415O - Alternating electric fields therapy for recurrent glioblastoma - NovoTTF-100A system: Updated outcomes and toxicity based on the analysis of patien...

Date 27 September 2014
Event ESMO 2014
Session CNS tumours
Topics Central Nervous System Malignancies
Translational Research
Surgery and/or Radiotherapy of Cancer
Presenter Maciej Mrugala
Citation Annals of Oncology (2014) 25 (suppl_4): iv137-iv145. 10.1093/annonc/mdu330
Authors M.M. Mrugala1, H.H. Engelhard2, N. Butowski3, D.D. Tran4, Y. Kew5, R. Cavaliere6, J. Villano7, D. Bota8, S. Kesari9, J. Rudnick10, A. Sumrall11, J.J. Zhu12, E.T. Wong13
  • 1Neurology, Univeristy of Washington, 98195 - Seattle/US
  • 2Neuro-oncology, University of Illinois at Chicago, Chicago/US
  • 3Neuro-oncology, University of California San Francisco, San Francisco/US
  • 4Medical Oncology, Washington University School of Medicine, St. Louis/US
  • 5Neurosurgery, Houston Methodist Hospital, Houston/US
  • 6Neurosurgery, The Ohio State University, Columbus/US
  • 7Neuro-oncology, University of Kentucky, Lexington/US
  • 8Neuro-oncology, University of California - Irvine, Irvine/US
  • 9Neurosciences, University of California San Diego, La Jolla/US
  • 10Neurology, Cedars Sinai Medical Center, Los Angeles/US
  • 11Medical Oncology, Carolinas Healthcare System, Charlotte/US
  • 12Neurology, University of Texas Health Science Center at Houston, Houston/US
  • 13Neuro-oncology, Beth Israel Deaconess Medical Center, Boston/US

Abstract

Aim

To present updated outcomes and toxicity data from patients with recurrent glioblastoma treated with the commercially available NovoTTF-100A System using patient registry database.

Methods

The NovoTTF-100A device has been available by prescription at 126 oncology centers in the United States since November 2011. We retrospectively analyzed the outcomes and toxicity data from patients who were prescribed the device from November 2011 to November 2013 as treatment for recurrent glioblastoma. Overall survival (OS) was calculated based on social security death registry data. It was defined as the time from the treatment start until the date of death or last known date patient was alive. We analyzed performance status, compliance records, treatment history and adverse effects for all subjects.

Results

There were 148 female and 309 male patients (n = 457) who were treated with NovoTTF-100A System. The median age was 55 years (range 18 to 86). Median Karnofsky Performance Status (KPS) was 80 (range 10-100) and 33% of patients were at their first recurrence when therapy was initiated. Over half of the patients (n = 252) received bevacizumab prior to NovoTTF- 100A therapy. The median OS was 9.6 (95% [CI] 8.0 to 13.7) months and the median treatment duration was 4.1 (95% [CI] 3.5 to 4.8) months. The average patient compliance with the use of the device was 70%. OS was positively correlated with higher compliance (= > 75%) and KPS (70-100), and negatively correlated with recurrence number and prior use of bevacizumab. Debulking surgery prior to the introduction of NovoTTF-100A therapy did not influence OS. The most common device-related adverse events included skin reactions (24.3%), neurological disorders (10.4%), heat sensation (8.9%), electric sensation (7.7%) and headache (5.7%).

Conclusions

Treatment with NovoTTF-100A System, as prescribed in the neuro-oncology clinical practice to patients with recurrent glioblastoma offers favorable outcomes when compared to historical data. Patient compliance with the prescribed use of the system is high and positively correlates with improved survival. Bevacizumab naïve patients benefit more while patients with poor KPS and multiple prior recurrences benefit less from this treatment. NovoTTF-100A System is well tolerated and has no new unexpected toxicities since its introduction to clinical practice.

Disclosure

M.M. Mrugala: On Advisory Board of Novocure. PI on the clinical trial sponsored by Novocure; H.H. Engelhard: I have participated in Novocure's Advisory Boards; N. Butowski: I participated in Novocure's Advisory Board; D.D. Tran: I have received honorarium from Novocure for advisory board and speaker bureau; Y. Kew: I have participated in Novocure's Advisory Boards; R. Cavaliere: I have been a consultant for Novocure; J. Villano: Member of a speakers bureau and served on an advisory board for Novocure. D. Bota: Novocure Advisory Board; S. Kesari: I have received funding for advisory board meetings and clinical trials sponsored by Novocure; J. Rudnick: I have been a consultant for Novocure; A. Sumrall: I have been a Faculty Speaker and participated in an Advisory Board for Novocure; J.J. Zhu: Novocure Advisory Board; E.T. Wong: I received research funding from Novocure.