期刊
CLINICAL AND TRANSLATIONAL RADIATION ONCOLOGY
卷 21, 期 -, 页码 49-55出版社
ELSEVIER IRELAND LTD
DOI: 10.1016/j.ctro.2019.12.002
关键词
Nitroglycerin; HX4; NSCLC; Hypoxia; Perfusion; Mitochondria
资金
- ERC [694812]
- Dutch Technology Foundation STW (DuCAT) [10696]
- Dutch Technology Foundation STW (Radiomics STRaTegy) [P14-19]
- EU 7th Framework Programme (METOXIA) [2008-222741]
- EU 7th Framework Programme (ARTFORCE) [257144]
- SME Phase 2 (EU) [673780]
- Health Foundation Limburg
- Dutch Cancer Society [KWF UM 2011-5020, KWF UM 2009-4454, KWF MAC 2013-6425, KWF 2015-7635, KWF MAC 2013-6089, KWF UM 2015-7635]
- Anticancer Fund
Background: Nitroglycerin is proposed as an agent to reduce tumour hypoxia by improving tumour perfusion. We investigated the potential of nitroglycerin as a radio-sensitizer in non-small cell lung cancer (NSCLC) and the potential of functional imaging for patient selection. Material and methods: Trial NCT01210378 is a single arm phase II trial, designed to detect 15% improvement in 2-year overall survival (primary endpoint) in stage IB-IV NSCLC patients treated with radical (chemo-) radiotherapy and a Transiderm-Nitro 5 patch during radiotherapy. Patients underwent dynamic contrast-enhanced CTs (DCE-CT) and HX4 (hypoxia) PET/CTs before and after nitroglycerin. Secondary endpoints were progression-free survival, toxicity and the prognostic value of tumour perfusion/hypoxia at baseline and after nitroglycerin. Results: The trial stopped after a futility analysis after 42 patients. At median follow-up of 41 months, two-year and median OS were 58% (95% CI: 44-78%) and 38 months (95% CI: 22-54 months), respectively. Nitroglycerin could not reduce tumour hypoxia. DCE-CT parameters did not correlate with OS, whereas hypoxic tumours had a worse OS (p = 0.029). Changes in high-uptake fraction of HX4 and tumour blood flow were negatively correlated (r = -0.650, p = 0.022). The heterogeneity in treatment modalities and patient characteristics combined with a small sample size made further subgroup analysis of survival results impossible. Toxicity related to nitroglyerin was limited to headache (17%) and hypotension (2.4%). Conclusion: Nitroglycerin did not improve OS of NSCLC patients treated with (chemo-)radiotherapy. A general ability of nitroglycerin to reduce hypoxia was not shown. (C) 2019 Published by Elsevier B.V. on behalf of European Society for Radiotherapy and Oncology.
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