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The first 457 patient with recurrent gbms who used the Novocure NovoTTF-100a therapy after it was FDA approved were analyzed to see how they did. This is for people outside of the trials. Results were much better than the large trial that resulted in FDA approval.
There are 2 trials going on novocure device. One for newly diagnosed gbm and one for recurrent gbm. It is also available by prescription at over 100 major brain tumor centers (The advantage of entering the trials are the costs.)
Sub-category:
Central Nervous System Tumors
Category:
Central Nervous System Tumors
Meeting:
2014 ASCO Annual Meeting
Abstract No:
e13033
Abstract DisclosuresAuthor(s): Eric T. Wong, Herbert H Engelhard, David Dinh Tran, Yvonne Kew, Maciej M. Mrugala, Robert Cavaliere, John L. Villano, Daniela Annenelie Bota, Jeremy Rudnick, Ashley Love Sumrall, Jay-Jiguang Zhu; Brain Tumor Center & Neuro-Oncology Unit, Beth Israel Deaconess Medical Center, Boston, MA; University of Illinois Hospital and Health Sciences System, Chicago, IL; Washington University School of Medicine in St. Louis, St. Louis, MO; Houston Methodist Hospital, Houston, TX; University of Washington, Seattle, WA; The Ohio State University, Columbus, OH; University of Illinois, Chicago, IL; University of California, Irvine, Medical Center, Orange, CA; Neuro-Oncology Program, Cedars-Sinai Medical Center, Los Angeles, CA; Levine Cancer Institute, Charlotte, NC; The University of Texas Health Science Center at Houston, Houston, TX
Abstract:
Background: The NovoTTF-100A is a first-of-a-kind anticancer device, approved by the Food and Drug Administration in 2011, for the treatment of recurrent glioblastomas. It emits alternating electric fields, at an intensity of 1 V/cm and a frequency of 200 kHz, that mimic the cytotoxic effect of chemotherapy by disrupting charged cytoplasmic proteins involved in the tightly orchestrated process of mitosis. Past phase III trial demonstrated equivalent efficacy when the device was compared to conventional cytotoxic chemotherapies and bevacizumab, but without their systemic side effects. Methods: The NovoTTF-100A device has been available by prescription at 91 oncology centers in the United States since November 2011. We retrospectively analyzed the outcome and toxicity data from patients who were prescribed the device from October 2011 to November 2013 as treatment for their recurrent glioblastomas. Results: There were 147 female and 310 male patients (n=457) who were treated with this device. The median age was 55 (range 18 to 86) years. The Kaplan-Meier median OS was 9.6 (95% confidence interval [CI] 8.0 to 13.7) months and the median treatment duration was 4.1 (95% CI 3.5 to 4.8) months. The most common device-related adverse events include skin reaction (24.3%), neurological disorders (10.4%), heat sensation (8.9%), electric sensation (7.7%) and headache (5.7%). Conclusions: Treatment with NovoTTF-100A, as prescribed in the general clinical setting to patients with recurrent glioblastomas, offers favorable outcomes compared to historical patient data. The adverse event profile of the device remains benign with no new unexpected toxicities.