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M. Tiseo
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P1.08 - Poster Session/ Thymoma, Mesothelioma and Other Thoracic Malignancies (ID 224)
- Event: WCLC 2015
- Type: Poster
- Track: Thymoma, Mesothelioma and Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P1.08-017 - microRNAs Expression in Malignant Pleural Mesothelioma, Asbestosis and Benign Pulmonary Disease (ID 2663)
09:30 - 09:30 | Author(s): M. Tiseo
- Abstract
Background:
To evaluate the diagnostic potential of a panel of microRNAs in plasma samples of patients with malignant pleural mesothelioma (MPM).
Methods:
A group of patients with pathological diagnosis of MPM were randomly selected from a prospective mesothelioma database. Similarly, a group of patients with asbestosis and one with benign pulmonary disease, were chosen for comparison. A panel of miRNA including miR-16, miR-17, miR-21, miR-126 and miR-486 were evaluated. VEGF (vascular endothelial growth factor) was evaluated in plasma samples of patients with mesothelioma. Analysis of covariance (ANCOVA) followed by Bonferroni post-hoc test were used for multiple comparisons. P<0.05 was considered significant.
Results:
14 patients with malignant pleural mesothelioma, 14 patients with asbestosis and 21 patients with benign pulmonary disease were studied. The expression of miR-16 (p=0.018), miR-17 (p=0.024) and miR-126 (p=0.019) was significantly lower in patients with MPM compared with patients with benign pulmonary disease. Interestingly, miR-486 was able to discriminate patients with MPM compared to patients with asbestosis (p=0.004). Considering patients with MPM, miR-17 (p=0.023) and miR-486 (p=0.015) were significantly more expressed in patients with epithelial type than in patients with sarcomatoid and biphasic type. Moreover, the expression of miR-16 (p<0.0001), miR-17 (p<0.0001), miR-21 (p=0.004), miR-126 (p=0.0016) and miR-486 (p=0.003) was significantly lower in patients with asbestosis compared with subjects with benign pulmonary disease. In MPM plasma samples, VEGF expression was negatively correlated to miR-126 (p=0.004).
Conclusion:
The expression of miR-16, miR-17 and miR-126 was able to distinguish patients with MPM compared with patients with benign pulmonary diseases. miR-17 and miR-486 were significantly higher in patients with epithelial mesothelioma. An immunohistochemistry analysis evaluating the expression of VEGF in MPM tissue samples is ongoing. The available data support the role of miRNAs in the aetiology of MPM, suggesting their possible use as diagnostic markers of the disease.
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P3.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 208)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.01-082 - Multicenter Randomized Trial Comparing Erlotinib vs. Gemcitabine or Vinorelbine as Third-Line in Advanced EGFR-Wild-Type or Unknown NSCLC (ID 651)
09:30 - 09:30 | Author(s): M. Tiseo
- Abstract
Background:
In clinical practice, approximately one third of patients with advanced non-small cell lung cancer (NSCLC) is candidate at third-line treatment. Currently, only erlotinib is licensed with this indication. Recent studies (TAILOR and DELTA trials) have questioned the role of erlotinib in second-line therapy of patients with advanced EGFR wild-type NSCLC, suggesting an inferiority in survival compared to chemotherapy with docetaxel. For this reason, the use of erlotinib is gradually shifting to the third-line. However, in this setting, chemotherapy drugs, such as gemcitabine or vinorelbine, could achieve similar survival results, with limited toxicity and lower costs than erlotinib. Therefore, the objective of this study is to evaluate the efficacy of chemotherapy (gemcitabine or vinorelbine) vs. erlotinib in the treatment of patients with advanced EGFR wild-type or unknown NSCLC progressing after two lines of chemotherapy in terms of overall survival (primary end-point). The treatments will be also compared in terms of activity, quality of life, toxicity and costs (secondary end-points).
Methods:
538 patients will be enrolled from 40 clinical Italian centers and assigned by randomization to one of 2 treatment arms (chemotherapy vs. erlotinib) with a ratio of 1:1. As stratification factors will be considered: the center, histology (squamous vs. non-squamous), EGFR (wild type vs. unknown) and PS (0-1 vs. 2). Patients will be randomized to receive treatment with erlotinib 150 mg/day (control arm) or chemotherapy with gemcitabine 1000 mg/m[2] or vinorelbine 25 mg/m[2] on days 1, 8 every 21 days (experimental arm), according to investigator choice and previous treatment received. Treatments will be administered until disease progression, patient refusal, unacceptable toxicity, patient clinical deterioration or investigator decision. It was estimated that with 440 deaths from any cause the study would have 85% power to detect a hazard ratio of 0.75 at a two-sided significance level of 5%. If the superiority comparison will fail to detect a significant difference between treatments, the non-inferiority of the chemotherapy arm will be tested with a power equal to 65% against a prospectively defined margin for non-inferiority of the HR equal to 1.25.
Results:
not applicable
Conclusion:
If this study should be positive, it will follow a change in clinical practice with an improvement in life expectancy of patients with advanced NSCLC and savings in terms of economic resources for the NHS. This study (CONFERMER trial) is supported by NHS, Regione Emila Romagna. As to 14 April 2015, 44 patients were randomized.
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-114 - IASLC and WHO 2004 Grading System as Prognostic Factors in 492 Cases of Pulmonary Adenocarcinoma (ID 2647)
09:30 - 09:30 | Author(s): M. Tiseo
- Abstract
Background:
Primary aim of the study was to evaluate the prognostic value of the IASLC grading system and the WHO 2004 classification on a consecutive series of resected primary pulmonary adenocarcinomas. Secondary aim was to identify new prognostic histological features.
Methods:
All consecutive patients undergoing radical resection with a pathological diagnosis of primary lung adenocarcinoma were considered. All histological slides were reviewed for the study. Tumor-specific survival was considered as primary outcome. Statistical analysis included Kaplan-Meyer analysis and Cox regression to identify variables with significant Hazard Ratios (HR).
Results:
492 patients were considered between January 2002 and December 2013. 67.7% were male, mean age was 67.4 years, mean follow-up was 55 months. In a first multivariate Cox Regression Model the WHO 2004 grading was considered; gender [males vs females HR=1.7 95% CI (1.2-2.3), p=0.002], stage (p-trend <0.001), lymphoplasmacellular infiltrate [yes vs no HR=0.5 95% CI (0.3-0.8), p=0.001], and WHO 2004 grade (p-trend = 0.002) were independent prognostic factors of survival. In a second model the IASLC grading was considered; gender [HR=1.7 95% CI (1.2-2.4), p=0.002], stage (p-trend<0.001), lymphoplasmacellular infiltrate [HR=0.5 95% CI (0.3-0.8), p=0.001], and combined grading score according to Sica (p-trend=0.011) were maintained as independent prognostic factors.
Conclusion:
Tumor grading was an independent prognostic factor of survival in patients with adenocarcinoma undergoing lung resection both considering IASLC and WHO 2004 classifications. Lymphoplasmacellular infiltrate was significantly and favorably related to survival.
