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O. Juan



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    Immunotherapy and next-generation TKIs: From second to frontline treatment (ID 55)

    • Event: ELCC 2018
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      137PD - Prognostic factors in oligometastatic non-small-cell lung cancer (OM-NSCLC) (ID 616)

      07:45 - 09:00  |  Presenting Author(s): O. Juan

      • Abstract
      • Slides

      Background:
      OM-NSCLC represents a distinct prognostic group within stage IV lung cancer. An increase in overall survival (OS) has been suggested with ablative (surgery or radiotherapy) therapy. We performed an analysis of clinical factors influencing outcome in a series of patients (pts) with OM-NSCLC treated in a tertiary hospital.

      Methods:
      OM-NSCLC pts (defined as ≤3 metastatic lesions at diagnosis) diagnosed between Jan-2012 and Dec-2016 were included in the analysis. Median OS was calculated with the Kaplan-Meier method. The association between clinical and pathological factors and OS was determined using uni- (UV) and multivariable (MV) Cox regression models. Variables with a p-value <0.01 in UV analysis were included in the MV model.

      Results:
      84 pts were identified: 25 pts squamous histology (29.8%), 58 adenocarcinoma (58%) and 1 (1.2%) undifferentiated carcinoma. 11 pts (13%) were EGFR-mutation positive. Most patients presented with one (78.3%) or two (20.5%) metastatic sites: CNS (39.2%), bone (29.8%), lung (17.9%), adrenal (11.9%) and liver (10.7%). 57 pts (67.9%) underwent local treatment (8.8% surgery, 70.2% radiotherapy, both 21.2%) before (68.2%) or during (49.1%) chemotherapy. Median follow-up was 10.5 months with a median OS of 15.8 months (95CI%:8.9–22.7). In MV OS analysis, only T-stage (p = 0.012) and histology (p = 0.006) were significantly associated with OS (Table).Table:UV and MV Cox-regression Models

      UnivariateMultivariate
      VariableHR (CI95%)p-valorHR (CI95%)p-valor
      Histology0,32 (0.18–0.58)<0.001*0.42 (0.23–0.78)0.006
      Sex0,44 (0.19–1.03)0.059*0.52 (0.22–1.25)0.142
      Smoking1,27 (0.79–2.05)0.320
      T stage1,47 (1.16–1.89)0.002*1.44 (1.09–1.92)0.012
      N stage1,01 (0.99–1.02)0.496
      N° of metastasis1,32 (0.72–2.41)0.366
      Site of metastasis
       Lung0.80 (0.41–1.58)0.522
       Adrenal gland0.91 (0.49–1.69)0.767
       CNS0.89 (0.55–1.45)0.647
       Liver1.36 (0.76–2.44)0.302
       Bone1.45 (0.91–2.33)0.118
       Other1.05 (0.42–2.63)0.916
      Local treatment (yes/no)0.42 (0.24–0.76)0.004*0.61 (0.33–1.12)0.115


      Conclusions:
      Ablative therapy in OM-NSCLC pts was not associated with higher OS. Only a lower initial T-stage in the primary tumor and adenocarcinoma histology could represent a favorable prognosis. The optimal management of NSC-OM patients will require robust data from well-designed prospective clinical trials.

      Clinical trial identification:


      Legal entity responsible for the study:
      Medical Oncology, Hospital La Fe.

      Funding:
      Has not received any funding

      Disclosure:
      All 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: 2
    • 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  |  Author(s): O. Juan

      • 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.

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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): O. Juan

      • 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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