1230P - hPG80 (circulating progastrin) is a new blood-based biomarker for diagnosis of early-stage non-small cell lung cancers

Background

Lung cancer is the most prevalent and deadliest cancer worldwide, mainly due to its advanced stage at diagnosis. Minimally invasive method for early detection of lung cancer is an urgent need to improve patients’ survival. hPG₈₀ (circulating progastrin) has been previously described as a promising multi-tumors blood biomarker (You et al. EbioMedicine, 2020). hPG₈₀ is produced and released from cancer cells and can be detected in the blood at early steps of tumorigenesis. In this study, we assess the diagnostic value and potential clinical utility of hPG₈₀ in patients with non-small cell lung cancers (NSCLC), including early-stage tumors.

Methods

Plasma hPG₈₀ levels were measured using the kit DxPG80.Lab (Biodena care, Montpellier, France) from two cohorts: (1) a retrospective cohort of 400 NSCLC patients comprising 100 samples per disease stage (I-IV) collected at diagnosis, before any treatment (Nice Hospital-Integrated Biobank BB-0033-00025); (2) a prospective matching age cohort of 330 healthy subjects. The diagnostic value of hPG₈₀ was assessed by comparing hPG₈₀ baseline concentrations in NSCLC patients with those of healthy subjects. Receiver operating characteristic (ROC) curves were used to evaluate the diagnostic accuracy of hPG₈₀ using the area under the curve (AUC).

Results

Overall, hPG₈₀ median concentration in all NSCLC patients was significantly higher than in healthy subjects (6.51 pM vs 1.95 pM, P<0.0001). hPG₈₀ median concentrations were significantly higher in all disease stage subgroups than those in healthy subjects (6.83 pM, 7.15 pM, 6.02 pM and 6.34 pM for stage I to stage IV, respectively) (P<0.0001). ROC curve analysis of the entire NSCLC cohort showed that the AUC value was 0.84 (95% CI: 0.81 to 0.87). Following subgroup analysis by disease stages I-IV, the AUC values were 0.86 (95% CI: 0.83 to 0.90), 0.85 (95% CI: 0.81 to 0.88), 0.82 (95% CI: 0.78 to 0.86) and 0.84 (95% CI: 0.80 to 0.87), respectively.

Conclusions

These findings uncover the potency of hPG₈₀ as a novel promising, accurate and non-invasive biomarker to diagnose NSCLC patients, notably at an early stage. Furthermore, its measurement by an ELISA assay may facilitate its routine use for cancer screening/early diagnosis.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Biodena Care.

Funding

Biodena Care.

Disclosure

A. Prieur, N. Mimoun: Financial Interests, Personal, Member of Board of Directors: Biodena Care. B. Vire: Financial Interests, Personal, Full or part-time Employment: Biodena Care. D. Joubert: Financial Interests, Personal, Advisory Board: Biodena Care. All other authors have declared no conflicts of interest.