QOLP-15. FEASIBILITY OF AN ELECTRONIC PATIENT REPORTED STEROID TOXICITY MONITORING PROGRAM IN PATIENTS WITH MALIGNANT GLIOMAS

OBJECTIVE To determine the feasibility of a longitudinal, electronic, patient-reported survey of steroid toxicity in patients with malignant glioma (MG). BACKGROUND Corticosteroids are frequently used for management of cerebral edema in MG, with side effects resulting from prolonged use or high dosage. Corticosteroid use is common and may negatively impact quality of life (QOL) and survival in MG. DESIGN/METHODS We prospectively enrolled patients with MG receiving neuro-oncologic care at the University of Rochester with or without their caregivers on an IRB-approved study. Subjects received 12 weekly electronic questionnaires through a secure health portal focused on symptoms of corticosteroid toxicities, dosing and functional status. Weekly toxicity scores were calculated based on the number of reported toxicities (0-17). Completed questionnaires were reviewed by a care team member to inform clinical management. Corticosteroid dosing adjustments were documented in the medical record. Feasibility was defined as an overall questionnaire completion rate of 70%. RESULTS 11 patient/caregiver pairs were enrolled (11 patients, including 9 with caregivers). Median patient age was 58. Patient tumors were glioblastoma (82%), anaplastic astrocytoma (9%) and anaplastic oligodendroglioma (9%). Phase of treatment was concurrent (55%), adjuvant (36%) and recurrence (9%). Median dexamethasone does at study start and conclusion were 4mg/day and 3mg/day. Median weekly toxicity score was 5/17 (range: 0-14). The most common toxicities were muscle weakness, sleep disturbance and weight gain and were reported by 82% of participants. Overall questionnaire completion rate was 81%. Ten percent of questionnaires resulted in clinically significant symptoms requiring follow-up from a provider. CONCLUSION Patients with MG experience frequent corticosteroid toxicities. Electronic corticosteroid toxicity monitoring is feasible in patients with MG and may lead to changes in management. Future studies are needed to assess utility of this tool and impact on QOL and survival.

Comparison of first choice cytostatic therapy with calcineurin inhibitors and nucleotides synthesis inhibitors in children with steroid-sensitive, steroid-dependent nephrotic syndrome with steroid toxicity

AIM. Evaluation in comparative study the efficiency of first choice cytostatic therapy with calcineurin inhibitor cyclosporine A and nucleotide synthesis inhibitormycophenolatemofetil (MMF)/mycophenolate sodium in children with relapsing and frequently relapsing steroid-dependent and steroid-sensitive nephrotic syndrome (NS) with steroid toxicity.PATIENTS AND METHODS. Follow-up study with analysis of onset, clinical course and treatment includes 48 children ((29 boys (60 %) и 19 girls (40 %)) with relapsing and frequently relapsing NS, developedsteroid dependence and/or steroid toxicity.The efficiency of first choice cytostatic therapy with calcineurin inhibitor cyclosporine Ain 17 patients and nucleotide synthesis inhibitormycophenolatemofetil (MMF)/mycophenolate sodium in 31 patients is estimated in comparative study by analysis of 6 month remission rate and one year remission rate after treatment.RESULTS. Statistically significant differences in 6 month and one year remission rate after first choice cytostatic therapy with MMF/ mycophenolate sodium and cyclosporine in children are established. Remission of NS during 6 months after MMF/ mycophenolate sodium treatment was in 67,7 % (in 21 from 31 patients) unlike of that after cyclosporine – in 29,4 % (in 5 from 17 patients) (р<0,05). Remission of NS during one year after MMF/ mycophenolate sodium treatment was in 58,1 % (in 18 from 31 patients) unlike of that after cyclosporine – 23,5 % (in 4 from 17 patients) (р<0,05). Cyclosporine toxicity was diagnosed in 5 from 17patients: increased creatinine (1),arterial hypertension (3), gingival hyperplasia (3) in treatment more than 12 months with reverse development after cancel. Side-effects after nucleotide synthesis inhibitor therapy was dignosed only in 1 from 31 patients (3,2 %) – lymphopenic crisis.CONCLUSION. Remission of relapsing and frequently relapsing steroid-dependent and steroid-sensitive with steroid toxicity NS during 6 months after first choice cytostatic therapy with MMF/ mycophenolate sodium and cyclosporine in children was in 67,7 % and 29,4 % respectively, during one year in 58,1 % and 23,5 % respectively. As the result of comparative study remission during 6 months and one year was statistically significant more often in children after first choice cytostatic therapy with MMF/ mycophenolate sodium.

P036: Digoxin immune fab treatment for digoxin and non-digoxin cardioactive steroid toxicity: a scoping review

Introduction: Cardioactive steroid poisoning occurs worldwide with the use of pharmaceutical digoxin and botanical cardiac glycosides. The wholesale price of the antidote, digoxin immune fab, has increased over 300% from 2010 to 2015. Our objective was to identify gaps in the existing literature with respect to the use of digoxin immune fab in cardioactive steroid toxicity in acute care settings. Methods: We used scoping study methodology, as described by Arksey and O'Malley, to assess the range and scope of empiric research and will report: 1) sources of cardioactive steroid toxicity in acute settings; 2) doses of digoxin immune fab used in treatment; and, 3) intervention outcomes of acute cardioactive steroid toxicity following the administration of digoxin immune fab as first or second-line therapy. We collaborated with a library scientist to devise search strategies for PubMed, CINAHL, EMBASE, CENTRAL and Toxnet. We sought unpublished literature through the Canadian Electronic Library, Proquest, and Scopus and searched reference lists of included studies. We hand searched relevant conference proceedings and applicable guidelines. Two reviewers independently reviewed titles and abstracts using predetermined criteria. Using a structured data abstraction form, two reviewers independently extracted data. All discrepancies were resolved through consensus. Results: Our search strategy yielded 3458 results. After screening titles and abstracts 384 underwent full text screening. We included 147 studies and are currently extracting data from 12 French studies and 135 English studies. To date we have extracted data from 90 case reports and case series. Conclusion: Given concerns over rising costs, our findings will shed light on the extent of the evidence for use of digoxin immune fab in acute care settings.

Profile of Steroid Toxicity During Maintenance Treatment in Teenage and Young Adult (TYA) Patients with Acute Lymphoblastic Leukaemia (ALL)

Abstract 4305 There has been recent interest in exploring the use of paediatric ALL protocols in treating older patients. TYA patients (16–25 years) were therefore included in the UKALL 2003 trial (Eudract No: 2007–004013-34) as the age range of the trial was raised in 2006 to 18 years and again in 2007 to include patients up to their 25th birthday. The tolerability of this approach is unknown and we therefore investigated the steroid toxicity during maintenance in a sub-set of the TYA cohort in this study. Data was collected through SAE reports, case report forms and additional questionnaires sent to participating centres. We report on 91 evaluable patients (40% of 229 recruited to the trial) who had commenced or completed maintenance. Given the nature of the survey, this cohort was enriched for the toxicities described and therefore the incidences reported are not representative of that observed in the full trial cohort. The median age of these 91 patients was 17 yrs (16–23) and there were 64 male (median18; range 16–23) and 27 female (median 17; range 16–22). Most patients had completed maintenance (median follow up 39.5 months; range 4–96 months) post start of induction.76 patients were on the intermediate risk Regimen B and 15 on the high risk Regimen C due poor cytogenetics at diagnosis or a poor marrow response at day 29. Of the 91 patients 66% (n=60) had grade 2 – 4 possible or probable steroid toxicity. This was grade 2–3 in the majority and only four patients experienced grade 4 toxicity (3 avascular necrosis – AVN, 1 infection). In 91 patients there were 68 grade 2–4 toxicities; AVN 41% (n=28/68), infection 27% (n=18/68), psychological disturbances 16% (n=11/68), joint pain/fracture 7% (n=5/68), GI bleed 3% (n=2/68), other 6% (n=4/68). The causes of infections are likely to have been multifactorial. 24/91 patients (26%) stopped steroids early during maintenance due to the toxicity. 13/91 (14%) patients required modification of steroids (pause, tapered or change to prednisolone) during maintenance. Treatment for AVN and joint pain or fracture ranged from bed rest, hydrotherapy and analgesia (grade 2–3 toxicity) to joint replacement in patients with grade 4 AVN. Toxicities were otherwise managed with appropriate medication. The use of bisphophonates was inconsistent and only used in a minority of patients (11% n=10). There was a significantly higher chance that patients did not receive steroids as per protocol if they had joint pains, fracture or AVN. There is increasing use of paediatric protocols in TYA patients. Steroid intensity might be difficult to deliver in this age group due to associated morbidity. Bony complications are a significant cause of steroid morbidity in this age group with uncertainty about their optimal management and impact on long term joint health. Disclosures: No relevant conflicts of interest to declare.