Evidence map›Paper›PMID 37747629›Full record

Observational studyBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2023

Real-World Clinical Outcomes of Bevacizumab-awwb Biosimilar versus Bevacizumab Reference Product in Patients with Metastatic Colorectal Cancer.

Catherine Pham, Fang Niu, Thomas Delate, Gary L Buchschacher, Yan Li, Ekim Ekinci, Kim Le, Rita L Hui

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.0field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Catherine PhamPharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Downey, CA, USA.
Fang NiuPharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Downey, CA, USA.
Thomas DelatePharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Aurora, CO, USA.
Gary L BuchschacherHematology/Oncology, Southern California Permanente Medical Group, Los Angeles, CA, USA.
Yan LiHematology/Oncology, The Permanente Medical Group, Oakland, CA, USA.
Ekim EkinciPharmacy Department, Kaiser Permanente Colorado, Lone Tree, CO, USA.
Kim LeClinical Pharmacy Services, Kaiser Permanente National Pharmacy, Downey, CA, USA.
Rita L HuiPharmacy Outcomes Research Group, Kaiser Permanente National Pharmacy, Oakland, CA, USA. Rita.L.Hui@kp.org.ORCID http://orcid.org/0000-0003-0014-2431
Kaiser Permanente · USColorado Permanente Medical Group · USKaiser Permanente Lone Tree Medical Offices · USLos Angeles Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBevacizumab-awwb was the first biosimilar approved for cancer treatment in the USA. Limited information is available on the real-world comparative safety and effectiveness of bevacizumab biosimilars, especially for indications granted approval through extrapolation.

objectiveTo evaluate the real-world outcomes of patients with metastatic colorectal cancer (mCRC) initiated on bevacizumab-awwb versus bevacizumab reference product. PATIENTS AND

methodsThis was an observational, longitudinal cohort study of US adult patients with mCRC from four integrated care delivery systems who were newly initiated on bevacizumab-awwb between 1 July 2019 and 30 March 2020 or bevacizumab reference product between 1 July 2015 and 30 June 2018. Patients were followed until 1 year after treatment initiation, end of plan membership, or death, whichever occurred first. The primary outcome of overall survival (OS) was analyzed using a binary non-inferiority test with lower margin of 10% and adjusted Cox proportional hazards regression analysis to assess all-cause mortality if non-inferiority was met. Secondary outcomes included counts of doses received, treatment duration, all-cause hospitalizations, and incidence of serious adverse events.

resultsA total of 1445 patients initiated on either bevacizumab-awwb (n = 239) or bevacizumab reference product (n = 1206) were included in the analysis. The mean overall age was 60 ± 13 years, 46% of patients were female, and 51% were white. The OS rate was 72.8% and 73.1% for patients receiving bevacizumab-awwb and bevacizumab reference product, respectively (p < 0.01 for non-inferiority). The adjusted hazard ratio for mortality was 1.01 (0.77-1.33, p = 0.93). There were no statistically significant differences in secondary outcomes between the study groups.

conclusionsThese findings suggest that bevacizumab-awwb is as effective and safe as bevacizumab reference product for the real-world treatment of mCRC.

Indexed as

Biosimilar PharmaceuticalsColorectal NeoplasmsAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCohort StudiesFemaleHumansLongitudinal StudiesMaleMiddle AgedBevacizumabBiosimilar Pharmaceuticals

Identifiers

PMID37747629
OpenAlexW4387002262

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.