ESTRO 35 Abstract book

S130 ESTRO 35 2016 _____________________________________________________________________________________________________ PV-0281 (ICORG 05-03): Radiotherapy in malignant spinal cord compression; The quality of life analysis K. Lee Proffered Papers: Donal Hollywood Award

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.

OC-0282 FLAME randomised trial: 95Gy MRI-boost vs 77Gy prostate radiotherapy: toxicity and quality of life M. Van Vulpen 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. 1 UMC Utrecht, Radiation Oncology, Utrecht, The Netherlands