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P. Dennis



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    ESMO-IASLC Best Abstracts (ID 61)

    • Event: ELCC 2018
    • Type: Best Abstract session
    • Track:
    • Presentations: 1
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      233O - Time to deterioration of symptoms with durvalumab in stage III, locally advanced, unresectable NSCLC: Post-hoc analysis of PACIFIC patient-reported outcomes (ID 703)

      16:45 - 18:30  |  Author(s): P. Dennis

      • Abstract
      • Presentation
      • Slides

      Background:
      Along with improving efficacy outcomes such as progression-free survival (PFS) after concurrent chemoradiotherapy (cCRT) in locally advanced, unresectable NSCLC, it is critical that new therapies are well tolerated in the curative intent setting. We studied the impact of 12 mo of durvalumab on disease symptoms in this setting using patient-reported outcomes (PROs). In a post-hoc analysis of time to deterioration, we adjusted for transient symptom changes by requiring two consecutive deterioration recordings.

      Methods:
      Patients whose disease did not progress after ≥2 cycles of platinum-based cCRT were randomised 2:1 1–42 days post-cCRT to durvalumab 10 mg/kg i.v. or placebo every 2 weeks for up to 12 mo/progression. Co-primary endpoints were PFS and overall survival. PROs were assessed using EORTC QLQ-C30 v3 and QLQ-LC13. Time to deterioration was defined as time from randomisation until the first clinically relevant deterioration (≥10 point change); in the post-hoc analysis, deterioration confirmation was required at the next time point. Hazard ratios (HR) and 95% confidence intervals (CIs) were estimated using a stratified Cox proportional-hazards model.

      Results:
      In the pre-specified analysis, there was no difference between treatment arms in time to deterioration besides other pain, which favoured durvalumab vs placebo (HR 0.72; 95% CI 0.58–0.89). Our post-hoc analysis indicated notable delays in deterioration of overall pain (HR 0.75; 95% CI 0.60–0.93), chest pain (HR 0.74; 95% CI 0.57–0.97), arm/shoulder pain (HR 0.74; 95% CI 0.58–0.95), nausea/vomiting (HR 0.72; 95% CI 0.54–0.97), insomnia (HR 0.75; 95% CI 0.58–0.97) and haemoptysis (HR 0.70; 95% CI 0.50–0.99) in favour of durvalumab, with no between-group differences for other items.

      Conclusions:
      PACIFIC primary analysis showed that durvalumab significantly improved PFS vs placebo (16.8 mo vs 5.6 mo, respectively) in the post-cCRT setting, and was well tolerated, largely without PRO deterioration. Our post-hoc analysis indicates a delay in several PROs with durvalumab not observed in the pre-specified analysis. Confirmation of worsening may provide a more precise picture of deterioration than one time point alone.

      Clinical trial identification:
      NCT02125461 (April 25, 2014)

      Legal entity responsible for the study:
      AstraZeneca PLC

      Funding:
      AstraZeneca

      Disclosure:
      R. Hui: Personal fees from the following: AstraZeneca, Merck Sharp and Dohme: Advisory Board Member and Speaker Honorarium; Novartis, Pfizer: Advisory Board Member; BMS, Boehringer Ingelheim: Speaker Honorarium. A. Villegas: Celgene, Alexion, BMS: Speaker's Bureau. A. Ryden, Y. Zhang, P. Dennis: AstraZeneca: full-time employment and stock ownership. S. Antonia: Moffitt Cancer Center: Full-time employment, Grants/research support; Novartis: Grants/research support, Advisory board, Honorarium recipient; BMS, Merck, Boehringer Ingelheim, AstraZeneca, Memgen: Advisory board, Honorarium recipient; CBMG: Advisory board, Stock/shareholder, Honorarium recipient. All other authors have declared no conflicts of interest.

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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      80P - Understanding the patient perspective of small cell lung cancer (SCLC) (ID 265)

      12:30 - 13:00  |  Author(s): P. Dennis

      • Abstract
      • Slides

      Background:
      When developing a patient-reported outcomes assessment strategy, empirical evidence based on literature review and therapeutic area experts should be complemented with input directly from patients to reliably reflect the patients’ experiences. Therefore, a set of research activities were initiated to identify, describe, and substantiate concepts that reflect the important and relevant symptoms, treatment-related side effects, and impacts of extensive stage (ES)-SCLC.

      Methods:
      Twenty-five articles were reviewed, four clinical experts participated in advice meetings and 17 US patients diagnosed with ES-SCLC were interviewed. Trained interviewers used a semi-structured interview guide to elicit information from patients. Interviews were transcribed, coded, and analysed using qualitative data analytic methods.

      Results:
      Patients’ mean age was 65.2 years (SD = 9.8) and patients self-reported as white (n = 11, 64.7%), black or African American (n = 5, 29.4%), and American Indian or Alaska Native (n = 1, 5.9%). Thirty-one signs/symptoms of ES-SCLC were elicited with fatigue being mentioned by most patients (n = 10). Also, the most frequently reported SCLC symptoms were shortness of breath (n = 6, 35.3%), pain (n = 5, 29.4%), and weight loss (n = 4, 23.5%). Patients also reported numerous ways that their lives were impacted by ES-SCLC (n = 68 concepts), and treatment-related side-effects they experienced (n = 41 concepts). These findings, along with evidence from literature review and clinical experts, showed that shortness of breath, pain, weight loss, cough, fatigue, nausea, paraneoplastic syndromes, haemoptysis, and loss of appetite were reported as signs and symptoms of SCLC in all three research activities.

      Conclusions:
      This study provides an overview of symptoms, treatment-related side effects, and impacts associated with ES-SCLC from the patient perspective. The results suggest that patients with SCLC have similar key symptoms to patients with non-small cell lung cancer, therefore similar measurement strategies can be applied. Using this evidence, recommendations can be made for ES-SCLC clinical trial outcomes that resonate with primary stakeholders including patients, healthcare providers, regulatory agencies, and payers.

      Clinical trial identification:
      Not applicable.

      Legal entity responsible for the study:
      AstraZeneca PLC

      Funding:
      AstraZeneca

      Disclosure:
      A. Rydén, H. Jiang, P. Dennis: AstraZeneca: full-time employment and stock ownership. S. Ollis, E. Love, A.L. Shields: Employee of Adelphi Values, which receives payment from pharmaceutical companies to conduct outcomes-based research.

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