Clinical practice experience with NovoTTF-100A™ system for glioblastoma: The patient registry dataset (PRiDe)

Maciej Mrugala, Herbert H. Engelhard, David Dinh Tran, Yvonne Kew, Robert Cavaliere, John L. Villano, Daniela Annenelie Bota, Jeremy Rudnick, Ashley Love Sumrall, Jay Jiguang Zhu, Nicholas Butowski

Research output: Contribution to journalArticle

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Abstract

Recurrent glioblastoma multiforme (GBM) is a highly aggressive cancer with poor prognosis, and an overall survival of 6 to 7 months with optimal therapies. The NovoTTF-100A™ System is a novel antimitotic cancer therapy recently approved for the treatment of recurrent GBM, based on phase III (EF-11) trial results. The Patient Registry Dataset (PRiDe) is a post-marketing registry of all recurrent GBM patients who received NovoTTF Therapy in a real-world, clinical practice setting in the United States between 2011 and 2013. Data were collected from all adult patients with recurrent GBM who began commercial NovoTTF Therapy in the United States between October 2011 and November 2013. All patients provided written consent before treatment was started. Overall survival (OS) curves were constructed for PRiDe using the Kaplan-Meier method. Median OS in PRiDe was compared for patients stratified by average daily compliance ( ≥75% v<75% per day) and other prognostic variables. Adverse events were also evaluated. Data from 457 recurrent GBM patients who received NovoTTF Therapy in 91 US cancer centers were analyzed. More patients in PRiDe than the EF-11 trial received NovoTTF Therapy for first recurrence (33% v 9%) and had received prior bevacizumab therapy (55.1% v 19%). Median OS was significantly longer with NovoTTF Therapy in clinical practice (PRiDe data set) than in the EF-11 trial (9.6 v 6.6 months; HR, 0.66; 95% CI, 0.05 to 0.86, P =.0003). One- and 2-year OS rates were more than double for NovoTTF Therapy patients in PRiDe than in the EF-11 trial (1-year: 44% v 20%; 2-year: 30% v 9%). First and second versus third and subsequent recurrences, high Karnofsky performance status (KPS), and no prior bevacizumab use were favorable prognostic factors. No unexpected adverse events were detected in PRiDe. As in the EF-11 trial, the most frequent adverse events were mild to moderate skin reactions associated with application of the NovoTTF Therapy transducer arrays. Results from PRiDe, together with those previously reported in the EF-11 trial, indicate that NovoTTF Therapy offers clinical benefit to patients with recurrent GBM. NovoTTF Therapy has high patient tolerability and favorable safety profile in the real-world, clinical practice setting.

Original languageEnglish (US)
Pages (from-to)S4-S13
JournalSeminars in oncology
Volume41
Issue numberS6
DOIs
StatePublished - Oct 1 2014
Externally publishedYes

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Glioblastoma
Registries
Therapeutics
Datasets
Survival
Antimitotic Agents
Karnofsky Performance Status
Recurrence
Neoplasms
Marketing
Transducers
Compliance

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Clinical practice experience with NovoTTF-100A™ system for glioblastoma : The patient registry dataset (PRiDe). / Mrugala, Maciej; Engelhard, Herbert H.; Dinh Tran, David; Kew, Yvonne; Cavaliere, Robert; Villano, John L.; Annenelie Bota, Daniela; Rudnick, Jeremy; Love Sumrall, Ashley; Zhu, Jay Jiguang; Butowski, Nicholas.

In: Seminars in oncology, Vol. 41, No. S6, 01.10.2014, p. S4-S13.

Research output: Contribution to journalArticle

Mrugala, M, Engelhard, HH, Dinh Tran, D, Kew, Y, Cavaliere, R, Villano, JL, Annenelie Bota, D, Rudnick, J, Love Sumrall, A, Zhu, JJ & Butowski, N 2014, 'Clinical practice experience with NovoTTF-100A™ system for glioblastoma: The patient registry dataset (PRiDe)', Seminars in oncology, vol. 41, no. S6, pp. S4-S13. https://doi.org/10.1053/j.seminoncol.2014.09.010
Mrugala, Maciej ; Engelhard, Herbert H. ; Dinh Tran, David ; Kew, Yvonne ; Cavaliere, Robert ; Villano, John L. ; Annenelie Bota, Daniela ; Rudnick, Jeremy ; Love Sumrall, Ashley ; Zhu, Jay Jiguang ; Butowski, Nicholas. / Clinical practice experience with NovoTTF-100A™ system for glioblastoma : The patient registry dataset (PRiDe). In: Seminars in oncology. 2014 ; Vol. 41, No. S6. pp. S4-S13.
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