Observational study of ifosfamide (Ifos) neurotoxicity (N): The prospective use of a nursing assessment tool.

Abstract

e19580 Background: Ifos chemotherapy is known to cause central nervous system toxicity. Risk factors have not been well identified in the literature, with limited information on the onset, duration, and severity of this toxicity. No clinical tools are available to assess and document N. Methods: We developed a clinical nursing assessment tool based upon review of the literature. Patients initiating inpatient Ifos chemotherapy, after informed consent was obtained under an IRB approved protocol, were prospectively monitored for signs and symptoms of N during 1 cycle of therapy. A full neurologic nursing assessment of 24 signs and symptoms including a hand writing sample was done at baseline and a basic assessment evaluating alertness, orientation, sense of well being and a hand writing sample was repeated every 12 hours. In the event N was identified, a full assessment was repeated; observed N was graded using the NCI CTC, version 3. Other variables collected were demographic traits, dose per day, hydration, and potential risk factors for N: renal function, albumin, largest pelvic tumor dimension, prior Ifos or cisplatin, use of other medications with potential for N, and alcohol use history. Individual factors were analyzed using Fisher’s exact test or the Wilcoxon two-sample test. Results: Eighty patients were accrued from 5/09-1/12. Median age was 54.5 (range: 21-85), 51% were males, PS 0 in 26.3%, 1 in 65%, 2 in 6.3% and 3 or 4 in 1.3% each. Diagnosis was sarcoma in 73.75%, lymphoma 22.5%, or germ cell tumor 3.75%. N was observed in 47.5% of patients. Toxicities in >15% of patients were sleepiness (25%), lethargy and restlessness (16.25% for each), and dizziness (15%). The majority were grade 1-2 (89.6%). Factors associated with N included generic versus brand formulation of Ifos (p=0.041) and prior history of a drug related neurotoxicity (p=0.047). BSA, performance status, gender, age, dose per m2, total planned dose, pretreatment Cr, and pretreatment albumin were not associated. Conclusions: The incidence of Ifos N is common using this nursing assessment tool, although usually low grade. We identified the formulation of Ifos and a prior history of drug related N as statistically correlated with developing N.