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 distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".