An exploratory comparative effectiveness analysis of febrile neutropenia incidence among patients with cancer receiving granulocyte colony stimulating factors.
Bibliographic record
Abstract
408 Background: We conducted an exploratory comparative effectiveness analysis comparing various G-CSF (pegfilgrastim/filgrastim) products to each other in incidence of febrile neutropenia (FN) among patients with breast, lung, colon, pancreatic, ovarian cancers or non-Hodgkin’s lymphoma (NHL) in the Biologics and Biosimilars Collective Intelligence Consortium’s (BBCIC) Distributed Research Network. Methods: We included patients aged > = 20 years who, in 2015-2019, per insurance claims, received any pegfilgrastim or filgrastim products as febrile neutropenia (FN) prophylaxis during the first cycle of chemotherapy posing a high or intermediate FN risk per National Comprehensive Cancer Network guidelines. We compared the FN risk starting at day 5 following day 1 of chemotherapy receipt between products using Poisson regression model with standardized inverse probability weights and robust variance to estimate the Relative Risk (RR) and 95% Confidence intervals (CI). Results: A total of 15,941 patients received a pegfilgrastim product in cycle 1 of chemotherapy: 15,115 (95%) pegfilgrastim, 484 (3%) pegfilgrastim_cbqv, 342 (2%) pegfilgrastim_jmdb. 565 patients received a filgrastim product: 284 (50%) filgrastim, 201 (36%) filgrastim_sndz, 80 (14%) tbo-filgrastim. FN events by product were: 346 pegfilgrastim (2.3% of users), 11 pegfilgrastim_cbqv (2.3%), 8 pegfilgrastim_jmdb (2.3%), 13 filgrastim (4.6%), 5 filgrastim_sndz (2.5%), 2 tbo-filgrastim (2.5%). We found no difference in FN incidence when comparing pegfilgrastim_cbqv to pegfilgrastim (RR 0.83, 95% CI 0.41-1.69), pegfilgrastim_jmdb to pegfilgrastim (RR 1.03, 95% CI 0.56-1.92), and pegfilgrastim_jmdb to pegfilgrastim_cbqv (RR 1.11, 95% CI 0.45-2.74). Similarly, we found no difference in FN incidence when comparing filgrastim_sndz to filgrastim (RR 0.46, 95% CI 0.17-1.28), tbo-filgrastim to filgrastim (RR = 0.30, 95% CI 0.06-1.36), or tbo-filgrastim to filgrastim_sndz (RR 0.54, 95% CI 0.10-2.77). Adverse events were rare, with similar rates observed among all products. Conclusions: We observed no significant difference in FN incidence among patients when comparing various G-CSF products, including when biosimilars were compared to their reference counterparts.
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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 | 0.029 | 0.044 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.009 |
| Bibliometrics | 0.003 | 0.002 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 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".