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O.T. Brustugun
Moderator of
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OA23 - EGFR Targeted Therapies in Advanced NSCLC (ID 410)
- Event: WCLC 2016
- Type: Oral Session
- Track: Advanced NSCLC
- Presentations: 8
- Moderators:O.T. Brustugun, S. Lu
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 2
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OA23.01 - Anti-EGFR Monoclonal Antibodies plus Chemotherapy in the First-Line Treatment of Advanced NSCLC: A Meta-Analysis (ID 4135)
14:20 - 15:50 | Author(s): G. Stock, P. Aguiar Jr, I. Santoro, H. Tadokoro, R. De Mello, G. Lopes
- Abstract
- Presentation
Background:
Monoclonal Antibodies (mAbs) against the Epidermal Growth Factor Receptor (EGFR) in association with platinum-based doublet chemotherapy have emerged as a potential first-line treatment option for advanced non-small cell lung cancer (NSCLC). This study was conducted to systematically review available data and evaluate the efficacy and toxicity of anti-EGFR mAbs plus chemotherapy vs chemotherapy alone for advanced NSCLC.
Methods:
We carried out a search on network databases and oncology conference abstracts for studies between 1990 and January 2016. Only prospective randomized clinical trials were included. Primary endpoints were overall survival (OS) and toxicity frequency. Secondary endpoints were progression-free survival (PFS) and overall response rate (ORR). Subgroup analysis was performed assessing histological subtypes, EGFR protein expression by immunohistochemistry (IHC), EGFR gene copy number by fluorescence in-situ hybridization (FISH), EGFR mutation status, and smoking status.
Results:
Seven studies (2 with necitumumab and 5 with cetuximab) were included with 5,057 patients. Compared to chemotherapy alone, significant benefits were demonstrated by the addition of anti-EGFR mAb to chemotherapy in OS (HR 0.90; 95%CI 0.84-0.95), PFS (HR 0.93; 95%CI 0.87-0.98), and ORR (OR 1.27; 95%CI 1.06-1.51). In subgroup analyses, the association of anti-EGFR mAb was associated with improved OS among patients with squamous histology (HR 0.84; 95%CI 0.76-0.92), tumours with high EGFR expression by IHC (HR 0.83; 95%CI 0.70-0.98), and smokers (HR 0.87; 95%CI 0.79-0.96). Patients with squamous histology and high EGFR expression by IHC achieved the highest benefit with the association (HR 0.71; 95%CI 0.59-0.86). The OS with the association also seemed to be higher in EGFR FISH negative and in EGFR wild-type tumours, but without statistical significance. Chemotherapy plus anti-EGFR mAb caused more grade 3 or worse adverse events (OR 1.73; 95%CI 1.50-2.00), remarkedly these known to be associated with anti-EGFR therapy, such as acne-like rash (OR 34.13; 95%CI 16.40-71.00) and hypomagnesemia (OR 6.23; 95%CI 3.04-12.77).
Conclusion:
Anti-EGFR therapy plus platinum-based doublet chemotherapy as first-line treatment demonstrated significant efficacy benefits with acceptable toxicity for advanced NSCLC. This benefit is more expressive among squamous histology with high EGFR expression. EGFR protein expression by IHC seems to be a predictive marker for survival in the association group. Further research is needed to corroborate these findings.
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OA23.02 - Efficacy and Safety of Necitumumab Continuation Monotherapy in Patients with EGFR-Expressing Tumors in SQUIRE, a Phase 3 Study (ID 4283)
14:20 - 15:50 | Author(s): T.E. Ciuleanu, M.A. Socinski, C.K. Obasaju, A.V. Luft, A. Szczęsna, R. Ramlau, B. Bálint, O. Molinier, H. Depenbrock, S. Nanda, L. Paz-Arez, N. Thatcher, P. Bonomi
- Abstract
- Presentation
Background:
SQUIRE (NCT00981058) demonstrated adding necitumumab (N) to gemcitabine/cisplatin (GC) improved survival in patients with Stage IV squamous NSCLC (SQ-NSCLC). Retrospective analysis revealed consistent treatment effect in favor of patients receiving N monotherapy as continuation after chemotherapy (CT) (GC+N continuation patients) versus continuation therapy-eligible GC arm patients (GC non-progressors). In the EU, N is approved for patients with EGFR-expressing tumors. We repeated the analysis in this patient population.
Methods:
Patients with Stage IV SQ-NSCLC were randomized 1:1 for ≤6 cycles of G (1250 mg/m[2] iv, Days [d] 1,8) and C (75 mg/m[2] iv, d1) either with or without N (800 mg iv, d1,8). Patients in GC+N without progression continued N until progressive disease (PD). SQUIRE included mandatory tissue collection. EGFR protein expression was assessed by IHC in a central lab (Dako EGFR PharmDx kit). Analyses were done in EGFR-expressing patients (EGFR >0). Patients who received ≥4 cycles of CT without PD were included. Overall survival (OS) and progression-free survival (PFS) were calculated by Kaplan-Meier method. 95% CIs and hazard ratios estimated using stratified Cox proportional hazards model.
Results:
Of 1093 patients (ITT population), 982 patients (89.8%) had evaluable IHC assay results; 935/982 (95.2%) had EGFR>0. GC+N arm continuation therapy patients included 228 patients with EGFR>0 and 194 patients (EGFR>0) were GC arm non-progressors. Baseline characteristics were similar except gender (Males: 81% in GC+N vs 91% in GC arm). CT exposure was balanced. Median OS from randomization in GC+N vs GC was 16.1 vs 14.9 months; HR 0.76 (95% CI, 0.61, 0.95). Median PFS in GC+N vs GC was 7.4 vs 6.9 months; HR 0.81 (95% CI, 0.66, 1.00). Figure 1
Conclusion:
In patients with EGFR-expressing tumors, a consistent treatment effect in favor of GC+N continuation maintenance compared to GC non-progressors was observed, similar to ITT population with no unexpected increases in AEs.
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OA23.03 - Second-Line Afatinib for Advanced Squamous Cell Carcinoma of the Lung: Analysis of Afatinib Long-Term Responders in the Phase III LUX-Lung 8 Trial (ID 4711)
14:20 - 15:50 | Author(s): G. Goss, M. Cobo, S. Lu, K. Syrigos, A. Morabito, I. Albert, G. Herodek, S. Chan, G. Ostoros, V. Sarosi, Z. Kiraly, D. Savior, R. Barton, F. Medina, S. Subramanian, A. Ardizzoni, E. Felip, S.M. Gadgeel, V. Georgoulias, J. Love, C. Bühnemann, N. Gibson, E. Ehrnrooth, J. Soria, N. Dupuis
- Abstract
- Presentation
Background:
Squamous cell carcinoma (SCC) of the lung is a genetically complex and difficult-to-treat cancer. In LUX-Lung 8, afatinib (40mg/day) significantly improved OS (median 7.9 vs 6.8 months, HR=0.81 [95% CI, 0.69‒0.95], p=0.008), PFS (2.6 vs 1.9 months, HR=0.81 [0.69‒0.96], p=0.010) and DCR versus erlotinib (150mg/day) in patients with relapsed/refractory SCC of the lung (n=795). Notably, 12-month (36 vs 28%; p=0.016) and 18-month survival (22 vs 14%; p=0.016) was significantly higher with afatinib than erlotinib, indicating that some patients derive prolonged benefit from afatinib. Here, we present post-hoc analysis of baseline characteristics and efficacy/safety of afatinib in long-term responders (treatment for ≥12 months). Hypothesis-generating analysis of archived tumor samples and blood serum was undertaken to identify possible molecular/clinical biomarkers.
Methods:
Tumor samples were retrospectively analyzed using FoundationOne[TM] next-generation sequencing (NGS); EGFR expression was determined by immunohistochemistry. Pre-treatment serum samples were analyzed with VeriStrat[®], a MALDI-TOF mass spectrometry test, and classified as VeriStrat-Good or VeriStrat-Poor-risk.
Results:
15/398 patients treated with afatinib were long-term responders. Median duration of treatment was 16.6 months (range: 12.3‒25.8). Patient characteristics were similar to the overall dataset (median age: 65 years [range: 54‒81]; male: 80.0%; Asian: 13.3%; ECOG 0/1: 40.0%/60.0%; best response to chemotherapy CR or PR/SD: 53.3%/46.7%; current and ex-smokers: 80.0%). Median PFS was 16.2 months (range: 2.8‒24.0); median OS was 23.1 months (range: 12.9‒31.5). The most common treatment-related AEs (all grade/grade 3) were: diarrhea (73.3%/6.7%); rash/acne (66.7%/6.7%); stomatitis (13%/7%). AEs generally occurred soon after treatment onset (median onset, days [range]: diarrhea 11 [5‒48]; rash/acne 17 [9‒107]; stomatitis 15 [11‒19]). Four patients required a dose reduction to 30mg/day due to treatment-related AEs (diarrhea, rash, stomatitis, diarrhea/rash). NGS was undertaken in 9 patients and details will be presented at the meeting. Genomic aberrations in the ErbB/FGF gene families were identified in 44.4%/55.6% of long-term responders (overall dataset: 29.4%/58.0%). Of 14 patients assessed by VeriStrat, 85.7% were VeriStrat-Good (overall dataset: 61.6%). Immunohistochemistry data was available for two patients; one overexpressed EGFR (≥10% positive cells; H-score ≥200)
Conclusion:
Baseline characteristics of long-term responders to afatinib were similar to the overall dataset. In this sub-group, afatinib conferred a survival benefit of nearly 2 years. Afatinib was well tolerated with predictable and transient AEs that occurred soon after treatment onset. The dataset was too small to identify any clear NGS/VeriStrat predictive signals. Further studies are required to predict long-term response to afatinib.
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OA23.04 - Discussant for OA23.01, OA23.02, OA23.03 (ID 6966)
14:20 - 15:50 | Author(s): M. Sebastian
- Abstract
- Presentation
Abstract not provided
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OA23.05 - First-Line Afatinib versus Gefitinib in EGFRm+ Advanced NSCLC: Updated Overall Survival Analysis of LUX-Lung 7 (ID 5347)
14:20 - 15:50 | Author(s): K. Park, E.H. Tan, L. Zhang, V. Hirsh, K. O’byrne, M. Boyer, J.C. Yang, T. Mok, K.H. Lee, S. Lu, Y. Shi, S. Kim, J. Laskin, D. Kim, S.A. Laurie, K. Kölbeck, J. Fan, N. Dodd, A. Märten, L. Paz-Arez
- Abstract
- Presentation
Background:
The irreversible ErbB family blocker afatinib and the reversible EGFR TKI gefitinib are approved for first-line treatment of advanced EGFRm+ NSCLC. This Phase IIb trial prospectively compared afatinib versus gefitinib in this setting.
Methods:
LUX-Lung 7 assessed afatinib (40 mg/day) versus gefitinib (250 mg/day) in treatment-naïve patients with stage IIIb/IV NSCLC harbouring a common EGFR mutation (Del19/L858R). Co-primary endpoints were PFS (independent review), time to treatment failure (TTF) and OS. Other endpoints included ORR and AEs. In case of grade ≥3/selected grade 2 drug-related AEs the afatinib dose could be reduced to 30 mg or 20 mg (minimum). The primary analysis of PFS/TTF was undertaken after ~250 PFS events. The primary OS analysis was planned after ~213 OS events and a follow-up period of ≥32 months.
Results:
319 patients were randomised (afatinib: 160; gefitinib: 159). At the time of primary analysis, PFS (HR [95% CI] 0.73 [0.57‒0.95], p=0.017), TTF (0.73 [0.58‒0.92], p=0.007) and ORR (70 vs 56%, p=0.008) were significantly improved with afatinib versus gefitinib. The most common grade ≥3 AEs were diarrhoea (13%) and rash/acne (9%) with afatinib and elevated ALT/AST (9%) with gefitinib. 42% of patients treated with afatinib had ≥1 dose reduction due to AEs; dose reductions were more common in females than males (77%/23%) and non-Asians than Asians (64%/36%). Dose reduction of afatinib did not negatively impact PFS (<40mg vs ≥40mg; HR [95% CI]: 1.34 [0.90‒2.00]) but reduced incidence and severity of drug-related grade ≥3 AEs. Treatment discontinuation due to drug-related AEs was the same in each arm (6%). The data cut-off for primary OS analysis occurred on 8 April 2016. At this time, median treatment duration (range) was 13.7 (0‒46.4) versus 11.5 (0.5‒48.7) months with afatinib and gefitinib. 25% (afatinib) and 13% (gefitinib) of patients received treatment for >24 months. 73% and 77% of patients in the afatinib and gefitinib arms had ≥1 subsequent systemic anti-cancer treatment, with 46% and 56% receiving a subsequent EGFR-TKI including osimertinib (14%)/olmutinib (14%). OS data, including subgroup analysis with respect to subsequent therapy will be presented at the meeting.
Conclusion:
Afatinib significantly improved PFS, TTF and ORR versus gefitinib in EGFRm+ NSCLC patients, with a manageable AE profile and few drug-related discontinuations. Dose adjustment of afatinib reduced drug-related AEs without compromising efficacy. Primary OS analysis will be reported.
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OA23.06 - Overall Survival (OS) of EGFR Mutation Positive Non-Small Cell Lung Cancer Patients: Real-World Treatment Patterns of 1,660 Japanese Patients (ID 5915)
14:20 - 15:50 | Author(s): K. Yoshida, Y. Ohe, A. Inoue, T. Kumagai, M. Takeda, N. Yamamoto, T. Seto, I. Okamoto, N. Tashiro, S. Morita, M. Fukuoka
- Abstract
- Presentation
Background:
Since the epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) was launched in Japan, the survival periods of advanced/recurrent EGFR mutation positive (EGFR m+) non-small cell lung cancer (NSCLC) patients have been getting longer. However, clinical factors which contributed to the extension of survival periods of these patients remain unclear. We investigated overall survival, prognostic factors and treatments patterns of EGFR m+ NSCLC patients in real-world clinical practice.
Methods:
This is a multi-center, observational, retrospective study. Histologically or cytologically diagnosed EGFR m+ NSCLC patients who were started first-line treatment from 1/1/2008 to 31/12/2012 were enrolled. The primary objective was the estimated OS. The secondary objectives were to determine prognostic factors, real-world treatment patterns.
Results:
1,660 EGFR m+ NSCLC patients were enrolled from 17 hospitals in Japan (median age 67.0 years, female 64.8%, 38.9% had smoking history, ECOG-performance status 0, 1, 2, 3, 4 were 39.5%, 41.1%, 7.1%, 4.9%, 0.7%, respectively, adenocarcinoma 95.2%, 50.1% exon 19 deletion, 66.7% at stage IV). Median estimated OS was 29.7 months. Cox regression analysis revealed age, smoking history, performance status, histological diagnosis, EGFR mutation type and clinical stage were independently associated with OS. Five year survival rate of stage IV patients was 13.8%. The median number of treatment regimens was two. EGFR-TKI and platinum-doublet chemotherapy were most frequently used as first- and second-line treatments.
Conclusion:
Real world treatment of the large data-set of 1,660 EGFR m+ NSCLC patients was retrospectively investigated. Median OS was 29.7 months and EGFR-TKIs are major components of the treatment regimens for these patients in Japan. (NCT0247520)
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OA23.07 - Analysis of Outcomes in US IRESSA Clinical Access Program (ICAP) Patients on Gefitinib for More Than 10 Years (ID 3731)
14:20 - 15:50 | Author(s): F.R. Hirsch, L.V. Sequist, I. Gore, M. Campo, G.R. Simon, E.F. Croft, D. Devincenzo, J. Munley, D. Stein, K. Freivogel, F. Sifakis, P.A. Bunn, Jr.
- Abstract
- Presentation
Background:
In 2011, following gefitinib (IRESSA[®]) NDA voluntary withdrawal, US patients benefiting from gefitinib were eligible to continue gefitinib through the IRESSA Clinical Access Program (ICAP), an IRB-approved protocol. A subset of ICAP investigators subsequently collected additional retrospective data on their ICAP patients through another IRB-approved project (“chart-review subset”).
Methods:
For all enrolled ICAP patients, demographic and serious adverse event (SAE) reports were reviewed. All ICAP investigators were invited to participate in chart review; 47 accepted and collected data on patient/tumor characteristics and safety/tolerability of prolonged gefitinib therapy among their 79 ICAP patients.
Results:
Across 137 US sites, 191 patients enrolled in ICAP. As of September 2016, 75 (39%) remain on gefitinib; discontinuations were due to progression (36%), death (34%), AEs (13%), or other (17%). Sixty-four (34%) patients reported 162 SAEs; 5 (2.6%) patients had 12 SAEs considered to be gefitinib-related by investigators. The chart-review subset included 79 (41%) patients with median age of 69 years at ICAP enrollment, who were predominantly female (70%) and white (84%); 95% had a confirmed NSCLC diagnosis. Due to the evolving understanding of genetic mutations in NSCLC at the time of gefitinib initiation, the majority of patients (79%) never had EGFR sequencing performed. Although tissue is not available for EGFR status confirmation, we assume these patients are nearly exclusively EGFR mutation-positive. Median total length of gefitinib was 11.1 years (6.5-15.1; Table). Long-term gefitinib was well-tolerated; 5% discontinued due to a gefitinib-related AE. Ten-year survival rate from first-ever initiation of gefitinib was 86% and 15-year was 59%. Table. Gefitinib treatment patterns and tolerability among ICAP chart-review patients.Parameter n, % Observed Population (N=79) Total time on gefitinib, prior to and during ICAP Median duration, y, range 11.1 (6.5-15.1) Prior to ICAP Median duration, y, range 7.8 (5.4-10.9) Starting dose 250 mg/day 67 (84.8) No dose changes due to AEs 75 (94.9) During ICAP Median duration, y, range 3.5 (0.04-4.7) Dose: 250 mg/day 76 (96.2) Treatment-related AEs Grade 1-2 Grade ≥3 Grade unknown 13 (16.5) 1 (1.3) 2 (2.5) Dose reductions due to treatment-related AEs 1 (1.3) Discontinuations due to treatment-related AEs 4 (5.1) Discontinuations due to progressive disease 11 (28.9)
Conclusion:
The majority of this subset of patients who participated in ICAP based on long-term clinical benefit from gefitinib continue to do well with gefitinib, demonstrating good tolerance of therapy and survival for a median duration of more than 10 years.
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OA23.08 - Discussant for OA23.05, OA23.06, OA23.07 (ID 7104)
14:20 - 15:50 | Author(s): M.L. Johnson
- Abstract
- Presentation
Abstract not provided
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Author of
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OA24 - Radiotherapy of Lung Cancer: Recent Developments (ID 411)
- Event: WCLC 2016
- Type: Oral Session
- Track: Radiotherapy
- Presentations: 1
- Moderators:K. Dieckmann, S. Rieken
- Coordinates: 12/07/2016, 14:20 - 15:50, Stolz 1
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OA24.05 - The Nordic HILUS-Trial - First Report of a Phase II Trial of SBRT of Centrally Located Lung Tumors (ID 6140)
14:20 - 15:50 | Author(s): O.T. Brustugun
- Abstract
- Presentation
Background:
Early attempts of stereotactic body radiation therapy (SBRT) of centrally located lung tumors resulted in high toxicity, questioning the utility of the method in this situation. Since then, different risk adapted fractionation schedules with acceptable toxic effects have been reported from various institutions. However, consensus on the tolerability of centrally located structures to high-fraction doses is still lacking and the clinical toxic effects in relation to dose to organs at risk (OAR) need to be evaluated.
Methods:
We here report a first toxicity analysis of the HILUS-trial – a prospective Nordic multicenter non-randomized phase II trial of SBRT to centrally located lung tumors. Patients with a centrally located tumor (defined as ≤1cm from the proximal bronchial tree) from either a primary non-small cell lung cancer (NSCLC) or a progressive metastasis from another solid tumor were eligible for the trial. Maximum tumor diameter was 5 cm. Patients receiving concomitant systemic anticancer therapy or with tumors reaching through the wall of a main bronchus were not eligible. All the patients were treated with 7Gyx8 and stratified to either arm A (=tumors close to a main bronchus) or arm B (=tumors close to a lobar bronchus). The aim was to include 30 patients in each arm. Follow-up was conducted every 3[rd] month during the first 2 years and thereafter every 6[th] month. The trial was approved by ethical committees in each country.
Results:
Seventy-four patients (42 in arm A and 31 in arm B) were included between 2011 and 2016. Sixty-five patients experienced side effects from the study treatment; the most common being grade 1-2 dyspnea, grade 1-2 cough and grade 1-2 fatigue. Twenty-one patients (28%) experienced grade 3-5 side effects (atrioventricular block, bleeding, dyspnea, empyema, fatigue, fever, fistula, lung infection, pain, pneumonitis, pneumothorax and ventricular arrhythmia). Seven patients (6 in group A and 1 in group B) may have suffered grade 5 side effects; six patients experienced lethal hemoptysis after a median of 15.5 months (2.5-21months) and one patient suffered from a lethal pneumonitis 5 months post study treatment. Grade 4-5 side effects occurred more frequently in group A than in group B (19% vs 3%). Further analyses of risk factors for serious toxicity in relation to dose-volume parameters and patient- and tumor characteristics will be presented.
Conclusion:
SBRT of centrally located tumors may be afflicted with high risk of serious toxicity and further evaluation of clinical and dose-volume dependent risk factors are highly warranted.
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P2.01 - Poster Session with Presenters Present (ID 461)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Biology/Pathology
- Presentations: 1
- Moderators:
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
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P2.01-002 - Serum Protein Signature in Lung Cancer Patients and in Patients with Chronic Obstructive Pulmonary Disease (ID 4153)
14:30 - 15:45 | Author(s): O.T. Brustugun
- Abstract
Background:
Chronic inflammation plays an important role in lung carcinogenesis and in chronic obstructive pulmonary disease (COPD), and is accompanied with alterations in specific serum-proteins. Both COPD and lung cancer are associated with smoking behavior, and 40-70% of lung cancer patients have COPD. The aim of the study is to compare levels of specific serum markers related to inflammation, extracellular matrix remodeling (ECM) and endothelial cell activation in patients with lung cancer and COPD.
Methods:
Blood samples were collected from 208 lung cancer patients with stage I-IIIA disease before surgery in addition to blood samples from 47 COPD patients, stage I-IV (4 patients in stage I, 16 in II, 19 in III and 8 in IV). Six of COPD-patients used oral steroids, 28 used inhaled corticosteroids. Serum levels of various markers were measured by enzyme immunoassays.
Results:
Of 17 proteins (table 1), 9 were significantly elevated in the COPD group compared to lung cancer group including proteins associated with lung cancer in other studies as OPG, PTX3, ePCR, GDF15 and endostatin. Only 3 proteins, CRP, vWF og GDF15 reflecting systemic inflammation and endothelial cell activation, were more abundant in serum from lung cancer patients, and one of these (CRP) significantly so.Table 1. Serum proteins measured in our study.
Protein short name Protein full name OPG Osteoprotegrin ePCR Endothelial cell protein C receptor vWF Von Willebrand factor PTX3 Pentraxin 3 Axl Tyrosine-protein kinase receptor CXCL16 C-X-C motif chemokine ligand 16 DLL1 Delta-like protein 1 Cats Cathepsin S (Chloramphenicol acetyl transferase) GDF15 Growth differentiation factor-15 Endostatin CD147 Cluster of differentiation 147 (Basigin. EMMPRIN) sTNFR1 Tumor necrosis factor receptor 1 CRP C-reactive protein Alcam (CD166) Activated leukocyte cell adhesion molecule PARC p53-associated parkin-like cytoplasmic protein sCD163 Cluster of differentiation 163 Gal3BP Galectin-3-binding protein
Conclusion:
Chronic inflammation plays an important role in both diseases: lung cancer and COPD. However, it seems that inflammation as determined by these selected markers is more pronounced in patients with COPD as most of the biomarkers levels were significantly higher in these patients than lung cancer group.
