Risk factors for ifosfamide-related encephalopathy (IRE) in sarcoma (S) patients (pts).

Stern, Natacha; Lervat, Cyril; Defachelles, Anne Sophie; Ryckewaert, Thomas; Marliot, Guillaume; Sakji, Ilyes; Peugniez, Charlotte; Penel, Nicolas

doi:10.1200/jco.2015.33.15_suppl.e21523

Cited by 7 publications

(16 citation statements)

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“…Although methylene blue is one of the therapies to consider at IIE onset, it is also important to determine the risk factors associated with IIE onset to be better prepared. The method of IFO injection (time of administration and duration of administration) and the received dosage of IFO are associated with IIE in adults, but the current analysis did not show the same results in children. In this study, none of the following were found to be the risk factors: number of regimens including IFO, total dose of IFO before the last regimen, period of administration of IFO, IFO dose, or administration time of IFO.…”

Section: Discussioncontrasting

confidence: 79%

Analysis of the clinical characteristics of pediatric patients who experience ifosfamide‐induced encephalopathy

Ide

Yanagisawa

Kubota

et al. 2019

Pediatric Blood & Cancer

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Background Several kinds of pediatric hematological and/or malignant diseases are treated with chemotherapy regimens including ifosfamide (IFO). IFO‐induced encephalopathy (IIE) is one of the serious side effects, but there is not enough evidence regarding the clinical features of IIE in children. Procedure We performed a retrospective study on pediatric patients treated with chemotherapy regimens, including IFO, at a single center. We recorded the clinical characteristics of all patients; we compared the clinical characteristics between patients who developed IIE and those who did not. Results In total, 88 patients received a chemotherapy regimen including IFO. IIE developed in seven patients (8.0%). The median age of patients at the time of IIE development was 4.3 (range 1.4‐6.5) years in the younger population. Six of seven patients with IIE improved with supportive therapy only; however, one patient died due to heart failure. Overall survival was not different between the two groups. Multivariable analysis revealed that the co‐administration of cisplatin (CDDP) or carboplatin (CBDCA) was a significant risk factor associated with IIE. Although there was no significant difference in laboratory data between the groups before chemotherapy, patients who developed IIE showed exacerbation in several laboratory tests, including those for renal and liver functions. Conclusions Renal dysfunction caused by the combination of nephrotoxic agents (IFO and CDDP/CBDCA) seems to be important for the development of pediatric IIE. It was thought to be difficult to predict IIE onset based on laboratory data before the initiation of chemotherapy regimens; however, careful observation of laboratory data during IFO chemotherapy regimens may help predict IIE onset and facilitate early treatment.

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Section: Discussioncontrasting

confidence: 79%

Analysis of the clinical characteristics of pediatric patients who experience ifosfamide‐induced encephalopathy

Ide

Yanagisawa

Kubota

et al. 2019

Pediatric Blood & Cancer

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“…An official pharmacovigilance survey conducted in March 2015 r eported a higher concentration of chloroethylamine in solution f or IFOSFAMIDE EG® than HOLOXAN®. The increase in the frequency of ifosfamide-ind uced encephalopathy we observed when patient performance status is greater than or equal to two confirms the results of Lo et a l andStern et al 11,14 In our study, all cases of ifosfamide-induced e ncephalopathy occurred after an infusion time greater than or equal to 12 hours. Expiry periods of IFOSFAMIDE EG® were not analysed in our study but 3 of 9 ifosfamide-induced encephalopathies occurred after June 2016.…”

supporting

confidence: 91%

“…14,18 Considering an alpha risk of 5% and a power of 80%, a minimum of 61 patients per group was required for the HOLOXAN® group and for the IFOSFAMIDE EG® group. 14,18 Considering an alpha risk of 5% and a power of 80%, a minimum of 61 patients per group was required for the HOLOXAN® group and for the IFOSFAMIDE EG® group.…”

Section: Discussionmentioning

confidence: 99%

Ifosfamide‐induced encephalopathy: Brand‐name (HOLOXAN®) vs generic formulation (IFOSFAMIDE EG®)

et al. 2019

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Summary What is known and Objective Two forms of ifosfamide are commercially available in France: HOLOXAN® (brand‐name drug) and IFOSFAMIDE EG® (generic drug). Following the marketing launch of the generic drug, there has been a significant increase in cases of ifosfamide‐induced encephalopathy reported in France. Our objective is to compare the incidence of ifosfamide‐induced encephalopathy in adult patients treated with HOLOXAN® or IFOSFAMIDE EG®. Methods This is a retrospective study of adult patients treated with ifosfamide in two medical centers from 2013 to 2017, with data analysed from medical records. Comparisons of patients were made, according to the formulation used and according to the occurrence of ifosfamide‐induced encephalopathy. The groups of patients were compared using a chi‐square or Fisher's exact test for qualitative parameters and a Wilcoxon test for quantitative parameters. To include confounding factors in the analysis of the impact of drug formulation on the occurrence of ifosfamide‐induced encephalopathy, a generalized linear model was performed with the occurrence of ifosfamide‐induced encephalopathy as the dependent parameter, and the formulation and the confounding factors as explanatory parameters. Results and Discussion A total of 191 patients were included: 103 patients received HOLOXAN® (53.9%) and 88 patients received IFOSFAMIDE EG® (46.1%). In the HOLOXAN® group, the median infusion time was higher (12 hours vs 3h, P < 0.001) and aprepitant was administered more frequently (78.6% vs 69.7%, P < 0.001) than for the IFOSFAMIDE EG® group. Ifosfamide‐induced encephalopathy occurred in 11 patients (5.8%, CI 95% [2.9%, 10.0%]). In the ifosfamide‐induced encephalopathy group, median infusion time was higher (12 hours [12; 24] vs 3 hours [2; 12] P < 0.001) and a poor performance status was more frequent (54.5% vs 13.9%, P = 0.002) than in the group without ifosfamide‐induced encephalopathy. The frequency of ifosfamide‐induced encephalopathy in the HOLOXAN® group was 1.9% (2/103) against 10.2% (9/88) in the IFOSFAMIDE EG® group (P = 0.014). Multivariate analysis revealed that treatment with IFOSFAMIDE EG® resulted in significantly more ifosfamide‐induced encephalopathies compared to HOLOXAN® (OR and CI 95%:7.4 [1.4; 39.5], P = 0.018). We identified two other risk factors for ifosfamide‐induced encephalopathy: long‐term infusion and a performance status of two or higher. What is New and Conclusion The formation of chloroethylamine in solution could be the cause of more frequent ifosfamide‐induced encephalopathies with IFOSFAMIDE EG® compared to HOLOXAN®. Application of these data could help in the choice of ifosfamide formulation in adult patients to decrease the risk of ifosfamide‐induced encephalopathy, and more specifically for patients with risk factors.

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“…Thirteen publications (six retrospective studies, nine case reports and one case series) evaluated neurotoxicity associated with the combination of ifosfamide and aprepitant/fosaprepitant. The interaction between aprepitant and ifosfamide was a probable cause of neurotoxicity in one of the nine case reports (DIPS: 6) .…”

Section: Resultsmentioning

confidence: 99%

“…Antineoplastic drugs. Twenty-four included publications reported adverse events attributed to co-administration of aprepitant or fosaprepitant and an antineoplastic agent (anthracyclines, bexarotene PO, dinaciclib IV, erlotinib, ifosfamide IV, and pazopanib IV) [23,25,33,[53][54][55][56][57][58][59][60][61][62][63][64][65][66][67][68][69][70]72]. Of these, interactions between fosaprepitant and anthracyclines and aprepitant and ifosfamide IV were the suspected cause.…”

Section: Adverse Events Ascribed To Interactions With Aprepitant or Fmentioning

confidence: 99%

Aprepitant and fosaprepitant drug interactions: a systematic review

Patel

Leeder

Piquette‐Miller

et al. 2017

Brit J Clinical Pharma

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Risk factors for ifosfamide-related encephalopathy (IRE) in sarcoma (S) patients (pts).

Cited by 7 publications

References 0 publications

Analysis of the clinical characteristics of pediatric patients who experience ifosfamide‐induced encephalopathy

Analysis of the clinical characteristics of pediatric patients who experience ifosfamide‐induced encephalopathy

Ifosfamide‐induced encephalopathy: Brand‐name (HOLOXAN®) vs generic formulation (IFOSFAMIDE EG®)

Aprepitant and fosaprepitant drug interactions: a systematic review

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