Pembrolizumab with trastuzumab and chemotherapy for HER2-positive advanced gastric cancer: health-related quality-of-life analysis from the randomized KEYNOTE-811 trial
Bibliographic record
Abstract
BACKGROUND: In the primary analysis of the randomized phase III KEYNOTE-811 trial (NCT03615326), pembrolizumab plus trastuzumab and chemotherapy improved progression-free survival and overall survival versus placebo plus trastuzumab and chemotherapy in participants with previously untreated human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer. PATIENTS AND METHODS: Overall, 698 participants were randomly assigned (1 : 1) to pembrolizumab 200 mg or placebo every 3 weeks, both with trastuzumab and chemotherapy. We report prespecified exploratory patient-reported outcomes (PROs), including change from baseline, time to deterioration (TTD), and overall improvement/stability rate assessed in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scales/items, EORTC Quality of Life Questionnaire-Stomach 22 pain scale, and EuroQoL 5-dimension 5-level questionnaire visual analog scale. RESULTS: The PRO population comprised 685 participants. At baseline, the rates of compliance and completion for all PRO questionnaires and for both treatment groups were >92%; at week 24, the rates were >80% and >55%, respectively. No between-group differences were observed from baseline to week 24 for the QLQ-C30 global health status/quality of life (GHS/QoL) scale [least squares mean (LSM) difference -1.16; 95% confidence interval (CI) -4.23 to 1.91] and EQ VAS (LSM difference, -0.69; 95% CI -3.06 to 1.68). Median TTD was not reached. A similar proportion of participants in each treatment group had improved and/or stable scores in the QLQ-C30 GHS/QoL scale (pembrolizumab group 71.9%; placebo group 71.5%). Findings were similar for all other prespecified scales/items. CONCLUSIONS: While improving clinical outcomes, the addition of pembrolizumab to trastuzumab and chemotherapy did not negatively impact health-related quality of life during treatment, supporting the use of pembrolizumab plus trastuzumab and chemotherapy for first-line treatment of HER2-positive advanced gastric cancer.
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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 | 0.009 | 0.007 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.004 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 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".