Evidence map›Paper›PMID 26423618›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09.

Ki Hyeong Lee, Ji-Yeon Kim, Moon Hee Lee, Hye Sook Han, Joo Han Lim, Keon Uk Park, In Hae Park, Eun Kyung Cho, So Young Yoon, Jee Hyun Kim and 8 more

Open access · hybridAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
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  6. Article
  7. Review
  8. Pegteograstim prophylaxis for chemotherapy-induced neutropenia and febrile neutropenia: a prospective, observational, postmarketing surveillance study in Korea.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
    Observational
  9. Article
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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

18 authors at 14 institutions in 1 country.

Ki Hyeong LeeDivision of Medical Oncology, Department of Internal Medicine, Chungbuk National University Hospital, CheongJu, South Korea.
Ji-Yeon KimDivision of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Moon Hee LeeDivision of Hemato-oncology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea.
Hye Sook HanDivision of Medical Oncology, Department of Internal Medicine, Chungbuk National University Hospital, CheongJu, South Korea.
Joo Han LimDivision of Hemato-oncology, Department of Internal Medicine, Inha University Hospital, Incheon, South Korea.
Keon Uk ParkDivision of Hematology/Oncology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, South Korea.
In Hae ParkCenter for Breast Cancer, Hospital of the National Cancer Center, National Cancer Center, Goyang, South Korea.
Eun Kyung ChoDivision of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.
So Young YoonDivision of Hematooncology, Department of Internal Medicine, Konkuk University Medical Center, Konkuk University School of Medicine, Seoul, South Korea.
Jee Hyun KimDivision of Hematology and Medical Oncology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
In Sil ChoiDivision of Hematology/Oncology, Department of Internal Medicine, SMG-SNU Boramae Medical Center, Seoul, South Korea.
Jae Hoo ParkDivision of Hematology and Oncology, Department of Internal Medicine, Ulsan University Hospital, Ulsan, South Korea.
Young Jin ChoiDivision of Hemato-oncology, Department of Internal Medicine, Pusan National University Hospital, Busan, South Korea.
Hee-Jun KimDivision of Hematology/Medical Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Seoul, South Korea.
Kyung Hae JungDepartment of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Si-Young KimDivision of Medical Oncology/Hematology, Department of Internal Medicine, Kyung Hee University Hospital, Seoul, South Korea.
Do-Youn OhDivision of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. ohdoyoun@snu.ac.kr.
Seock-Ah ImDivision of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. moisa@snu.ac.kr.
Chungbuk National University Hospital · KRInha University Hospital · KRSeoul National University Bundang Hospital · KRSeoul National University Hospital · KRChung-Ang University Hospital · KRGachon University Gil Medical Center · KRKeimyung University · KRKonkuk University Medical Center · KRKyung Hee University Medical Center · KRNational Cancer Center · KRPusan National University Hospital · KRSNUH SMG-SNU Boramae Medical Center · KRUlsan University Hospital · KRUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposePegylated granulocyte-colony-stimulating factor (G-CSF) is frequently used to prevent febrile neutropenia (FN) in patients undergoing chemotherapy with a high risk of myelosuppression. This phase II/III study was conducted to determine the adequate dose of pegteograstim, a new formulation of pegylated G-CSF, and to evaluate the efficacy and safety of pegteograstim compared to pegfilgrastim.

methodsIn the phase II part, 60 breast cancer patients who were undergoing DA (docetaxel and doxorubicin) or TAC (docetaxel, doxorubicin, and cyclophosphamide) chemotherapy were randomly selected to receive a single subcutaneous injection of 3.6 or 6.0 mg pegteograstim on day 2 of each chemotherapy cycle. The phase III part was seamlessly started to compare the dose of pegteograstim at selected in phase II with 6.0 mg pegfilgrastim in 117 breast cancer patients. The primary endpoint of both the phase II and III parts was the duration of grade 4 neutropenia in the chemotherapy cycle 1.

resultsThe mean duration of grade 4 neutropenia for the 3.6 mg pegteograstim (n = 33) was similar to that for the 6.0 mg pegteograstim (n = 26) (1.97 ± 1.79 days vs. 1.54 ± 0.95 days, p = 0.33). The 6.0 mg pegteograstim was selected to be compared with the 6.0 mg pegfilgrastim in the phase III part. In the phase III part, the primary analysis revealed that the efficacy of pegteograstim (n = 56) was non-inferior to that of pegfilgrastim (n = 59) [duration of grade 4 neutropenia, 1.64 ± 1.18 days vs. 1.80 ± 1.05 days; difference, -0.15 ± 1.11 (p = 0.36, 97.5 % confidence intervals = 0.57 and 0.26)]. The time to the absolute neutrophil count (ANC) recovery of pegteograstim (≥2000/μL) was significantly shorter than that of pegfilgrastim (8.85 ± 1.45 days vs. 9.83 ± 1.20 days, p < 0.0001). Other secondary endpoints showed no significant difference between the two groups. The safety profiles of the two groups did not differ significantly.

conclusionsPegteograstim was shown to be as effective as pegfilgrastim in the reduction of chemotherapy-induced neutropenia in the breast cancer patients who were undergoing chemotherapy with a high risk of myelosuppression.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsFemaleFilgrastimGranulocyte Colony-Stimulating FactorHumansInduction ChemotherapyMaximum Tolerated DoseMiddle AgedNeutropeniaPolyethylene GlycolsRecombinant ProteinsFilgrastimGranulocyte Colony-Stimulating Factorpegfilgrastimpegylated granulocyte colony-stimulating factorPolyethylene GlycolsRecombinant ProteinsBreast cancerChemotherapy-induced neutropeniaPegteograstimPegylated G-CSFProphylaxis

Identifiers

PMID26423618
PMCPMC4766213
OpenAlexW2121985645

What OpenQuestion holds

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Registered trials

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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.