EP1.01-39 A Randomised Phase II Trial of Vitamin C Synergy with Hyperthermia in Patients with Advanced Non-Small-Cell Lung Cancer

Abstract

Intravenous vitamin C (IVC) and modulated electrohyperthermia (mEHT) are widely used by integrative cancer practitioners for many years. However, there are no sufficient data in quality of life (QoL), clinical response and survival time of the above treatments in patients with stage III-IV Non-Small Cell Lung Cancer (NSCLC). Our phase I clinical trial proved that IVC simultaneously with mEHT were safe for NSCLC patients. A randomised phase II controlled trial was performed to compare supportive care with and without IVC + mEHT concomitant treatment (In the active arm: patients were allocated into 1 g/kg d, 1.2 g/kg d, 1.5 g/kg d dosage groups simultaneously with mEHT, three times a week for 25 treatments in total)on tumour size, progression-free survival (PFS) and overall survival (OS) in advanced Chinese NSCLC patients. Subsequently, 97 patients were analysed at the data cut-off (17th July, 2018). Enhanced chest and abdomen CT scans, brain MRI and bone scans were carried out at baseline, and every 4 weeks for the first 12 weeks from the start of the study. Response measurements were carried out according to RECIST 1.1. 3 month disease control rate(DCR) was measured 3 months after the therapy and defined as the percentage of subjects with complete response (CR), partial response (PR) or stable disease (SD) at 3 months relative to all randomly assigned patients. After a median follow up of 10 months, both the PFS and OS were significantly improved by IVC + mEHT compared to control (PFS: 3 month vs. 1.85 months, P<0.05; OS: 12 months vs. 7.5 months, P<0.05). The average scores for the functioning scales increased continuously, so that the QoL improved in the active arm despite the advanced stage of the disease(P<0.05). 3-month DCR after treatment was 42.9% in the active arm and 16.7% in the control arm (P<0.05). Both interleukin-6 and c-reactive protein were significantly decrease after treatments in active arm in comparison with control arm (P<0.05). However, there were no significant differences in 3 month DCR, PFS and OS between the three groups with different applied dosages of vitamin C. No significant differences were observed between parameters of adenocarcinoma and squamous cell carcinoma and between EGFR(+) and EGFR(–). IVC + mEHT treatment significantly improves QoL, prolongs PFS and OS, and moderates cancer-related inflammation, and so is a feasible treatment for patients with advanced NSCLC. This trial is registered in ClinicalTrials.gov (ID: NCT02655913).