Health-Related Quality of Life in Pediatric Patients With Low-Grade Glioma

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<ul><li><p>Conclusions: An interim analysis data indicated that MAH was safe and</p><p>effective in mitigating OM.</p><p>Author Disclosure: D.P. Nowotnik: A. Employee; Access Pharmaceuticals,</p><p>Inc. K. Stock; Access Pharmaceuticals, Inc. O. Patent/License Fee/Copy-</p><p>right; Access Pharmaceuticals, Inc. Q. Leadership; Access Pharmaceuti-</p><p>cals, Inc. R.R. Allison: E. Research Grant; Access Pharmaceuticals, Inc.</p><p>Y.M. Arshoun: None. R. Carmel: None. D.F. Ciuba: None. E. Feldman: E.</p><p>Research Grant; Access Pharmaceuticals, Inc. C. Meakin: None. D.</p><p>Papadopoulos: E. Research Grant; Vassar Brothers Medical Center. W.M.</p><p>Wisbeck: E. Research Grant; Access Pharmaceuticals, Inc. S.T. Sonis: G.</p><p>Consultant; Clinical Assistance Programs LLC, ActoGeniX NV, Alder</p><p>Biopharmaceuticals, Galera Therapeutics, Synedgen, Pfizer, Piramal,Conclusions: Acute GI toxicity during definitive RT for anal cancer wasmost significant during weeks 4-5, while rectal bleeding improved during</p><p>treatment. The discrepancies in patient and clinician reported symptoms of</p><p>proctitis are consistent with studies in rectal cancer, and demonstrate the</p><p>potential for patient-reported outcomes to be useful tools for anal cancer</p><p>clinical assessments. Additional research is needed to explore ways these</p><p>assessments can improve management of treatment-related toxicity.</p><p>Author Disclosure: A. Tom: None. A. Bennett: None. D. Rothenstein:</p><p>None. S. Milgrom: None. E. Law: None. E. Mangarin: None. A. Wu:</p><p>None. K.A. Goodman: None.</p><p>2967Results from the Multi-institutional, Randomized, Double-Blind,Placebo-Controlled Trial to Assess the Efficacy of a MucoadhesiveHydrogel Rinse in Mitigating Oral Mucositis (OM) inChemoradiation-Treated (CRT) Head-and-Neck Cancer (HNC)PatientsD.P. Nowotnik,1 R.R. Allison,2 Y.M. Arshoun,3 R. Carmel,4 D.F. Ciuba,5</p><p>E. Feldman,6 C. Meakin,7 D. Papadopoulos,8 W.M. Wisbeck,9</p><p>and S.T. Sonis10; 1Access Pharmaceuticals, Inc., Dallas, TX, 221st Century</p><p>Oncology Carolina Radiation Medicine, Greenville, NC, 3Allegheny</p><p>General Hospital, Pittsburgh, PA, 4John Muir Health Medical Center,</p><p>Dallas, CA, 5John B. Amos Cancer Center, Columbus, GA, 6MD Anderson</p><p>Cancer Center, Orlando, FL, 7CaroMont Health Comprehensive Cancer</p><p>Center, Gastonia, NC, 8Vassar Brothers Medical Center, Poughkeepsie, NY,9Providence Regional Medical Center, Everett, WA, 10Clinical Assistance</p><p>Programs LLC, Boston, MA</p><p>Purpose/Objective(s): OM is a frequent adverse side effect of concom-itant CRT used to treat HNC causing such pain as to be debilitating. There</p><p>is no accepted prophylaxis or therapy. Based on a comparison with</p><p>historical control data, a proprietary mucoadhesive hydrogel (MAH) rinse</p><p>was shown to favorably affect OM symptoms. To provide more definitive</p><p>evidence of MAHs safety and efficacy, a multi-institutional, double-blind,</p><p>randomized, placebo-controlled clinical study was undertaken comparing</p><p>MAH with a saline bicarbonate rinse (SBC) to mitigate OM symptoms in</p><p>HNC patients receiving CRT. SBC is commonly included as standard of</p><p>care for patients with OM, and its use is recommended by the NCI. Details</p><p>of the trial are provided on clinicaltrials.gov as study number</p><p>NCT01283906.</p><p>Materials/Methods: Patients rinsed up to six times daily during CRT (6-8weeks) and completed the validated Oral Mucositis Daily Questionnaire</p><p>(OMDQ) daily, reporting mouth and throat soreness (MTS) and other</p><p>parameters. Weight, opiate use, and mucositis assessment based on WHO</p><p>criteria were recorded. Efficacy end points compared the effectiveness of</p><p>MAH vs SBC on reducing OM symptoms, as determined by the area-</p><p>under-the-curve (AUC) of MTS, time to onset of severe pain, opiod use,</p><p>days of opiod use, and weight loss.</p><p>Results: An interim data analysis of the first 70-patients were reported in2012 and showed that for the primary objective, the MAH group had</p><p>a mean AUC of 58.9 in patients completing treatment compared with 92.1</p><p>in the SBC group; p Z 0.041. MAH was also significantly superior inseveral other key parameters. Results of data analysis of 120+ patients will</p><p>be presented.</p><p>Volume 87 Number 2S Supplement 2013Polymedix, BioAlliance Pharma. Q. Leadership; Biomodels LLC.a 3 year follow-up from time of data collection and were at least 18 years</p><p>of age were sent the European Organization for Research and Treatment of</p><p>Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30), which</p><p>was supplemented by the EORTC QLQ-BN20 specifically developed and</p><p>validated for patients with brain tumors as well as long term follow-up</p><p>questionnaires regarding chronic medical conditions and neurocognitive</p><p>functioning.</p><p>Results: The median follow for 121 out of 313 (39%) patients whocompleted the survey was 21.9 years. Ninety-three (77%) patients had</p><p>a gross total resection, 23 (19%) had a subtotal resection and 5 (4%) had</p><p>biopsy only. Ninety-seven (80%) patients were observed post-operatively,</p><p>17 (21%) received radiation therapy, 1 patient received chemotherapy and</p><p>2 received chemotherapy and radiation. Functional QOL scores for all</p><p>patients for physical, role, emotional, cognitive and social function were</p><p>91.9, 91.3, 79.9, 83.5, and 87 (higher values reflect higher function or</p><p>better quality of life), respectively. Symptomatic scores for fatigue, nausea</p><p>and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea</p><p>and financial burden were 16.9, 2.4, 10.2, 6.6, 15.4, 18.1, 7.5, 7.3 and 16.2</p><p>(higher scores reflect greater degree of difficulty), respectively. With</p><p>regard to brain specific symptoms, QOL for domains of future uncertainty,</p><p>visual disorders, motor dysfunction, communication difficulties, head-</p><p>aches, seizures, and drowsiness were: 0.13, 8.7, 15.4, 14.5, 16.5, 4.8 and</p><p>20.2 (higher scores reflect greater degree of dysfunction), respectively.</p><p>Conclusions: Long-term survivors of pediatric LGG have excellent QOLwith regard to physical and role functioning, but have lower scores with</p><p>emotional, cognitive and social functioning. In general, long term symp-</p><p>toms are well tolerated in pediatric LGG patients, but symptomatic scores</p><p>show that fatigue, appetite loss, constipation, diarrhea and financial</p><p>burdens remain areas of concern even 20 years after diagnosis.</p><p>Author Disclosure: C. Nwachukwu: None. R. Youland: None. N.N. Laack:</p><p>None.</p><p>2969Geriatric Assessment in Radiation Oncology Clinic: A Pilot StudyS. Chawla,1 M. Milano,2 L. Nichols,1 L. Dimitroff,1 R. OLoughlin,1</p><p>J. Walker,1 C. Andrews,1 M. Nagel,2 D. Maracle,1 and S. Mohile2;1Rochester General Hospital, Rochester, NY, 2University of Rochester,</p><p>Rochester, NY</p><p>Purpose/Objective(s): More than 50% of all cancers and 60% of cancermortality occurs in patients over the age of 65. There are limited studies</p><p>that have investigated the comprehensive geriatric assessment in radiation</p><p>oncology clinics. This feasibility Study was offered to cancer patients over</p><p>the age of 65 who received definitive radiation therapy or combination of</p><p>radiation and chemotherapy. The goals of the current study were to develop</p><p>a brief, but comprehensive, primarily self-administered cancer-specific</p><p>geriatric assessment measure and to determine its feasibility as measured</p><p>by 1) the percentage of patients able to complete the measure on their own,</p><p>2) the length of time to complete and 3) patient satisfaction with the2968Health-Related Quality of Life in Pediatric Patients With Low-Grade GliomaC. Nwachukwu, R. Youland, and N.N. Laack; Mayo Clinic, Rochester, MN</p><p>Purpose/Objective(s): Because pediatric LGG patients have an excellentprognosis, with median survival extending &gt;10 years, assessing quality of</p><p>life is important in guiding treatment decisions. Controversy exists</p><p>regarding the most appropriate tool to measure HRQOL in this population.</p><p>The purpose of this study was to evaluate health related quality of life</p><p>(HRQOL) in adult, long term survivors of pediatric LGG patients diag-</p><p>nosed at Mayo Clinic between 1970 and 2009 using adult HRQOL</p><p>instruments as well as assess the impact of various patient and treatment</p><p>factors on QOL.</p><p>Materials/Methods: The Mayo Clinic Tumor Registry Database was usedto identify 351 pediatric patients with pathology proven LGG who were 21</p><p>years of age or younger at the time of diagnoses by 2009. 313 patients with</p><p>Poster Viewing Abstracts S571measure.</p><p>Outline placeholderConclusions</p><p>Results from the Multi-institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoad ...Purpose/Objective(s)Materials/MethodsResultsConclusions</p><p>Health-Related Quality of Life in Pediatric Patients With Low-Grade GliomaPurpose/Objective(s)Materials/MethodsResultsConclusions</p><p>Geriatric Assessment in Radiation Oncology Clinic: A Pilot StudyPurpose/Objective(s)</p></li></ul>

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