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M. Batus
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03a-006 - Frequency of 2 Year PFS Milestone in Stage IV NSCLC Patients Treated with First Line Pemetrexed/Platinum and Pemetrexed Maintenance (ID 6288)
14:30 - 14:30 | Author(s): M. Batus
- Abstract
Background:
Focusing on median progression free and overall survival does not fully inform us, or our patients, of the maximum achievable benefit found at the tail end of the survival curve (Hellman M, JAMA Oncology 2016). Milestone metrics in this context may be more informative; however, mature data are scarce. Our anecdotal observations suggested that some of our non-squamous NSCLC pts treated with pemetrexed continuation maintenance had long-term disease control beyond the reported median PFS. The objective of our single institution retrospective study was to determine the % of patients who reach the 2 year PFS milestone in patients whose treatment plan included continuation pemetrexed maintenance. Evaluation of the potential predictive value of clinical parameters was a secondary objective.
Methods:
Pts with stage IV NSCLC who received at least once cycle of pemetrexed/platinum with planned pemetrexed maintenance (N = 241) between May 2010 and December, 2013 were included in this retrospective analysis. Minimum follow up for every patient was > 24 months. Patient demographics, routine laboratory values, first and last dates of pemetrexed therapy, and date of progression were collected. Pts were grouped according to duration of disease control ≥24 months vs < 24 months. Potential associations between patient demographics and comparison of laboratory values for the two groups were assessed using a Mann-Whitney-Wilcoxon test.
Results:
Median age 66, male/female 40.25%/59.75%, 21% never smoker. The median progression free survival was 6.2 months. 34 pts (14.1%) had no progression of disease at ≥24 months since starting treatment with pemetrexed/platinum followed by pemetrexed maintenance. A PFS ≥24 months was associated with a lower baseline neutrophil/lymphocyte ratio (NLR) (median 3.3 vs 4.55; 25-75 percentile 2.32-3.94 vs 2.8-7.89; p=0.0011). PS at baseline was also significantly associated with a PFS≥24 months (p=0.02). Long term PFS was not significantly related to gender, age, sites of metastases, or number of disease sites.
Conclusion:
Considering that the two year OS rate for first line chemotherapy in clinical trials is approximately 25%, the 2 year PFS milestone rate of 14.1% patients is encouraging. Significantly lower baseline NLR, was observed in patients who reached the two year PFS milestone. Studies evaluating the potential predictive value of other clinical and molecular parameters are ongoing.
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P2.03b - Poster Session with Presenters Present (ID 465)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.03b-060 - Baseline Skeletal Muscle Index (SMI) Values Are Associated with Biomarkers of Insulin Resistance in Stage IV Non-Small Cell Lung Cancer (ID 5286)
14:30 - 14:30 | Author(s): M. Batus
- Abstract
Background:
The aim of this project was to correlate pretreatment levels of circulating biomarkers of insulin resistance with computed tomography measured evidence of sarcopenia in stage IV NSCLC patients receiving platinum doublet chemotherapy.
Methods:
Pretreatment serum from 93 patients with frontline stage IV NSCLC was evaluated for 13 metabolism biomarkers with the Bio-Plex Pro Human Diabetes Assay Panel and 20 inflammation-related biomarkers using the Milliplex Human High Sensitivity T Cell Panel. All patients were treated with standard platinum doublet based chemotherapy. All patients had skeletal muscle index (SMI) calculated from baseline CT images using the Slice-O-Matic software package (Tomovision); where SMI = (muscle cross sectional area in cm2) / height in m2. Associations of biomarkers with SMI were assessed using a Spearman’s Rank Correlation Coefficient. The Log-Rank test was performed to evaluate the association of individual biomarkers with overall survival (OS).
Results:
High levels of adiponectin (with low levels of adiponectin being correlating with obesity in the literature) were associated with good OS (p=0.036) and low baseline SMI value specifically for males (p=0.00029). High levels adipsin was associated with favorable OS (p=0.015) and a higher baseline SMI specifically for females (p=0.66 x10-5). Low levels of ghrelin were associated with favorable OS (p=0.005) and were inversely associated with SMI values for both genders (p=0.021).
Conclusion:
Altered values of several biomarkers of insulin resistance were associated with inferior survival and a greater degree of sarcopenia in frontline NSCLC patients receiving platinum double therapy. These findings suggest a certain subset of patients that may have improvements in cancer cachexia by targeting insulin resistance.
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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): M. Batus
- 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.
