ESTRO 36 Abstract Book

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S395 ESTRO 36
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Conclusion
Older patients have a remarkable benefit from palliative
RT. A higher age should not be a reason to withhold
palliative RT.
PO-0749 Early impact of pulmonary SBRT on Quality of
Life: Benefit for patients with low initial QoL/GHS
S. Adebahr1,2, M. Hechtner3, N. Schräder1, T. Schimek-
Jasch1, K. Kaier4, V. Duncker- Rohr5, F. Momm5, J.
Gärtner6, A.L. Grosu1,2, U. Nestle1,2
1 University Medical Center Freiburg, Department of
Radiation Oncology, Freiburg, Germany
2 German Cancer Consortium DKTK, Partner Site Freiburg,
Freiburg, Germany
3 University of Mainz, Department of Medical
Biostatistics- Epidemiology and Informatics, Freiburg,
Germany
4 Faculty of Medicine and Medical Center - University of
Freiburg, Institute of Medical Biometry and Statistics,
Freiburg, Germany
5 St. Josefsklinik Offenburg, Department of Radio-
oncology, Offenburg, Germany
6 Medical Center- Faculty of Medicine- University of
Freiburg, Clinic for Palliative Care, Freiburg, Germany
Purpose or Objective
To determine the early impact of stereotactic body
radiotherapy (SBRT) on the quality of life (QoL) of
inoperable elderly and comorbid patients with small
pulmonary lesions.
Material and Methods
100 inoperable patients with pulmonary lesion <= 5cm
(early stage NSCLC or ≤ 2 pulmonary metastases of a
controlled primary tumor) were treated with SBRT (3x12.5
Gy or 5X 7Gy to 60% isodose) from 02/2011 to 12/2014
within the prospective, monocenter phase II STRIPE trial.
The European Organization for Research and Treatment of
Cancer Quality of Life Questionnaire (EORTC QLQ) C30 and
the QLQ LC13 lung cancer-specific questionnaire were
used to evaluate quality of life. Assessments were done
before treatment, 2 and 7 weeks, as well as 3 monthly
after SBRT for 2 years of follow up (FU) or until death.
Here we report on the primary descriptive analysis of early
changes from baseline to 7 week-FU. A clinically
significant change was defined as a change in HRQOL
scores of >=10 points compared with baseline.
Results
QoL was assessed in 97 patients. Compliance was 92% at
baseline and 85% at 7 weeks after SBRT. Overall, regarding
the whole cohort, the Qol /Global Health Status (GHS), all
function scores, and all inquired symptoms were
unchanged from baseline until 7 weeks after SBRT.
However, patients who initially scored their QoL / GHS
below the median of 50 showed a clinically relevant
improvement in QoL / GHS (delta 14), Emotional Function
(delta 15.12), and loss of appetite (delta 15.12). In
contrary, patients with initial scores of >= the median of
50 showed no clinically relevant alterations over time.
Patients with an initial low Karnofsky Index (KI) <=80
revealed a clinical relevant improvement in Emotional
Function (delta 10.2), whereas patients with high initial KI
>80 did not show any alterations. Univariate, multivariate
and further subgroup analysis are object of current
investigations.
Conclusion
In short-term FU QoL is well maintained after pulmonary
SBRT for elderly and comorbid inoperable patients.
Interestingly, especially patients with initially low
QoL/GHS may benefit from SBRT with respect to QoL.
Further analyses of predefined predictors are in progress.
Poster: Clinical track: Health services research / health
economics
PO-0750 Failure to publish the results of clinical trials
in oncology is skewing our medical practice
P. Gallego 1, J. Perez-Alija 1, E. Ambroa2, I. Linares3, A.
Pedro1
1Hospital Plató, Radiation Oncology Department,
Barcelona, Spain
2Consorci Sanitari de Terrasa, Medical Physics Unit-
Radiation Oncology Department, Terrasa, Spain
3Institut Català d'Oncologia, Radiation Oncology
Department, L'Hospitalet de Llobregat, Spain
Purpose or Objective
Clinical trials produce the best data available for decision-
making in modern evidence-based medicine. Publication
of all trials conducted in oncology is needed to fully
determine the benefits and risks of treatments currently
in use in our clinics. A US Federal law requires responsible
parties of all interventional trials to submit summary
results to the ClinicalTrials.gov database 12 months after
the completion date. We aimed to determine how many
of the interventional phase 3 and 4 trials conducted in
oncology were in compliance with the law and make their
results publicly available. We also analysed if there was
any difference when we take into account only radiation
oncology trials or molecular oncology ones. Finally we
estimated how many of these trials have not published in
a peer-reviewed journal (PRJ).
Material and Methods
As of 6 May 2016, the ClinicalTrials.gov database was
searched for interventional phase 3 and 4 trials in
Oncology with a primary completion date before 1 January
2013. We determined how many of these registry entries
have not published the compulsory deposition of their
results in the database. We then categorised our data into
a radiation oncology subset and a molecular oncology one.
For each trial registered in the database,
ClinicalTrials.gov also displayed publication citations
either submitted by sponsors or investigators, or
automatically indexed by ClinicalTrials.gov. We reviewed