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A. Navarro



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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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      219P - Outcomes of malignant pleural mesothelioma (MPM) patients (p) treated after first line chemotherapy (CT) (ID 510)

      12:30 - 13:00  |  Author(s): A. Navarro

      • Abstract
      • Slides

      Background:
      The increasing incidence and poor outcome associated with MPM requires identification of novel treatment options. Initial reports have demonstrated beneficial effects of pemetrexed, gemcitabine and vinorelbine in previously treated MPM, however there is no clear agreement on the role of different agents after first line. The aim of this study is to evaluate the outcomes of p with MPM treated in second and third lines at our institution.

      Methods:
      91 MPM p treated with CT or experimental agents in clinical trials beyond first line between September 2002 and October 2017 were retrospectively reviewed (49 p received a third line regimen). Survival was calculated using the Kaplan–Meier method and log-rank test was used for statistical comparison. The associations of type of regimen with outcomes were assessed with Cox proportional-hazard models.

      Results:
      Patient's characteristics: median age 65 years (29–84 years), males: 73%, performance status 1: 66%, asbestos exposure: 81%, stage III at diagnosis: 48%, epithelial subtype: 77%. All p were treated with chemotherapy in first line, 77% received cisplatin plus pemetrexed, 19% carboplatin plus pemetrexed and 4% others. Median PFS in first line was 5.1 months (m; CI95% 4.6–5.2). Median overall survival after first line was 11.6 m (9.8–15.9). Regimen offered as second- or third-line: platinum doublet in 24%, vinorelbine in 32%, gemcitabine in 10%, immunotherapy in 22%, and targeted agents in 12%. Median PFS in second or third line with platinum doublet was 4.9 m (4.3–5.9), vinorelbine 2.7 m (2.1–3.8), gemcitabine 3 m (1.4 – NA), immunotherapy 3 m (2.2–4.5) and targeted agents 3 m (0.8 – NA) (p > 0.05). In the third line setting, median survival after initiation of vinorelbine was 8.5 m (5.5 – NA) versus 3 m (3 – NA) for gemcitabine-treated p (p = 0.001).

      Conclusions:
      In our single institution series of previously treated MPM p, second or third line treatment produces modest benefit, with no clear differences in outcome for CT or clinical trial alternatives. Further research is necessary to treat p who failed to first line CT, including choice of therapy sequence in the second and third lines.

      Clinical trial identification:
      NA

      Legal entity responsible for the study:
      N/A

      Funding:
      Has not received any funding

      Disclosure:
      All authors have declared no conflicts of interest.

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      88P - Feasibility of outpatient dinutuximab (D) and irinotecan (I) for second-line treatment of relapsed or refractory small cell lung cancer (RR SCLC): Part 1 of an open-label, randomized, phase 2/3 study (ID 589)

      12:30 - 13:00  |  Author(s): A. Navarro

      • Abstract
      • Slides

      Background:
      D, a chimeric monoclonal antibody that binds cell-surface GD2 expressed on SCLC, can cause significant pain. Combined tolerability with I in RR SCLC patients (pts) is unknown.

      Methods:
      Part 1, an intrasubject dose-escalation lead in to the main study, investigated outpatient use of D + I. Eligibility: RR SCLC following first-line platinum-based therapy with a life expectancy of ≥12 weeks, PS 0-1. Pts received intravenous (IV) D and I (fixed dose 350 mg/m[2]) on Day 1 q 21-days. D was dosed 10 mg/m[2], and increased 2 mg/m[2]/cycle, if pain was < Grade 2, no opioid medications were required, and prior dose was otherwise tolerated. Doses could be decreased based on toxicity observed. Pretreatment included IV hydration, antihistamines, and antipyretics. Pts were monitored for 4 hours after D. Pts remain on treatment until intolerance, progression, or death.

      Results:
      12 pts were treated (8 male) in US and Spain. Mean (range) age was 68 (47–79) years. A median (range) of 3 (2–4) cycles were completed per pt. Median (range) D dose achieved was 14 (10–16) mg/m[2]. 121 adverse events (AEs) were reported in the Table. There were no grade (gr) 5 AEs. Pain AEs, attributable to D, were mainly gr 1 (80%), with most resolving within hours of infusion; one subject experienced gr 3 AEs, and received the same D dose in the subsequent cycle. Overall, pain did not result in D dose reductions, discontinuations or hospitalizations. Most other AEs were GI in nature and likely attributable to I.

      AEGrade, N subjects (%)
      1234
      Pain
      Back pain5 (41.7%)1 (8.3%)1 (8.3%)0
      Pain in extremity3 (25.0%)000
      Abdominal pain1 (8.3%)1 (8.3%)00
      Arthralgia1 (8.3%)01 (8.3%)0
      Headache2 (16.7%)000
      Non-pain
      Diarrhea10 (83.3%)2 (16.7%)00
      Nausea5 (41.7%)3 (25.0%)00
      Cough3 (25.0%)1 (8.3%)00
      Vomiting3 (25.0%)1 (8.3%)00
      Anaemia2 (16.7%)01 (8.3%)0
      Constipation3 (25.0%)000
      Decreased appetite3 (25.0%)1 (8.3%)00
      Asthenia2 (16.7%)1 (8.3%)00
      Dehydration2 (16.7%)000
      Fatigue1 (8.3%)1 (8.3%)00
      Hypomagnesaemia1 (8.3%)1 (8.3%)00
      Infusion related reaction1 (8.3%)000


      Conclusions:
      D up to 16 mg/m[2] + I have been tolerated with no unanticipated AEs. Part 2 of the study has begun and will randomize ∼460 subjects to: I vs. D + I vs. topotecan.

      Clinical trial identification:
      EudraCT 2017-000758-20 ClinTrials NCT03098030

      Legal entity responsible for the study:
      United Therapeutics Corporation

      Funding:
      United Therapeutics Corporation

      Disclosure:
      M.J. Edelman: Primary investigator for this corporate-sponsored research. O. Juan, A. Navarro: Principal investigator for this corporate-sponsored research. G. Golden, A. Saunders: Employed by United Therapeutics Corporation who is the sponsor of this study.

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