Evidence map›Paper›PMID 36701846›Full record

ArticleCancer research and treatment2023

Eflapegrastim versus Pegfilgrastim for Chemotherapy-Induced Neutropenia in Korean and Asian Patients with Early Breast Cancer: Results from the Two Phase III ADVANCE and RECOVER Studies.

Yong Wha Moon, Seung Ki Kim, Keun Seok Lee, Moon Hee Lee, Yeon Hee Park, Kyong Hwa Park, Gun Min Kim, Seungtaek Lim, Seung Ah Lee, Jae Duk Choi and 4 more

Open access · diamondAbstract readEquivalence Trial
In one paragraph

Article in Cancer research and treatment, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 25% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Trial
  2. 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

14 authors at 8 institutions in 1 country.

Yong Wha MoonHematology and Oncology, Department of Internal Medicine, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
Seung Ki KimDepartment of Surgery, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
Keun Seok LeeCenter for Breast Cancer, National Cancer Center, Goyang, Korea.
Moon Hee LeeDepartment of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
Yeon Hee ParkDivision of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kyong Hwa ParkDivision of Medical Oncology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Korea.
Gun Min KimDivision of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
Seungtaek LimDepartment of Hemato-Oncology, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, Korea.
Seung Ah LeeDepartment of Surgery, CHA Bundang Medical Center, CHA University, Seongnam, Korea.
Jae Duk ChoiClinical Research and Development, Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.
Eunhye BaekClinical Research and Development, Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.
Hyesun HanClinical Research and Development, Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.
Seungjae BaekClinical Research and Development, Hanmi Pharmaceutical Co., Ltd., Seoul, Korea.
Seock-Ah ImDepartment of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Hanmi Pharmaceutical (South Korea) · KRCHA University · KRYonsei University · KRInha University · KRKorea University Medical Center · KRNational Cancer Center · KRSamsung Medical Center · KRSeoul National University Hospital · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeWe investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations.

resultsAmong a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: -0.120 days (95% confidence interval [CI], -0.227 to -0.016), -0.288 (95% CI, -0.714 to 0.143), and -0.267 (95% CI, -0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations.

conclusionThis study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

Indexed as

Antineoplastic AgentsBreast NeoplasmsFilgrastimGranulocyte Colony-Stimulating FactorNeutropeniaAntineoplastic Combined Chemotherapy ProtocolsEast Asian PeopleFemaleHumansImmunoglobulin Fc FragmentsPolyethylene GlycolsRepublic of KoreaAntineoplastic AgentseflapegrastimFilgrastimGranulocyte Colony-Stimulating FactorImmunoglobulin Fc FragmentspegfilgrastimPolyethylene GlycolsAsiansBreast neoplasmsKoreansLong-acting granulocyte-colony stimulating factorNeutropenia

Identifiers

PMID36701846
PMCPMC10372586
OpenAlexW4317360804

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.