cases. After one week administration of TJ-
17, fifty-three cases (77.9%) were improved the
symptoms. In improved group, the median of decrease in
the number of stool frequency was four times (range; 1-
19), and the median Bristol stool scale was type 6
(average; 5.4). Bloody stools were disappeared in three of
6 cases (50%). By using the Pearson product-moment
correlation coefficient, from the appearance enteritis
symptoms, it showed a correlation of moderate to start
administering the TJ-17 earlier.
Conclusion
Japanese traditional Kampo medicines Goreisan (TJ-17)
was effective against in acute radiation enteritis.
EP-1421 Outcome by prognostic factors of AVM
treated with LINAC:18 years experience, Spanish
Institution
S. Cafiero
1
1
Clinica de Occidente, Radiation Oncology, Santiago de
Cali, Colombia
Purpose or Objective
Outcomes of cerebral arteriovenous malformations
(cAVMs) treated with SRS by using LINAC, and results
according to the Spetzler-Martin (SM) grading system and
the Pollock-Flickinger (PF) score, in a series of patients
(pts) from Onkologikoa in Spain
Material and Methods
1995 to 2013, 320 pts with cAVMs treated with SRS by using
a Clinac 21EX . Mean age 40 years ( 9-76), 61% men and
39% women. 57% of cAMVs in an eloquent area, 93% at
the surface site (hemispheric/corpus callosum/cerebellar)
and 7% at a deep site (basal ganglia/thalamus/
brainstem). Prior embolization in 36% of pts. A deep
venous drainage was in 30% of cAVMs. The cAVM nidus
volume PTV was divided into 3 groups: 0-2 cc (30.3%), 2.1