Final follow-up (f/u) results from RADIANT: A randomized double blind phase 3 trial of adjuvant erlotinib (E) versus placebo (P) following complete tumor resection in patients (pts) with stage IB–IIIA <i>EGFR</i> positive (IHC/FISH) non-small cell lung cancer (NSCLC).
Bibliographic record
Abstract
7540 Background: Adjuvant chemotherapy for NSCLC has reached a plateau. The use of the tyrosine kinase inhibitor (TKI), E, was explored in the adjuvant setting given success in advanced setting.We report final f/u from RADIANT. Methods: Completely resected IB–IIIA NSCLC pts were randomized 2:1 to receive E 150 mg daily or P for 2 years. The primary endpoint was disease free survival (DFS) in the full analysis set (FAS). Secondary endpoints included overall survival (OS) in the FAS and DFS and OS in EGFR mutation (M+) subset (del19/L858R). 973 pts were randomized and the planned final analysis was performed after 410 DFS events (April 2013 data cutoff, ASCO14 #7501). A subsequent exploratory analysis occurred after final f/u (June 2014 cutoff). Results: The median f/u is 59.6m (95% CI 56.7–61.2). There was no statistically significant difference in DFS or OS overall or in the EGFR M+ group. The OS data remain immature with 33.5% deaths in the E arm and 31.4% in the P arm. The most common site of relapse (>15% pts) overall and in EGFR M+ were lung and brain in E treated pts and lung, bone and brain in P pts. Among the 13 pts in the EGFRM+ subgroup with brain as site of relapse, 11 of these patients relapsed after E cessation. There were no new safety concerns. Conclusions: Overall adjuvant E did not prolong DFS; a trend for E benefit previously observed (ASCO14 #7513) in EGFR M+ subgroup is no longer apparent. EGFR mutation status was not a stratification factor in this trial and was not a prognostic factor (ESMO14 #1177PD). Further results from ongoing trials are awaited to determine the role of TKI in EGFR M+ early stage lung cancer. Clinical trial information: NCT00373425. Full Analysis Set HR (95% CI) P-Value E (N=623) P (N=350) DFS Median 55 56.2 0.94 (0.78–1.144) 0.5620 # Events (%) 280 (44.9) 168 (48.0) OS Median NR NR 1.12 (0.890–1.413) 0.3306 # Events (%) 209 (33.5) 110 (31.4) EGFR M+ Subset HR (95% CI) P-Value E (N=102) P (N=59) DFS Median 47.8 28.5 0.75 (0.482–1.158) 0.1906 # Events (%) 49 (48.0) 34 (57.6) OS Median NR NR 1.19 (0.609–2.310) 0.6142 # Events (%) 26 (25.5) 13 (22.0) HR: Hazard Ratio; NR: Not Reached.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
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".