43P - A phase I-II clinical trial to evaluate the safety, pharmacokinetics and efficacy of high dose intravenous ascorbic acid synergy with mEHT in Chine...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Thoracic Malignancies
Translational Research
Non-Small Cell Lung Cancer
Basic Principles in the Management and Treatment (of cancer)
Presenter Junwen Ou
Citation Annals of Oncology (2017) 28 (suppl_2): ii9-ii13. 10.1093/annonc/mdx089
Authors J. Ou1, X. Zhu2, Y. Lu2, C. Zhao2, H. Zhang2, X. Gui2, X. Wang2, X. Zhang3, T. Zhang2, C.L.K. Pang2
  • 1Phd Student Of Guangzhou University Of Chinese Medicine, Clifford Hospital, Guangzhou University of Chinese Medicine, 511495 - Guangzhou/CN
  • 2Clifford Hospital, Guangzhou University of Chinese Medicine, Guangzhou/CN
  • 3Guangzhou Clifford Hospital, Guangzhou University of Chinese Medicine, Guangzhou/CN

Abstract

Background

Ascorbic acid (AA) infusion and modulated electrohyperthermia (mEHT) have been widely used by integrative cancer practitioners for many years. However, there are no safety and pharmacokinetics data in Chinese cancer patients.

Methods

Blood ascorbic acid in the fasting state was obtained from 35 NSCLC patients; selecting from them 15 patients with stage III-IV entered the phase I -II study. They were randomized allocated into 3 groups, and received doses 1.0, 1.2, 1.5g/kgAA infusions. Pharmacokinetic profiles were obtained when they received solely IVAA at concentrations of 1g/kg, 1.2g/kg, and 1.5g/kg, and when IVAA in combination with mEHT. The process was applied 3 times a week (every other day, weekend days off) for 4 weeks. Participants in the first group received intravenous AA (IVAA) when mEHT was finished; in the second group IVAA was administered simultaneously with mEHT; and in the third group IVAA was applied first, and followed with mEHT. All patients started the trial doses of 1 g/kg for 8 treatments. When there was no DLT observed, the test dose for patients increased to 1.2 g/kg continuously for 8 treatments, and then the test dose for patients was escalated to 1.5 g/kg continuously for 8 treatments. DLT was defined as any reversible grade ≥3 adverse events, whether haematological or non-haematological.

Results

Fasting plasma AA levels were significantly correlated with stage of the disease. Peak concentrations of AA were significantly higher in the simultaneous treatments than in other combinations with mEHT or in solely IVAA-managed groups. The average scores for the functioning scales continuously increased and the symptoms gradually decreased over the full cycle of the study. 3/7 patients with squamous cell lung cancer were CR, 4/7 were PR. 1/8 patient with adenocarcinoma cell lung cancer was PR, 5/8 were SD, and 2/8 died.

Conclusions

IVAA synergies with simultaneous mEHT is safe and the concomitant application significantly increases the plasma AA level for NSCLC patients. QOL is improved when they receive the above treatments. Patients diagnosed with squamous cell lung cancer were sensitive to the above two treatments.

Clinical trial identification

NCT02655913

Legal entity responsible for the study

Junwen Ou

Funding

Clifford Hospital

Disclosure

All authors have declared no conflicts of interest.