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K.A. Kolquist
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 2
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-074 - Prognostic Multi-Gene Molecular Assay Might Improve Identification of Pathologic Stage IB Lung Adenocarcinoma Patients at Risk for Recurrence (ID 1726)
09:30 - 09:30 | Author(s): K.A. Kolquist
- Abstract
Background:
Adjuvant chemotherapy improves survival for some patients with NSCLC and is recommended for consideration by NCCN guidelines for pathologic stage IB patients presenting certain high risk features. A validated, 46-gene RNA expression assay has been shown to stratify lung cancer specific, post-resection mortality risk in pathologic stage I and II NSCLC adenocarcinoma independently of pathologic staging and high risk features. The aim of this study was to compare Stage IB patient risk as assessed by cell cycle progression (CCP) and prognostic score, a combination of CCP score and pathologic stage, versus NCCN high risk features.
Methods:
Formalin-fixed paraffin-embedded surgical tumor samples from 92 stage IB lung adenocarcinoma patients, who underwent definitive surgical treatment and complete lymph node evaluation, were stratified to high or low risk groups by analysis of the molecular assay and the remaining NCCN high risk features of wedge resection, tumor size >4 cm, poorly differentiated tumor, lymphovascular invasion, and visceral pleural invasion.
Results:
Of the 92 Stage IB patients, 63 (68.5%) were designated high risk by the 46-gene molecular assay. Of these molecularly designated high risk patients, 5 (7.9%) presented no NCCN high risk features, 23 (36.5%) presented only 1 high risk feature, 22 (34.9%) presented 2 high risk features, 11 (17.5%) presented 3 high risk features, and 2 (3.2%) presented 4 high risk features. No patients presented with all 5 high risk features.
Conclusion:
This study demonstrates that a validated measure of recurrence in Stage IB adenocarcinoma patients can identify high risk patients that would have been otherwise designated as low risk according to pathological features. Significantly, in the Stage IB population, prognostic score provide quantitative risk information above that captured by current NCCN high risk features. Patients with resected Stage I lung adenocarcinoma and a high prognostic score may be candidates for adjuvant therapy to reduce cancer related mortality.
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P3.04-084 - Analytical Validation of a Proliferation-Based Molecular Signature Used as a Prognostic Marker in Early Stage Lung Adenocarcinoma (ID 1716)
09:30 - 09:30 | Author(s): K.A. Kolquist
- Abstract
Background:
We have developed a gene expression signature that provides prognostic information for patients with early stage lung adenocarcinoma that would benefit from adjuvant chemotherapy. This signature uses quantitative reverse transcription PCR to measure RNA expression of 31 cell-cycle progression (CCP) genes normalized to 15 housekeeping genes to provide a quantitative CCP score. The signature can identify aggressive early stage tumors that might be suitable for post-surgical therapy. The aim of these studies was to validate the analytical performance of the CCP gene signature.
Methods:
The analytical performance of the CCP gene signature was evaluated using formalin-fixed, paraffin-embedded lung resections by assessing parameters such as precision, dynamic range, and RNA input requirements.
Results:
The signature had a standard deviation (SD) of 0.06 score units, which is 1% of the clinical range of scores. The dynamic range of CCP scores in this signature was from -13 and 14 score units. The average amplicon efficiencies for target and housekeeper genes were comparable at 107% and 105%, respectively. All but one amplicon had a SD <0.5 CT. The gene signature reproducibly generated a consistent CCP score with RNA input concentrations between 0.12 and 62.5 ng/μL, which is considerably larger than the concentration ranges used for clinical testing (2–40 ng/μL).
Conclusion:
These studies demonstrate that the gene signature is robust and reproducible, making it suitable for use in a clinical setting.
