A phase II trial of arsenic trioxide and temozolomide in combination with radiation therapy for patients with malignant gliomas View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2017-05-16

AUTHORS

Priya Kumthekar, Sean Grimm, James Chandler, Minesh Mehta, Maryanne Marymont, Robert Levy, Kenji Muro, Irene Helenowski, Katie McCarthy, Leanne Fountas, Jeffrey Raizer

ABSTRACT

Standard treatment for GBM is radiation (RT) and temozolomide (TMZ). Arsenic trioxide (ATO) is synergistic with RT based on several mechanisms of action previously identified, however not tested herein. The MTD of ATO, RT and TMZ was determined in a Phase I trial. We now present the combined Phase I/II data. Patients with newly diagnosed malignant gliomas were eligible for treatment. Patients were treated with RT (60 GY), TMZ (75 mg/m2 daily × 42 days) and ATO 0.20 mg/kg daily in week 1 then twice a week ×5 weeks, after completing RT they were treated with TMZ 5/28 for up to 12 months. MRIs were performed every 8 weeks. A total of 42 patients were enrolled in both the Phase I and II trials for this study treatment. Of the 42 enrolled patients (24 M and 18 W) the median age was 54 (24–80) and median KPS 90 (60–100). 28 patients had a GBM and 14 had anaplastic glioma (AG). All patients completed RT/TMZ/ATO and went on to maintenance TMZ. Median number of post RT cycles of TMZ was 4 (0–12). Median PFS was 7 m for GBM and 75 m for AG and median OS was 17 m for GBM and NR for AG. Best response was CR in 2, SD in 28, PR in 5 and PD in 7. There were no unexpected adverse events. Grade 3 toxicities likely attributable to ATO included prolonged Qtc (n = 1), elevated liver enzymes (n = 2 for ALT/n = 1 for AST) and elevated bilirubin (n = 1). Adding ATO to RT and TMZ is feasible with no increased side effects. The addition of arsenic did not improve overall survival in the GBM patients as compared to historic data. MGMT status was analyzed in 20 of the 42 patients where tissue was available for retrieval and MGMT testing. More... »

PAGES

589-594

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s11060-017-2469-x

DOI

http://dx.doi.org/10.1007/s11060-017-2469-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1085422047

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28510787


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34 schema:description Standard treatment for GBM is radiation (RT) and temozolomide (TMZ). Arsenic trioxide (ATO) is synergistic with RT based on several mechanisms of action previously identified, however not tested herein. The MTD of ATO, RT and TMZ was determined in a Phase I trial. We now present the combined Phase I/II data. Patients with newly diagnosed malignant gliomas were eligible for treatment. Patients were treated with RT (60 GY), TMZ (75 mg/m2 daily × 42 days) and ATO 0.20 mg/kg daily in week 1 then twice a week ×5 weeks, after completing RT they were treated with TMZ 5/28 for up to 12 months. MRIs were performed every 8 weeks. A total of 42 patients were enrolled in both the Phase I and II trials for this study treatment. Of the 42 enrolled patients (24 M and 18 W) the median age was 54 (24–80) and median KPS 90 (60–100). 28 patients had a GBM and 14 had anaplastic glioma (AG). All patients completed RT/TMZ/ATO and went on to maintenance TMZ. Median number of post RT cycles of TMZ was 4 (0–12). Median PFS was 7 m for GBM and 75 m for AG and median OS was 17 m for GBM and NR for AG. Best response was CR in 2, SD in 28, PR in 5 and PD in 7. There were no unexpected adverse events. Grade 3 toxicities likely attributable to ATO included prolonged Qtc (n = 1), elevated liver enzymes (n = 2 for ALT/n = 1 for AST) and elevated bilirubin (n = 1). Adding ATO to RT and TMZ is feasible with no increased side effects. The addition of arsenic did not improve overall survival in the GBM patients as compared to historic data. MGMT status was analyzed in 20 of the 42 patients where tissue was available for retrieval and MGMT testing.
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42 GBM
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49 MGMT status
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51 MRI
52 MTD
53 MTD of ATO
54 NR
55 OS
56 PFS
57 PR
58 Pd
59 QTc
60 RT cycles
61 RT/TMZ/ATO
62 SD
63 TMZ 5/28
64 TMZ/ATO
65 action
66 addition
67 addition of arsenic
68 adverse events
69 age
70 anaplastic gliomas
71 arsenic
72 arsenic trioxide
73 bilirubin
74 combination
75 combined Phase I/II data
76 cycle
77 data
78 effect
79 elevated bilirubin
80 elevated liver enzymes
81 enzyme
82 events
83 gliomas
84 good response
85 grade 3 toxicity
86 historic data
87 increased side effects
88 liver enzymes
89 maintenance temozolomide
90 malignant gliomas
91 mechanism
92 mechanism of action
93 median KPS 90
94 median OS
95 median PFS
96 median age
97 median number
98 months
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