Volume 87 � Number 2S � Supplement 2013 Poster Viewing Abstracts S571

Conclusions: Acute GI toxicity during definitive RT for anal cancer was

most significant during weeks 4-5, while rectal bleeding improved during

treatment. The discrepancies in patient and clinician reported symptoms of

proctitis are consistent with studies in rectal cancer, and demonstrate the

potential for patient-reported outcomes to be useful tools for anal cancer

clinical assessments. Additional research is needed to explore ways these

assessments can improve management of treatment-related toxicity.

Author Disclosure: A. Tom: None. A. Bennett: None. D. Rothenstein:

None. S. Milgrom: None. E. Law: None. E. Mangarin: None. A. Wu:

None. K.A. Goodman: None.

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

E. Feldman,6 C. Meakin,7 D. Papadopoulos,8 W.M. Wisbeck,9

and S.T. Sonis10; 1Access Pharmaceuticals, Inc., Dallas, TX, 221st Century

Oncology Carolina Radiation Medicine, Greenville, NC, 3Allegheny

General Hospital, Pittsburgh, PA, 4John Muir Health Medical Center,

Dallas, CA, 5John B. Amos Cancer Center, Columbus, GA, 6MD Anderson

Cancer Center, Orlando, FL, 7CaroMont Health Comprehensive Cancer

Center, Gastonia, NC, 8Vassar Brothers Medical Center, Poughkeepsie, NY,9Providence Regional Medical Center, Everett, WA, 10Clinical Assistance

Programs LLC, Boston, MA

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

is no accepted prophylaxis or therapy. Based on a comparison with

historical control data, a proprietary mucoadhesive hydrogel (MAH) rinse

was shown to favorably affect OM symptoms. To provide more definitive

evidence of MAH’s safety and efficacy, a multi-institutional, double-blind,

randomized, placebo-controlled clinical study was undertaken comparing

MAH with a saline bicarbonate rinse (SBC) to mitigate OM symptoms in

HNC patients receiving CRT. SBC is commonly included as standard of

care for patients with OM, and its use is recommended by the NCI. Details

of the trial are provided on clinicaltrials.gov as study number

NCT01283906.

Materials/Methods: Patients rinsed up to six times daily during CRT (6-8

weeks) and completed the validated Oral Mucositis Daily Questionnaire

(OMDQ) daily, reporting mouth and throat soreness (MTS) and other

parameters. Weight, opiate use, and mucositis assessment based on WHO

criteria were recorded. Efficacy end points compared the effectiveness of

MAH vs SBC on reducing OM symptoms, as determined by the area-

under-the-curve (AUC) of MTS, time to onset of severe pain, opiod use,

days of opiod use, and weight loss.

Results: An interim data analysis of the first 70-patients were reported in

2012 and showed that for the primary objective, the MAH group had

a mean AUC of 58.9 in patients completing treatment compared with 92.1

in the SBC group; p Z 0.041. MAH was also significantly superior in

several other key parameters. Results of data analysis of 120+ patients will

be presented.

Conclusions: An interim analysis data indicated that MAH was safe and

effective in mitigating OM.

Author Disclosure: D.P. Nowotnik: A. Employee; Access Pharmaceuticals,

Inc. K. Stock; Access Pharmaceuticals, Inc. O. Patent/License Fee/Copy-

right; Access Pharmaceuticals, Inc. Q. Leadership; Access Pharmaceuti-

cals, Inc. R.R. Allison: E. Research Grant; Access Pharmaceuticals, Inc.

Y.M. Arshoun: None. R. Carmel: None. D.F. Ciuba: None. E. Feldman: E.

Research Grant; Access Pharmaceuticals, Inc. C. Meakin: None. D.

Papadopoulos: E. Research Grant; Vassar Brothers Medical Center. W.M.

Wisbeck: E. Research Grant; Access Pharmaceuticals, Inc. S.T. Sonis: G.

Consultant; Clinical Assistance Programs LLC, ActoGeniX NV, Alder

Biopharmaceuticals, Galera Therapeutics, Synedgen, Pfizer, Piramal,

Polymedix, BioAlliance Pharma. Q. Leadership; Biomodels LLC.

2968Health-Related Quality of Life in Pediatric Patients With Low-Grade GliomaC. Nwachukwu, R. Youland, and N.N. Laack; Mayo Clinic, Rochester, MN

Purpose/Objective(s): Because pediatric LGG patients have an excellent

prognosis, with median survival extending >10 years, assessing quality of

life is important in guiding treatment decisions. Controversy exists

regarding the most appropriate tool to measure HRQOL in this population.

The purpose of this study was to evaluate health related quality of life

(HRQOL) in adult, long term survivors of pediatric LGG patients diag-

nosed at Mayo Clinic between 1970 and 2009 using adult HRQOL

instruments as well as assess the impact of various patient and treatment

factors on QOL.

Materials/Methods: The Mayo Clinic Tumor Registry Database was used

to identify 351 pediatric patients with pathology proven LGG who were 21

years of age or younger at the time of diagnoses by 2009. 313 patients with

a 3 year follow-up from time of data collection and were at least 18 years

of age were sent the European Organization for Research and Treatment of

Cancer Core Quality of Life Questionnaire (EORTC-QLQ-C30), which

was supplemented by the EORTC QLQ-BN20 specifically developed and

validated for patients with brain tumors as well as long term follow-up

questionnaires regarding chronic medical conditions and neurocognitive

functioning.

Results: The median follow for 121 out of 313 (39%) patients who

completed the survey was 21.9 years. Ninety-three (77%) patients had

a gross total resection, 23 (19%) had a subtotal resection and 5 (4%) had

biopsy only. Ninety-seven (80%) patients were observed post-operatively,

17 (21%) received radiation therapy, 1 patient received chemotherapy and

2 received chemotherapy and radiation. Functional QOL scores for all

patients for physical, role, emotional, cognitive and social function were

91.9, 91.3, 79.9, 83.5, and 87 (higher values reflect higher function or

better quality of life), respectively. Symptomatic scores for fatigue, nausea

and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea

and financial burden were 16.9, 2.4, 10.2, 6.6, 15.4, 18.1, 7.5, 7.3 and 16.2

(higher scores reflect greater degree of difficulty), respectively. With

regard to brain specific symptoms, QOL for domains of future uncertainty,

visual disorders, motor dysfunction, communication difficulties, head-

aches, seizures, and drowsiness were: 0.13, 8.7, 15.4, 14.5, 16.5, 4.8 and

20.2 (higher scores reflect greater degree of dysfunction), respectively.

Conclusions: Long-term survivors of pediatric LGG have excellent QOL

with regard to physical and role functioning, but have lower scores with

emotional, cognitive and social functioning. In general, long term symp-

toms are well tolerated in pediatric LGG patients, but symptomatic scores

show that fatigue, appetite loss, constipation, diarrhea and financial

burdens remain areas of concern even 20 years after diagnosis.

Author Disclosure: C. Nwachukwu: None. R. Youland: None. N.N. Laack:

None.

2969Geriatric Assessment in Radiation Oncology Clinic: A Pilot StudyS. Chawla,1 M. Milano,2 L. Nichols,1 L. Dimitroff,1 R. O’Loughlin,1

J. Walker,1 C. Andrews,1 M. Nagel,2 D. Maracle,1 and S. Mohile2;1Rochester General Hospital, Rochester, NY, 2University of Rochester,

Rochester, NY

Purpose/Objective(s): More than 50% of all cancers and 60% of cancer

mortality occurs in patients over the age of 65. There are limited studies

that have investigated the comprehensive geriatric assessment in radiation

oncology clinics. This feasibility Study was offered to cancer patients over

the age of 65 who received definitive radiation therapy or combination of

radiation and chemotherapy. The goals of the current study were to develop

a brief, but comprehensive, primarily self-administered cancer-specific

geriatric assessment measure and to determine its feasibility as measured

by 1) the percentage of patients able to complete the measure on their own,

2) the length of time to complete and 3) patient satisfaction with the

measure.