E394
International Journal of Radiation Oncology Biology Physics
2971
Materials/Methods: MAUDE data was obtained from 1991-2015. Product codes representing RODs were sorted into 4 categories: external beam, brachytherapy, planning systems, and simulation. Device problem codes associated with RODs were grouped as: software, mechanical, electrical, user error, and treatment output. Descriptive statistics were performed, comparing RODs to other devices. Outcomes included whether the device was evaluated by manufacturer, event type, remedial action, problem code, and device age. Time since FDA 510K clearance of each device was computed by merging of the FDA 510K database. RODs were compared to other devices by Pearson’s Chi-squared test or two-sample KolmogorovSmirnov test. Results: There were 4228 ROD and 4,985,704 other device reports. Among RODs, most (50.9%) involved external beam, followed by brachytherapy (24.8%), planning systems (21.7%), and simulation systems (2.7%). The top 3 problem code categories were software (30.4%), mechanical (20.9%), and user error (20.4%). Comparisons between RODs and other devices are shown in Table 1. Time since 510K clearance for RODs tended to decrease over time (beta Z -0.58 years/year, P Z .08). Conclusion: Compared to other devices, RODs may experience adverse events sooner after manufacture and market clearance. RODs are more likely to be evaluated by the manufacturer after an event, but less likely to be recalled. Given the high rate of issues involving human interface among RODs - software problems, user errors, and notifications as remedial action - it is critical to involve professionals at every stage of radiation delivery in quality improvement and reporting. Information from centralized, mandated reporting databases such as MAUDE can inform efforts to improve patient safety.
Long-Term Toxicities in Survivors of Radiation Treatment for Head and Neck Cancer Y. Dong, T. Li, T.M. Churilla, R. Mehra, M. Lango, J. Bauman, J.A. Ridge, and T.J. Galloway; Fox Chase Cancer Center, Philadelphia, PA Purpose/Objective(s): To characterize the well-recognized but poorly understood long-term toxicities of head and neck radiation. Materials/Methods: We evaluated patients treated with radiation therapy (RT) for head and neck cancer (HNC) (excluding T1 glottis) from 1990 to 2002 at a single institution with scheduled long-term multi-modality follow up. Upper aerodigestive tract toxicities potentially due to radiation and discovered > 6 months after completion of RT were recorded. Events were assigned to 3 broad categories: swallowing (esophageal dilation, failed swallowing test, feeding tube lasting more than 1 year), laryngeal (tracheotomy, palliative laryngectomy, aspiration pneumonia), and oral cavity (osteoradionecrosis (ORN), hyperbaric oxygen (HBO) therapy, trismus). Kaplan-Meier estimate and Chi-square test were used for univariable analysis (UVA). Logistic regression was used for multivariable analysis (MVA). Results: There were 112 patients with a median follow-up of 12.8 years (6.3-22.9 years). 88% were followed more than 10 years. 2D radiation planning was used for 98% of patients. The median RT dose was 68 Gy (50-75 Gy). The primary tumor sites were: oral cavity (n Z 44, 39%), larynx (n Z 16, 14%), pharynx (n Z 42, 38%), other (n Z 10, 9%). Fiftyfive (49%) received post-op RT, 25(22%) received post-RT neck dissection, and 36 (32%) received chemotherapy (sequential or concurrent). Thirty-three (29%) patients developed swallowing toxicity; 23 (21%) required permanent feeding tubes placed at a median of 8.5 years after completion of RT. Nineteen (17%) patients developed laryngeal toxicity, including 14 (13%) with aspiration pneumonia diagnosed at a median of 7.3 years after completion of RT. Forty-eight (43%) patients developed oral cavity toxicity, including ORN in 22 (20%) found at a median of 6.2 years after completion of RT. Moreover, 10 (9%) patients developed permanent cranial nerve (CN) deficit, most common being CN X causing vocal cord paralysis; 7(6%) patients needed chronic narcotic use for pain in the head and neck. On UVA, factors predictive for swallowing toxicity were cancer of larynx/pharynx, surgery, post-RT neck dissection, increased RT dose, and chemotherapy. Those predictive for laryngeal toxicity were site of larynx/pharynx, surgery, and chemotherapy. Oral cavity toxicity was associated with oral cavity site. On MVA, swallowing and laryngeal toxicity were both significantly associated with chemotherapy (OR 4.5, CI 1.4-14.6 for swallowing toxicity; OR 4.7, CI 1.1-19.8 for laryngeal toxicity); nothing else was significant on MVA. Conclusion: Among patients radiated for HNC swallowing, laryngeal, and oral cavity toxicities are frequent after a decade, especially in those treated with chemotherapy. Long-term follow up is essential as these toxicities often do not emerge for years. Author Disclosure: Y. Dong: None. T. Li: None. T.M. Churilla: None. R. Mehra: Employee; NTAP. Consultant; Novartis, BMS, Bayer, Genentech. M. Lango: None. J. Bauman: None. J.A. Ridge: None. T.J. Galloway: None.
2972 Food and Drug Administration (FDA) Medical Device Reports From 1991 to 2015: Are Radiation Oncology Devices Different? M. Connor, D.C. Marshall, R. Karunamuni, K.L. Moore, T. Pawlicki, A.J. Mundt, III, and J.A. Hattangadi; University of California, San Diego, La Jolla, CA Purpose/Objective(s): The field of radiation oncology relies heavily on rapidly evolving technology and highly complex processes. The FDA collects and records all reported adverse events from medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the FDA’s post-market surveillance MAUDE (Manufacturer and User Facility Device Experience) database, and compare these to other non-radiation oncology devices.
Abstract 2972; Table 1. Characteristic Report Source Code Manufacturer Voluntary Device Evaluated By Manufacturer Yes No Event Type Malfunction Injury Other Death Remedial Action (n [ 972, 474783) Notification Modification/Adjustment Repair Recall Device Age (n [ 2258, 3047057) Median # of days (range) Time Since 510K Clearance (n [ 361, 291351) Median # of days (range)
RODs (%)
Other Devices (%) Chi-square P < .001
3511 (83.0) 495 (11.7)
4742724 (95.1) 103818 (2.1)
1984 (46.9) 1399 (33.1)
1643233 (33.0) 2811961 (56.4)
2637 (62.4) 688 (16.3) 587 (13.9) 98 (2.3)
3038150 (60.9) 1681578 (33.7) 100809 (2.0) 112388 (2.3)
424 122 109 102
48153 (10.1) 7530 (1.6) 135525 (28.5) 179850 (37.9)
(43.6) (12.6) (11.2) (10.5)
544 (12 - 13136) 753 (1 - 21944)
P < .001
P < .001
P < .001
P < .001 P < .001
1450 (24 - 7683) 2605 (1 - 11261)
Author Disclosure: M. Connor: None. D.C. Marshall: None. R. Karunamuni: None. K.L. Moore: Master Research Agreement, Consulting, Honoraria; Varian Medical Systems. T. Pawlicki: Honoraria, Travel Expenses; Varian Medical Systems. Partnership; TreatSafely, LLC, Oncology Owl, LLC. Founding Partner; TreatSafely, LLC. A.J. Mundt: None. J.A. Hattangadi: Research Grant; Varian Medical Systems.
2973 Supply and Demand for Radiation Oncology in the United States: Updated Projections for 2015 to 2025 H.Y. Pan,1 B.G. Haffty,2 B. Falit,3 T.A. Buchholz,4 L.D. Wilson,5 S.M. Hahn,6 and B.D. Smith7; 1MD Anderson Cancer Center, Houston, TX, 2Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, 3 Harvard Radiation Oncology Program, Boston, MA, United States, 4The University of Texas MD Anderson Cancer Center, Houston, TX,
Volume 96 Number 2S Supplement 2016 5
Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT, 6Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, 7MD Anderson, Houston, TX Purpose/Objective(s): Prior studies forecast demand for radiation therapy to grow 10 times faster than supply between 2010 and 2020. We updated these projections for 2015 to 2025 to determine whether this imbalance persists and to assess the accuracy of prior projections. Materials/Methods: Demand for radiation therapy between 2015 and 2025 was estimated by combining current radiation utilization rates determined by Surveillance, Epidemiology, and End Results data with population projections provided by the Census Bureau. Supply of radiation oncologists was forecast using workforce demographics and full-time equivalent (FTE) status provided by the American Society for Radiation Oncology (ASTRO), current resident class sizes, and expected survival per life tables from the Center for Disease Control. Results: Between 2015 and 2025, the annual total number of patients receiving radiation therapy during their initial treatment course is expected to increase by 19%, from 490,000 to 580,000. Assuming a graduating resident class size of 200, the number of FTE physicians is expected to increase by 27%, from 3,903 to 4,965. Compared to prior projections, the new projected demand for radiation therapy in 2020 dropped by 24,000 cases (a 4% relative decline). This decrease is attributable to an overall reduction in the utilization of radiation to treat cancer, from 28% of all newly diagnosed cancers in the prior projections down to 26% for the new projections. In contrast, the new projected supply of radiation oncologists in 2020 increased by 275 FTEs compared to the prior projection for 2020 (a 7% relative increase), attributable to rising residency class sizes. Conclusion: The supply of radiation oncologists is expected to grow more quickly than demand for radiation therapy from 2015 to 2025. Further research is needed to determine whether this is an appropriate correction or will result in excess capacity. Author Disclosure: H.Y. Pan: Employee; Memorial Hermann Medical Group. B.G. Haffty: None. B. Falit: None. T.A. Buchholz: None. L.D. Wilson: Member of Board; American Board of Radiology. S.M. Hahn: None. B.D. Smith: Research Grant; Varian Medical Systems.
2974 Short-Course Radiation Therapy for Locally Advanced Rectal Cancer: Less Costly, More Effective? A. Roy,1,2 S.H. Chang,1 M.Y. Leung,1 and P.J. Parikh1; 1Washington University School of Medicine, St. Louis, MO, 2University of Missouri Kansas City School of Medicine, Kansas City, MO Purpose/Objective(s): The optimal preoperative regimen for locally advanced rectal cancer remains controversial. Short course radiation therapy (SCRT) with 25Gy over 5 fractions is less costly than conventional chemoradiation (CRT) and has recently been included in the NCCN and ASTRO guidelines as an alternative treatment option. We performed a cost-utility analysis comparing the two regimens and hypothesize that SCRT is more cost-effective in the US setting. Materials/Methods: A Markov decision model was created to simulate the clinical history of a 63-year-old patient with locally advanced rectal cancer treated with either neoadjuvant SCRT or CRT followed by surgery and adjuvant chemotherapy. The model was designed with 3-month cycles over a lifetime horizon. Probability values for local recurrence (LR), distant metastases (DM), disease-free survival (DFS), post-operative complications, and acute and late toxicities for each regimen were extracted from randomized trials comparing the two regimens. Health states included disease-free, alive with LR, alive with DM, and death. Utility values for each health state were extracted from published literature. We assumed no difference in quality-of-life associated with treatment regimen due to lack of comparative data. Treatment costs (in US dollars) were calculated from the payer perspective and based on the 2015 Medicare reimbursement schedule. In addition to radiation therapy, we included costs of surgery, adjuvant chemotherapy, follow-up care and management of recurrence and toxicities. The primary model outcomes were lifetime costs and health
Poster Viewing E395 benefits, expressed as quality-adjusted life years (QALYs). Both were discounted at an annual rate of 3%. Incremental cost-effectiveness ratios (ICER) were calculated and a willingness to pay (WTP) threshold of $50,000 per QALY was used. One-way and two-way sensitivity analyses were performed to account for uncertainties in the model. Results: Upfront neoadjuvant treatment costs were $4,105 and $13,932 for SCRT and CRT, respectively (cost difference of $9,827). In the base case, the mean expected lifetime costs per QALY were $73080 / 2.28 QALYs for SCRT compared to $86852 / 2.12 QALYs for CRT. The ICER for CRT was $86075 / QALY, significantly above the standard $50,000 WTP threshold. Sensitivity analysis showed that the ICER was most sensitive to variations in LR, DM, and DFS for each regimen, though SCRT remained more-cost effective under nearly all assumptions. Conclusion: In our model, we found that preoperative SCRT was more cost-effective than conventional CRT over the lifetime of the average rectal cancer patient. These findings, in conjunction with recent changes to the national guidelines, support the use of SCRT in the US setting. Author Disclosure: A. Roy: None. S. Chang: None. M. Leung: None. P.J. Parikh: None.
2975 Radiation Oncology Drug Prescription Patterns in Medicare Part D S. Maroongroge,1,2 K.B. Roberts,2,3 and J.B. Yu3,4; 1Yale University School of Medicine, New Haven, CT, 2Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale University, New Haven, CT, 3Department of Therapeutic Radiology, Yale University School of Medicine, New Haven, CT, 4Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale School of Medicine, New Haven, CT Purpose/Objective(s): Despite the fact that pharmacologic management of symptoms and disease play a vital role in holistic, patient-centered oncologic care, prior literature has placed little emphasis on pharmaceutical prescribing habits of radiation oncologists. Our objective is to provide a descriptive analysis of radiation oncology prescription patterns in the primarily elderly Medicare Part D population in 2013. Materials/Methods: Data were extracted from the 2013 Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File. This file contains data on nearly all prescription drug events submitted to the Medicare Part D program in 2013. Expenditure data are defined as overall costs to Medicare, third party payers, and beneficiaries. Descriptive statistics were analyzed for providers who self-identified as radiation oncologists on CMS claims. We identified the drugs most commonly prescribed by radiation oncologists and categorized them by class. Results: Prescriptions from 2,884 radiation oncologists accounted for $10.9 million of the $80.9 billion spent on patients in the 2013 Medicare Part D program. The total average drug expenditure per radiation oncologist was $3,783. The top 10 drugs prescribed by radiation oncologists are listed below based on various criteria. The 50 most commonly prescribed drugs by number of prescriptions and refills constitute nearly 89% of all claims. Of this high-frequency prescription list, 39% are autonomic
Abstract 2975; Table 1. Top 10 Drugs Prescribed by Radiation Oncologists Top drugs by number of prescribing radiation oncologists 1 Tamsulosin 2 Hydrocodone/ Acetaminophen 3 Dexamethasone 4 Silver Sulfadiazine 5 Lidocaine 6 Oxycodone 7 Fentanyl 8 Bicalutamide 9 Ciprofloxacin 10 Oxycodone/ Acetaminophen
Top drugs by number of prescriptions and refills Tamsulosin Hydrocodone/ Acetaminophen Dexamethasone Bicalutamide Silver Sulfadiazine Levothyroxine Lidocaine Oxycodone Ciprofloxacin Fentanyl
Top drugs by total cost Tamsulosin Hydrocodone/ Acetaminophen Oxycodone Abiraterone Fentanyl Silodosin Bicalutamide Dutasteride Solifenacin Memantine