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Fiona Helen Blackhall



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    Lunch & Poster Display session (ID 58)

    • Event: ELCC 2019
    • Type: Poster Display session
    • Track:
    • Presentations: 2
    • Moderators:
    • Coordinates: 4/11/2019, 12:30 - 13:00, Hall 1
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      140P - Brigatinib experience on the ALK project (ID 576)

      12:30 - 13:00  |  Author(s): Fiona Helen Blackhall

      • Abstract

      Background

      The ALK Project established a network across the UK with the aim to analyse treatment patterns/outcomes and promote collaborations and research. The treatment pathway for ALK+ patients has been revolutionised in recent years.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      A multicentre retrospective analysis across 32 NHS hospitals/trusts identified 196 ALK+ non-small cell lung cancer (NSCLC) patients who were offered treatment by Dec-2018. Patients who received brigatinib during their treatment pathway were selected. The primary aims were 2-years overall survival (OS) and median OS from start of brigatinib. The secondary aims were objective response rate (ORR), incidence of grade 3-4 toxicity and 5-years/median OS from diagnosis of advanced NSCLC.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      A total of 50 patients were included with 48% being males, 70% never smoked tobacco and the median age at diagnosis was 50 years. 66% of patients developed brain metastasis at some point during their care and 52% had brain metastasis at the start of brigatinib. Brigatinib was used as the first, second or subsequent ALK inhibitor in 18%, 50% and 32% of cases, respectively. 82% of patients were exposed to other ALK inhibitors during their treatment pathway and 46% received chemotherapy prior to the start of any ALK inhibitor. On a median follow-up (since start of brigatinib) of 10 months, patients stayed on brigatinib for a median of 9 months (95% CI, 3.1-14.9), reaching 14 months (95%CI 11.0-19.9) if no brain metastasis (p = 0.15). The overall ORR was 64% and the incidence of grade 3-4 toxicity was 16%. Median OS from start of brigatinib was not reached and the 2-years OS according to brain metastasis was 61% or 83%, in favour of those without brain metastasis (p = 0.037). The median OS from diagnosis of advanced NSCLC was not reached and the 5-years OS was 55%.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Brigatinib is well tolerated and an effective treatment even in heavily pre-treated patients or in those with brain metastasis. A nationwide collaboration is possible and revealed the remarkable survival improvements for ALK+ patients with the development of newer generations of ALK inhibitors.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The Christie NHS Foundation Trust.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      All authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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      66P - Treatment (tx) characteristics and clinical outcomes in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with carboplatin (carbo) or cisplatin (cis) in combination with etoposide (etop) in US clinical practice (ID 309)

      12:30 - 13:00  |  Author(s): Fiona Helen Blackhall

      • Abstract
      • Slides

      Background

      For pts with ES-SCLC, guidelines recommend carbo or cis + etop as first-line (1L) tx. However, real-world data (RWD) on tx patterns and outcomes are limited. Here, we describe pt characteristics, tx duration and clinical outcomes associated with these 2 regimens.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Pts with ES-SCLC diagnosis (or limited-stage [LS] SCLC who initiated second-line [2L] tx) between 1 Jan 2013 and 31 Aug 2017 (follow-up to 31 Aug 2018) were identified from the US-based Flatiron Health electronic health record–derived database. Pts receiving tx with either carbo + etop or cis + etop were included in the analysis.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      RWD on 2161 pts from 156 tx centres were included; 84% of pts received carbo + etop. See table below for pt characteristics. The median tx duration was 3.4 mo (95% CI: 3.4, 3.4) with carbo + etop and 3.0 mo (95% CI: 2.8, 3.4) with cis + etop. The distribution of tx cycles administered was similar between carbo and cis, with 20% and 28% of pts completing 4 or 6 cycles, respectively. Median overall survival (OS) was 8.3 mo (95% CI: 8.1, 8.7) with carbo + etop and 9.7 mo (95% CI: 9.3, 11.0) with cis + etop. The 1-yr OS rates were 30% (95% CI: 28, 33) and 41% (95% CI: 36, 47), respectively. In pts with Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 and ≥ 2, median OS was 9.3 mo (95% CI: 8.6, 9.9) and 7.1 mo (95% CI: 6.3, 8.3), respectively. Pts with unknown ECOG PS had a median OS of 8.4 mo (95% CI: 8.0, 8.9).

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      Tx duration was similar between the 2 regimens. Pts who received cis + etop had numerically increased OS vs pts who received carbo + etop, as did pts with ECOG PS 0-1. However, these findings may be due to pts receiving cis + etop being fitter (younger and lower ECOG PS) at baseline.

      b651e8a99c4375feb982b7c2cad376e9 Editorial acknowledgement

      Medical writing assistance for this abstract was provided by Steffen Biechele, PhD, of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.

      934ce5ff971f1ab29e840a35e3ca96e9 Legal entity responsible for the study

      F. Hoffmann-La Roche, Ltd.

      213f68309caaa4ccc14d5f99789640ad Funding

      F. Hoffmann-La Roche, Ltd.

      682889d0a1d3b50267a69346a750433d Disclosure

      M. Sebastian: Honoraria, consulting: AZ, BI, BMS, Eli Lilly, Merck Sharp & Dohme, Novartis, Pfizer, Roche; Honoraria: Pierre Fabre; Consulting: Celgene. F. Barlesi: Personal fees/clinical trials (inst.): AZ, BMS, BI, Lilly, Roche, Novartis, Merck, MSD, Pierre Fabre, Pfizer, Takeda; Clinical trials (inst.): AbbVie, ACEA, Amgen, Bayer, Eisai, Genentech, Ipsen, Ignyta, Innate Pharma, Loxo, Medimmune, Sanofi-Aventis. R. Califano: Honoraria/consult: BI; Stock: Christie Private Care; Grants/nonremunerated activities: Clovis, AbbVie; Leadership (nonrem): ESMO; Nonrem membership: EORTC; Honoraria/consult/grants/nonrem activities: AZ, Roche, Pfizer, Lilly, MSD, Takeda, Novartis, BMS. A.S. Mansfield: Research funding (inst.): Novartis, Verily; Honoraria/Ad board (inst.): Genentech, AbbVie, BMS Mesothelioma Applied Research Foundation; Board member (non-rem.) ASCO; Lung Cancer Education Committee member (non-rem). F.H. Blackhall: Grant/research: Roche, BI, AZ, Cellmedica, AbbVie, Pfizer; Advisory board: AZ, Cellmedica, AbbVie, Ipsen, Takeda, Roche; Consulting/speakers: Takeda; Honoraria: Takeda, Roche, AbbVie, Ipsen; Study, editorial support: Roche. E.M. Flahavan: Employee: Roche; Stock: Lilly, Roche; support of parent study and funding of editorial support: Roche. J. Davies: Employee: Roche. P. Arnold: Employee: Roche; Stock: Novartis Pharma AG. S. Morris: Employee, Stock: Roche. M. Reck: Support of parent study, funding of editorial support: Roche; Honoraria for lectures and consulting: Amgen, AbbVie, BI, BMS, Celgene, Merck-Serono, MSD, Lilly, Novartis, Pfizer, Roche.

      Characteristics

      Carbo + EtopCis + Etop
      Pts, n1815346
      Age, median (IQR), y68 (61-74)64 (58-69)
       35-64, n (%)663 (37)189 (55)
       65-69, n (%)357 (20)77 (22)
       ≥ 70, n (%)795 (44)80 (23)
      Male, n (%)919 (51)184 (53)
      White race, n (%)1383 (76)259 (75)
      Baseline ECOG PS, n (%)
       0-1716 (39)144 (42)
       ≥ 2296 (16)29 (8)
       Not provided803 (44)173 (50)
      Type of ES-SCLC, n (%)
       1L tx of ES-SCLC1757 (97)335 (97)
       2L tx of LS-SCLC58 (3)11 (3)

      IQR, interquartile range.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    Proffered Paper session II (ID 61)

    • Event: ELCC 2019
    • Type: Proffered Paper session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 09:00 - 10:30, Room A
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      21O - EPAC-Lung: Pooled analysis of circulating tumor cells in advanced non-small cell lung cancer (ID 434)

      09:00 - 10:30  |  Author(s): Fiona Helen Blackhall

      • Abstract
      • Presentation
      • Slides

      Background

      We assessed the clinical validity of circulating tumor cell (CTC) quantification for prognostication of patients with advanced non-small cell lung cancer (NSCLC) by undertaking a European pooled analysis of individual patient data. This is the largest study of its kind and the first to examine between-centre heterogeneity of CTC identification in NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Methods

      Nine European NSCLC CTC centers were asked to provide reported/unreported anonymised data for patients with advanced NSCLC who participated in CellSearch CTC studies from January 2003 - March 2017. We used Cox regression models, stratified by centre, to establish the association between CTC count and survival. We assessed the added value of CTCs to prognostic clinico-pathological models using likelihood ratio (LR) statistics and c-indices.

      20c51b5f4e9aeb5334c90ff072e6f928 Results

      Seven out of nine eligible centers provided data for 550 eligible patients, including 209 patients whose prognostic information was previously unpublished. CTC counts of ≥ 2 and ≥5 per 7·5 mL were associated with reduced progression-free survival (≥2 CTCs: HR 1.72, p < 0·001; ≥5 CTCs: HR 2.21, p < 0·001) and overall survival (≥2 CTCs: HR 2·18, p < 0·001; ≥5 CTCs: HR 2·75, p < 0·001), respectively. Survival prediction was significantly improved by addition of baseline CTC count to LR clinico-pathological models (log-transformed CTCs p < 0·0001; ≥2 CTCs p < 0·0001; ≥5 CTCs p < 0·0001), while more moderate improvements were observed with the use of c-index models. There was minor evidence of between-center heterogeneity in the effect on PFS, but not OS.No difference in CTC profile was observed between key NSCLC molecular subsets such as EGFR, ALK, and KRAS.

      fd69c5cf902969e6fb71d043085ddee6 Conclusions

      These data confirm CTCs as an independent prognostic indicator of progression-free survival and overall survival in advanced NSCLC. CTC count improves prognostication when added to full clinico-pathological predictive models. ≥2 CTCs is an appropriate cutoff to move towards establishing clinical utility.

      b651e8a99c4375feb982b7c2cad376e9 Legal entity responsible for the study

      The authors.

      213f68309caaa4ccc14d5f99789640ad Funding

      Has not received any funding.

      682889d0a1d3b50267a69346a750433d Disclosure

      C.R. Lindsay: Institutional funding for an ongoing phase II trial for which I am PI; Supported by Roche as part of an ESMO translational fellowship awarded in 2014-2016. F.H. Blackhall: Grants: AstraZeneca, Novartis, Pfizer, Amgen, BMS; Consultancy fees: Cell Medica, MSD; Speaker bureau: BI; Advisory board work: Regeneron, Medivation, AbbVie, Takeda, Roche, Ibsen. M.G. Krebs: Advisory board: J&J. L. Terstappen: Inventor on a number of US patents related to CellSearch, rights of which assigned to Johnson&Johnson, CellSearch kits obtained from Johnson&Johnson through a collaborative agreement with the MCBP. J-C. Soria: Consultancy fees: AZ, Astex, Clovis, GSK, GamaMabs, Lilly, MSD, Mission Therapeutics, Merus, Pfizer, PharmaMar, Pierre Fabre, Roche/Genentech, Sanofi, Servier, Symphogen, Takeda; Full time employee: MedImmune; Shareholder: AZ, Gritstone. All other authors have declared no conflicts of interest.

      cffcb1a185b2d7d5c44e9dc785b6bb25

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    SCLC: What are the challenges and how can we face them? (ID 23)

    • Event: ELCC 2019
    • Type: Educational session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/11/2019, 14:45 - 16:15, Room C
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      The medical oncologist’s point of view (ID 65)

      14:45 - 16:15  |  Presenting Author(s): Fiona Helen Blackhall

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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