title: A phase I/II trial of Tumor Treating Fields (TTFields) therapy in combination with pemetrexed for advanced non-small cell lung cancer.
abstract: BACKGROUND
  Low intensity, intermediate frequency, alternating electric fields (Tumor Treating Fields; TTFields) exhibit anti-mitotic activity in cancer cells. Promising preclinical data have led to a single arm phase I/II trial in NSCLC patients.
  
  
  METHODS
  Forty-two inoperable stage IIIB (with pleural effusion) and IV NSCLC patients who had had tumor progression received pemetrexed 500 mg/m(2) iv q3w together with daily TTFields therapy until disease progression. The primary endpoint was time to "in-field" progression.
  
  
  RESULTS
  Median age for all patients was 63 years, 76% had stage IV disease, 78% had adenocarcinoma and 17% had performance status of 2. The median time to in-field progression was 28 weeks and the median time to systemic progression was 22 weeks. Six patients (14.6%) had a partial remission (PR) and 20 had stable disease (SD) (48.8%). Median overall survival was 13.8 months and 1 year survival rate was 57%. There were no TTFields-related serious adverse events.
  
  
  CONCLUSIONS
  The combination of TTFields and pemetrexed as a second line therapy for NSCLC is safe and potentially more effective than pemetrexed alone. TTFields improved disease control within the treatment field and a phase III study is planned to further investigate its role as a novel treatment in NSCLC.
authors.affiliation: Medical Oncology, Kantonsspital Winterthur, Switzerland. Electronic address: Miklos.Pless@ksw.ch.
authors.forename: Miklos
authors.initials: M
authors.lastname: Pless
authors.affiliation: Medical Oncology, University Hospital Basel, Switzerland.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Droege
authors.affiliation: Medical Oncology, Kantonsspital Graubünden, Switzerland.
authors.forename: Roger
authors.initials: R
authors.lastname: von Moos
authors.affiliation: Medpace Inc., USA.
authors.forename: Marc
authors.initials: M
authors.lastname: Salzberg
authors.affiliation: Medical Oncology, Cantonal Hospital Fribourg, Switzerland.
authors.forename: Daniel
authors.initials: D
authors.lastname: Betticher
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D005971:Glutamates / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006147:Guanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D000068437:Pemetrexed; D026741:Physical Therapy Modalities / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine
keywords: In-field progression; Local control; Low intensity electric fields; Metastatic NSCLC; NovoTTF; Second line treatment