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B. Han
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OA19 - Translational Research in Early Stage NSCLC (ID 402)
- Event: WCLC 2016
- Type: Oral Session
- Track: Early Stage NSCLC
- Presentations: 1
- Moderators:G. Heller, G. Goss
- Coordinates: 12/07/2016, 11:00 - 12:30, Schubert 3
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OA19.03 - Identify Lung Adenocarcinoma in Situ among Pulmonary Micro-Nodules through Blood Gene Expression Profiles (ID 4749)
11:20 - 11:30 | Author(s): B. Han
- Abstract
- Presentation
Background:
The national lung cancer screening test (NLST) confirmed: low dose CT screening could reduce lung cancer mortality. However, the high false-positive rates of LDCT screening, especially the difficulty of diagnosis of micro-nodules with size less than 10 mm highlight the need of complementary biomarkers to discriminate micro-nodular lung cancer from benign pulmonary diseases.
Methods:
The blood gene expression profiles of 46 lung cancer patients, 38 pulmonary lesions and 51 healthy were investigated to identify the lung cancer-specific genetic signatures. The lung cancer patients containing micro-nodules less than 10 mm were surgically and pathologically diagnosed as lung adenocarcinoma in situ
Results:
A self-training logistic regression method was used to identify the lung cancer-specific gene signatures as we previously reported. Six genes, including DDX51, PSME2, ACTL6A, GMEB1, FAM200B, GEMIN6, were identified for discriminating lung adenocarcinoma in situ from health and benign pulmonary diseases. The performance of the six-gene panel for diagnosis of lung adenocarcinoma in situ identified was exhibited in Table 1. Through self-training SVM classifier, the logarithmic odds of each sample was calculated and exhibited, in which the cutoff value was set as zero in logarithmic odds for differentiating lung cancer from benign and control group. The predictive model based on 6-gene panel correctly classified 43 of 46 lung cancer, 39 of 42 benign pulmonary diseases with 93% accuracy, 94% sensitivity, and 93% specificity and 0.97 of ROC AUC.
Conclusion:
The predictive model based on 6-gene panel (DDX51, PSME2, ACTL6A, GMEB1, FAM200B, GEMIN6) can be used for discriminating between the malignant or benign nodules with size less than 10 mm
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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-001 - A Randomized Phase III Clinical Trial of Anlotinib Hydrochloride in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) (ID 4722)
14:30 - 14:30 | Author(s): B. Han
- Abstract
Background:
Anlotinib hydrochloride, a novel multi-targeted tyrosine kinase inhibitor (TKI) was found to exhibit excellent inhibitory efficiency on a variety of receptor tyrosine kinases (RTK) involved in tumor progression, especially the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR) and stem cell-factor receptor (c-Kit). This ongoing trial aimed at evaluating the efficacy and safety of anlotinib hydrochloride comparing with placebo in advanced NSCLC patients who had received at least two previous chemotherapy and EGFR/ALK targeted therapy regimens.
Methods:
This Phase III, randomized, double-blind, placebo-controlled study (NCT 02388919) is ongoing in 31 centers in China under the supervision of Independent Data Monitoring Committee (IDMC). Pathological stage IIIB/IV adult advanced NSCLC patients (Pts) who had failed with at least two previous chemotherapy and EGFR/ALK targeted therapy regimens were eligible. The status of EGFR and ALK genes should be clear in all enrolled pts. Pts with sensitive EGFR or ALK mutations must had received and appeared intolerance to pervious targeted therapies. Pts were randomized (2:1) to receive Anlotinib hydrochloride or placebo once daily (12 mg) from day 1 to 14 of a 21-day cycle until progression. Dose reduction to 8 or 10 mg/day could be applied when grade 3 or 4 treatment-related toxicities were observed. The minimal sample size was estimated to 450 patients. The primary endpoint is overall survival (OS) and second endpoints are progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR) and quality of life (QoL). Quality of life was assessed via EORTC QLQ-C30, safety is determined using standard NCI-CTCAE v4.02, and responses are evaluated according to RECIST v1.1.
Results:
This study started in February 2015, up to early July 2016, a total of 420 pts have been enrolled (93.3 % of 450 pts). Among enrolled pts, about 80 % were diagnosed as adenocarcinoma, EGFR mutation or ALK rearrangement was found in 1/3 of the pts. The overall analyses will start after 300 OS events.
Conclusion:
Anti-angiogenesis is the main mechanism of Anlotinib hydrochloride for preventing the tumor progression. Results of randomized, placebo-controlled Phase II trial (NCT01924195) has been reported in WCLC 2015, however, advantages in PFS (4.8 vs. 1.2 months) and OS (9.3 vs. 6.3 months) were observed in Anlotinib arm from the renewed data. Based on these exciting data, we are looking forward for the results of the Phase III trial
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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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P2.06-020 - A Open-Label Randomised Controlled Trial of First-Line Genexol-PM/ CrEL-Based Paclitaxel plus Cisplatin in Advanced NSCLC Patients (ID 4569)
14:30 - 14:30 | Author(s): B. Han
- Abstract
Background:
Genexol-PM is a novel Cremophor EL(CrEL)-free polymeric micelle formation of paclitaxel.This multicentre study was designed to compare Genexol-PM and CrEL-based paclitaxel in combination with cisplatin in terms of efficacy and safety as first-line therapy in advanced non-small cell lung cancer.
Methods:
Chemonaive patients aged from 18 to 70 years with histologically or cytologically confirmed, locally advanced, metastatic or recurrent advanced NSCLC and an ECOG performance status of 0–1 were randomised 2:1 to the treatment group (Genexol-PM+ cisplatin ) and the controll group (paclitaxel+cisplatin) .Patients were treated with Genexol-PM 230mg/m2 intravenously without premedication or paclitaxel 175mg/m2 intravenously with premedication plus cisplatin 70mg/m2 on day 1 of a 3-week cycle for up to six cycles. Intrapatient dose escalation of Genexol-PM to 300mg/m2 was carried out in treatment group from the second cycle if the prespecified toxic effects were not observed after the first cycle.
Results:
170 patients were randomised into the study. PFS and OS data are not yet mature.
Conclusion:
This multicentre study is in progress.
