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M. Pless



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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      126TiP - SAKK 16/14: Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC): A multicenter single-arm phase II trial (ID 638)

      12:30 - 13:00  |  Author(s): M. Pless

      • Abstract
      • Slides

      Background:
      Improving the outcome of locally advanced non-small cell lung cancer (NSCLC) is one of the major challenges in thoracic oncology. SAKK substantially contributed to establish a standard of care for patients with stage III NSCLC: The trial SAKK 16/96 established neoadjuvant chemotherapy with three cycles of cisplatin and docetaxel. The randomized trial SAKK 16/00 showed no benefit by adding neoadjuvant radiotherapy as third treatment modality. Our results consistently showed a 5-year overall survival (OS) of 37%. Recently, the PACIFIC trial showed significantly improved progression-free survival for durvalumab as consolidation therapy after definitive chemoradiotherapy in unresectable stage III NSCLC.

      Trial design:
      This is a single-arm phase II clinical trial designed to evaluate the addition of perioperative immunotherapy with durvalumab to the previously established standard of care for stage IIIA(N2) patients. Eligible patients with WHO performance status 0–1 and age of 18–75 years must have pathologically proven NSCLC stage IIIA(N2) (T1-3 N2 M0) according to the 7th edition of the TNM classification, irrespective of histological subtype, genomic aberrations or PD-L1 expression status. Tumor tissue has to be available for the mandatory translational research. Patients whose tumor is deemed resectable at diagnosis receive three cycles of chemotherapy with cisplatin 100 mg/m[2] and docetaxel 85 mg/m[2] every three weeks followed by two cycles of durvalumab 750 mg every two weeks. Following surgery, patients will be treated with durvalumab 750 mg every two weeks for 12 months. The primary endpoint of the trial is event-free survival at 12 months. Secondary endpoints include OS, objective response, nodal down-staging, complete resection, pattern of recurrence and toxicity. Additionally, a large translation research program accompanies the trial investigating potential predictive biomarkers of anti-PD-L1 therapy. Based on the data of first 25 operated patients and given that the results showed that their 30-day post-operative mortality is less than 10%, according to the decision rule described in the protocol of the trial there is no reason for further detailed safety analysis (evaluated by an IDMC) and thus shall continue as per protocol.

      Clinical trial identification:
      NCT 02572843

      Legal entity responsible for the study:
      Swiss Group for Clinical Cancer Research

      Funding:
      Swiss Group for Clinical Cancer Research; AstraZeneca; Rising Tide Foundation, Gateway for Cancer Research

      Disclosure:
      S.I. Rothschild: SAKK 16/14 study is supported by AstraZeneca. All other authors have declared no conflicts of interest.

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      180P - Significant progress in palliative treatment of NSCLC over the last decades: Correlation of treatment milestones with survival in unselected patients (ID 645)

      12:30 - 13:00  |  Author(s): M. Pless

      • Abstract
      • Slides

      Background:
      Therapeutic options for patients (pts) with metastatic non-small cell lung cancer (mNSCLC) have considerably changed during the last decades. Introduction of 3rd-generation chemotherapeutic agents (1997), molecularly targeted drugs (2009) and immune checkpoint inhibitors (2015) are milestones in the treatment of NSCLC. We analyzed the outcomes of all consecutive patients with mNSCLC in a single institution to determine whether these milestones improved the outcome of unselected patients in a real-world setting.

      Methods:
      576 consecutive patients with palliative treatment for NSCLC at the University Hospital Basel between 1990 and 2016 were analyzed. Probabilities of survival were calculated using the Kaplan-Meier estimator. Groups were compared using the log-rank test. Multivariate analysis was performed to determine factors associated with improved overall survival (OS).

      Results:
      Mean age at diagnosis was 62.9 years, 68% were male, 81% were smokers and 55% had adenocarcinoma. Four cohorts of pts were created according to the described milestones in NSCLC therapy and approval of the drugs. There was a significant statistical difference in median OS for the four-time periods: 1990–1996 8.1 months, 1997–2008 10.7 months, 2009–2014 9.0 months, and 2015–2016 12.4 months (p = 0.027). The four cohorts did not differ significantly in gender, stage, performance and smoking status. In the multivariate analysis, the time period was an independent prognostic factor for OS (p < 0.001). A further independent prognostic factors for OS was sequential therapy with at least two therapies (p = 0.002). Lack of response to 1st-line therapy was an independent negative prognostic factor (p < 0.0001).

      Conclusions:
      Our analysis shows that results obtained in prospective clinical trials are applicable to an unselected real-world population of NSCLC pts. In the period from 2009 to 2014 there was no overall progress, perhaps because introduction of targeted agents benefitted only a minority of selected pts harboring a specific molecular aberration. On the whole, a clinically meaningful and encouraging improvement of survival in m NSCLC was observed in the last decades.

      Clinical trial identification:


      Legal entity responsible for the study:
      University Hospital Basel

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

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