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P. Ubiali



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    P1.06 - Poster Session with Presenters Present (ID 458)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P1.06-025 - Analysis of Risk Factors for Development of Skeletal-Related Events in Women with Bone Metastases from NSCLC and Breast Cancer (ID 4933)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Bone metastasis (BM) are common (up to 50% of cases) in patients with advanced non-small cell lung cancer (NSCLC) and other malignancies, including prostate cancer and breast cancer (BC). In patients with BMs, the onset of skeletal-related events (SREs), such as pathological fracture, malignant hypercalcemia, or spinal cord compression requiring surgery or radiation therapy, seriously affects the quality of life of patients and overall survival. The purpose of this study was to analyze the risk factors (RFs) for development of SREs in women with advanced NSCLC and BC, with the aim of highlighting the differences (if any) between the two groups of patients.

      Methods:
      The medical records of 16 women with BMs from NSCLC (Group A) and 15 women with BMs from luminal-type BC (Group B) were reviewed. The following RFs have been considered: age >65 years, ECOG performance status (PS) <2, the presence of extra-skeletal metastases (ESM) or hypercalcemia (>2.65 mmol/L), and number of BMs >1. Odds ratio (OR) estimates and the relative 95% confidence interval (CI) were calculated. A p-value level <0.05 was considered statistically significant.

      Results:
      During follow-up, 5 (33.3%) Group A and 111 (68.7%) Group B patients developed SREs (OR=4.40, p=0.04), respectively. The results are reported in the Table. No significant difference (p=NS) was found between groups in relation to ECOG-PS, ESM or hypercalcemia, and number of BMs. Only the age >65 years (OR=0.22, p=0.04) represented a weak significant risk factor.

      Parameter NSCLC BC OR 95% CI p-value
      No. of patients 15 16 - - -
      Skeletal-related events 33.3% 68.7% 4.40 0.97-19.85 0.04
      Age >65 years 73.3% 37.5% 0.22 0.05-1.01 0.04
      ECOG-Performance status >2 40.0% 18.8% 0.34 0.07-1.76 0.25
      Extra-skeletal metastases 26.7% 43.7% 2.14 0.47-9.70 0.32
      Malignant hypercalcemia 26.7% 12.5% 0.39 0.06-2.55 0.39
      Multiple bone metastases 53.5% 37.5% 0.52 0.12-2.20 0.38


      Conclusion:
      Women with BMs from NSCLC has a reduced risk for development of SREs compared to those with BC, but elderly (>65 years) patients require a closer surveillance, and a precocious bisphosphonate treatment could be suggested.

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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
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      P2.01-003 - Serum VEGF, MMP-7 and CYFRA 21-1 as Predictive Markers of Lung Metastases from Colorectal Cancer (ID 4717)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Colorectal cancer (CRC) is one of the most common malignancy and the most frequent cause of cancer-related death in Western countries. In patients with CRC, the presence of liver or lung metastases (LMs) seriously affects survival, and the early diagnosis and resection of LMs significantly improves the outcome. Unfortunately, the sensitivity of imaging studies in detecting LMs is low, because the onset of solitary pulmonary nodules is common during follow-up, the most part of them are not malignant. The aim of this study was to evaluate the accuracy of serum carcinoembryonic antigen (CEA), vascular endothelial growth factor (VEGF) and matrix metalloproteinase (MMP)-7 and cyrokeratin-19 fragment (CYFRA 21-1) as predictive markers of LMs from CRC.

      Methods:
      We retrospectively reviewed the medical charts of 21 patients with a history of CRC who developed histologically confirmed solitary or multiple PMs. There were 13 (61.9%) men and 8 (38.1%) women, with an overall median age of 65 years (range 31-82 years). Controls were 24 age-matched patients with CRC in whom the presence of PMs was excluded using 18F-FDG PET. The receiver operating characteristic (ROC) curve was used to obtain the optimal threshold value (cutoff point) for each TM.

      Results:
      The optimal cutoff was set at 5 ng/mL, 7.5 ng/mL, 250 pg/mL, and 2.8 ng/mL for CEA, VEGF, MMP-7, and CYFRA 21-1, respectively. The sensibility, specificity, positive (PPV) and negative (NPV) predictive value, and accuracy are reported in the Table. The logistic regression analysis excluded CYFRA 21-1 from the model, and thus we calculated the results also considering the combination of CEA+VEGF+MMP-7. The area under the ROC curve (AUC) was 0.712 (95% CI: 0.432-0.802).

      RESULTS CEA VEGF MMP-7 CYFRA 21-1 CEA+VEGF+MMP-7
      Sensitivity 71.4% (52.1-90.7) 80.9% (64.2-97.7) 85.7% (70.5-99.9) 84.2% (67.8-99.9) 90.5% (77.9-99.9)
      Specificity 91.7% (80.6-99.9) 95.8% (87.8-99.9) 95.6% (87.8.99.9) 91.7% (80.6-99.9) 99.6% (98.7-99.9)
      Positive predictive value 88.2% (72.9-99.9) 94.4% (83.9.99.9) 94.7% (84.7-99.9) 88.9% (74.4-99.9) 95.0% (85.4-99.9)
      Negative predictive value 78.6 % (63.4-93.8) 85.2% (71.8-98.6) 88.5% (76.2-99.9) 88.0% (75.3-99.9) 99.1% (97.9-99.9)
      Likelihood ratio positive 28.57 19.43 20.57 10.11 212.62
      Likelihood ratio negative 0.31 0.20 0.15 0.17 0.10
      False positive rate (α) 8.33% 4.17% 4.17% 8.33% 0.43%
      False negative rate (β) 28.57% 19.05% 19.05% 15.79% 9.52%
      Clinical accuracy 82.2% 88.9% 91.1% 84.4% 93.3%


      Conclusion:
      The periodic assay of CEA+VEGF+MMP-7 together may help to suspect the presence of LMs, suggesting the need to anticipate further evaluations.

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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
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      P2.03a-031 - Metronomic Oral Vinorelbine as First-Line Treatment in Elderly (>65 Year) Patients with Advanced NSCLC (ID 4769)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Non-small cell lung cancer (NSCLC) is one of the most frequent malignancies, and the majority of diagnosis are made at an advanced stage (IIIB/IV), with unsatisfactory results. Vinorelbine is a microtubule-targeting agent, with a favorable safety profile, and is currently available also as oral chemotherapeutic agent. Metronomic chemotherapy (MCT) is an attractive strategy for treating cancer, which has been shown to reduce toxicities and to extend duration of treatment, resulting in lower resistances and prolonged survival rates. The aim of our study was to evaluate the role of oral metronomic vinorelbine (mVNR) as first-line treatment in population of elderly unfit-platin patients with advanced NSCLC.

      Methods:
      Twenty patients (13 men and 7 women, median age 78 years, range 66-88) with advanced NSCLC (3 patients stage IIIb, 17 patients stage IV) and a median of 4 major co-morbidities, non-oncogenic addicted and unfit for platin, were treated with oral mVNR as first-line treatment, at a dose of 40 mg (Group 1, 9 patients) or 50 mg (Group 2, 11 patients) as MCT on days Monday, Wednesday and Friday. The ECOG performance status was 1 (PS1) in 11 patients and 2 or 3 (PS2-3) in 9.

      Results:
      The median overall survival (OS) was 7.80 months (PS1: 11.27 months; PS2-3: 4.3 months) and time-to-progression (TTP) was 3.07 months (PS1: 3.0 months; PS2-3: 3.5 months). The median OS in Group 1 was 4.5 months and 9.4 months in Group 2. Best response showed stable disease in 5 cases, partial response in 4, progression disease in 7. Low toxicity was reported because grade 1-2 asthenia was the most frequently reported symptom.

      Conclusion:
      Metronomic chemotherapy is a new approach that combines good tolerability and acceptable activity. Our preliminary data suggest that oral mVNR in advanced NSCLC may be an effective first-line treatment, even in elderly and unfit patients with major co-morbidities.

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    P2.03b - Poster Session with Presenters Present (ID 465)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Advanced NSCLC
    • Presentations: 1
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      P2.03b-066 - Diagnostic Value of Pleural Cytology Together with Pleural CEA and VEGF in Patients with NSCLC and Lung Metastases from Breast Cancer (ID 5325)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Pleural effusion (PE) is common in patients with advanced non-small cell lung cancer (NSCLC) and lung metastases from breast cancer, accounting for at least 20-30% of cases. Unfortunately, many patients with malignant PE exhibit a negative pleural cytology (PC), and thus further invasive diagnostic procedures, including VAT-guided biopsy, are required. The aim of this study was to evaluate the diagnostic value of PC together with pleural carcinoembryonic antigen (pCEA) and vascular endothelial growth factor (pVEGF) assay in cancer patients with PE.

      Methods:
      Thirty-six patients with suspicious PE scheduled to undergo VAT-guided biopsy underwent both PC and pCEA and pVEGF measurement before surgery. There were 20 (55.6%) males and 16 (44.4%) females, with an overall median age of 67 (range 40-82 years). Patients with non-diagnostic cytology were excluded from the study. pCEA was measured with automated method of immuno-chemiluminescence (LOCI, Dimension Vista, Siemens HD, Camberley, UK), while pVEGF with an enzyme-linked immunosorbent assay (ELISA) commercially available kit. According to previously obtained data from laboratory archival information, the optimum cutoff levels were 5 ng/mL and 6 ng/mL for pCEA and pVEGF, respectively.

      Results:
      Final pathology showed 10 (27.8%) patients with NSCLC, 13 (36.1%) with lung metastases, and 13 (36.1%) with benign PE. The age did not differ between groups (p=0.59). The sensitivity, specificity and accuracy of PC, and pleural CEA and VEGF are reported in the Table. The area under the curve (AUC) of the ROC curve of PC+pCEA+pVEGF in combination was 0.921 (95% CI: 0.513-0.973), and the diagnostic accuracy was 97.2%.

      RESULTS Cytology pCEA pVEGF Cytology+pCEA+pVEGF
      Sensitivity 65.2% (45.7-84.7) 73.9% (56.0-91.9) 78.3% (61.4-95.1) 95.6% (87.3-99.9)
      Specificity 92.3% (77.7-99.9) 92.3% (77.8-99.9) 92.3% (77.8-99.9) 100%
      Negative predictive value 93.7% (81.9-99.9) 66.7% (44.9-88.4) 70.6% (48.9-92.2) 92.9% (79.4-99.9)
      False negative rate (α) 34.8% 26.1% 21.7% 4.35%
      Accuracy 75.0% 80.5% 83.3% 97.2%


      Conclusion:
      In patients with PE, according to our results, the measurement of pleural CEA and VEGF, and PC evaluation together reached a very good accuracy and 100% specificity, and should be suggested in all cancer patients when a noninvasive evaluation of a PE is required as non-invasive procedure.

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    P2.04 - Poster Session with Presenters Present (ID 466)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
    • Presentations: 1
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      P2.04-054 - Pleural CEA and C-Reactive Protein in Patients with Lung Metastases and Malignant Pleural Effusion. A Prospective Case-Control Study (ID 5429)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Malignant pleural effusion (PE) is common cancer patients, and may require invasive investivations. The aim of this study was to evaluate the diagnostic utility of pleural carcinoembryonic antigen (pCEA) and pleural C-reactive protein (pCRP) assay in cancer patients with PE.

      Methods:
      We prospectively measured both pCEA and pPCR in 41 consecutive patients with a history of cancer and PE (cases). Controls were 41 age- and sex-matched patients with confirmed benign PE. There were 52 (63.4%) men and 39 (47.6%) women, with an overall median age of 71 years (range 40-88 years).

      Results:
      The age (p=0.943) and male-to-female ratio (p=0.254) did not differ significantly between groups. pCEA (34.9±104.8 vs. 1.5±1.3 ng/mL; p<0.0001) was higher in patients with malignant PE, while pCRP was higher (11.7±7.2 vs. 5.5±3.4 mg/L; p=0.0001) in controls. The results are reported in the Table (95% CI). A weak inverse correlation was found between pCRP and pCEA (R= ‒0.107, p=0.505). The relative linear regression equation (Figure) was pCPR=11.725‒0.573 pCEA, suggesting that the two markers were independent parameters. Figure 1 Figure 2





      Conclusion:
      The measurement of pCRP+pCEA together represents an accurate and easy to perform tool useful in differentiating between benign and malignant PE, and should be suggested in all cancer patients requiring PE analysis.

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    P3.03 - Poster Session with Presenters Present (ID 473)

    • Event: WCLC 2016
    • Type: Poster Presenters Present
    • Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
    • Presentations: 1
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      P3.03-022 - Serum CEA, VEGF and MMP-7 in Patients with Malignant Pleural Effusion. A Prospective Study with Logistic Regression Analysis of Accuracy (ID 5427)

      14:30 - 15:45  |  Author(s): P. Ubiali

      • Abstract
      • Slides

      Background:
      Several tumor markers have been proposed in differentiating between benign and malignant pleural effusions (PE). The aim of this prospective study was to evaluate the usefulness of serum carcinoembryonic antigen (CEA), vascular endothelial growth factor (VEGF), and matrix metalloproteinase-7 (MMP-7) assay in patients with PE of uncertain origin.

      Methods:
      A series of 36 consecutive patients with suspicious PE requiring VATS-guided biopsy underwent serum CEA, VEGF, MMP-7 measurement before PC and biopsy. There were 20 (55.6%) males and 16 (44.4%) females, with an overall median age of 67 (range 40-82 years). According to the receiver operating characteristic (ROC) curve, the optimum cutoff levels were 5 ng/mL, 7.5 ng/mL, and 250 pg/mL for CEA, VEGF and MMP-7, respectively.

      Results:
      Final pathology showed 10 (27.8%) patients with NSCLC, 13 (36.1%) with LMs, and 13 (36.1%) with benign PE. The age did not differ between groups (p=0.59). The sensitivity, specificity and accuracy of PC were 56.5%, 92.3%, and 69.4%, respectively. The results of serum markers measurement are reported in the Table (95% CI). The logistic regression excluded CEA from the model, and thus we calculated the area under the curve (AUC) of the combination VEGF+MMP-7. The AUC was 0.681 (95% CI: 0.413-0.743) and the diagnostic accuracy was 77.8%, which was superior than that of MMP-7 alone (72.2%, p=0.41). Figure 1



      Conclusion:
      In patients with PEs, the measurement of serum VEGF and MMP-7 together reached a good accuracy with a fair AUC, and should be suggested when a noninvasive evaluation of a PE is required.

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