Pan-Canadian rash trial with EGFR inhibitors.
Bibliographic record
Abstract
8013 Background: Erlotinib prolongs survival in advanced non-small cell lung cancer (NSCLC), as a first-line treatment for EGFR mutation, and second-/third-line upon progression on chemotherapy. Rash is a major side effect of erlotinib; studies have retrospectively illustrated a relationship between rash and efficacy. The primary objective of this study was to determine the optimal treatment of rash secondary to erlotinib Methods: The Pan Canadian Rash Trial studied rash in patients who received erlotinib for advanced NSCLC in the second or third-line setting. This trial was initiated before EGFR mutational testing was available. Patients were randomized to one of three arm: Prophylactic (Arm 1) minocycline (150 po bid) on day 1 of erlotinib; Reactive (Arm 2) treatment with topical clindamycin + hydrocortisone +/- minocycline upon rash occurrence depending on grade; Observation (Arm 3) no treatment of rash unless severe (Gr 3). Endpoints included the overall incidence and severity of rash and relationship to survival. Results: 150 patients were enrolled. 75% were Caucasian and 76% were current/former smokers. Overall incidence of rash was 83%. Time to occurrence of rash was significantly longer in Arm 1. (Table) Prophylactic minocycline reduced the probability of rash by 39.8% compared to Arms 2 and 3 combined (odds ratio 0.602, p = 0.3210). The incidence of Grade 3 rash was greater in Arm 3 (34.1%) versus Arms 1 (14.3%) and 2 (9.5%). Patients in Arm 1 were on erlotinib 50% longer than in arms 2 and 3 (6.34 months vs 4.02 and 4.16 respectively). Although not statistically significant, Arm 1 had the longest overall survival. Conclusions: Incidence of rash secondary to erlotinib treatment is common. Prophylactic minocycline reduced occurrence and severity of rash, was well tolerated and conferred a non-significant survival advantage. This may reflect improvement in patient compliance. Observation until severe rash (Gr 3) led to the worst outcome. Prophylactic treatment did not reduce erlotinib efficacy, and should be considered in patients upon initiation of erlotinib therapy. Clinical trial information: NCT00473083.Time to first presentation of rash, all grades. Incidence of rash n (%) Median (days) Mean (days) P value ARM 1 (N=50) 42 (84) 12.0 17.4 p 0.0147 ARM 2 (N=50) 42 (84) 9.0 13.3 Arm 3 (N=50) 41 (82) 8.0 12.0
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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 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.012 | 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".