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H. Kim
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-016 - Diagnostic Accuracy of Visual Assessment on Growth of Non-Measurable Target Pulmonary Nodules According to RECIST Criteria (ID 4683)
14:30 - 14:30 | Author(s): H. Kim
- Abstract
Background:
Two-dimensional CT measurement considered unreliable in the evaluation of small pulmonary nodule less than 2 cm, and a nodule less than 1 cm in diameter considered non-measurable according to RECIST criteria. The aim of this study was to determine the accuracy of visual assessment on the growth of immeasurable small pulmonary nodules less than 1 cm in diameter on CT.
Methods:
We selected 125 CT images (1-mm slice thickness axial images, lung window setting, lung algorithm) which have a small pulmonary nodule less than 1cm. Then, we magnified the pulmonary nodules to 120% in diameter using the Photoshop. We coupled these images to 125 sets of ingrowth and growth groups, respectively. Four radiologists with varying experience read these sets to five-point scale using visual assessment (definitely ingrowth, probably ingrowth, possibly growth, probably growth, and definitely growth).
Results:
The areas under the receiver-operator characteristic curves of visual assessment on growth of small pulmonary nodules were 0.975 for observer 1, 0.986 for observer 2, 0.989 for observer 3, and 0.913 for observer 4, respectively. Sensitivities were 96.0% (120/125), 98.4% (123/125), 98.4% (123/125), and 88.0% (110/125), respectively. Specificities were 99.2% (124/125), 99.2% (123/125), 98.4% (124/125), and 96.8% (121/125), respectively.
Conclusion:
Visual assessment showed high diagnostic performance for determining growth of non-measurable target pulmonary nodules with 20% increase in diameter.
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P2.06 - Poster Session with Presenters Present (ID 467)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Scientific Co-Operation/Research Groups (Clinical Trials in Progress should be submitted in this category)
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.06-017 - Amethyst NSCLC Trial: Phase 2 Study of MGCD265 in Patients with Advanced or Metastatic NSCLC with Activating Genetic Alterations in MET (ID 5384)
14:30 - 14:30 | Author(s): H. Kim
- Abstract
Background:
MGCD265 is a potent, orally available, small molecule RTK inhibitor of MET and Axl, both of which mediate signals for cell growth, survival, and migration. The Amethyst NSCLC trial is designed to evaluate the activity of MGCD265 in patients with NSCLC exhibiting genetic alterations involving MET. Alterations in MET, including gene amplification and/or genetic mutations, occur in approximately 7% of NSCLC cases converting MET to an oncogene capable of driving cancer development and progression. Amplification of MET has been associated with a poor prognosis in NSCLC. In addition, various genetic mutations result in the deletion of exon 14 in MET mRNA (METex14del) and the subsequent loss of the Y1003 regulatory binding site for CBL ubiquitin ligase, required for MET degradation and signal attenuation. Loss of the Y1003 binding site of MET results in sustained MET signaling, which has been implicated as an oncogenic driver in a subset of NSCLC. The importance of MET as a driver is demonstrated in xenograft models of NSCLC with METex14del and MET amplification, and where MGCD265 induces tumor regression. Additionally, confirmed partial responses have been observed in pts with NSCLC characterized by METex14del who were treated with MGCD265 in the Phase 1 setting.
Methods:
Pts with platinum pre-treated NSCLC characterized by activating genetic MET alterations identified in tumor tissue or circulating tumor DNA (ctDNA) are eligible for this multi-center, global, Phase 2 trial. Pts are assigned to one of four cohorts based on the type of MET dysregulation and detection method: 1) mutations in tissue, 2) amplification in tissue, 3) mutations in ctDNA, and 4) amplification in ctDNA. The primary endpoint is Objective Response Rate (ORR) in accordance with RECIST 1.1; a Bayesian Predictive Probability Design is applied independently to each cohort. Secondary objectives include safety, tolerability, response duration, survival, correlation between tissue and ctDNA testing, and PK/PD. This study is currently open globally, and recruitment is ongoing.
Results:
Section not applicable.
Conclusion:
Section not applicable.
