title: NovoTTF-100A versus physician's choice chemotherapy in recurrent glioblastoma: a randomised phase III trial of a novel treatment modality.
abstract: OBJECTIVE
  NovoTTF-100A is a portable device delivering low-intensity, intermediate frequency electric fields via non-invasive, transducer arrays. Tumour Treatment Fields (TTF), a completely new therapeutic modality in cancer treatment, physically interfere with cell division.
  
  
  METHODS
  Phase III trial of chemotherapy-free treatment of NovoTTF (20-24h/day) versus active chemotherapy in the treatment of patients with recurrent glioblastoma. Primary end-point was improvement of overall survival.
  
  
  RESULTS
  Patients (median age 54 years (range 23-80), Karnofsky performance status 80% (range 50-100) were randomised to TTF alone (n=120) or active chemotherapy control (n=117). Number of prior treatments was two (range 1-6). Median survival was 6.6 versus 6.0 months (hazard ratio 0.86 [95% CI 0.66-1.12]; p=0.27), 1-year survival rate was 20% and 20%, progression-free survival rate at 6 months was 21.4% and 15.1% (p=0.13), respectively in TTF and active control patients. Responses were more common in the TTF arm (14% versus 9.6%, p=0.19). The TTF-related adverse events were mild (14%) to moderate (2%) skin rash beneath the transducer arrays. Severe adverse events occurred in 6% and 16% (p=0.022) of patients treated with TTF and chemotherapy, respectively. Quality of life analyses favoured TTF therapy in most domains.
  
  
  CONCLUSIONS
  This is the first controlled trial evaluating an entirely novel cancer treatment modality delivering electric fields rather than chemotherapy. No improvement in overall survival was demonstrated, however efficacy and activity with this chemotherapy-free treatment device appears comparable to chemotherapy regimens that are commonly used for recurrent glioblastoma. Toxicity and quality of life clearly favoured TTF.
authors.affiliation: Centre Hospitalier Universitaire Vaudois, University of Lausanne, Lausanne, Switzerland. Roger.Stupp@chuv.ch
authors.forename: Roger
authors.initials: R
authors.lastname: Stupp
authors.forename: Eric T
authors.initials: ET
authors.lastname: Wong
authors.forename: Andrew A
authors.initials: AA
authors.lastname: Kanner
authors.forename: David
authors.initials: D
authors.lastname: Steinberg
authors.forename: Herbert
authors.initials: H
authors.lastname: Engelhard
authors.forename: Volkmar
authors.initials: V
authors.lastname: Heidecke
authors.forename: Eilon D
authors.initials: ED
authors.lastname: Kirson
authors.forename: Sophie
authors.initials: S
authors.lastname: Taillibert
authors.forename: Frank
authors.initials: F
authors.lastname: Liebermann
authors.forename: Vladimir
authors.initials: V
authors.lastname: Dbalý
authors.forename: Zvi
authors.initials: Z
authors.lastname: Ram
authors.forename: J Lee
authors.initials: JL
authors.lastname: Villano
authors.forename: Nikolai
authors.initials: N
authors.lastname: Rainov
authors.forename: Uri
authors.initials: U
authors.lastname: Weinberg
authors.forename: David
authors.initials: D
authors.lastname: Schiff
authors.forename: Lara
authors.initials: L
authors.lastname: Kunschner
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Raizer
authors.forename: Jerome
authors.initials: J
authors.lastname: Honnorat
authors.forename: Andrew
authors.initials: A
authors.lastname: Sloan
authors.forename: Mark
authors.initials: M
authors.lastname: Malkin
authors.forename: Joseph C
authors.initials: JC
authors.lastname: Landolfi
authors.forename: Franz
authors.initials: F
authors.lastname: Payer
authors.forename: Maximilian
authors.initials: M
authors.lastname: Mehdorn
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Weil
authors.forename: Susan C
authors.initials: SC
authors.lastname: Pannullo
authors.forename: Manfred
authors.initials: M
authors.lastname: Westphal
authors.forename: Martin
authors.initials: M
authors.lastname: Smrcka
authors.forename: Lawrence
authors.initials: L
authors.lastname: Chin
authors.forename: Herwig
authors.initials: H
authors.lastname: Kostron
authors.forename: Silvia
authors.initials: S
authors.lastname: Hofer
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Bruce
authors.forename: Rees
authors.initials: R
authors.lastname: Cosgrove
authors.forename: Nina
authors.initials: N
authors.lastname: Paleologous
authors.forename: Yoram
authors.initials: Y
authors.lastname: Palti
authors.forename: Philip H
authors.initials: PH
authors.lastname: Gutin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D018572:Disease-Free Survival; D004599:Electric Stimulation Therapy / Q000009:adverse effects; D005060:Europe; D005260:Female; D005909:Glioblastoma / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D007557:Israel; D053208:Kaplan-Meier Estimate; D017567:Karnofsky Performance Status; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D016016:Proportional Hazards Models; D011788:Quality of Life; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents