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EFFECTS: an expanded access program of everolimus for patients with subependymal giant cell astrocytoma associated with tuberous sclerosis complex

Overview of attention for article published in BMC Neurology, August 2016
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Title
EFFECTS: an expanded access program of everolimus for patients with subependymal giant cell astrocytoma associated with tuberous sclerosis complex
Published in
BMC Neurology, August 2016
DOI 10.1186/s12883-016-0658-4
Pubmed ID
Authors

Andras Fogarasi, Liesbeth De Waele, Gabriella Bartalini, Sergiusz Jozwiak, Nicola Laforgia, Helene Verhelst, Borivoj Petrak, Jean-Michel Pedespan, Olaf Witt, Ramon Castellana, Stefania Crippa, Gabriella Gislimberti, Zsuzsanna Gyorsok

Abstract

Everolimus, a mammalian target of rapamycin (mTOR) inhibitor, has been shown to be effective and safe in the treatment of subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC). The Everolimus For Fast Expanded aCcess in TSC SEGA (EFFECTS) study was designed to provide everolimus access to patients with SEGA associated with TSC and to mainly assess the safety and also efficacy of everolimus in a real-world setting. EFFECTS was a phase 3b, open-label, noncomparative, multicenter, expanded access study. Eligible patients were ≥ 3 years of age, with a definite diagnosis of TSC, and with at least one SEGA lesion identified by MRI or CT scan. Patients received once daily everolimus (dose adjusted to attain a trough level of 5-15 ng/mL). Safety evaluation was the primary objective and included collection of adverse events (AEs) and serious AEs, with their severity and relationship to everolimus. Efficacy evaluation, which was the secondary objective, was based on the best overall response as per medical judgment. Of the 120 patients enrolled, 100 (83.3 %) completed the study. Median age of patients was 11 years (range, 1-47). Median daily dose of everolimus was 5.82 mg (range, 2.0-11.8). Median duration of exposure was 56.5 weeks (range, 0.3-130). The overall incidence of AEs was 74.2 %. Aphthous stomatitis (18 [15.0 %]), pyrexia (18 [15.0 %]), bronchitis (11 [9.2 %]), and stomatitis (10 [8.3 %]) were the most common AEs reported. Overall, 25 patients had grade 3 AEs; most frequent was stomatitis (4 [3.3 %]). Grade 4 AEs were reported in three (2.5 %) patients. A total of 62 (51.7 %) patients had suspected drug-related AEs, of which 15 (12.5 %) were of grade 3 or 4. In eight (6.7 %) patients, AEs led to drug discontinuation. With regard to efficacy, 81 (67.5 %) patients had a partial response, 35 (29.2 %) had a stable disease, and one (0.8 %) had progressive disease. The response was unknown in three (2.5 %) patients. This study confirms the acceptable safety profile of everolimus in patients with SEGA associated with TSC in a real-world setting. The results further support the efficacy of everolimus in the treatment of SEGA associated with TSC. (EudraCT: 2010-022583-13).

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Mendeley readers

Mendeley readers

The data shown below were compiled from readership statistics for 94 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
United States 1 1%
Poland 1 1%
Unknown 92 98%

Demographic breakdown

Readers by professional status Count As %
Student > Master 16 17%
Student > Bachelor 11 12%
Researcher 9 10%
Student > Ph. D. Student 8 9%
Student > Doctoral Student 7 7%
Other 22 23%
Unknown 21 22%
Readers by discipline Count As %
Medicine and Dentistry 34 36%
Nursing and Health Professions 9 10%
Biochemistry, Genetics and Molecular Biology 9 10%
Agricultural and Biological Sciences 4 4%
Psychology 4 4%
Other 12 13%
Unknown 22 23%
Attention Score in Context

Attention Score in Context

This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 12 December 2017.
All research outputs
#20,411,380
of 22,961,203 outputs
Outputs from BMC Neurology
#2,158
of 2,454 outputs
Outputs of similar age
#320,071
of 364,846 outputs
Outputs of similar age from BMC Neurology
#63
of 67 outputs
Altmetric has tracked 22,961,203 research outputs across all sources so far. This one is in the 1st percentile – i.e., 1% of other outputs scored the same or lower than it.
So far Altmetric has tracked 2,454 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.8. This one is in the 1st percentile – i.e., 1% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 364,846 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 67 others from the same source and published within six weeks on either side of this one. This one is in the 1st percentile – i.e., 1% of its contemporaries scored the same or lower than it.