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T.W. Jang
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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.01-075 - Phase III, Randomized, Double-Blind Trial of Bavituximab Plus Docetaxel in Previously Treated Stage IIIb/IV Non-Squamous NSCLC (SUNRISE) (ID 1581)
09:30 - 09:30 | Author(s): T.W. Jang
- Abstract
Background:
Exposed phosphatidylserine (PS) in the tumor microenvironment is highly immunosuppressive. PS binding to PS receptors on myeloid derived suppressor cells (MDSC) and M2 macrophages leads to production of anti-inflammatory cytokines such as TGF-β and IL-10. Bavituximab, a first-in-class PS-targeting monoclonal antibody, counters these effects, resulting in production of pro-inflammatory cytokines such as TNF-α and IL-12, maturation of dendritic cells and induction of tumor specific cytotoxic T lymphocyte (CTL) immunity. Docetaxel has also been shown to suppress MDSCs while increasing tumor antigens and T-cell mediated cytotoxicity, thereby enhancing bavituximab’s immunomodulatory effects. In a prior double-blind Phase II trial in 2nd line non-squamous non-small cell lung cancer, bavituximab 3 mg/kg plus docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 month) in median overall survival (OS) compared to control.
Methods:
SUNRISE is a Phase III, double-blind trial where patients with previously treated Stage IIIb/IV non-squamous, non-small cell lung cancer are randomized in a 1:1 ratio to receive up to six 21-day cycles of docetaxel in combination with either weekly 3 mg/kg bavituximab or placebo, followed by maintenance with weekly bavituximab or placebo until progression or toxicity. Patients will be stratified by region (North America, Europe, or Rest of World), disease stage (IIIb or IV), and previous maintenance/targeted therapy (yes or no). This trial was initiated in December 2013 and accrual of 582 patients across 160+ sites in 14 countries is planned over 24 months. The primary endpoint is OS and two interim analyses are planned. Secondary endpoints include progression-free survival (PFS), overall response rate (ORR) and safety. Radiographic tumor response is centrally assessed every two cycles during combination therapy and every nine weeks during maintenance. Exploratory analysis will include the assessment of changes in circulating immune cells and cytokines to better understand the immunotherapeutic mechanism.
Results:
Trial in progress
Conclusion:
Trial in progress
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P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P2.01-020 - Clinical Differences of EGFR Mutations in Exon 19 and 21 in Clinical Course of Non-Small Cell Lung Cancer Patients (ID 1464)
09:30 - 09:30 | Author(s): T.W. Jang
- Abstract
Background:
In patients with non -small cell lung cancer (NSCLC), mutations in the epidermal growth factor receptor (EGFR) have been associated with sensitivity to EGRF-tyrosin kinase inhibitors (TKIs). However, clinical course of EGFR mutation subtypes are still controvertial. The aim of this study was to analyze clinical features between EGFR mutation exon 19 and 21, including treatment with EGFR-TKIs
Methods:
In patients with NSCLC, EGFR exon 19 deletion mutations and EGFR L858R point mutations were analyzed by DNA sequencing method or pyrosequencing method from paraffin blocks of tissue obtained before treatment. We reviewed clinical characteristics of the patients, retrospectively.
Results:
One hundred and sixty seven patients displayed EGFR mutations in exon 19 and exon 21 from October 2002 to December 2013. 63.6% (n=100) had EGFR 19 deletion, whereas 36.3 % (n=67) had an EGFR L858R mutation. There were no differences in sex, smoking, ECOG status, stages, blood chemistry, tumor marker, and overall survivals (OS) between two groups. Overall survival was similar in both groups. However, OS was longer in non-smoker (p=0.000), female (p=0.007), and age ≥ 65 (p=0.031) only in 19 deletion group. After treatment with gefitinib (n=74), erlotinib (n=31), and afatinib (n=2), patients with EGFR mutations had a median overall survival of 47 month. Among the patients treated with gefitinib or erlotinib, gefitinib treated patients had significantly longer progression free survival (PFS) than erlotinib treated patients in EGFR exon 19 deletions (10.3 versus 5.1 months; p=0.002), but not in exon 21 mutation. The median PFS of the patients with higher body surface area (BSA, ≥1.5 m[2]) was worse than that of those with lower BSA (3.9 vs. 8.9 month; p=0.063) in exon 21 mutation group.
Conclusion:
There are different clinical course between types of EGFR exon 19 and 21 mutations. We need confirmation in a prospective study and have to more elucidation of the biological mechanisms of the differences between the two major EGFR mutations.
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P3.06 - Poster Session/ Screening and Early Detection (ID 220)
- Event: WCLC 2015
- Type: Poster
- Track: Screening and Early Detection
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.06-010 - The Performance of a Novel Amino Acid Multivariate Index for Detecting Lung Cancer: A Case Control Study in Korea (ID 755)
09:30 - 09:30 | Author(s): T.W. Jang
- Abstract
Background:
Previous studies have shown that plasma free amino acid (PFAA) profiles are altered in cancer patients compared with healthy controls. A multivariate index based on PFAAs was generated from a Japanese dataset and has been previously demonstrated to be clinically valuable for discriminating patients in the early stages of lung cancer. However, it remains unclear whether similar PFAA profile changes occur in cancer patients from other populations. Therefore, this study aimed to validate the performance of this index in discriminating lung cancer patients from controls in the Korean population.
Methods:
Samples were collected from a total of 142 Korean subjects (72 lung cancer/70 controls) for this study. PFAAs were quantified by high-performance liquid chromatography-electrospray ionization-mass spectrometry, and the clinical performance characteristics of the amino acid multivariate index were evaluated across cancer stages and histological types.
Results:
The concentrations of several PFAAs were significantly decreased in the Korean lung cancer patients compared with the controls. Significant decreases in threonine, citrulline, histidine and tryptophan and increases in proline, isoleucine, phenylalanine and ornithine were observed, which are similar to the PFAA changes reported by a previous Japanese study. The area under the receiver-operator characteristic curve (AUC of the ROC) for the index was 0.80, and similar performances were demonstrated for the different histological types.
Conclusion:
These results suggest that the amino acid multivariate index previously developed from a Japanese dataset has the potential to aid in the early detection of lung cancers of different histological types in Korean patients.
