29P - Baseline characteristics of participants in pl-208: A multi-center trial of the prolung test™ (Transthoracic Bioconductance Measurement) as an adju...

Date 07 May 2017
Event ELCC 2017
Session Poster Display Session
Topics Cancer Aetiology, Epidemiology, Prevention
Lung and other Thoracic Tumours
Presenter Rex Yung
Citation Annals of Oncology (2017) 28 (suppl_2): ii6-ii8. 10.1093/annonc/mdx087
Authors R.C. Yung1, D. Ost2, M. Simoff3, C. Reddy4, A. Goyal5, I. Barjakarevic6, M. Garff7, K. Larson7, J. O'Driscoll7, S. Makani8
  • 1Oncology & Medicine, Johns Hopkins University, 21204 - Baltimore/US
  • 2Medicine, MD Anderson Cancer Center, Houston/US
  • 3Medicine, Henry Ford Hospital, Detroit/US
  • 4Medicine, Huntsman Cancer Institute, Salt Lake City/US
  • 5Medicine, Loyola University Medical Center LUMC, Maywood/US
  • 6Medicine, UCLA - School of Medicine, Los Angeles/US
  • 7ProLungDx, 84102 - Salt Lake City/US
  • 8Medicine, UC San Diego, San Diego/US

Abstract

Background

Lung cancer screening with low dose CTs shows numerous indeterminate pulmonary lesions (IPLs). Followup evaluation entail additional radiation (full dose CT/PET) or invasive biopsies. Alternative, novel adjunctive risk-stratification pathways are needed. Volume-averaged thoracic bioconductance, is a non-invasive technology measured transcutaneously by ProLung’s Electro-Pulmonary Nodule Scan (EPNS). A single center study had demonstrated potential to risk stratify such lesions.1 with sensitivity/specificity of 90%/92% respectively and ROC >0.90. We present interim patient data of PL-208, a pivotal multicenter EPNS validation study.

Methods

This is IRB approved and prospectively enrolled IPNs being evaluated. It is a two-phase study consisting of 350 subjects, 200 in the algorithm stabilization phase and 150 subjects in a subsequent algorithm validation phase. EPNS is performed within 60 days of the CT and pre tissue biopsies. In this prospective study, all study subjects & investigators are blinded to the EPNS results.

Results

We present data on the initial 133 subjects in the table comparing data between the earlier feasibility study FML2041 and PL208. 46(35%) subjects were asymptomatic; the rest had symptoms leading to imaging. Diagnoses include: 84 (63%) lung cancers, 4 (3%) non-primary lung cancers, 20 (15%) benign by biopsy, and 25 (19%) benign by CT follow-up.

Conclusions

PL-208 cohort has a similar gender and age distribution to the PL204 feasibility study using EPNS as a risk-stratifying tool in evaluating suspicious IPLs. PL-208 includes asymptomatic nodules detected during LDCT screening, and hence more subjects with small T1a IPLs (17% Vs 7%), but overall a majority of subjects have IPNs < 3 cm (59%/56%). Of LCs diagnosed, 38%/41% are in stages I/II. 1Yung et al. Transcutaneous Computed Bioconductance Measurement. J Thorac Oncol 2012; 7:681–9.\r\nTable: 29P

Comparison FML-204 and PL-208 patient characteristics

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SUBJECTSFML-204PL-208
Age Mean(range)64 (34-80)65 (22-85)
Male (%)22 (54%)68 (51%)
Symptomatic41 (100%)87 (65%)
COPD diagnosis19 (46%)27 (20%)
NODULE FEATURES\r\n\r\n
Solitary/multiple17(41%)/24 (59%)45 (34%)/88 (66%)
0-10 mm (T1a)2 (7%)23 (17%)
11-20 mm (T1b)13 (32%)35 (26%)
21-30 mm (T1c)7 (17%)21 (16%)
31-50 mm (T2a)9 (22%)25 (19%)
> 50 mm (T2b/c)8 (20%)22 (17%)
Solid37 (90%)111 (83%)
Part solid/GGO3 (7%)/1 (2%)13 (10%)/9 (7%)
DIAGNOSIS\r\n\r\n
Benign by biopsy/CT-fu9 (22%)/3 (7%)20 (15%)/25 (19%)
Small cell lung cancer2 (5%)10 (8%)
Adenocarcinoma20 (49%)51 (38%)
Squamous cell carcinoma6 (15%)17 (13%)
Carcinoid1 (2%)6 (5%)
Non-lung malignancy0 (0%)4 (3%)
STAGE\r\n\r\n
I11 (38%)20 (24%)
II1 (3%)12 (14%)
III6 (21%)23 (27%)
IV11 (38%)20 (24%)
Other0 (0%)9 (11%)
\r\n

Clinical trial identification

NCT01566682

Legal entity responsible for the study

ProLungDx

Funding

ProLungDx

Disclosure

R.C. Yung: Conducted study with ProLung (corporate) sponsorship of study. Lead author also on ProLung Advisory Board, have received consultation fees and travel support (to meetings). Have been offered stock options. D. Ost: Conducted study with ProLung (corporate) sponsorship of study. Have received consultation fees on Advisory Board. M. Simoff, C. Reddy, A. Goyal, I. Barjakarevic: Conducted study with ProLung (corporate) sponsorship of study. M. Garff: Employee of ProLungDx. K. Larson: Employee of ProLung. J. O\'Driscoll: Chief Medical Officer and member of the Board of Directors for ProLungDx. S. Makani: Funded corporate sponsored research from ProLungDx.