Post-Market Surveillance of Consumer Products: Framework for Adverse Event Management

Abstract BACKGROUND Despite considerable progress in molecular characterization and evidence for certain regimens, treatment of grade III gliomas is still ambiguous and, with surgery, radiotherapy and chemotherapy, in analogy to grade IV glioma treatment. Tumor treating fields (TTFields) therapy proved to be effective as an additional anti-mitotic treatment in glioblastoma and is available in several countries. While TTFields in grade III glioma are being investigated in several clinical trials, we report an analysis of surveillance safety data in patients with grade III glioma already treated with TTFields in the EMEA region. METHODS We reviewed post-marketing surveillance data of the EMEA region. Using the MedDRA body system with system organ class and preferred terms, adverse events reported in the subgroup of patients with grade III glioma treated with TTFields were systematically analysed. Patients with diagnosis of anaplastic astrocytoma and anaplastic oligodendroglioma were included. RESULTS This analysis includes 142 patients with grade III glioma treated with TTFields in the EMEA region. Median age was 47 years (range 5–78 years). 64% of the patients reported at least one adverse event. With an incidence of 35%, skin reaction was the most common reported adverse event, none of them were severe. 29 % of the patients reported general disorders, including general health deterioration (15%) and fatigue/malaise (6%). Adverse events related to the nervous system were reported in 26% of patients; seizures were noted in 9% and headache in 7% of patients. CONCLUSION The retrospective analysis of available post-market surveillance data of EMEA patients with grade III glioma showed no occurrence of serious adverse events that were associated with TTFields. Skin reaction, as the most commonly reported adverse event, but also other reported adverse events had comparable incidences to the rates observed in the phase III trials for patients with recurrent (EF-11) and newly diagnosed GBM (EF-14). In summary, this analysis identifies no additional safety signals on the use of TTFields in the treatment of patients with grade III glioma. Future results of clinical trials in these indications will give further insight into safety and efficacy in this subgroup.

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P14.62 Safety and adverse event profile post-market surveillance analysis of Tumor Treating Fields (TTFields) in EMEA

Neuro-Oncology ◽

10.1093/neuonc/noz126.297 ◽

2019 ◽

Vol 21 (Supplement_3) ◽

pp. iii81-iii82

Author(s):

T Schmidt ◽

S Kebir ◽

L Lazaridis ◽

A Stoppek ◽

M Glas

Keyword(s):

Adverse Event ◽

Adverse Events ◽

Elderly Patients ◽

Surveillance Data ◽

Phase 3 ◽

Skin Reactions ◽

Market Surveillance ◽

Tumor Treating Fields ◽

Post Market Surveillance ◽

Post Market

Abstract BACKGROUND Tumor Treating Fields (TTFields) are established as modality in glioblastoma (GBM) therapy. GBM is the most aggressive brain tumor in adults, constituting approximately 15 % of all primary brain tumors. At diagnosis, a considerable subgroup of GBM patients is ≥65 years of age. The phase 3 EF-14 trial demonstrated a significant improvement of progression free, overall and longterm survival in newly diagnosed GBM (ndGBM) patients by the addition of TTFields compared temozolomide therapy. No treatment limiting systemic adverse events in the EF-14 trial for ndGBM or in the EF-11 trial for recurrent GBM (rGBM) were observable. Here, we present post-market surveillance data from patients in the EMEA region including elderly patients (≥ 65 years) treated with TTFields. METHODS Based on the MedDRA body system (system organ class) and preferred terms surveillance data of patients in the EMEA region were assessed. Additionally, surveillance data of patients < 65 as well as ≥ 65 years of age in this region were separately analyzed. RESULTS A total of 11,048 patients were treated with TTFields (ndGBM 53.3 %, rGBM 39.5 %, other diagnoses 7.2 %) of whom 2,252 (20.4 %) patients were treated in the EMEA region. 19.6 % of patients treated in this region were ≥65 years of age at the time of TTFields therapy initiation. One or more adverse events were reported by 64 % of EMEA patients < 65 and in 67 % of elderly EMEA patients. The most prevalent adverse event in both age groups was skin reactions, occurring in 30 % of patients < 65 years of age and 33 % elderly patients. Likewise, further adverse events in elderly patients in the EMEA region were comparable to patients younger than 65 years of age, e.g. heat sensation (< 65; ≥ 65: 4 %; 4 %) and general physical health deterioration (14 %; 18 %). CONCLUSION These real-life data demonstrate a good safety profile of TTFields in elderly patients as well as in patients < 65. The most frequent registered adverse event was skin reaction, which is in line with the results of the phase 3 EF-11 trial for rGBM and the EF-14 trial for ndGBM patients. In summary, these results from post-marketing surveillance emphasize the safety of TTFields in GBM treatment, particularly in the elderly population.

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