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Suzanne Dahlberg



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    P1.16 - Treatment of Early Stage/Localized Disease (Not CME Accredited Session) (ID 948)

    • 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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      P1.16-47 - Adjuvant Targeted Therapy Following Standard Adjuvant Therapy for Resected NSCLC: An Initial Report from ALCHEMIST (Alliance A151216) (ID 12828)

      16:45 - 18:00  |  Author(s): Suzanne Dahlberg

      • Abstract
      • Slides

      Background

      The Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST) was launched in 2014 across the National Clinical Trials Network (NCTN) of the National Cancer Institute (NCI). This trial platform aims to enroll up to 8300 patients with resected high-risk non-small cell lung cancer (NSCLC) to facilitate enrollment to adjuvant targeted therapy trials following completion of standard adjuvant therapy, and to collect biospecimens for clinical and investigational genomics. On 5/1/2016, the study was expanded to include squamous NSCLC and PDL1 testing to facilitate enrollment to a new immunotherapy study.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Eligible patients have completely resected NSCLC, stage IB (>4cm) to IIIA by AJCC 7. Eligibility window extends 75-285 days post-op depending upon receipt of adjuvant chemotherapy and/or radiation. Molecular testing of EGFR, ALK, PDL1 is performed centrally (depending on the histology and testing results) and results are returned to sites within 7-21 days. FFPE tissue and blood are collected by the NCI for genomic analysis. Appropriate patients may then enroll to one of three therapeutic trials studying single agent adjuvant targeted therapy (erlotinib NCT02193282, crizotinib NCT02201992, or nivolumab NCT02595944) versus observation.

      4c3880bb027f159e801041b1021e88e8 Result

      As of March 19, 2018, 2945 patients have been enrolled from 575 sites within the US, with a median enrollment of 98/month (range: 71-133) in 2017. Central molecular testing was completed in 83%-92% of appropriate patients: EGFR L858R/19del was detected in 395 of 2468 patients (16.0%), ALK FISH was positive in 106 of 2458 patients (4.3%), and PDL1 IHC was >1% in 902 of 1464 patients (61.6%). Adequate tissue and blood for whole exome sequencing (WES) was collected on 1928 patients (65.5%), and enrollment plasma (added January 2017) has been collected on 885 patients (30.1%). Of 1960 patients deemed to be eligible for the adjuvant treatment trials with sufficient follow-up, 560 (28.6%) were enrolled; those enrolled were younger (p=0.01) and had higher N stage (<0.01) than those not enrolled. The primary reason for eligible patients not enrolling to treatment trials was lack of interest in further adjuvant therapy (53%).

      8eea62084ca7e541d918e823422bd82e Conclusion

      ALCHEMIST has achieved an enrollment of ~100 patients/month with resected high-risk NSCLC. This initial report demonstrates the feasibility of central molecular testing for enrollment to adjuvant targeted therapies. Efforts are ongoing to plan clinically-informed genomic analyses of tumor and plasma, as well as the planning of new treatment arms that leverage this ongoing trial platform.

      Support: U10CA180821, U10CA180882, U10CA180820, U10CA180868, U10CA180888; ClinicalTrials.gov Identifier: NCT02194738

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)

    • 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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      P2.01-73 - Automated Image Analysis Tool for Tumor Volume Growth Rate to Guide Precision Cancer Therapy: EGFR-Mutant NSCLC as a Paradigm (ID 11971)

      16:45 - 18:00  |  Author(s): Suzanne Dahlberg

      • Abstract

      Background

      Imaging remains a crucial component in the evaluation of the therapeutic benefit of precision cancer therapy, because it objectively characterizes tumor burden changes during therapy and provides guides for treatment decisions. The purpose of the present study is to develop an automated analytic module for calculation of tumor growth rate from serial CT scans and evaluate the module functionality and reproducibility in a pilot cohort of advanced NSCLC patients with EGFR mutations treated with EGFR tyrosine kinase inhibitors.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      The module utilized a commercially available image-processing workstation equipped with a validated tumor volume measurement tool. A novel analytic software module was programmed with the capability to record and display serial tumor volume changes and to calculate tumor volume growth rate over time and added to the workstation. The functionality and reproducibility of the module was evaluated using a pilot cohort of 24 EGFR-mutant patients treated with EGFR inhibitors by two independent thoracic radiologists.

      4c3880bb027f159e801041b1021e88e8 Result

      The module analyzed chest CT scans from 24 patients (5 males, 19 females; median age: 61) with a median of 8 scans per patient, totaling 227 scans and provided a graphical display with an automated calculation of tumor growth rate after the nadir volume for each patient. High inter and intraobserver agreements were noted for tumor growth rates, with concordance correlation coefficients of 0.9323 and 0.9668, respectively. Interpretation of slow versus fast tumor growth using previously identified threshold of ≤0.15/month had a perfect interobserver agreement (κ=1.00), and an excellent intraobserver agreement (κ=0.895).

      8eea62084ca7e541d918e823422bd82e Conclusion

      The present study describes the development of an image analytic module for assessing tumor growth rate and the data demonstrates the functionality and reproducibility of the module in a pilot cohort of EGFR-mutant NSCLC patients treated with EGFR-TKI. The image analytic module is an initial step for clinical translation of the tumor growth rate approach to guide cancer treatment in precision oncology.

      6f8b794f3246b0c1e1780bb4d4d5dc53

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    P3.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 978)

    • Event: WCLC 2018
    • Type: Poster Viewing in the Exhibit Hall
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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      P3.12-06 - SLFN11 Expression and Efficacy of PARP Inhibitor Therapy in Extensive Stage Small Cell Lung Cancer: ECOG-ACRIN 2511 Study (ID 14113)

      12:00 - 13:30  |  Author(s): Suzanne Dahlberg

      • Abstract

      Background

      Veliparib (V),an oral small molecule inhibitor of poly (ADP) ribose polymerase (PARP) enhanced cytotoxic chemotherapy in preclinical models of small cell lung cancer (SCLC). The combination of V with cisplatin/etoposide (CE) doublet showed efficacy improvement as first-line therapy of extensive stage SCLC (ES-SCLC) with adjusted PFS HR: 0.63 1-sided p=0.01. There was differential treatment effect by strata (adjusted treatment HR comparing CE+V: CE: 0.34; 80% CI: 0.22 - 0.51; 1-sided p<0.001 for male patients with high tumor burden versus adjusted HR: 0.81 80% CI: 0.60 - 1.09; 1-sided p=0.18 for other patients subsets) highlighting the need to identify patient subset most likely to benefit. SLFN11 expression was previously shown to be associated with benefit of V when combined with temozolomide in relapsed SCLC and also predicted benefit of CE in preclinical models. We assessed the utility of SLFN11 as a predictive biomarker in the context of E2511 frontline clinical trial.

      a9ded1e5ce5d75814730bb4caaf49419 Method

      Archival tissue samples collected from patients with ES-SCLC enrolled and treated on E2511 study was employed for biomarker analysis looking at SLFN11 expression by immunohistochemistry. The study has 88% power to detect a PFS hazard ratio of 0.5 comparing SLFN11 (+) and (-) patients using a one-sided 0.025 level logrank test.

      4c3880bb027f159e801041b1021e88e8 Result

      There was an imbalance between control and experimental arms in the Male/abnormal LDH stratum (in strata) with respect to Age: p=0.006; malignant pleural effusion: p=0.095 and T stage: p=0.02. Median PFS was 5.1 mos on CE (95% CI 4.1-6.1) vs. 6.2 mos on CE+V (95% CI 5.9-8.8); HR=0.32, p=0.002 (unadjusted); median OS on CE was 8.8 mos (95% CI 6.6-11.1) vs. 9.5 mos on CE+V (95% CI 7.8-12.8); HR=0.76, p=0.39. Clinical outcome differences based on SLFN11 expression is ongoing and will be presented at the meeting.

      8eea62084ca7e541d918e823422bd82e Conclusion

      Pending ongoing analysis of correaltion of biomarker with clinical outcomes

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