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Scott Owen
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OA05 - Clinical Trials in IO (ID 899)
- Event: WCLC 2018
- Type: Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 13:30 - 15:00, Room 106
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OA05.04 - Discussant - OA 05.01, OA 05.02, OA 05.03 (ID 14554)
14:00 - 14:15 | Presenting Author(s): Scott Owen
- Abstract
Abstract not provided
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P1.09 - Pathology (Not CME Accredited Session) (ID 941)
- 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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P1.09-08 - Integrating NGS Information for Staging Multiple Lung Adenocarcinoma: A McGill University Health Centre Retrospective Study. (ID 12635)
16:45 - 18:00 | Author(s): Scott Owen
- Abstract
Background
The incidence of patients with multiple primary lung adenocarcinoma (MPLC) is increasing and the optimal management of these patients remains unclear. Distinguishing between MPLC and intrapulmonary metastases is at the heart of the diagnostic dilemma. The Comprehensive Histologic Assessment (CHA) relies on microscopic examination including histological subtypes, cytological and stromal features. CHA has shown a good reproducibility but with a non-negligible rate of disagreement, even between expert pathologists. Moreover, predictive biomarker testing has become standard of care for lung cancer patients and the use of Next-Generation Sequencing (NGS) is now widely available. The goal of this study was to evaluate how the NGS information may be integrated in the diagnostic strategy for distinguishing between MPLC and patients with stage III/IV disease.
a9ded1e5ce5d75814730bb4caaf49419 Method
We conducted a retrospective study of all surgical patients with > 1 synchronous lung carcinoma over two years. We identified 59 cases and reviewed initial clinical, pathological and molecular reports. Patients having multifocal lung adenocarcinoma with prominent lepidic component or an adenocarcinoma associated with another histological type were considered as synchronous primaries and not tested for molecular aberrations. The NGS panel analysis using an Illumina miSeq platform included the following genes: AKT1, BRAF, EGFR, ERBB2, FOXL2, GNA11, GNAQ, KIT, KRAS, MET, NRAS, PDGFRA, PIK3A, RET, and TP53.
4c3880bb027f159e801041b1021e88e8 Result
Histologically, the majority were considered as MPLC with only four suspected metastases. Twenty-five patients had adenocarcinoma with prominent lepidic component and one case had two different histological differentiations (adenocarcinoma and squamous cell carcinoma). Most of the suspected synchronous primary tumours had different mutations in the separate tumours. Relevant mutations were found in KRAS and P53 genes, with fewer mutations in EGFR, PIK3CA and BRAF genes, in accordance with known frequencies. In 12% of the cases, the NGS was not informative with no molecular mutation in either tumours. One case was reclassified from MPLC to intra-pulmonary metastases and restaged after NGS. For one patient, a TP53 mutation allowed us to reclassify two nodules as metastases from a previous adenocarcinoma originally diagnosed in 2012. In one patient having three separate nodules, different KRAS and TP53 mutations allowed the diagnosis of two nodules as intrapulmonary metastases and one contralateral nodule as synchronous primary adenocarcinoma.
8eea62084ca7e541d918e823422bd82e Conclusion
Although CHA is an efficient method for diagnosing MPLC from intra-pulmonary metastases there are still difficult cases with a risk of misdiagnosis. Integrating NGS analysis in the diagnostic strategy may lead to improved quality and accuracy in the staging of MPLC.
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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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P2.01-04 - Reducing Time to Molecular Diagnosis for Advanced NSCLC in the Context of a Reference Testing Center (ID 13972)
16:45 - 18:00 | Author(s): Scott Owen
- Abstract
Background
Testing for mutation of the epidermal growth factor receptor (EGFR) gene is required for treatment of patients with advanced non-small cell lung cancer (NSCLC). First-line treatment with an EGFR tyrosine kinase inhibitor (TKI) in NSCLC patients with an activating EGFR mutation significantly impacts survival. Within the Rossy Cancer Network, the McGill University Health Centre (MUHC) has a supra-regional designation to perform all thoracic surgeries, while the Jewish General Hospital (JGH) is the reference testing center for specialized molecular pathology services. Significant differences in time to TKI therapy were noted between these centers. Our objective was to identify contributing factors to reduce network-wide delays.
a9ded1e5ce5d75814730bb4caaf49419 Method
We used the JGH molecular pathology database to identify all specimens tested for EGFR between 2015 and 2016 and mapped the process steps from diagnostic procedure to start of TKI therapy. We identified process differences and initiated reflex testing at the MUHC; EGFR testing was ordered reflexively by pathologists for all non-squamous NSCLC biopsies and other specimens from known or suspected advanced stage NSCLC.
4c3880bb027f159e801041b1021e88e8 Result
Implementation of reflex testing led to a 13-day reduction from pathology report to EGFR request (Figure 1, BàC). We subsequently identified that MUHC time from molecular results to start of TKI therapy was twice that of the JGH (24 vs 12 mean days). This was due to an additional step requiring integration of faxed molecular results into the patients’ electronic health record.
8eea62084ca7e541d918e823422bd82e Conclusion
We applied lean strategies to reduce time to initiation of targeted therapy. Within our network and in the context of a reference testing center, we identified two critical components that significantly contributed to delays in treatment planning: (i) absence of reflex testing and (ii) unlinked information technology systems. As Quebec moves towards specialized testing centers, it is important to be cognisant of their impact on timely treatment.
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P2.13 - Targeted Therapy (Not CME Accredited Session) (ID 962)
- 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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P2.13-13 - Real-World Study of Osimertinib in EGFR T790M-Mutated Non-Small Cell Lung Cancer (NSCLC): ASTRIS Canadian Cohort Analysis (ID 12986)
16:45 - 18:00 | Author(s): Scott Owen
- Abstract
Background
ASTRIS is an open-label, single-arm, multinational, real world study of osimertinib for patients with advanced/metastatic epidermal growth factor receptor-mutated (EGFRm) T790M-positive non-small cell lung cancer (NSCLC) who previously received therapy with an EGFR tyrosine kinase inhibitor (EGFR-TKI) (NCT02474355). Data cut-off (DCO) for the second interim analysis was 20 October 2017, with 3014 patients enrolled (full analysis set), including 99 patients in Canada.
a9ded1e5ce5d75814730bb4caaf49419 Method
Adult patients with locally advanced/metastatic EGFRm NSCLC, not amenable to curative surgery/radiotherapy, with confirmation of T790M and prior EGFR-TKI therapy were enrolled. Patients were included with World Health Organization performance status of 0 to 2, as well as those with asymptomatic stable central nervous system (CNS) metastases. Patients received osimertinib 80 mg once daily until loss of clinical benefit. The primary efficacy outcome was overall survival (OS), with secondary outcomes of investigator-assessed response rate (RR), progression-free survival (PFS), and time to treatment discontinuation (TTD).
4c3880bb027f159e801041b1021e88e8 Result
From study start (14 January 2016) to DCO (20 October 2017), 99 patients were enrolled at 12 Canadian centres. Median age was 64 years (30-89 years). Patients were 68% female, 57% Asian, and had ECOG 0/1/2 of 22%/65%/13%. Twenty-five patients had CNS metastases at screening. Gefitinib was the most commonly used previous EGFR-TKI (gefitinib, erlotinib and afatinib were 80%, 14%, and 14%, respectively). Thirty-nine percent had previous chemotherapy; 6% previous immunotherapy; 46% previous radiotherapy. All patients had T790M: 75% tissue, 7% blood and 18% cytology. Biomarker testing methods varied, with the majority (61%) identified by Entrogen EGFR kit. At DCO, 45 patients had discontinued treatment. OS data were immature. Median PFS was 11.0 months (95% CI, 8.9-13.3). Median TTD was 14.9 months (95% CI, 11.2-not calculated). RR was 67.0% (95% CI, 56.7-76.2); sub-analyses showed RR of 69.9% (58.0-80.1), 66.7% (22.3, 95.7) and 55.6% (30.8, 78.5) for patients with T790M by tissue, blood and cytology, respectively. Serious adverse events (AEs) were reported for 18% of patients. AEs leading to dose modifications and discontinuations were reported for 12% and 5% of patients, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
The Canadian results from this real world study of osimertinib in advanced/metastatic EGFRm T790M-positive NSCLC, which includes heavily pretreated patients and various approaches to biomarker testing, were comparable to outcomes reported in the phase III study AURA3 (NCT02151981). These findings provide further support for osimertinib as standard of care for EGFRm T790M-positive NSCLC.
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P3.04 - Immunooncology (Not CME Accredited Session) (ID 970)
- 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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P3.04-17 - Cost-Effectiveness of Atezolizumab for Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) in Canada (ID 13497)
12:00 - 13:30 | Author(s): Scott Owen
- Abstract
Background
Atezolizumab is a humanized monoclonal antibody targeting PD-L1 that enhances tumour-specific T-lymphocyte responses. The efficacy and safety of atezolizumab versus docetaxel was demonstrated in patients with advanced NSCLC previously treated with chemotherapy in the phase III OAK trial (NCT02008227). Here, we report the cost-effectiveness in Canada of atezolizumab compared with docetaxel and nivolumab in previously-treated advanced NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
A cost-utility analysis was performed to estimate the cost per quality-adjusted life-year (QALY) associated with atezolizumab treatment compared to docetaxel and nivolumab in previously-treated advanced NSCLC. A three-state partitioned-survival model was developed, and the target population reflected patients in the OAK study. The analysis was conducted using a 10-year time horizon from the perspective of the Canadian publicly-funded healthcare system. Treatment efficacy was informed by the OAK trial (data cut-off date of January 23, 2017), with crossover adjustment. Overall survival (OS), progression-free survival (PFS), and time to treatment discontinuation (TTD) for atezolizumab were estimated by parametric extrapolation of Kaplan-Meier (KM) data from OAK. For OS, a cure modelling approach was used with an assumed cure fraction of 1% for atezolizumab to represent long-term survivorship as seen with cancer immunotherapy. OS, PFS and TTD for docetaxel and nivolumab were estimated through network meta-analysis of randomized controlled trials. A discount rate of 1.5% was applied in the base case to costs and effects. Costs considered in the analysis included treatments and administration, supportive care, adverse events management, subsequent treatments, and terminal care. Most costs were obtained from publicly-available sources. Health-related quality of life was estimated using EQ-5D-3L data from OAK. All analyses were performed probabilistically, and several scenario analyses were performed to assess the robustness of results.
4c3880bb027f159e801041b1021e88e8 Result
The base-case incremental cost per QALY for atezolizumab versus docetaxel was $142,074 (2017 CAD). Atezolizumab resulted in more QALYs and less costs compared to nivolumab; however, differences were small. Docetaxel had the highest probability of being cost effective at a willingness-to-pay (WTP) threshold below $125,000/QALY; the probability that atezolizumab was cost effective approached 40% at WTP thresholds beyond $125,000/QALY. Results were generally consistent in scenario analyses.
8eea62084ca7e541d918e823422bd82e Conclusion
The ICER of atezolizumab vs. docetaxel used as second-line treatment for advanced NSCLC was $142,074/QALY. Atezolizumab dominated nivolumab; however, differences were small. The results of our analysis, as well as the added convenience of a fixed-dose regimen administered every three weeks, support the use of atezolizumab for patients in Canada with advanced NSCLC after progression on chemotherapy.
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