Outcomes of patients with advanced EGFR mutant lung cancer treated with first line (1L) osimertinib (osi) who would not have met eligibility criteria for the FLAURA trial.
Bibliographic record
Abstract
9072 Background: Osi is a 1L therapy for EGFR mutant lung cancer based on the results of the FLAURA clinical trial. Patients on clinical trial are typically highly selected and the overall effectiveness of therapies may be lower in the real-world setting. We report the real-world outcomes of patients treated with first line osi and compare the outcomes of trial eligible and ineligible patients. Methods: Pharmacy records from January 2020 to October 2022 were used to retrospectively identify patients who received 1L osi for advanced EGFR mutant (exon 19 del. or exon 21 L858R) lung cancer in British Columbia, Canada. Patients were deemed ineligible for the FLAURA trial if they met one of five criteria: ECOG ³2, unstable brain metastases (symptomatic or on steroids), hemoglobin <90, platelet <100, or creatinine clearance <50. Comparisons of overall survival (OS) and time to treatment discontinuation (TTD) were made between using Kaplan-Meier survival curves and log-rank testing. Hazard ratios (HR) are reported using Cox regression adjusting for baseline factors (Table). Results: Of 312 patients included, 133 (43%) were considered FLAURA-ineligible. Reasons for ineligibility were poor ECOG (n=120 [including ECOG 2=69, ECOG 3=48, and ECOG 4=4]), unstable brain metastases (n=21), anemia (n=7), thrombocytopenia (n=5), and low creatinine clearance (n=9). Median follow up was 22.7 months. At the time of analysis, 103/133 (77%) of ineligible patients had discontinued osi and 87/133 (65%) had died. 82/179 (45%) of eligible patients had discontinued osi and 53/179 (30%) were deceased. The median TTD in the ineligible group was 11.9 months (95% CI 10.5-15.5) vs 26.9 months (95% CI 21.9- 34.6) in the eligible group (p<0.001), HR 2.1 (95% CI 1.5-2.9, p<0.001). The median OS in the ineligible group was 15.8 months (95% CI 12.4 to 21.1) vs NR [not reached] (95%CI 28.5 to NR) in the eligible group (p<0.001), HR 2.6 (95% CI 1.8-3.7, p<0.001). Rates of dose reduction for toxicity were similar between ineligible (25%) and eligible (19%) patients (p=0.25). Second-line therapy was received by 28/102 (27%) of trial ineligible patients and 46/82 (56%) of trial eligible patients. Conclusions: Over 40% of the real-world population receiving 1L osi would have been ineligible for the FLAURA clinical trial. These patients had significantly inferior outcomes. This study provides benchmark data to better inform patient prognosis using real-world data. [Table: see text]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".