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R. Zhong
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Poster Display Session (ID 63)
- Event: ELCC 2017
- Type: Poster Display Session
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 5/07/2017, 12:30 - 13:00, Hall 1
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116P - A randomized study to evaluate safety of DCVAC/LUCA added to chemotherapy with carboplatin and pemetrexed vs. chemotherapy alone in patients with stage IV non-small cell lung cancer (ID 239)
12:30 - 13:00 | Author(s): R. Zhong
- Abstract
Background:
DCVAC/LuCa is an active autologous cellular immunotherapy consisting of autologous dendritic cells (DCs) loaded with NSCLC antigens (whole tumor cell antigens of tumor cell lines, like Her2/neu, MAGE-A3 and Survivin, et al.). DCVAC has the ability to induce an immune response, including cytotoxic CD8+ T cells, against tumor-associated antigens expressed by patients’ cancer cells. However, advanced-stage NSCLC with a heavy tumor burden establishes a harsh landscape for immunotherapy due to immune tolerance towards tumor antigens. Combination of DC treatment and chemotherapy is anticipated to achieve stronger immune responses than either of the treatments alone. AEs were collected in this study to evaluate the safety of DCVAC/LuCa added to chemotherapy with pemetrexed and carboplatin vs. chemotherapy alone in patients with stage IV non-small cell lung cancer.
Methods:
This is a randomized, open-label study. A total of 20 newly diagnosed stage IV, non-squamous, wild-type EGFR, ALK-negative or unknown NSCLC patients treated between January 2016- December 2016 in Shanghai Chest Hospital were enrolled.10 patients were randomized to group A: DCVAC/LuCa + chemotherapy (4-6 cycles of pemetrexed/carboplatin followed by pemetrexed as maintenance therapy); 10 patients were randomized to group B: 4-6 cycles of pemetrexed/carboplatin followed by pemetrexed as maintenance therapy.Patients in the group A started with DCVAC/LuCa (5 × 106 DCs/aliquots) treatment on Day 15 (+/- 3 days) of chemotherapy Cycle 3.The initial 5 doses of DCVAC/LCa were administered at a 3-week interval. The DCVAC/LuCa was then injected every 6 weeks up to the maximum number of 15 doses (75 × 106 DCs/15 aliquots). AEs were collected and analyzed.
Results:
The common adverse events in both group were chemotherapy related leukopenia, hemoglobin decrease etc. All AEs were grade 1 or 2 according to CTCAE V4.03, and there were no grade 4 toxicities or treatment-related deaths. One patient in group A got non-infectious fever and returned to normal without treatment.
Conclusions:
In patients with stage IV NSCLC, DCVAC/LuCa therapy was well tolerated with the favorable safety profile.
Clinical trial identification:
Legal entity responsible for the study:
Shanghai Chest Hospital
Funding:
Sotio Medical Research (Beijing) Co., Ltd
Disclosure:
All authors have declared no conflicts of interest.
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128P - Serum DKK-1 as a clinical and prognostic factor in non-small cell lung cancer patients with bone metastases (ID 192)
12:30 - 13:00 | Author(s): R. Zhong
- Abstract
Background:
The Wnt/β-catenin pathway plays a crucial role in tumor pathogenesis, specifically in cell proliferation, angiogenesis, motility and invasiveness. The activity of Wnt family ligands is antagonized by several secreted factors including Dickkopf (DKK). A member of the Dickkopf family, DKK-1, is a 35 kDa secreted protein that is a potent inhibitor of Wnt/β-catenin signaling. The study was designed to evaluate the association between serum Dickkopf-1(DKK-1) and non- small cell lung cancer(NSCLC) bone metastases.
Methods:
Serum DKK-1and CEA levels were quantified in 318 NSCLC patients, 140 with osseous metastases and 178 with extraosseous metastases. We used receiver operating characteristics (ROC) to evaluate the predictive qualities of these parameters for bone metastases.
Results:
Serum DKK-1 levels were significantly higher in patients with osseous metastases compared with patients with extraosseous metastases (P < 0.001). ROC curves showed that the optimum cutoff was 311.8 ng/ml (area under curve [AUC] 0.791, 95% confidence interval [CI] 0.739–0.843, sensitivity 77.1% and specificity 71.4%). ROC analysis also showed that testing both DKK-1 and CEA increased the detection accuracy for NSCLC bone metastases compared with CEA alone (AUC 0.797, 95% CI 0.746–0.848, sensitivity 82.9% and specificity 68.9%; DKK-1 plus CEA vs. DKK-1 alone P = 0.370; DKK-1 plus CEA vs. CEA alone P = 0.0001). Thus, serum DKK-1 correlated with the number of bone lesions (P = 0.042). In osseous metastases group, Kaplan–Meier analysis showed that patients with high serum DKK-1 levels had poorer overall survival than patients with low serum DKK-1 levels (P = 0.025), and multivariable analyses showed serum DKK-1 to be an independent prognostic factor for overall survival (P = 0.029).
Conclusions:
Our data shows that serum DKK-1 levels are increased in NSCLC patients with bone metastases. More importantly this is the first report to show that high serum DKK-1 levels are associated with the extent of bone metastases and poor survival in NSCLC patients with bone metastases.
Clinical trial identification:
Legal entity responsible for the study:
Shanghai Chest Hospital
Funding:
The Science and Technology Development Fund of Shanghai Chest Hospital (Grant No. 2014YZDC10101)
Disclosure:
All authors have declared no conflicts of interest.
