Abstract 1108P
Background
Real-world data (RWD) play an increasing role in health care decisions. Using the curated Integra Connect Database (ICD), this study aimed to determine the outcome impact when treatment was initiated before or after report of OD results.
Methods
RWD were obtained from the ICD of pts newly diagnosed with NSCLC-4 from 1/1/2018 through 31/12/2020. We identified 510 pts harboring OD, of whom 131 had been treated prior to the report of OD with chemotherapy, immune checkpoint inhibitors or both. Outcomes of these pts were compared to the 379 pts treated with first line therapy (LOT1) guided by an OD report. Pts with genomic mutations of EGFR, ALK, ROS1, BRAF, MET, RET, ERBB2, and NTRK and treatment record capture were included. Demographics, ECOG score, date of OD report, and dates of LOT1 and any second LOT and death were included. Outcomes were assessed by time to next treatment or death (TTNT) and by overall survival (OS). Descriptive statistics used were Kaplan-Meier (K-M) estimates and Hazard Ratios (HR) using Cox regression. Three cohorts were defined as characterized in the Data Table (DT).
Results
As shown in the DT, TTNT was significantly inferior in Groups B and C compared to Gr A as was OS in Gr C. Two potential confounders were identified: urgency to treat and disproportionate representation of mutated EGFR (mEGFR). Similar proportions of ECOG ≥ 2 in the groups was against the former; separating each cohort by EGFR mutation status did not alter the results. Table: 1108P
| Group A (Gr A): Comparator group; treated after report of OD | Group B (Gr B): Treated prior to report of OD but switched to TKI in ≤ 35 days | Group C (Gr C): Treated prior to report of OD and not switched in ≤ 35 days | ||||||||
| Cohort | n | ECOG≥ 2 | mEGFR | Median TTNT (95% CI, months) | TTNT HR (p-value) | Median OS (95% CI, months) | OS HR (p-value) | HR (p-value) adjusted for EGFR status |
| Gr A | 379 | 27.2% | 62.0% | 13.0 (10.5,15.5) | Ref | 28.8 (23.3, 34.6) | Ref | Ref |
| Gr B | 47 | 44.7% | 59.5% | 5.5 (3.4, 8.9) | 1.73 (0.002) | 21.7 (12.2, NR) | 1.12 (0.59) | TTNT: 1.8 (0.002) OS: 1.1 (0.6) |
| Gr C | 84 | 25.0% | 28.5% | 6.4 (4.9, 8.7) | 1.71 (0.0002) | 15.3 (11.5, 19.7) | 1.62 (0.003) | TTNT: 1.5 (0.008) OS: 1.5 (0.01) |
| (Data cut-off 30/6/2021) |
Conclusions
While subject to limitations inherent to RWD study, these results strongly suggest outcomes are significantly inferior in pts harboring an OD but treated initially without a targeted TKI, even if quickly switched to a TKI. This emphasizes the need for near universal testing and encourages use of ultra-fast or liquid biopsy next gen sequencing (NGS) to shorten turnaround time, while inferior results even in non-mEGFR pts emphasizes the need for broad NGS panel testing.
Clinical trial identification
Editorial acknowledgement
Formatting by Jenna Bassett, Medical Writer, Integra Connect.
Legal entity responsible for the study
Integra PrecisionQ, LLC.
Funding
Thermo Fisher Scientific.
Disclosure
R. Smith, M. Xue, P. Varughese, N. Dorrow, B. Wang, A. Vasudevan, M. Gart, H. Gierman, J. Scott: Financial Interests, Personal, Full or part-time Employment: Integra Connect. All other authors have declared no conflicts of interest