Safety of 30 min infusion of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in first-line treatment (tx) of advanced biliary tract cancer (aBTC): TOURMALINE early results
Bibliographic record
Abstract
Background : The global, single-arm, Phase 3b TOURMALINE study (NCT05771480) assesses the safety and efficacy of D+G-based chemotherapy as first-line tx in aBTC. Optimising care by reducing infusion time may benefit patients and physicians. Preliminary safety data, including 30 min infusion time with D are reported. Methods : Participants (pts) received D 1500 mg (first infusion: 60 min; subsequent infusions: 30 min) with an investigator-selected G-based chemotherapy (D+G alone or in combination with oxaliplatin, carboplatin, cisplatin (cis), tegafur-gimeracil-oteracil (S-1), cis+S-1, or cis+nab-paclitaxel). D was administered every 3 weeks (Q3W) with a G-based chemotherapy Q3W (8 cycles of D) or Q4W with G+cis+S-1 Q2W (4 cycles of D). Data cut-off (DCO) for the predefined safety review was 27 March 2024. Results : Overall, 62 pts could have received≥2 cycles of D by DCO. Over 90% of pts were Asian with a median age of 66 years; 23% had locally advanced disease, 61% had metastatic disease and 16% had both. At screening, 24% of pts had ECOG PS 2, reflecting pts with more severe disease versus the TOPAZ-1 study (NCT03875235). Safety was comparable between 60 and 30 min D infusion time. One pt had an infusion reaction adverse event (AE) at Cycle 4 following D+G+oxaliplatin (possibly related to oxaliplatin). AEs and serious AEs (SAEs) were reported in 98% and 29% of pts, respectively, and 87% and 6% of pts had an AE or SAE possibly related to any study tx, respectively (Table). Grade 3 or 4 AEs and SAEs were reported in 68% and 24% of pts, respectively. AEs led to a D dose delay in 26% of pts and discontinuation in 2% of pts. Immune-related AEs (imAEs) occurred in 29% of pts (Table). There were no AEs with an outcome of death. Conclusions : No difference in infusion-related safety between 30 and 60 min infusion time was observed. No new safety signals were seen with the addition of D to other chemotherapy regimens beyond TOPAZ-1 regimens. Previously presented at ESMO ASIA 2024,
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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 | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 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) | 0.002 | 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".