The abstract, “ICORG 05-03: Prospective Randomised Non-Inferiority Phase 3 Trial Comparing Two Radiation Schedules in Malignant Spinal Cord Compression not Proceeding with Surgical Decompression,” will be presented in detail during the plenary session at ASTRO’s 56th Annual Meeting at 2:15 p.m., Pacific time on Monday, September 15, 2014. To speak with Dr. Thirion, please call Michelle Kirkwood on September 14 – 17, 2014, in the ASTRO Press Office at the Moscone Center in San Francisco Center at 415-978-3503 or 415-978-3504, or email [email protected].
ASTRO’s 56th Annual Meeting, to be held at the Moscone Center in San Francisco, September 14-17, 2014, is the nation’s premier scientific meeting in radiation oncology. The 2014 Annual Meeting is expected to attract more than 11,000 attendees including oncologists from all disciplines, medical physicists, dosimetrists, radiation therapists, radiation oncology nurses and nurse practitioners, biologists, physician assistants, practice administrators, industry representatives and other health care professionals from around the world. Led by ASTRO President Bruce G. Haffty, MD, FASTRO, a radiation oncologist specializing in breast cancer, the theme of the 2014 Meeting is “Targeting Cancer: Technology and Biology,” and the Presidential Symposium, “Local-regional Management of Breast Cancer: A Changing Paradigm,” will feature Jay R. Harris, MD, FASTRO, and Thomas A. Buchholz, MD, FASTRO, to highlight recent practice-changing, landmark studies and current developments in the local-regional management of breast cancer. ASTRO’s four-day scientific meeting includes presentation of up to four plenary papers, 360 oral presentations, 1,862 posters and 144 digital posters in more than 50 educational sessions and scientific panels for 20 disease-site tracks. Three keynote speakers will address a range of topics including oncologic imaging, biology and targeting in oncology, and human error and safety concerns: Hedvig Hricak, MD, PhD, Chair of the Department of Radiology and the Carroll and Milton Petrie Chair at Memorial Sloan Kettering Cancer Center; Frank McCormick, PhD, FRS, DSc (hon), Professor Emeritus and the David A. Wood Distinguished Professor of Tumor Biology and Cancer Research of the University of California at San Francisco Helen Diller Family Comprehensive Cancer Center; and Sidney Dekker, PhD, MA, MSc, Professor and Director of the Safety Science Innovation Lab at Griffith University, Brisbane, Australia. ABOUT ASTROASTRO is the premier radiation oncology society in the world, with more than 10,000 members who are physicians, nurses, biologists, physicists, radiation therapists, dosimetrists and other health care professionals that specialize in treating patients with radiation therapies. As the leading organization in radiation oncology, the Society is dedicated to improving patient care through professional education and training, support for clinical practice and health policy standards, advancement of science and research, and advocacy. ASTRO publishes two medical journals, International Journal of Radiation Oncology • Biology • Physics (www.redjournal.org) and Practical Radiation Oncology (www.practicalradonc.org); developed and maintains an extensive patient website, www.rtanswers.org; and created the Radiation Oncology Institute (www.roinstitute.org), a non-profit foundation to support research and education efforts around the world that enhance and confirm the critical role of radiation therapy in improving cancer treatment. To learn more about ASTRO, visit www.astro.org.
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2014 American Society for Radiation Oncology (ASTRO) 56th Annual MeetingNews Briefing, Monday, September 15, 2014, 11:00 a.m., Pacific time
Scientific Session: Monday, September 15, 2014, 2:15 – 3:25 p.m., PT, the Moscone Center
LBA2 ICORG 05-03: Prospective Randomised Non-Inferiority Phase 3 Trial Comparing Two Radiation Schedules in Malignant Spinal Cord Compression not Proceeding with Surgical Decompression Author Block: P. Thirion1,2, L. O'Sullivan*1,2, A. Clayton-Lea*1,2, C. Small*1,3, O. McArdle*1,2, P. Kelly*1,4, I. Parker*1, J. O'Sullivan*1,5, D. Hacking*1,6, C. Collins*2, M. Pomeroy*1,3, M. Moriarty*1,2. , 1All Ireland Cooperative Oncology Research Group, Dublin, Ireland, 2St Luke's Radiation Oncology Network, Dublin, Ireland, 3Galway University Hospital, Galway, Ireland, 4Cork University Hospital, Cork, Ireland, 5Belfast City Hospital, Belfast, United Kingdom, 6Whitfield Clinic, Waterford, Ireland,
Purpose / Objective(s): To prospectively compare two External Beam Radiation Therapy (EBRT) Fractionation Schedules (FS) in patients (pts) with Malignant Spinal Cord Compression (MSCC) not proceeding with surgical decompression.
Materials / Methods: An ICH-GCP compliant prospective (1.1) randomised non-inferiority phase 3 trial compared two EBRT-FS: arm 1 (control): 20 Gy / 5 fractions (#) vs. arm 2 (experimental): 10 Gy / 1 #, with 90% power, 5% significant level and +0.4 non-inferiority margin. The primary end-point was the change in mobility at 5 weeks (Modified Tomita score); the secondary end-points were change in bladder function at 5 weeks (in-house score), acute and long-term toxicity (RTOG scale), and overall survival (OS). Eligible pts had pathologically proven metastatic cancer, excluding haematological/ germ cell malignancies, and diagnosed with a MRI documented treatment naïve symptomatic MSCC.
Results: From 2006 to 2014, 5 institutions accrued 116 pts (1 non-eligible pt, no treatment allocation violation), 76 pts alive at 5 weeks were evaluable. The baseline characteristics were balanced between arms [♀/♂ ratio: 36/64, median age: 69 (range: 30-87), median baseline KPS: 60 (range: 30 - 100)]. The main primary tumour sites were prostate (24%), breast (20%) and lung (19%). The MSCC sites were cervical (4.3%), thoracic (67%), lumbar (23.5%), sacral (2.6%) and two synchronous levels (2.6%, 3 pts treated with same FS). Analysis of evaluable pts showed no statistically significant differences in 1) overall mobility score change at 5 week [Overall response (Improvement/Stability) rate: arm 1: 68.4% (10.5/57.9) vs. arm 2: 78.9% (10.5/68.4); mean mobility score change: arm 1: -0.29 vs. arm 2: -0.08, difference= -0.21, 95%CI: -0.56 to 0.14, +0.4 non-inferiority margin outside 95%CI] or 2) bladder function score change at 5 weeks [Overall response (Improvement/stability) rate: arm 1: 75.7% (10.8/ 64.9) vs. arm 2: 86.8% (2.6/84.); mean sphincter score change: arm 1: -0.22 vs arm 2: -0.16, difference = -0.06, 95%CI: -0.44 to 0.32]. The mobility deterioration free survival and overall survival median durations were similar in both arms respectively 1.4 months and 4 months. Independent favourable prognostic factors were 1) for 5 week mobility overall response: preserved baseline mobility, and 2) for OS: preserved baseline mobility, high baseline KPS, young age and non-lung primary. The reported overall toxicity was low with 1 G3-acute and 1 G3-long-term toxicity events (arm 2) and no higher grade toxicity reported.
Conclusions: With respect to mobility preservation, 10 Gy / 1 # is at least equivalent to 20 Gy / 5#. When using EBRT in similar pts, a single fraction schedule should be considered. Author Disclosure Block: P. Thirion: None. L. O'Sullivan: None. A. Clayton-Lea: None. C. Small: None. O. McArdle: None. P. Kelly: None. I. Parker: None. J. O'Sullivan: None. D. Hacking: None. C. Collins: None. M. Pomeroy: None. M. Moriarty: None.