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Donato Pezzulla



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    EP1.04 - Immuno-oncology (ID 194)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Immuno-oncology
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.04-02 - Predictors of Lung Toxicity in First Line Pembrolizumb for Advanced NSCLC: An Interim Analysis of PRELUTOX Study (ID 1951)

      08:00 - 18:00  |  Author(s): Donato Pezzulla

      • Abstract
      • Slides

      Background

      Pembrolizumab, an anti-PD–1 antibody, is an immuno-checkpoint inhibitor (ICI) approved for advanced disease in frontline setting if PDL1 is ≥ 50%, in second line if PDL1 is >1%. ICIs are associated with immune-related adverse events (irAE), including pneumonitis or interstitial lung disease (ICI–ILD): the mechanisms that lead to irAE are not entirely known. Clinical trials found an incidence of ICI–ILD of 3 to 5% but in recent studies it is greater, with fatal cases described. Reports about real incidence, risk factors, features of pneumonitis are still few. We designed a prospective observational study in this setting of patients in order to predict pulmonary toxicity by clinical -radiological and respiratory functional variables.

      Method

      PRELUTOX is a prospective observational study. Our purpose is to enroll at least 50 patients in 2 years. Inclusion criteria: locally advanced or metastatic NSCLC whit PD-L1 expression ≥ 50%, with no EGFR or ALK-ROS1 mutations. Exclusion criteria: previous chemotherapy or thoracic radiotherapy; active infections or systemic autoimmune disease; interstitial lung diseases; prior pneumonitis requiring systemic steroids; immunosuppressive or corticosteroid treatment; renal or hepatic failure. Aims of our study: incidence of ICI – ILD; features of all patients including pulmonary function and comorbidities, especially the respiratory ones; features of patients who develop pneumonitis with greater attention to the HRCT pattern. Patients perform therapy and radiological exams according to routine clinical practice; pulmonary function tests (PFTs) at the beginning of Pembrolizumab and every three months

      Result

      This is an interim analysis. 33 patients have been recruited from May 2018 to March 2019. Patients characteristics are summarized in table 1.

      table 1.gif

      ILD occurred in one patient with thoracic massive involvement (incidence 3%) with an HRCT pattern of organizing pneumonia. He presented progressive worsening of the obstructive ventilatory defect and drastic reduction of diffusing capacity, associated with severe hypoxemia

      Conclusion

      In literature incidence of ICI-ILD seems to be higher for NSCLC compared with other cancers: this may be related to the underlying lung status (exposure to tobacco, COPD and the thoracic tumor burden). PFTs have been described in several studies for their capacity to predict lung toxicity. In our preliminary data, during Pembrolizumab therapy, if toxicity does not occur, airways obstruction parameters and lung volumes seem to remain constant and related to the respiratory comorbidity (COPD). The same appears for diffusing capacity. Finally we suppose that the thoracic tumor burden could be related to the risk of lung toxicity but the study is still ongoing.

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    P2.17 - Treatment of Early Stage/Localized Disease (ID 189)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Treatment of Early Stage/Localized Disease
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.17-20 - A Radiomic Approach to Predict Nodal and Distant Relapse in Patients Treated with Stereotactic Body Radiation Therapy for Early Stage NSCLC (Now Available) (ID 2178)

      10:15 - 18:15  |  Author(s): Donato Pezzulla

      • Abstract
      • Slides

      Background

      Regional and distant relapse remain a significant issue in the treatment of early stage non small cell lung cancer with Stereotactic Body Radiation Therapy (SBRT). There is a need for predictive biomarkers able to identify patients that are at higher risk of relapse. In this work we present a radiomic approach using features extracted by routine planning CT, to predict the risk of nodal and distant recurrence.

      Method

      A cohort of 102 patients was retrospectively investigated. All patients were affected by early stage (T1-T2) lung cancer and received the same radiation treatment with 48Gy delivered in 4 fractions. For all patients, a set of 45 radiomics textural features was computed for the tumor volumes segmented on the treatment planning CT images. Patients were split into two independent cohorts used for training (70% of cases) and validation (30% of cases). A stepwise backward linear discriminant analysis (LDA) was applied as a classifier to identify patients at risk of lymph-nodal progression. The performance of the model was assessed by means of standard metrics derived from the confusion matrix. Furthermore, all textural features were correlated to survival data to build predictive models: the features/predictors found significant at univariate analysis and to elastic net regularization, were included in a multivariate model to predict disease specific progression free survival (PFS) and disease specific survival (DS OS). Low and high risk groups were identified by maximizing the separation by means of the Youden method.

      Result

      In the total cohort (77 (75.5%) males and 25 (24.5%) females, median age 76.6 years), 15 patients presented nodal progression at the time of analysis (11 in the training and 4 in the validation sets); 19 patients (18.6%) died because of disease specific causes, 25 (24.5%) died for other reasons, 28 (27.5%) were alive without disease and 30 (29.4%) with either local or distant progression. The mean tumor volume was 5.6±6.4cm3. Figure 1 illustrates the actuarial curves for PFS and DS OS over the entire training and test cohorts (in both cases the difference was not significant) and the same data stratified in low and high risk groups identified. In all case highly significant differences were identified.

      curves.jpg

      Conclusion

      Radiomics features extracted from treatment planning CT images can distinguish patients with low and high risk of tumor progression and disease specific death in early stage lung cancer treated with SBRT.

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