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Stan Skrzypczak
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MA02 - Improving Outcomes for Patients with Lung Cancer (ID 895)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 10:30 - 12:00, Room 201 BD
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MA02.11 - Achieving Value in Cancer Diagnostics: Blood Versus Tissue Molecular Profiling - A Prospective Canadian Study (VALUE) (ID 13611)
11:40 - 11:45 | Author(s): Stan Skrzypczak
- Abstract
- Presentation
Background
Cell-free DNA (cfDNA) next-generation sequencing (NGS) has emerged as an effective molecular profiling technique that is potentially faster and cost-saving in comparison to standard-of-care (SOC) tumour biopsy and tissue-based profiling. In a public payer system, the added value of cfDNA blood-based profiling compared to SOC remains unknown. This study will determine the incremental clinical utility and cost of cfDNA NGS versus SOC genotyping in patients with advanced non-squamous non-small cell lung cancer (NSCLC).
a9ded1e5ce5d75814730bb4caaf49419 Method
This multicentre, non-randomized, longitudinal study will be conducted at 6 sites across Canada (BC, Alberta, Ontario, Quebec). The Guardant360® assay will be used to perform plasma-based cfDNA testing, and includes mutations, rearrangements and copy number variations in 73 known cancer associated genes. Two patient cohorts will be recruited: (1) treatment naïve patients with ≤10 pack year smoking history; and (2) patients with known abnormalities of EGFR, ALK, ROS-1 or BRAF after disease progression on all standard targeted therapies. SOC tissue profiling will be performed for all patients per institutional standards. The study will begin recruiting in May 2018, with estimated completion in 12 months. The primary endpoints are comparison of response rate (RR), progression-free survival (PFS) and time-to-treatment failure (TTF) using cfDNA versus tissue genomic testing. Secondary endpoints include time to treatment initiation, number of actionable genomic abnormalities identified, result turnaround time, potentially avoidable repeat tissue biopsies, costs, patient-reported quality of life (EQ-5D) and willingness-to-pay. Exploratory analyses of treatment outcomes in selected molecular subgroups will also be undertaken, including response to immunotherapy in those with KRAS/STK11 co-mutations. A decision-analytic model will be developed to perform cost-consequence analyses using a cfDNA versus tissue-based approach.
4c3880bb027f159e801041b1021e88e8 Result
A total of 210 patients will be recruited across Canada, (Cohort 1 N=150, Cohort 2 N=60). Based on testing with either blood-based GUARDANT360TM or tissue-based profiling, the costs and benefits of blood-based profiling either at initial diagnosis or upon TKI progression will be determined versus initial or repeat tumour biopsy and tissue-based profiling. Data from patients accrued until 08/2018 will be presented at the meeting.
8eea62084ca7e541d918e823422bd82e Conclusion
This study will determine the added value of cfDNA blood-based genotyping compared to SOC from the perspective of a public payer system (Canada).
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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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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P2.15-16 - Clinical Economic Impact of Improved Genotyping in Patients with Advanced Non-Small Cell Lung Adenocarcinoma (NSCLC) (ID 14255)
16:45 - 18:00 | Author(s): Stan Skrzypczak
- Abstract
Background
Comprehensive genomic profiling (CGP) at diagnosis and progression identifies NSCLC patients who may benefit from targeted therapies and are unlikely to respond to immunotherapy, however many patients are incompletely or undergenotyped. We developed a cost benefit model to evaluate the clinical and economic impact of using plasma-based cfDNA CGP to guide treatment decisions in first- and second-line advanced NSCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
The model compares the clinical and economic impact of an NCCN guideline driven care paradigm, utilizing Guardant360â (G360), a CLIA certified, CAP accredited, NYSDOH approved cfDNA CGP test, for stage IIIB/IV NSCLC patients versus the current care paradigm and assesses the impact of additional genomic information to aid in therapy selection and subsequent effects on biopsy rates, drug costs, and clinical outcomes (RR, PFS, and median OS). The model targeted patients with NSCLC receiving first or second line treatment enrolled in a U.S. Commercial Health Plan with 10 million lives. Frequency of NCCN genomic targets in first-line patients was per The Cancer Genome Atlas with second-line frequencies modified to reflect the first-line testing, genotyping QNS, biopsy, and undergenotyping rates. Therapy current care distributions were derived from 2017 Integra Connect’s proprietary database.
4c3880bb027f159e801041b1021e88e8 Result
Under the guideline directed care, immunotherapy and chemotherapy use decreased as patients are re-assigned to targeted therapy in both first line QNS and second line progression settings, resulting in improved clinical outcomes, including a second line repeat tissue biopsy rate reduction. Individual and overall cost savings were observed in both settings (Table).
8eea62084ca7e541d918e823422bd82e ConclusionFirst-Line QNS Patients
Second-Line Patients
Current
Guideline Directed
Difference
Current
Guideline Directed
Difference
Overall Patient Cohort
Immunotherapy Monotherapy
19.2%
13.2%
- 6.00%
52.5%
42.9%
- 9.6%
Immunotherapy + Chemotherapy
5.6%
3.9%
- 1.7%
3.3%
2.7%
- 0.6%
Chemotherapy +/- Biologics
75.2%
51.7%
- 23.5%
35.7%
29.2%
- 6.5%
Targeted Therapy
0%
31.3%
+ 31.3%
8.6%
25.3%
+ 16.7%
Overall Clinical Outcome Measures
Response Rate
18.1%
28.3%
+ 10.2%
20.9%
25.7%
+ 4.8%
Progression Free Survival (months)
4.7
6.0
+ 1.3
4.7
5.6
+ 0.9
Overall Survival (months)
11.1
12.6
+ 1.5
11.0
12.1
+ 1.1
Reassigned Patient Cohort
Immunotherapy Monotherapy
6.0%
-
-6.0%
9.6%
-
- 9.6%
Immunotherapy + Chemotherapy
1.8%
-
- 1.8%
0.6%%
-
- 0.6%
Chemotherapy +/- Biologics
23.5%
-
- 23.5%
6.5%
-
- 6.5%
Targeted Therapy
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31.3%
+ 31.3%
-
16.7%
+ 16.7%
Clinical Outcome Measures for Reassigned Patients
Response Rate
18.1%
50.7%
+ 32.6%
17.7%
49.5%
+ 31.8%
Progression Free Survival (months)
4.7
8.8
+ 4.0
4.2
9.7
+ 5.5
Overall Survival (months)
11.1
15.9
+ 4.9
10.3
17.3
+ 7.0
Second-line re-biopsy rate
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25%
11%
-14%
Overall Cost per Patient
$140,950
$130,141
-$10,809
$175,563
$161,810
- $13,753
Overall Total Cost
$55,516,110
$51,258,713
-$4,257,397
$209,553,002
$193,136,843
- $16,416,159
cfDNA CGP application in first line tissue QNS and second line progressing advanced NSCLC patients improved outcomes and cost savings. Shifting from chemotherapy and immunotherapy to relatively more efficacious, less toxic, and less expensive targeted therapies resulted in improved patient outcomes. Cost savings are driven by decrease in immunotherapy, infusion costs, emergency room/hospital visits, and avoidance of tissue biopsy.
6f8b794f3246b0c1e1780bb4d4d5dc53
