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S130
ESTRO 35 2016
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PV-0281
(ICORG 05-03): Radiotherapy in malignant spinal cord
compression; The quality of life analysis
K. Lee
1
St Luke's Radiation Oncology Network, Radiation Oncology,
Dublin, Ireland Republic of
1
, C. Small
2,3
, P. Kelly
2,4
, O. McArdle
1,2
, J. O'Sullivan
2,5
,
D. Hacking
2,6
, M. Pomeroy
2,3
, M. Stevenson
2
, J. Armstrong
1,2
,
M. Moriarty
1,2
, M. Dunne
7
, A. Clayton-Lea
2,8
, I. Parker
2
, C.
Collins
9
, P. Thirion
1,2
2
All Ireland Cooperative Oncology Research Group, Radiation
Oncology, Dublin, Ireland Republic of
3
Galway University Hospital, Radiation Oncology, Galway,
Ireland Republic of
4
Cork University Hospital, Radiation Oncology, Cork, Ireland
Republic of
5
Belfast City Hospital, Radiation Oncology, Belfast, United
Kingdom
6
Whitfield Clinic, Radiation Oncology, Waterford, Ireland
Republic of
7
St Luke's Radiation Oncology Network, Clinical Trials,
Dublin, Ireland Republic of
8
St Luke's Radiation Oncology Network, Operational Services,
Dublin, Ireland Republic of
9
St Luke's Radiation Oncology Network, Radiology, Dublin,
Ireland Republic of
Purpose or Objective:
To compare Quality of Life (QoL)
outcomes in patients (pts) with Malignant Spinal Cord
Compression (MSCC) not proceeding with surgical
decompression and treated by External Beam Radiation
Therapy (EBRT) with one of two Fractionation Schedules (FS).
Material and Methods:
ICORG 05-03 was an ICH-GCP
compliant prospective (1.1) randomised non-inferiority phase
III trial comparing two FS: arm 1 (control): 20Gy/5 Fractions
(#) vs. arm 2 (experimental): 10Gy/1#, with 80% power, 5%
significant level and 0.4 non-inferiority margin. While the
primary end point of this trial (previously presented (ASTRO
2014)) was change in mobility at 5 weeks (wks), the current
focus is on a secondary endpoint, QoL (EORTC QLQ-C30
questionnaire).
Results:
From 2006 to 2014, 5 institutions accrued 115
eligible pts (2 non-eligible pts, no treatment allocation
violation). 70 pts with QoL data at 5 wks were evaluable.
Baseline characteristics were balanced between arms [
♀
/
♂
:
30/40, median age: 69 (range: 30-87)]. Analysis showed a
statistically significant benefit of radiotherapy (RT) for ‘Pain
interfered with daily activities’ but not for Overall OoL.
There was no statistically significant benefit between arms
for either: 1. Overall QoL (mean change from pre-treatment
.52 in arm 1 vs. .21 in arm 2; 95% CI: -0.84 – 1.45, p = 0.596);
2. Pain interfered with daily activities (mean change: .84 in
arm 1 vs. 1.00 in arm 2; 95% CI: -0.66 – .98, p = 0.698). A
non-planned exploratory regression analysis checked for
independent prognostic factors for less pain at 5 wks.
Multiple regression analysis revealed baseline pain as the
strongest unique and statistically significant contributor to
explaining less pain at 5-wks (beta = -0.63; p=0.002).
Exploratory analyses were also conducted to characterise pts
dying at <5 wks,who might not benefit from RT. Primary
malignancy (Chi-square test: Χ2 (3, n=106) = 15.6, p = 0.001,
phi = 0.38) and initial mobility status (Chi-square test, Χ2 (2,
n=106) = 11.0, p = 0.004, phi = 0.32.) were found to be
associated with a life expectancy <5 wks. 67% of lung and 13%
of breast cancer pts died before 5 wks, as did 49% of bed-
bound and 15% of pts who could walk unaided.
Conclusion:
With respect to QoL, primary RT significantly
improves the pain related variables used in the trial, with
10Gy/1# FS being at least equivalent to 20Gy/5#. Baseline
pain is the most significant independent prognostic factor for
less pain at 5 wks. Tumour site and mobility should be
considered when offering RT treatment to similar pts.
Proffered Papers: Donal Hollywood Award
OC-0282
FLAME randomised trial: 95Gy MRI-boost vs 77Gy prostate
radiotherapy: toxicity and quality of life
M. Van Vulpen
1
UMC Utrecht, Radiation Oncology, Utrecht, The Netherlands
1
, J. Van Loon
1
, F. Pos
2
, K. Haustermans
3
, R.
Smeenk
4
, L. Van den Bergh
3
, S. Isebaert
3
, G. McColl
4
, M.
Kunze-Busch
4
, B. Doodeman
2
, J. Noteboom
1
, E. Monninkhof
5
,
U. Van der Heide
2
2
AvL/NKI, Radiation Oncology, Amsterdam, The Netherlands
3
UZ Leuven, Radiation Oncology, Leuven, Belgium
4
Radboud UMC, Radiation Oncology, Nijmegen, The
Netherlands
5
UMC Utrecht, Julius Center for methodology, Utrecht, The
Netherlands
Purpose or Objective:
The aim of this study was to compare
treatment related side-effects and quality of life of an MRI-
based 95Gy boost to the multi-parametric MRI visible tumor
with 77Gy whole prostate external beam radiotherapy in
patients with intermediate or high risk localized prostate
cancer.
Material and Methods:
FLAME (NCT01168479) was a phase 3,
single blind, multi-center randomized controlled trial.
Patients with biopsy proven intermediate and high risk
prostate cancer (D’Amico risk classification) were randomly
assigned and stratified per center. Analysis was done by
intention to treat. The control group received a dose to the
entire prostate of 77Gy in 35 fractions. The experimental arm
received an additional integrated boost up to 95 Gy to the
mp-MRI-visible lesions. Treatment related toxicity was
measured by the Common Toxicity Criteria for adverse events
version 3.0 (CTCAE). Quality of Life (QoL) was measured by
SF-36, EORTC QLQ-C30 and EORTC QLQ-PR25. All items and
scale scores were linearly transformed to a 0–100 scale, with
higher scores reflecting either more symptoms or higher
levels of functioning. Clinical relevance was considered a
difference of more than 10 points between arms. Mean
differences between groups were calculated using a linear
mixed model with adjustment for baseline values. Statistical
significance was considered P<0.01.
Results:
Between 2009 and 2015 287 patients were assigned
to the control group and 284 to the dose-escalated (FLAME)
arm. Mean follow up was 22 months. In both arms, 84% of
patients had high risk disease. Regarding GU toxicity, 134
patients (47.2%) in the FLAME arm and 147 patients (51.4%) in
de control arm experienced any grade 2 or higher toxicity.
Grade 3 GU toxicity occurred in 15 patients (5.3%) in the
FLAME arm and 12 patients (4.2%) in the control arm.
Regarding GI toxicity, 60 patients (21.1%) in the FLAME arm
and 47 patients (16.4%) in the control arm experienced grade
2 or higher toxicity. Grade 3 toxicity occurred in 2 patients
(0.7%) in the FLAME arm and in 5 patients (1.7%) in the
control arm. None of these differences were statistically
significant. For all quality of life measures no statistically
significant or clinical relevant differences were observed.