Associations between safety and tolerability and reporting of health-related quality of life in phase III randomized trials in common solid tumors.
Bibliographic record
Abstract
e19206 Background: Anti-cancer drugs are approved typically on the basis of efficacy and safety as evaluated in phase III randomized trials (RCTs). Health related quality of life (HRQoL) is a direct measure of patient benefit from drugs. Despite this, HRQoL is not reported universally for all anti-cancer drugs. Here we explore associations with reporting of HRQoL data in phase III RCTs in common solid tumors. Methods: We searched ClinicalTrials.gov to identify phase III oncology RCTs evaluating new drugs in adult patients with breast, colorectal, lung, or prostate cancers. We included all completed or active trials that completed accrual between January 1, 2005 and October 31, 2016. Data were extracted from published trials including HRQoL data and toxicity data on toxic death, treatment discontinuation and commonly reported grade 3 or 4 adverse events (AEs). Then, we explored associations between these safety and tolerability measures and the odds of reporting HRQoL data and whether HRQoL were favourable or not. Analysis comprised logistic regression and was performed in SPSS version 25. Results: A total of 377 phase III RCTs were initially identified. After excluding ineligible studies, a total of 143 studies were analysed. All trials (100%) were in the metastatic setting with 79 (55%) being positive trials. 40 (28%) were breast cancer trials, 38 (26%) were focused on evaluating chemotherapy, and 128 (90%) of trials were industry sponsored. 84 (59%) trials reported measuring HRQoL data, however of these, only 47 (56%) reported HRQoL data. In 14 (30%) HRQoL was improved with experimental therapy. There was no association between treatment related death (OR 1.25, 95%CI 0.74-2.12, p = 0.398) or treatment discontinuation (OR 1.12, 95%CI 0.73-1.72, p = 0.61) with reporting of HRQoL data. Associations with grade 3 or 4 AEs are shown in the Table. Conclusions: HRQoL is reported for only around a half of RCTs that collect such data. Reporting of HRQoL is not associated with safety and tolerability of anti-cancer drugs. [Table: see text]
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Direct model labels (unvalidated)
Per-model category and study-design labels from the labeling rounds. They are machine output, unvalidated, and the disagreement between models ships as data. No study design here is MEDLINE-validated yet.
| Model arm | Categories | Study design | Confidence |
|---|---|---|---|
| gemma | Metaresearch Domain: Reporting · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Observational | high |
| gpt | MetaresearchMeta-epidemiology (broad) Domain: Reporting · Genre: Empirical About the Canadian research system: no · About a Canadian topic: no | Observational | high |
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 | 0.585 | 0.606 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.025 | 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) | 0.000 | 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, unvalidatedLabeled directly by 2 models reading the full record.
The models disagree on parts of this classification; every voice is preserved in the section at the end of the page.
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".