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Health-Related Quality of Life in Pediatric Patients With Low-Grade Glioma
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Volume 87 Number 2S Supplement 2013 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.
2967 Results from the Multi-institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel Rinse in Mitigating Oral Mucositis (OM) in Chemoradiation-Treated (CRT) Head-and-Neck Cancer (HNC) Patients D.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, 9 Providence Regional Medical Center, Everett, WA, 10Clinical Assistance Programs LLC, Boston, MA Purpose/Objective(s): OM is a frequent adverse side effect of concomitant 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 areaunder-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/Copyright; Access Pharmaceuticals, Inc. Q. Leadership; Access Pharmaceuticals, 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.
2968 Health-Related Quality of Life in Pediatric Patients With LowGrade Glioma C. 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 diagnosed 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, headaches, 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 symptoms 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.
2969 Geriatric Assessment in Radiation Oncology Clinic: A Pilot Study S. 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; 1 Rochester 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.
Volume 87 Number 2S Supplement 2013 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.
2967 Results from the Multi-institutional, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy of a Mucoadhesive Hydrogel Rinse in Mitigating Oral Mucositis (OM) in Chemoradiation-Treated (CRT) Head-and-Neck Cancer (HNC) Patients D.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, 9 Providence Regional Medical Center, Everett, WA, 10Clinical Assistance Programs LLC, Boston, MA Purpose/Objective(s): OM is a frequent adverse side effect of concomitant 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 areaunder-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/Copyright; Access Pharmaceuticals, Inc. Q. Leadership; Access Pharmaceuticals, 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.
2968 Health-Related Quality of Life in Pediatric Patients With LowGrade Glioma C. 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 diagnosed 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, headaches, 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 symptoms 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.
2969 Geriatric Assessment in Radiation Oncology Clinic: A Pilot Study S. 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; 1 Rochester 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.