Avelumab (Ave) first-line (1L) maintenance plus best supportive care (BSC) versus BSC alone for advanced urothelial carcinoma (UC): JAVELIN Bladder 100 subgroup analysis based on duration and cycles of 1L chemotherapy.
Bibliographic record
Abstract
438 Background: Avelumab 1L maintenance is approved in the United States for patients with advanced UC that has not progressed with 1L platinum-containing chemotherapy based on significantly prolonged overall survival (OS) vs BSC seen in the phase III JAVELIN Bladder 100 trial (NCT02603432). However, optimal duration of 1L chemotherapy is unknown and some patients are unable to receive 6 cycles. We report a post hoc analysis of efficacy by duration or number of cycles of 1L chemotherapy. Methods: Eligible patients with unresectable locally advanced or metastatic UC that had not progressed with 4-6 cycles of 1L gemcitabine + cisplatin or carboplatin were randomized to receive maintenance avelumab + BSC or BSC alone within 4-10 weeks. Subgroups were defined by quartiles (Qs) for duration ( Q3 [>20.1 weeks]) or estimated number of cycles (4, 5, or 6) of 1L chemotherapy. Duration of chemotherapy included dosing delays/interruptions, and the decision to stop 1L chemotherapy was at the investigator’s discretion. Treatment arms were compared using an unstratified Cox proportional hazards model for OS. The potential impact of baseline characteristics on treatment patterns or dose intensity was not explored. Results: Numbers of patients in 1L chemotherapy subgroups were generally well balanced between arms (Table). An OS benefit was observed for avelumab + BSC vs BSC alone across subgroups with differing durations or cycles of 1L chemotherapy (Table). A progression-free survival benefit was also observed for avelumab + BSC vs BSC alone across subgroups. No significant treatment-by-cycle interaction (at 0.05 level) was observed. Conclusions: Improved OS was observed with avelumab 1L maintenance vs BSC alone irrespective of duration or cycles of 1L chemotherapy received prior to entering the trial. Among patients who stopped 1L chemotherapy prior to 6 cycles, avelumab 1L maintenance still provided an OS benefit. Clinical trial information: NCT02603432 . Research Sponsor: Pfizer Inc, Pharmaceutical/Biotech Company[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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.005 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.004 | 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".