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Ancilla W. Fernandes



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    EX04 - Mini Oral Abstract Session - MA08.06, MA18.02, MA19.02, MA20.11 (ID 1006)

    • Event: WCLC 2018
    • Type: Exhibit Showcase
    • Track: Advanced NSCLC
    • Presentations: 1
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      EX04.01 - Outcomes Among Patients with EGFR-Mutant Metastatic NSCLC with and without Brain Metastases (ID 13671)

      09:55 - 10:00  |  Author(s): Ancilla W. Fernandes

      • Abstract
      • Slides

      Background

      Brain metastases (BM) in patients with non-small cell lung cancer (NSCLC) are common, with reported frequencies of up to 44%. The epidermal growth factor receptor-mutant (EGFRm) subtype of NSCLC is known to have specific pathologic features that may influence patterns of metastases and outcomes. The prevalence of BM in patients with EGFRm NSCLC is unknown; however, incidence is expected to increase as new treatments emerge that prolong survival. Therefore, an understanding of the impact of BM and burden of illness in this population is needed.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      A retrospective observational matched cohort study of adults with EGFRm metastatic NSCLC, with BM and without BM (NBM), between January 1, 2014, and July 31, 2016, with follow-up to March 31, 2017. Data were extracted from the iKnowMedTM electronic health record database of patients in the US Oncology Network of community oncology practices, supplemented with chart review. Patients were matched 1:1 by age categories and sex. Patients enrolled in interventional clinical trials or with other cancer diagnoses were excluded. Categorical variables were analyzed using chi-squared tests; time to treatment failure (TTF) and overall survival (OS) were assessed using the Kaplan-Meier method starting from the matched line of therapy for TTF and from NSCLC diagnosis for OS.

      4c3880bb027f159e801041b1021e88e8 Result

      A total of 402 (BM, 201; NBM, 201) patients were included; median age was 70 and 77 years, respectively (p<.05). Patients in both cohorts were predominantly female (65%), Caucasian (69%), non-smokers (42%), and had adenocarcinoma (92%). Over 90% of patients were treated in the first-line setting. Median TTF in the BM and NBM cohorts following initial treatment was 10.9 months (95% confidence interval [CI], 9.5-12.0) and 10.4 months (95% CI, 8.9-12.2), respectively. Median OS for the BM and NBM cohorts was 11.9 months (95% CI, 9.7-13.4) and 16.0 months (95% CI, 9.1-20.6), respectively (log-rank p=.017). Median OS from onset of BM in the BM cohort was 10.0 months (95% CI, 7.4-11.2). While CNS symptoms were present in both cohorts, they were significantly higher in the BM cohort; patients in the BM cohort had significantly greater use of home healthcare, physical therapy, and social work services (p<.05).

      8eea62084ca7e541d918e823422bd82e Conclusion

      Median TTF was similar in patients with EGFRm metastatic NSCLC with BM and NBM; however, OS was significantly worse in the BM cohort. Symptom burden and healthcare resource utilization were also higher in the BM cohort. These findings highlight an unmet treatment need for patients with EGFRm NSCLC with BM.

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    MA15 - Colliding Approaches - EGFR and Immunotherapy (ID 916)

    • Event: WCLC 2018
    • Type: Mini Oral Abstract Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 13:30 - 15:00, Room 107
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      MA15.11 - Real World Biomarker Testing and Treatment Patterns in Patients with Advanced NSCLC Receiving EGFR-TKIs (ID 12705)

      14:40 - 14:45  |  Author(s): Ancilla W. Fernandes

      • Abstract
      • Presentation
      • Slides

      Background

      In patients who progress on treatment with first- or second-generation EGFR-TKIs, 50–60% will have an EGFR T790M resistance mutation. Osimertinib, a third-generation EGFR-TKI, is FDA approved for use in patients with metastatic EGFR T790M-positive NSCLC and disease progression on or after prior EGFR-TKI therapy, and recently gained additional approval for first-line treatment for patients with EGFR Ex19del/L858R positive advanced NSCLC. We sought to observe how many patients in the real world underwent biomarker testing on progression and subsequently received osimertinib, when T790M positive.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Flatiron Health EHR-derived database was used to identify adult patients with NSCLC treated with a first- or second-generation EGFR-TKI from 11/2015–09/2017, with the start of first EGFR-TKI defined as the index date. Patients were stratified by EGFR-TKI use as a first (1L) or later line (2L+) treatment. EGFRm status, including T790M testing and subsequent treatments received after initiating first- or second-generation EGFR-TKI, were described. Chart review was conducted on patients who received a subsequent therapy to confirm disease progression.

      4c3880bb027f159e801041b1021e88e8 Result

      Patients in this study (n=782; 1L: n=435; 2L+: n=347) had a median age of 69 years, 64% were female, 56% were white, 87% were seen in the community, with a median follow-up of 307 days. During the study period, 30% (235/782; 1L: 96/435 [22%]; 2L+: 139/347 [40%]) of patients died without receiving a subsequent therapy, and 38% (294/782; 1L: 160/435 [37%]; 2L+: 134/347 [39%]) received subsequent therapies. From post-index date to initiation of subsequent therapies, 30% (88/294; 1L 63/160 [39%]; 2L+ 25/134 [19%]) of patients were tested for EGFR mutations including T790M. Among patients who received subsequent therapies, treatments included chemotherapies (1L=23%; 2L+=37%), immunotherapies (1L=16%; 2L+=43%), and targeted therapies (1L=64%; 2L+=30%). On progression, 25% (1L 40/160) and 5% (2L+ 7/134) of the patients received osimertinib. Of those tested for EGFR mutation post-index date (n=88), 28% (n=25) were positive for T790M and 96% of these (n=24) received osimertinib. Most patients (251/294 [85%]; 1L: 136/160 [85%]; 2L+: 115/134 [86%]) on subsequent therapies were confirmed to have disease progression at chart review.

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this study, a third of patients were tested for subsequent EGFR mutations including EGFR T790M following treatment with first- or second-generation EGFR-TKI. Of these, a third were positive for T790M and nearly all of the T790M positive patients received osimertinib. These findings highlight low rates of biomarker testing at progression, and the need for optimal treatments that maximize benefits for patients with EGFRm NSCLC.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    OA10 - Right Patient, Right Target & Right Drug - Novel Treatments and Research Partnerships (ID 910)

    • Event: WCLC 2018
    • Type: Oral Abstract Session
    • Track: Targeted Therapy
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/25/2018, 10:30 - 12:00, Room 106
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      OA10.01 - Patient Preferences for Tyrosine Kinase Inhibitor Treatments for EGFR Mutation Positive Metastatic NSCLC (ID 13735)

      10:30 - 10:40  |  Author(s): Ancilla W. Fernandes

      • Abstract
      • Presentation
      • Slides

      Background

      EGFR mutation positive (EGFRm) NSCLC responds to EGFR-tyrosine kinase inhibitors (TKIs). First-, second-, and third-generation EGFR-TKI treatment attributes vary in efficacy, side effects, and dosing regimen. We used two different methods to explore treatment preferences among patients with EGFRm metastatic NSCLC.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Patients with EGFRm metastatic NSCLC were recruited in the US to participate in an online survey containing two complimentary preference elicitation methods. First, preferences were assessed through direct elicitation exercises where participants chose between competing treatment profiles. The first exercise compared two profiles with a large difference in progression-free survival (PFS) (6 vs 18 months). The second exercise compared two profiles with a smaller difference (10 vs 18 months). Both exercises compared the same side effect risks (0–1% vs 2–16% risk). Second, a discrete choice experiment (DCE) was used to assess preferences for variation in treatments in terms of PFS, severity of side effects (mild/moderate/severe), and mode of administration. These attributes and levels were varied based on a D-efficient design. Participants completed 10 DCE choice tasks where they saw pairs of hypothetical treatments with different attribute levels and selected their preferred treatment. A choice model was estimated using conditional logit regression.

      4c3880bb027f159e801041b1021e88e8 Result

      Between 10/2017 and 03/2018, 90 patients with EGFRm metastatic NSCLC were recruited and completed the survey: 42% female; 79% white; 76% taking first-line or second-line EGFR-TKIs at time of survey. Median time since diagnosis: 2.1 years (inter-quartile range: 1.1–2.7). In the direct elicitation exercise, participants opted for shorter PFS in exchange for more favorable side effects, but were less likely to do so for a large difference in PFS (52% of participants) vs a smaller difference (66%; p<0.001). Participants who chose shorter PFS when difference in PFS was large were more likely to be taking EGFR-TKIs (odds ratio: 21.4; 95% confidence interval: 2.24, 204.88). No relationship between choice and treatment characteristic was observed when difference in PFS was small. In the DCE, conditional logit regression indicated that to avoid severe levels of nausea/vomiting, diarrhea, rash, or fatigue, participants on average would accept reductions in PFS of 13, 11, 9, and 8 months, respectively. Participants would accept reduction in PFS of 7 months for oral treatment taken with/without food vs IV.

      8eea62084ca7e541d918e823422bd82e Conclusion

      In this online survey of patients with EGFRm metastatic NSCLC, some patients were willing to accept shorter PFS for a better safety profile and dosing convenience; however, PFS remained an important attribute in treatment choice.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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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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      P2.15-26 - Rates and Economic Burden of Adverse Events in Patients With Metastatic NSCLC Treated with EGFR-TKIs (ID 13643)

      16:45 - 18:00  |  Author(s): Ancilla W. Fernandes

      • Abstract
      • Slides

      Background

      Trials of first- and second-generation epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitors (TKIs) have reported severe adverse events (SAEs) in 6%–49% of patients with EGFR-mutant (EGFRm) metastatic non-small cell lung cancer (mNSCLC). This study describes the real-world rates and incremental cost of AEs in this population.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Adults with mNSCLC treated with EGFR-TKIs as first-line therapy (first dispensing defined as the index date) with ≥1 lung cancer diagnosis code, no claim for a lung surgery, and no administration of other NSCLC therapies during 3 months pre-index date were identified from the IQVIATM Real-World Data Adjudicated Claims – US database (Q2/2012–Q1/2017). The select AEs identified from prescribing information of EGFR-TKIs were skin and ocular disorders, interstitial lung disease (ILD), diarrhea, microangiopathic hemolytic anemia, gastrointestinal perforation, cardiac and cerebrovascular events, renal failure, and hepatotoxicity. AE rates per 1,000 patient-years and healthcare cost per-patient-per-month (PPPM) were calculated during first-line therapy. Multivariate linear regression was used to assess cost differences (CD) for patients with and without AEs, adjusting for baseline characteristics. All AEs (outpatient and hospitalization claims) and a subgroup of SAEs (hospitalization claims) were analyzed.

      4c3880bb027f159e801041b1021e88e8 Result

      Among 1,646 patients, 86.1% were treated with erlotinib, 12.1% with afatinib, and 1.0% with gefitinib. During first-line therapy, 549 patients had ≥1 acute AE (33.4%, 870.9 per 1,000 patient-years) and 200 patients had ≥1 acute SAE (12.2%, 220.1 per 1,000 patient-years). Skin and ocular disorders (17.6%, 482.9 per 1,000 patient-years) and ILD (4.5%, 139.6 per 1,000 patient-years) had the highest rate among all AEs and SAEs, respectively (Figure). Patients with AEs had higher PPPM healthcare costs than patients without AEs (all AEs: CD=$1,079, p<0.001; SAEs: CD=$4,700, p<0.001).

      figue_rate of occurrence of acute aes during treatment period.jpg

      8eea62084ca7e541d918e823422bd82e Conclusion

      Over one-tenth of patients suffered from SAEs, resulting in a sizeable economic burden. EGFR-TKIs with more favorable safety profiles may reduce substantial healthcare costs in this patient population.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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