Miklos Pless1, Cornelia Droege2, Roger von Moos3, Marc Salzberg4, Daniel Betticher5. 1. Medical Oncology, Kantonsspital Winterthur, Switzerland. Electronic address: Miklos.Pless@ksw.ch. 2. Medical Oncology, University Hospital Basel, Switzerland. 3. Medical Oncology, Kantonsspital Graubünden, Switzerland. 4. Medpace Inc., USA. 5. Medical Oncology, Cantonal Hospital Fribourg, Switzerland.
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.
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 NSCLCpatients. METHODS: Forty-two inoperable stage IIIB (with pleural effusion) and IV NSCLCpatients 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: Sandeep Mittal; Neil V Klinger; Sharon K Michelhaugh; Geoffrey R Barger; Susan C Pannullo; Csaba Juhász Journal: J Neurosurg Date: 2017-02-24 Impact factor: 5.115