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Abstract P4-03-33: A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer

2023· article· en· W4322775565 on OpenAlexaffabout
Pamala A. Pawloski, Cara L. McDermott, Gabriela Vazquez‐Benitez, Terese A. DeFor, Aaron B. Mendelsohn, James Marshall, Érick Moyneur, Catherine M. Lockhart

Bibliographic record

VenueCancer Research · 2023
Typearticle
Languageen
FieldMedicine
TopicNeutropenia and Cancer Infections
Canadian institutionsF. Ménard (Canada)
Fundersnot available
KeywordsMedicineDocetaxelFebrile neutropeniaInternal medicinePertuzumabCyclophosphamideOncologyBiosimilarBreast cancerTrastuzumabCarboplatinMetastatic breast cancerPopulationCancerNeutropeniaChemotherapyCisplatin

Abstract

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Abstract A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer Pawloski PA1, McDermott CL2, Vazquez Benitez G1, DeFor T1, Mendelsohn A3, Marshall J3, Moyneur E4, Lockhart CM2; on behalf of the G-CSF Comparative Effectiveness Research Team. 1HealthPartners Institute, Bloomington MN USA 2Biologics and Biosimilars Collective Intelligence Consortium, Alexandria VA USA 3Harvard Pilgrim Healthcare Institute, Boston MA USA 4StatLog, Montreal QC Canada Objectives: To characterize G-CSF product use, including product switching, among patients diagnosed with breast cancer in the Biologics and Biosimilars Collective Intelligence Consortium’s (BBCIC) Distributed Research Network (DRN). Methods: A retrospective analysis of electronically extracted insurance claims from 2015-2019 at 4 Research Partner Sites was conducted. Patients aged >=20 years with a diagnosis of breast cancer who received chemotherapy associated with a risk of febrile neutropenia (FN) risk per National Comprehensive Cancer Network guidelines and any prophylactic granulocyte-colony stimulating factor (G-CSF), defined as before day 2 of the first cycle of chemotherapy were included. Results: A total of 11,788 patients were included; 89 (0.8%) were male sex per insurance records. The age distribution was 5,743 (49%) 50-64 years; 4,296 (36%) 20-49 years, and 1749 (15%) 65+ years. Chemotherapy regimens included cyclophosphamide/doxorubicin (n=7,377), carboplatin/docetaxel/trastuzumab/pertuzumab (n=1,862), cyclophosphamide/docetaxel (n=1,383), carboplatin/docetaxel/trastuzumab (n=430), cyclophosphamide/docetaxel/doxorubicin (n=147), and docetaxel/trastuzumab/pertuzumab (n=128). Overall, 218 patients (1.8%) developed FN during the first chemotherapy cycle. G-CSF utilization was pegfilgrastim 10,895 (92%), pegfilgrastim-cbqv 315 (3%), pegfilgrastim-jmdb 225 (2%), filgrastim 156 (1%), filgrastim-sndz 118 (1%), tbo-filgrastim 46 (< 1%), a combination of pegfilgrastim+filgrastim 26 (< 1%), and a combination of filgrastim+biosimilar 7 (< 1%) received. A total of 10,953 (93%) patients received high-risk chemotherapy and G-CSF utilization was 10,162 (93%) pegfilgrastim, 288 (3%) pegfilgrastim-cbqv, 200 (2%) pegfilgrastim-jmdb, 132 (1%) filgrastim, 101 (< 1%) filgrastim-sndz, 40 (< 1%) tbo-filgrastim, and 30 (< 1%) combination of products. Eight hundred fifteen (7%) patients received intermediate-risk chemotherapy and G-CSF utilization was, 716 (88%) pegfilgrastim, 27 (3%) pegfilgrastim-cbqv, 25 (3%) pegfilgrastim-jmdb, 23 (3%) filgrastim, 16 (2%) filgrastim-sndz, 5 (< 1%) tbo-filgrastim, and 3 (< 1%) combination. Twenty patients received low risk chemotherapy and of those 17 (85%) received pegfilgrastim. In 2019, the first full year of pegfilgrastim biosimilar availability, pegfilgrastim use was 76% pegfilgrastim, 13% pegfilgrastim-cbqv, and 9% pegfilgrastim-jmdb. Most patients who received a second cycle of chemotherapy received the same G-CSF product in the second cycle, specifically 67% received filgrastim, 71% tbo-filgrastim, 73% filgrastim-sndz, 96% pegfilgrastim, 84% pegfilgrastim-cbqv, and 81% pegfilgrastim-jmdb. Conclusions: The most common chemotherapy agents included cyclophosphamide, carboplatin, doxorubicin, docetaxel, or pertuzumab. Pegfilgrastim biosimilar uptake occurred following market availability. Within each G-CSF product, most patients received the same product during the second cycle of chemotherapy rather than switching products. Citation Format: Pamala A. Pawloski, Cara L McDermott, Gabriela Vazquez Benitez, Terese DeFor, Aaron B. Mendelsohn, James Marshall, Erick Moyneur, Catherine Lockhart. A Population-based Analysis of Prophylactic G-CSF Biosimilar and Originator Administration over time among Patients Diagnosed with Breast Cancer [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P4-03-33.

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

Full frame machine prediction

Teacher imitation

Not 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.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.003
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.009

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0010.003
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.001
Bibliometrics0.0010.002
Science and technology studies0.0000.000
Scholarly communication0.0010.001
Open science0.0010.001
Research integrity0.0010.000
Insufficient payload (model declined to judge)0.0020.000

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.

Opus teacher head0.030
GPT teacher head0.381
Teacher spread0.351 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

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".

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Citations1
Published2023
Admission routes2
Has abstractyes

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