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D. Vicente Baz



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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): D. Vicente Baz

      • 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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      156P - ASTRIS, a real-world study with osimertinib in patients with non-small cell lung cancer (NSCLC) EGFR T790M mutated: Characteristics and diagnostic methods used for patients included in Spain (ID 547)

      12:30 - 13:00  |  Presenting Author(s): D. Vicente Baz

      • Abstract

      Background:
      We present demographic and diagnostic data for the first planned interim analysis of ASTRIS study, currently ongoing.

      Methods:
      ASTRIS is a single-arm, open-label, phase IIIb clinical trial to evaluate the efficacy and safety of osimertinib monotherapy in real practice. Eligible patients had stage IIIB-IV NSCLC with a T790M mutation determined by a locally validated test (not restricted by sample type), had received at least a previous EGFR-TKI, ECOG 0-2, with no history of interstitial lung disease or QTc prolongation. Asymptomatic and stable CNS metastases were allowed. Patients received osimertinib 80 mg once daily.

      Results:
      We included 132 patients in 18 centers, 130 began treatment. At data cut-off (3 Nov 2016), 72% continued in the study, median follow-up 5.2 (<1–12) months. Median age 66 (32–89) years, 69% women, 98% caucasian, 85% ECOG 0/1, 15% ECOG 2, 84% stage IV, 40% cerebral / leptomeningeal metastasis, 42% previous chemotherapy, 34% previous radiotherapy. EGFR-TKIs: gefinitib (43%), erlotinib (57%), afatinib (17%) and dacomitinib (2%). Only patients with a T790M positive test result were treated in the study: 73 (56%) were recruited to the study after a positive tissue test, 47 (36%) after a positive plasma test, 4 (3%) cytology and 6 (5%) after testing another specimen type. The origin of the biopsy tissue was primary tumor (60%), metastasis (40%). The local laboratory was used in 62% of the patients. Testing methods: Roche cobas (50%), Qiagen therascreen (17%), PCR-Invader (20%), TaqMan (9%), ARMS-PCR (1%), Illumina MiSeq / HiSeq (1%), AMOY (1%) and others (2%). Other EGFR mutations were EXON 19 deletions (58%), L858R (27%), S768I (5%) and G719X (3%).

      Conclusions:
      The patient profile included in the study expands the patient population studied in the published studies, including excluded patients (PS-2, treated with non-marketed TKIs) or characteristics typical of the Spanish population, with a majority of Caucasians. The data from the ASTRIS study will give external validity to the results obtained in studies published with osimertinib.

      Clinical trial identification:
      NCT02474355

      Legal entity responsible for the study:
      AstraZeneca

      Funding:
      AstraZeneca

      Disclosure:
      D. Vicente Baz: Consultant or Advisory Role: Astra Zeneca, BMS, Pfizer, Roche Research Funding: Pfizer, Boehringer. G. Marquez: AstraZeneca employee. All other authors have declared no conflicts of interest.