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J. Laskin
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MA 04 - Advocacy: Listen to the Patients (ID 655)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Patient Advocacy
- Presentations: 1
- Moderators:Rudolf M Huber, C.L. Dégi
- Coordinates: 10/16/2017, 11:00 - 12:30, Room 313 + 314
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MA 04.02 - Assessing the Psychosocial Needs of Newly Diagnosed NSCLC Patients: Identifying the Population Most At-Risk (ID 8345)
11:00 - 12:30 | Author(s): J. Laskin
- Abstract
- Presentation
Background:
The Psychosocial Screen for Cancer (PSSCAN-R) questionnaire and the Canadian Problem Checklist (CPC) are validated screening tools used to identify the psychosocial needs of patients with cancer. The questionnaire identifies at-risk patients requiring timely psychosocial intervention and the CPC comprises of patient-reported support needs in 6 psychosocial domains. The study goal was to review reported needs of patients with NSCLC to facilitate the development of programs and resources specific to those identified as at-risk for psychosocial distress.
Method:
All patients with NSCLC referred to BC Cancer Agency centres from 2011-2015, who completed a prospective PSSCAN-R and CPC questionnaire at the time of their first visit, were included in the study. Demographics and baseline disease characteristics were collected retrospectively. Univariate analysis using the Chi-squared test and Fisher’s exact test were used to compare patient groups based on gender, age and stage of disease.
Result:
4313 patients completed the PSSCAN-R and CPC questionnaire. The median age was 70 (21-99), with 50% female and 51% of patients with stage IV disease. 29% of patients live alone with 13% having lost their spouse/partner. However, 93% of patients report regular contact with friends/relatives and 85% have someone who can provide assistance with daily tasks (shopping, cooking, transportation). Female patients, patients aged 65 or younger, and those with advanced disease were more likely to report significantly higher levels of anxiety and depression, and reported higher number of needs on the CPC. Figure 1
Conclusion:
Newly diagnosed patients with NSCLC report clinically higher levels of anxiety and depression and have greater number of concerns in multiple psychosocial domains. Resources should be developed for lung cancer patients based on their care needs with careful consideration of patients' age, gender and disease stage to optimally support their psychosocial needs during treatment and follow up.
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OA 10 - Liquid Biopsy for Genomic Alterations (ID 678)
- Event: WCLC 2017
- Type: Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:Adrian G. Sacher, Pasi A Jänne
- Coordinates: 10/18/2017, 11:00 - 12:30, F201 + F202 (Annex Hall)
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OA 10.01 - Detection of EGFR mutations from plasma ctDNA in the osimertinib Phase III trial (AURA3): comparison of three plasma assays (ID 8984)
11:00 - 12:30 | Author(s): J. Laskin
- Abstract
- Presentation
Background:
AURA3 (NCT02151981) showed osimertinib, a third-generation EGFR-TKI, significantly prolongs progression‑free survival and improves response rate vs platinum‑pemetrexed in patients with T790M-positive advanced NSCLC, whose tumors had progressed on first-line EGFR-TKI therapy. Using patient baseline samples, we report concordance between plasma circulating tumor DNA (ctDNA) and tissue for the detection of EGFR mutations (T790M, exon 19 deletions [Ex19Del], L858R) using three distinct plasma detection technologies.
Method:
Tumor tissue biopsy samples were taken following progression on first-line EGFR‑TKI treatment. Baseline central confirmation of EGFR mutation status was by cobas[®] EGFR Mutation Test (Roche Molecular Systems). Where possible, baseline blood samples for plasma ctDNA screening were collected from patients in the osimertinib treatment group and analyzed using allele specific (AS)‑PCR (cobas[®] EGFR Mutation Test v2), ddPCR (Biodesix) and next generation sequencing (NGS, Guardant Health).
Result:
Figure 1 ctDNA was undetectable (negative for all three EGFR mutations [T790M, Ex19Del, L858R]) in 51/228 (22%) patients by AS-PCR, 58/211 (27%) by ddPCR, and 54/230 (23%) by NGS. Robust correlations (Spearman’s Rank) were observed for EGFR mutant allelic fractions (AFs) between ddPCR and NGS assays: T790M R[2] 0.9129 (n=201), Ex19Del R[2] 0.9384 (n=201), L858R R[2] 0.8090 (n=200). Discordant results between ddPCR and NGS were observed in 24/201 (12%) samples for T790M, 17/201 (8%) Ex19Del and 11/200 (6%) L858R. All discordant samples had AFs ≤1% by both assays.
Conclusion:
Using cobas tissue test as a reference, sensitivity for the detection of plasma T790M appeared higher for ddPCR and NGS assays compared with AS-PCR. Robust correlations were observed between quantitative ddPCR and NGS assays for determination of AFs across all three mutations. About 25% of AURA3 patients did not appear to shed ctDNA, as evidenced by absence of all three EGFR mutations across the three platforms.
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-020 - Detection of Hypoxia Using EF5 PET/CT in 10 Patients with Advanced NSCLC Receiving Chemotherapy with and without Bevacizumab (ID 8084)
09:30 - 16:00 | Author(s): J. Laskin
- Abstract
Background:
Hypoxia is associated with increased resistance to radiation and chemotherapy treatments and may be an important prognostic factor in non-small cell lung cancer (NSCLC). Antiangiogenic drugs such as bevacizumab can have the paradoxical effect of transiently improving perfusion by normalizing blood vessels and reducing interstitial pressure, which may improve chemotherapy delivery and tumor cell killing. The aim of this study was to non-invasively assess tumor hypoxia with [18]F-EF5 PET/CT imaging in patients with advanced-stage NSCLC prior to systemic therapy and to compare changes during and after chemotherapy treatments with and without bevacizumab. [18]F-EF5 is a 2-nitroimidazole-based PET tracer reported as a good surrogate for hypoxia.
Method:
Eligibility included patients with incurable stage III/IV NSCLC who were to receive first-line platinum-based doublet chemotherapy alone or in combination with bevacizumab; prior radiation therapy was not allowed. 10 patients completed the study; 5 were treated with standard chemotherapy alone and 5 with chemotherapy plus bevacizumab. Each patient had three [18]F-EF5 PET/CT studies: one baseline pre-treatment, one at day 15 after the first cycle and one post-treatment study after 4-6 cycles of therapy. The investigators reading the PET/CT studies were blinded as to whether patients were treated with bevacizumab or not and no clinical information was available. [18]F-EF5 PET/CT images were acquired from shoulders to upper abdomen and analyzed by calculating tumor-to-muscle (T/M) uptake ratios. A ratio ≥1.50 was considered positive for hypoxia.
Result:
A total of 64 lesions were analyzed on baseline [18]F-EF5 PET/CT scans: 42 in the bevacizumab group and 22 in the control group. 51 of these lesions were positive for hypoxia (79.7%): 37 in the bevacizumab group (88.1%) and 14 in the control group (63.6%). Using a Dunn’s multiple comparisons test, there was a significant decrease in [18]F-EF5 uptake only on post-treatment study versus baseline in the group treated with chemotherapy alone (p=0.009). On the other hand, in the group treated with chemotherapy plus bevacizumab, T/M ratios obtained after one cycle of chemotherapy and after treatment completion were statistically lower when compared to baseline (p<0.0001).
Conclusion:
Preliminary data suggest that many advanced NSCLC are hypoxic and that the combination of bevacizumab and chemotherapy leads to a greater decrease in [18]F-EF5 accumulation compared to chemotherapy alone in primary tumors and metastatic lymph nodes. Further studies are necessary to understand the clinical significance of this finding and to explore this as a potential predictive marker for the use of bevacizumab.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 2
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-019 - Canadian Multicentre Validation Study of Plasma Circulating Tumour DNA for Epidermal Growth Factor (EGFR) T790M Testing (ID 8878)
09:30 - 16:00 | Author(s): J. Laskin
- Abstract
Background:
Plasma detection of EGFR T790M mutations in circulating tumour DNA (ctDNA) of advanced lung cancer patients with acquired resistance to EGFR tyrosine kinase inhibitor (TKI) has been proposed as alternative to tumor re-biopsy. This national validation study across Canadian centres aimed to establish the sensitivity and specificity of plasma detection of T790M as a clinical test using digital droplet (dd)PCR and next generation sequencing (NGS) assays.
Method:
Canadian patients at 7 centres undergoing screening for ASTRIS (NCT02474355) were invited to participate in this companion blood-based study. Patients with acquired resistance to EGFR TKI consented to collection of blood samples and demographic data. Samples were analysed using ddPCR and/or NGS platforms available at 4 molecular diagnostic laboratories across Canada. Concordance between the results of plasma T790M assayed in these 4 laboratories with reference tissue/plasma testing conducted for ASTRIS was assessed.
Result:
63 patients participated; the median age was 64 years (range 31-87), 69%(40/58) were Asian; 55%(33/60) were male. All patients received prior EGFR TKI, 17%(10/60) also received prior chemotherapy. Reference testing for EGFR T790M for ASTRIS eligibility identified positive T790M(+) results for 31(49%), negative(-) for 30(48%) and indeterminate(i) results for 2(3%) patients. One laboratory tested all 63 patient samples using both ddPCR and NGS (Oncomine Lung cfDNA assay), another laboratory tested 18 samples using ddPCR and NextSeq, a third tested 10 samples using ddPCR and COBAS EGFRv2, and a fourth tested 6 samples using Ion Torrent PGM. A total of 188 tests were performed including 91 by ddPCR, 87 NGS and 10 COBAS assays. Combining test results for each patient, 60%(38/63) of patient plasma samples were T790M+, 23(37%) were T790M-, and 2(3%) were inconclusive. Of 31 patients with reference T790M+ results from ASTRIS, 23(74%) had T790M detected in plasma, 6(19%) did not (T790M-), and 2(7%) had indeterminate (T790Mi) plasma results. For 30 patients with T790M- reference results from ASTRIS, 13(43%) had plasma T790M+ and 17 plasma T790M- results. The 2 patients with T790Mi by reference testing both had T790M+ results from plasma. Altogether, 47%(15/32) of patients deemed to have T790M-/i tumours by reference testing were found to have T790M+ results by plasma in this multicentre study. Combining results from both tissue and plasma testing, 73%(46/63) of study patients had T790M+ results.
Conclusion:
Plasma ctDNA testing in this multicentre Canadian study identified a significant number of additional patients eligible for osimertinib therapy beyond routine biopsy tissue testing for EGFR T790M.
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P3.01-062 - The Perceived Value of Avoiding Biopsy: Patients' Willingness to Pay for Circulating Tumour DNA T790M Testing (ID 10004)
09:30 - 16:00 | Author(s): J. Laskin
- Abstract
Background:
Plasma detection of circulating tumour DNA (ctDNA) with T790M mutation in the context of EGFR tyrosine kinase resistance has been shown to have high concordance with tissue biopsy specimens. In a public healthcare system, patients’ perceived value of a test and willingness to pay can inform policy decisions regarding implementation and funding of a novel technology.
Method:
As part of screening for the ASTRIS clinical trial (NCT02474355), Canadian patients were invited to participate in a national validation study of blood-based ctDNA T790M testing. Eligible patients had acquired resistance to EGFR TKI and consented to collection of blood samples, demographic data, and completion of a structured interview measuring their perceived value of blood-based ctDNA testing as an alternative to tumour biopsy. They were asked about their willingness to pay for testing using both open-ended and iterative bidding approaches. The study was supported by a grant from AstraZeneca.
Result:
60 patients were accrued to the study. Median age of the cohort is 64 years (range 31-87); 69% are Asian (40/58); 55% (33/60) are male. All patients had received prior EGFR kinase inhibitor treatment, with 67% (45/60) receiving gefitinib. 17% of patients also received chemotherapy (10/60). A median of 1 prior line of therapy had been received (range 1-6). All patients preferred to have the blood test over repeat tumour biopsy. Patients estimated a mean reasonable price to pay for the test of $954; median $300 (range 0-10,000; IQR 150-800). Patients were personally willing to pay a mean of $281; median $100 (range 0-2500; IQR 33-350).
Conclusion:
In a public health system that covers the cost of standard diagnostic tests, Canadian patients indicated a willingness to pay out of pocket for peripheral blood detection of ctT790M. Patients have high perceived value of ctDNA and prefer it to tumor biopsy.
