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Daniele Lavacchi

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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): Daniele Lavacchi

      • Abstract
      • Slides


      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.


      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


      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


      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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