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A.J. Layton
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MA 11 - Emerging Diagnostic/Biomarkers in NSCLC (ID 668)
- Event: WCLC 2017
- Type: Mini Oral
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M.I. Abdul Wahid, Martin Reck
- Coordinates: 10/17/2017, 11:00 - 12:30, Room 313 + 314
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MA 11.06 - Retrospective Analysis of NSCLC Testing in Low Tumor Content Samples: Single-Gene Tests, NGS, & the Oncomine™ Dx Target Test (ID 7577)
11:35 - 11:40 | Author(s): A.J. Layton
- Abstract
- Presentation
Background:
Clinical practice guidelines recommend genetic testing for advanced non-small cell lung cancer (aNSCLC) to guide 1[st]-line treatment. Small biopsies and low-tumor-content samples pose challenges to testing and reporting on an increasing number of relevant biomarkers. This study compared clinical aNSCLC biomarker testing to investigational use of the Oncomine™ Dx Target Test for different sample types.
Method:
A retrospective analysis was conducted using lung tissue testing data from a large, US-based commercial laboratory that offered single-gene tests (EGFR therascreen, ALK Vysis, BRAF cobas, and laboratory developed tests [LDT] for ROS1, HER2, BRAF, KRAS, MET, RET, and FGFR1) and a 173-gene next-generation sequencing (NGS) LDT panel (Illumina NextSeq 500). Clinical test orders received September 2015 – October 2016 were evaluated. This laboratory also conducted investigational testing on the Oncomine™ Dx Target Test (Ion Torrent PGM Dx) using archival tissue. Testing success rates and slide consumption were evaluated for core needle biopsies (CNBs; overall and by tumor content), fine needle aspirations (FNAs), and surgical resections.
Result:
Clinical testing orders were received on 1,029 CNBs, 144 FNAs, and 181 surgical resections. Among CNBs, 934 had tumor content data: 214 were 1-24% tumor; 720 were ≥25% tumor. Altogether, 3,571 single-gene tests and 198 NGS LDT panels were ordered. The Oncomine™ Dx Target Test was conducted on 169 archival samples: 69 CNBs (41 were 1-24% tumor; 28 were ≥25% tumor); 13 FNAs; 87 surgical resections.Sample characteristics Single-gene tests per clinical sample (N)* 173-gene NGS LDT (N) Oncomine™ Dx Target Test (N) 1 2 3 4 5 6 7 N samples 1,295 1,039 633 191 114 98 28 198 169 % samples able to successfully generate results for at least X tests, when ordered[†] CNB[‡] 89.2% (988) 85.3% (788) 76.2% (495) 77.9% (154) 70.8% (96) 61.9% (84) 58.3% (24) N/A[§] 75.4% (69) • 1-24% tumor 95.7% (209) 87.1% (170) 70.0% (110) 70.8% (24) 62.5% (16) 60.0% (15) N/A (4) 70.7% (41) • ≥25% tumor 98.2% (685) 91.8% (570) 82.9% (362) 85.8% (120) 76.3% (76) 66.2% (65) 61.1% (18) 82.1% (28) FNA 79.3% (140) 72.4% (116) 75.0% (60) 40.0% (10) N/A (4) N/A (4) N/A (1) 69.2% (13) Surgical resection 100% (167) 98.5% (135) 91.0% (78) 88.9% (27) 64.3% (14) 50.0% (10) N/A (3) 98.9% (87) Total number of slides used to initiate exactly X tests CNB[‡] 2.6 (165) 4.1 (268) 5.5 (324) 8.7 (56) 8.5 (11) 11.8 (55) 16.8 (16) 16.5 (24) 1.0[¶] • 1-24% tumor 2.7 (39) 4.8 (60) 5.9 (83) 9.5 (8) 9.0 (1) 12.3 (11) 18.3 (3) 18.7 (3) • ≥25% tumor 2.6 (118) 3.9 (208) 5.4 (241) 8.7 (47) 8.4 (10) 11.7 (44) 16.5 (13) 16.1 (21) FNA 2.4 (21) 4.3 (41) 6.1 (42) 9.8 (5) N/A (0) 11.5 (2) 18.0 (1) 14.0 (2) Surgical resection 1.8 (32) 4.5 (57) 5.4 (51) 9.5 (13) 11.0 (4) 16.3 (7) 14.0 (2) 8.2 (13) * Excludes clinical samples on which the NGS LDT panel had been initiated. † Success rates were not evaluated if N<10. ‡ While all samples had tumor content >0%, exact percentages were missing for 94 CNBs, 28 FNAs, and 1 surgical resection. § Success rates not evaluated; nearly all NGS LDT panels were ordered on samples that also initiated single-gene tests, and tissue depletion prevented initiation of most of the ordered NGS LDT panels. ¶ All tests were conducted using 1 slide according to protocol.
Conclusion:
Among lung tissue samples submitted for clinical testing, 13.4% were surgical resections, 10.6% FNAs, and 76% CNBs. The Oncomine™ Dx Target Test had higher testing success rates using fewer slides than single-gene testing for ≥5 biomarkers on CNBs, ≥4 on FNAs, and ≥2 on surgical resections. These preliminary results suggest the Oncomine™ Dx Target Test may facilitate multiple-biomarker testing for more aNSCLC patients to support therapy decisions as more gene targets are identified.
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