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Christos Chouaid



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    MA14 - Survivorship, Socioeconomic and End-of-Life Considerations (ID 915)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Treatment in the Real World - Support, Survivorship, Systems Research
    • Presentations: 2
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 205 BD
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      MA14.03 - Aggressiveness of Cares on the Month Before Death of Patients with Lung Cancer: A French National Database Survey (ID 12005)

      10:40 - 10:45  |  Author(s): Christos Chouaid

      • Abstract
      • Presentation
      • Slides

      Background

      Prior studies have demonstrated that high-intensity end of life (EOL) cares improves neither survival nor quality of life for cancer patients. The National Quality Forum endorses markers of poor EOL care for cancer patients but there is little data’s concerning lung cancer patients (1). The aim of this study was to assess, the quality of management during the last month of life of lung cancer patients managed in France and factors associated EOL aggressiveness.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Using a French hospital discharge database (PMSI, Programme de Médicalisation des Systèmes d’Information), all patients with lung cancer who died between January 1, 2010 and December 31, 2011 (cohort 1) and between January 1, 2015 and December 31, 2016 (cohort 2) were identified through the International Classification of Diseases 10th version (ICD-10). Aggressiveness of EOL cares was assessed by the following criteria’s 1) chemotherapy administrated within last 14 days of life (DOL); 2) > 1 hospitalization within 30 DOL; 3) ICU admission within 30 DOL; and 4) Palliative care < 3 days before death. Multivariate analysis was performed to identify individual determinants EOL aggressiveness.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 90,827 incident adult patients were identified (cohort 1: 43,862, cohort 2: 46,965): men: 74%, median age: 67 years], metastatic at diagnosis: 70%; 57% have at least one marker of aggressiveness of EOL cares (repeated hospitalizations: 49%, ICU admissions: 12%, chemotherapy within 14 DOL: 9%, palliative care < 3 days before death: 5%). A significant increase was observed between 2010/2011 and 2015/2016 for repeated hospitalizations (48% vs 51%, p<.001) and ICU admissions (11% vs 13%, p<.001); the two other markers have remained stable. In multivariate analysis of cohort 2, the risk of aggressiveness of care in EOL was increased by the presence of COPD (OR: 1.08, 95%CI: 1.02-1.14) and a management in an anti-cancer center (OR: 2.32,95%CI 2.05-2.61) while advanced age (OR: 0.51, 95%CI 0.47-0.55), female sex (OR: 0.86 95%CI: 0.82-0.90), malnutrition (OR: 0.72, 95%CI:0.68-0.76) were protective factors for EOL aggressiveness of cares.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Despite growing focus on providing appropriate EOL cares, in this analysis 57% of deceased lung cancer patients in France received aggressive EOL cares. Research must be undertaken to better identify patients at risk of aggressive EOL cares and to improve the quality of cares of last days of life these patients.

      1.McNiff KK, . Measuring supportive care in medical oncology practice: lessons learned from the quality oncology practice initiative. JCO 2008;

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      MA14.08 - Discussant - MA 14.05, MA 14.06, MA 14.07 (ID 14637)

      11:15 - 11:30  |  Presenting Author(s): Christos Chouaid

      • Abstract
      • Presentation
      • Slides

      Abstract not provided

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    OA12 - Novel Therapies in MET, RET and BRAF (ID 921)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 15:15 - 16:45, Room 106
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      OA12.03 - Activity of Crizotinib in MET or ROS1 Positive (+) NSCLC: Results of the AcSé Trial. (ID 12937)

      15:35 - 15:45  |  Author(s): Christos Chouaid

      • Abstract
      • Presentation
      • Slides

      Background

      Crizotinib was registered for ALK+ NSCLC in 2013 and recently for ROS1+ stage IV NSCLC. To generate high evidenced-based knowledge and to prevent off-label use, the French National Cancer Institute (INCa) launched the AcSé Program: equal access to tumor molecular diagnosis including an exploratory phase II trial. AcSé allows nationwide safe and controlled access to crizotinib off-label.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Biomarkers were identified with INCa molecular genetic platforms. Patients with amplification [amp] MET or mutation [mut] MET or translocation [tlc] ROS1 advanced NSCLC and not eligible for any other trial, were proposed crizotinib 250 mg BID. Tumor response was evaluated every 2 months (mo) using RECIST v1.1. The primary endpoint was the objective response rate (ORR) at 2 mo (complete + partiale response). A two-stage Simon design was applied to each cohort. Median and 95% confidence interval (CI) was estimated through Kaplan-Meier for progression-free survival (PFS), overall survival (OS), and response duration. Response duration was the delay between CR/PR and first progression/death or last follow-up.

      4c3880bb027f159e801041b1021e88e8 Result

      From 08/2013 to 03/2018, 5407 patients from 186 centers entered the biomarker program. Tumor alterations found in patients were: ROS1 tlc in 77/4050; MET amp (≥6 copies/diploid genome) in 251/4171; MET mut in 76/1007.

      Overall, 90 patients (median age, 63 years [30–92]) received crizotinib 250 mg BID.

      #12937.jpg

      73 grade ≥3 adverse events (AEs) or SAE were reported in 70/90 patients. Grade ≥3 AEs were: hematologic toxicities (23%) including neutropenia (11%), and general disorders (16%) including fatigue (10%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      This study confirms the excellent response rate of crizotinib in the ROS1+ population. Response rate in the MET mut population is comparable to the MET amp population. In addition, the response rate to crizotinib in the MET mut population is lower than that in the PROFILE 1001 study. The tolerance profile is good as previously reported.

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    P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.01-21 - Safety of Durvalumab Retreatment in Advanced NSCLC Patients Who Progressed Following Initial Disease Control In ATLANTIC (ID 12386)

      16:45 - 18:00  |  Author(s): Christos Chouaid

      • Abstract
      • Slides

      Background

      In ATLANTIC, patients who completed a year of durvalumab (anti-PD-L1) treatment but later progressed off therapy were eligible for retreatment. We evaluated safety in these patients compared with the overall study population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      ATLANTIC (NCT02087423) was a Phase 2, open-label, single-arm trial in patients with Stage IIIB–IV NSCLC who had received ≥2 prior systemic treatment regimens, including one platinum-based. The study included three independent cohorts. In C1 (EGFR+/ALK+) and C2 (EGFR−/ALK−), enrollment was enriched for patients with ≥25% of tumor cells (TC) expressing PD-L1, while patients in C3 (EGFR−/ALK−) only had PD-L1 TC ≥90%. Patients received durvalumab 10 mg/kg q2w for ≤12 months. Patients who achieved and maintained disease control but then progressed after completing the initial 12-month treatment period were offered retreatment for a maximum of 12 months of further treatment. Safety and tolerability was a secondary outcome.

      4c3880bb027f159e801041b1021e88e8 Result

      As of November 7, 2017, of 442 patients in the ATLANTIC full analysis set, 102 (23.1%) had completed 12 months of initial treatment and 95 (21.5%) had disease control at the end of initial treatment. A total of 40 patients started retreatment. The median actual duration of exposure to durvalumab was 16.0 weeks (range 1–62; 40.1% of patients on treatment for ≥24 weeks) during initial treatment and 18.1 weeks (range 2–52; 37.5% of patients on retreatment for ≥24 weeks) during retreatment. The table shows safety during initial treatment and retreatment.

      Initial treatment (n=444)

      Retreatment phase (n=40)

      Cohort,* n (%)

      C1 (EGFR+/ALK+)

      111 (25.0)

      7 (17.5)

      C2 (EGFR−/ALK−)

      265 (59.7)

      26 (65.0)

      C3 (EGFR−/ALK−; TC ≥90%)

      68 (15.3)

      7 (17.5)

      Any TRAE, n (%)

      256 (57.7)

      19 (47.5)

      Grade ≥3 TRAEs

      42 (9.5)

      6 (15.0)

      TRAEs leading to death

      0

      2 (5.0)

      Serious TRAEs

      28 (6.3)

      4 (10.0)

      TRAEs leading to discontinuation

      10 (2.3)

      4 (10.0)

      Safety analysis set. *A more detailed analysis of exposure and safety by cohort will be presented. Causes of death were: pneumonitis and respiratory failure; cardiac arrest. TRAE=treatment-related adverse event.

      8eea62084ca7e541d918e823422bd82e Conclusion

      A large proportion of patients (37.5%) maintained retreatment for ≥24 weeks, suggesting that patients who originally completed 12 months of treatment can tolerate sustained retreatment. The tolerability profile of durvalumab upon retreatment was similar to that seen during initial treatment, although there were two treatment-related deaths during the retreatment phase. Retreatment with anti-PD-L1 may be feasible for selected patients with NSCLC who demonstrate original benefit and progress off therapy.

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    P1.04 - Immunooncology (Not CME Accredited Session) (ID 936)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.04-31 - Efficacy and Tolerance of Immune-Checkpoint Inhibitors in EGFR, ALK/ROS 1 Non-Small-Cell-Lung-Cancer (NSCLC): GFPC 03-2016 IMAD Study (ID 11166)

      16:45 - 18:00  |  Author(s): Christos Chouaid

      • Abstract
      • Slides

      Background

      Patients with molecular alterations are considered to be poor candidates for immune- checkpoint inhibitors (ICI) on the second-line phase III trials. Here, we analyze the efficacy of ICI in EGFR /ALK/ROS1 NSCLC patients in real world setting

      a9ded1e5ce5d75814730bb4caaf49419 Method

      This retrospective, multicentric study in EGFR, ALK and ROS1 NSCLC treated by ICI, analyzed clinical characteristics and outcomes (progression free survival (PFS), duration of ICI treatment and overall survival (OS), since initiation of ICI .

      4c3880bb027f159e801041b1021e88e8 Result

      51 patients were included from 20 centers in France: 100% adenocarcinoma, 60.7% never smokers, 58.8% female, 58 ± 8.8 years age at diagnosis (36-83), 82.3% EGFR mutated, 15.7 % and 2% ALK and ROS 1 translocated respectively. ICI was a third line treatment in 35,3% of cases, a fourth and more lines treatment in 64,7% of cases. Median PFS was 2.1. [95% CI: 1.5-3.2] months for the whole population, 2.15 [95% CI: 1.4-3;2], for EGFR patients and 2.4 [95% CI: 2.1; NR] for ALK tranlocated patients; 3 months-PFS were 37,3% [95% CI: 26.1; 53.2]; 8 weeks ORR were 19.6% (10 pts with partial response). The median OS for the whole population was 14.7.[95%CI: 12.1-19.2] months, 13.9 [95% CI: 8.8-20] for EGFR patients, 19.2. [95% CI: 13.1-NR] for ALK translocated; 7 (13.7%) patients were treated more than 9 months by ICI; 21.6% (11/51) of patients reported toxicities, all < grade3.

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      8eea62084ca7e541d918e823422bd82e Conclusion

      In this real-world setting analysis, efficacy of ICI in EGFR, ALK, ROS1 NSCLC patients appears close to the efficacy observed in pretreated unselected NSCLC patients. Large prospective studies are needed in these populations

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    P1.13 - Targeted Therapy (Not CME Accredited Session) (ID 945)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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      P1.13-09 - Efficacy and Tolerance of Osimertinib in Real Word Setting: Results of the French Early Access Program (EXPLORE T790M GFPC Study). (ID 11335)

      16:45 - 18:00  |  Author(s): Christos Chouaid

      • Abstract
      • Slides

      Background

      Based on the Phase III AURA3 trial, osimertinib a third-generation EGFR TKI is approved in France in EGFR T790M-positive advanced NSCLC whose disease have progressed on or after first or second generation EGFR TKI.

      Objective: to assess efficacy and tolerance of Osimertinib in real world setting.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Retrospective, multicentric study including T790M-positive advanced NSCLC receiving osimertinib from 07 April 2015 to 27 April 2016 in French early access program. Overall survival (OS) and progression free survival PFS) were analyzed in the whole population, in the subgroup of patients with cerebral metastasis at osimertinib initiation and according to the number of previous treatment lines (1 versus 2 or more).

      4c3880bb027f159e801041b1021e88e8 Result

      The analysis included 205 patients treated in 52 centers; mean age 69.5 ± 11.1 years, female 68.8%, adenocarcinoma 97.5%, EGFR mutations exons 19/21: 66.5%/ 30.5%, never smokers 71.5 %, PS 0-1/2/ 3-4: 54%/18,8%/27.2%, stage IV: 87.4%,presence of cerebral metastasis at osimertinib initiation: 43.7% .

      EGFR T790M mutation diagnosis have been done by liquid biopsy in 34.4 % or on tissue re-biopsy in 65.6%. Patients received a median of 2.8 ± 1.5 lines of treatment before osimertinib initiation. All patients received a first or second generation EGFR TKI before osimertinib. Osimertinib has been used in second line setting in 18% of cases and in third line or more setting in 82%.

      Median PFS was 12.4 (CI 95%: 10.1-15.1) months in the whole population, 9.7 (CI 95%: 7.7-13.5) in patients with cerebral metastasis and 15.8 (CI 95%: 11.9-17) months in patients without cerebral metastasis, (p : 0.2). PFS was not significantly different according to the use of osimertinib as second or third line of treatment: 12.6 (CI 95%: 6.7-17.5) vs 12.4 (CI 95%: 9.7-15.3) months, respectively.

      Median OS since osimertinib initiation was 20.5 (CI 95%: 16.9-24.3) months, 23.06 [18.56;27.83] and 18.00 [12.16;22.21] months in patients without and with cerebral metastasis, respectively. OS was not significantly different according the use of osimertinib as second or third line of treatment: 17.5 (CI 95%: 11.6;27.8) vs 21.7 (CI 95%: 17.3;24.3) months (p=0.4).

      A new biopsy was performed at disease progression on osimertinib in 50 patients: data will be presented.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Efficacy of Osimertinib in real world setting appears similar to that observed in clinical trials in patients with EGFR T790M mutation in ≥2ndline.

      Clinical trial information: Supported by an academic grant from Astra Zeneca

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    P2.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 964)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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      P2.15-04 - Costs of Cares on the Month Before Death of Patients with Lung Cancer: A French National Database Survey (ID 12006)

      16:45 - 18:00  |  Author(s): Christos Chouaid

      • Abstract
      • Slides

      Background

      There is a few data’s on the burden of the last month of life of patient with lung cancer and on impact of end of life (EOL) aggressiveness of cares. The aim of this study was to assess the costs of the month before death in patients with lung cancer and the impact of aggressiveness of cares during this period.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Using a French hospital discharge database (PMSI, Programme de Médicalisation des Systèmes d’Information), all adult patients with lung cancer who death between January 1, 2010 and December 31, 2011 (cohort 1) and between January 1, 2015 and December 31, 2016 (cohort 2) were identified through the International Classification of Diseases 10th version (ICD-10). Aggressiveness of EOL cares was assessed by the following criteria’s 1) chemotherapy administrated within last 14 days of life (DOL); 2) > 1 hospitalizations within 30 DOL; 3) ICU admission within 30 DOL; and 4) palliative care < 3 days before death.Direct hospital costs were assessed from the French public health insurer perspective based on DRG tariffs. Costs were expressed in 2017 Euros.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 90,827 i patients were identified: men: 74%, median age: 67 years [59-77], metastatic at diagnosis: 70%;57% have at least one marker of aggressiveness of EOL cares (repeated hospitalization: 49%, ICU admissions: 12%, chemotherapy within 14 DOL: 9%, and palliative care < 3 days before death: 5%). The mean cost of last month of EOL was € 8,152 ± 5,117 (346 - 91,537) per patient, significantly more important in patients with at least one aggressiveness marker of EOL cares (€ 9,480±5,946 vs € 6,376±2,898, p <0.001). These over-costs were explained in large part by hospitalizations and intensives cares costs (€ 8,080 ± 4,296 vs € 6,228 ±2,752 and € 1,063 ± 2,948 vs € 92 ± 546). The cost of expensive drugs (€ 285 ± 888 vs € 39 ± 330), radiotherapy (€ 14 ± 138 vs € 6 ± 84) and medical devices (€ 38 ± 352 vs € 11 ± 137) does not impact the extra costs of patients with markers of aggressiveness of cares.

      8eea62084ca7e541d918e823422bd82e Conclusion

      The EOL economic burden is major for the healthcare system, with extra costs of more than € 3,000 per patient in case of EOL aggressiveness markers. Organizing a precocious palliative care system may improve the quality of cares of EOL and reduce the financial costs of the last days of life of lung cancers patients.

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