DUBLIN-3 results on quality of life (QoL) in second/third-line EGFR-wild type NSCLC patients (pts) receiving docetaxel (Doc) with or without plinabulin (Plin) using the validated EORTC QLQ C30 and QLQ LC13 questionnaires.
Bibliographic record
Abstract
9091 Background: Plin, a novel immune-enhancing small molecule, enhances dendritic cell maturation and T-cell proliferation. In the ITT population, the Plin/Doc combination had superior Efficacy (mOS; p = 0.0399), Safety (Gr3/4 AE rate/pt/year; p = 0.038) and QTWiST (p = 0.026) vs standard of care (SoC) Doc alone in NSCLC pts in DUBLIN-3 (Han, ESMO 2021). Here we report DUBLIN-3 QoL results. Methods: DUBLIN-3(NCT02504489) was a randomized, single-blinded (pts only), active-controlled Ph3 study in 2nd/3rd line stage IIIB/IV, EGFR wt NSCLC pts with a measurable lesion (RECIST 1.1) in the lung, and ECOG ≤ 2, conducted in US, Australia, and China. Pts (n = 559) were randomized 1:1 to Plin/Doc or Doc/Placebo (21-day (D) cycle). Doc (75 mg/m2 on D1 and Plin 30 mg/m2 on D1 and D8 were given by IV infusion. QoL was evaluated by the validated questionnaires EORTC QLQ C30 and QLQ LC13 (which is specific for Lung Cancer), and patient-reported scores were collected at baseline and D1, D8 of each cycle (C). Results: Baseline characteristics and QLQ C30 and LC13 scores were comparable between both groups. Plin/Doc was well tolerated. Cumulative C30 sand LC13 scores were calculated for each patient. Mean (SEM) change from baseline in cumulative C30 and LC13 scores were comparable for Plin/Doc and Doc in the first 10 cycles, however separated after C10 in favor of Plin/Doc (table). LC13 items in favor of Plin/Doc vs Doc alone, were items 31 (Coughing; p < 0.05), 36 (Sore Mouth; p < 0.01), 37 (Dysphagia; p < 0.01). Conclusions: We previously reported an OS, Safety, and QTWiST benefit with Plin/Doc vs Doc alone (ESMO 2021) in EGFR wild type 2nd/3rd line NSCLC pts from DUBLIN-3. Here, we report statistically significant QoL benefits with Plin/Doc vs Doc alone, as assessed with EORTC QLQ C30 and LC13, which may be relevant to guide treatment decisions in this generally sick patient population. Clinical trial information: NCT02504489. [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 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 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".