Health-related quality of life (HRQoL) for patients with advanced/metastatic urothelial carcinoma (UC) enrolled in KEYNOTE-052 who are potentially platinum ineligible.
Bibliographic record
Abstract
4561 Background: Frontline cisplatin-based chemotherapy improves survival in patients (pts) with UC, but ̃50% are cisplatin-ineligible owing to poor performance status or comorbidity. The definition of platinum ineligibility is not standardized; hence, treatment decisions are almost solely made by clinical judgment. Pembrolizumab (pembro) showed antitumor activity and manageable toxicity as frontline therapy in 370 cisplatin-ineligible pts in the single arm, phase 2 KEYNOTE-052 trial (NCT02335424). We present effects of pembro on HRQoL of pts in KEYNOTE-052 who were potentially platinum ineligible in this exploratory analysis. Methods: Eligible pts for KEYNOTE-052 were adults with no prior systemic chemotherapy for advanced/metastatic UC, ECOG PS ≤2, and measurable disease per RECIST v1.1 by blinded independent central review. Pembro 200 mg IV was administered Q3W for up to 2 y. Clinical characteristics of frail pts (platinum ineligible) were identified by extensive review of real-world treatment patterns and relevant literature. Consequently, platinum ineligibility was defined as having an ECOG PS ≥2 plus ≥1 of the following: visceral disease, creatinine clearance < 60 mL/min, or age ≥80 y. HRQoL was assessed using the EORTC QLQ-C30 and EQ-5D-3L during the first 4 cycles, then every 2 cycles for 1 year or until treatment discontinuation (whichever occurred first), and at least 30 days after treatment discontinuation. Key end points were change from baseline per the QLQ-C30 global health status (GHS)/QoL score, QLQ-C30 physical functioning subscale, and EQ-5D visual analog scale (VAS). The minimum important difference (MID) was 10 for QLQ-C30 score change (improved: ≥10; stable: –10 to 10; deteriorated: –10 or less); MID for VAS score change was 7 (improved: ≥7; stable: –7 to 7; deteriorated: –7 or less). Results: Median age for 143 pts was 75 y (range, 34-91); 129 pts (90.2%) had visceral disease; 142 (99.3%) had ECOG PS 2; 1 had ECOG PS 3 (enrolled in error). Compliance rate for HRQoL questionnaires was 93.7% at baseline. At the prespecified analysis time of week 9, 77.6% of pts had improved (n = 51) or stable (n = 60) QLQ-C30 GHS/QoL scores, 64.3% had improved (n = 35) or stable (n = 57) QLQ-C30 physical functioning scores, and 62.2% had improved (n = 56) or stable (n = 33) EQ-5D VAS scores. These scores were stable throughout the HRQoL assessment period for pts who continued pembro. Conclusions: In this exploratory analysis, pembro maintained HRQoL for pts with advanced/metastatic UC in KEYNOTE-052 who were potentially platinum-ineligible per the above criteria. Together with the efficacy and safety data from KEYNOTE-052, these data suggest that pembro monotherapy is a valuable treatment option for select pts with advanced UC who are more senior and/or deemed medically frail. Clinical trial information: NCT02335424.
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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 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 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".