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.