title: Clinical practice experience with NovoTTF-100A™ system for glioblastoma: The Patient Registry Dataset (PRiDe).
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.
authors.affiliation: University of Washington, Seattle, WA mmrugala@uw.edu.
authors.forename: Maciej M
authors.initials: MM
authors.lastname: Mrugala
authors.affiliation: University of Illinois Hospital and Health Sciences System, Chicago, IL.
authors.forename: Herbert H
authors.initials: HH
authors.lastname: Engelhard
authors.affiliation: Washington University School of Medicine, St. Louis, MO.
authors.forename: David
authors.initials: D
authors.lastname: Dinh Tran
authors.affiliation: Houston Methodist Hospital, Houston, TX.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Kew
authors.affiliation: The Ohio State University, Columbus, OH.
authors.forename: Robert
authors.initials: R
authors.lastname: Cavaliere
authors.affiliation: University of Illinois, Chicago, IL.
authors.forename: John L
authors.initials: JL
authors.lastname: Villano
authors.affiliation: University of California, Irvine Medical Center, Orange, CA.
authors.forename: Daniela
authors.initials: D
authors.lastname: Annenelie Bota
authors.affiliation: Neuro-Oncology Program, Cedars-Sinai Medical Center, Los Angeles, CA.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Rudnick
authors.affiliation: Levine Cancer Institute, Charlotte, NC.
authors.forename: Ashley
authors.initials: A
authors.lastname: Love Sumrall
authors.affiliation: University of Texas Health Science Center at Houston, Houston, TX.
authors.forename: Jay-Jiguang
authors.initials: JJ
authors.lastname: Zhu
authors.affiliation: University of California, San Francisco, San Francisco, CA.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Butowski
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D004599:Electric Stimulation Therapy; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D010818:Practice Patterns, Physicians'; D011379:Prognosis; D012042:Registries; D015996:Survival Rate; D055815:Young Adult