PMID- 30235921
OWN - NLM
STAT- MEDLINE
DCOM- 20190807
LR  - 20220409
IS  - 2005-9256 (Electronic)
IS  - 1598-2998 (Print)
IS  - 1598-2998 (Linking)
VI  - 51
IP  - 2
DP  - 2019 Apr
TI  - A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean 
      Breast Cancer Patients Receiving Dose-Dense Doxorubicin/Cyclophosphamide.
PG  - 812-818
LID - 10.4143/crt.2018.383 [doi]
AB  - PURPOSE: Dose-dense chemotherapy (DD-CT) is a preferred (neo)adjuvant regimen in 
      early breast cancer (BC). Although the results of reported randomized trials are 
      conflicting, a recent metaanalysis showed improved overall and disease-free 
      survival with DD-CT compared to conventional schedules. However, no DD-CT safety 
      data for Korean BC patients are available. This phase II study was conducted to 
      evaluate the safety and efficacy of pegteograstim in Korean BC patients receiving 
      DD-CT. MATERIALS AND METHODS: Patients with operable (stage I-III), 
      histologically confirmed BC received four cycles of intravenous doxorubicin (60 
      mg/m2) and cyclophosphamide (600 mg/m2) on day 1 every 2 weeks as neoadjuvant or 
      adjuvant therapy. Pegteograstim (6.0 mg) was administered subcutaneously on day 2 
      of each cycle. The primary endpoint was the incidence of febrile neutropenia 
      (FN). The secondary endpoints were safety and tolerability. RESULTS: Of 63 
      patients, one (1.6%) developed FN during all cycles of DD-CT. Dose delay was 
      observed in four patients (6.3%) and dose reduction in two (3.2%) during DD-CT. 
      Frequent adverse events (AEs) were nausea, alopecia, generalized muscle weakness, 
      myalgia, mucositis, anorexia, dyspepsia, and diarrhea; most AEs were related to 
      chemotherapy. Grade 3-4 AEs were reported in five of 63 patients (7.9%), and all 
      grade 3 and 4 AEs were related to chemotherapy. Adverse drug reactions possibly 
      linked to pegteograstim were abdominal pain, bone pain, myalgia, generalized 
      muscle weakness, and headache in five of 63 patients (7.9%). CONCLUSION: 
      Dose-dense AC (doxorubicin/cyclophosphamide) chemotherapywith pegteograstim 
      support is a tolerable and safe regimen in Korean early BC patients.
FAU - Kim, Gun Min
AU  - Kim GM
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Seoul, Korea.
FAU - Kim, Joo Hoon
AU  - Kim JH
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Seoul, Korea.
FAU - Kim, Ji Heung
AU  - Kim JH
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Seoul, Korea.
FAU - Cho, Young Up
AU  - Cho YU
AD  - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
FAU - Kim, Seung Il
AU  - Kim SI
AD  - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
FAU - Park, Seho
AU  - Park S
AD  - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
FAU - Park, Hyung Seok
AU  - Park HS
AD  - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
FAU - Kim, Ji Ye
AU  - Kim JY
AD  - Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
FAU - Sohn, Joohyuk
AU  - Sohn J
AD  - Division of Medical Oncology, Department of Internal Medicine, Yonsei University 
      College of Medicine, Seoul, Korea.
LA  - eng
GR  - Korea Health Industry Development Institute/
GR  - HI14C1324/Ministry of Health and Welfare/
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20180919
PL  - Korea (South)
TA  - Cancer Res Treat
JT  - Cancer research and treatment
JID - 101155137
RN  - 0 (Biomarkers)
RN  - 80168379AG (Doxorubicin)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - AC protocol
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Biomarkers
MH  - Breast Neoplasms/*drug therapy/mortality/pathology
MH  - Cyclophosphamide/adverse effects/therapeutic use
MH  - Doxorubicin/adverse effects/therapeutic use
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Neoplasm Grading
MH  - Neoplasm Staging
MH  - Republic of Korea
MH  - Treatment Outcome
PMC - PMC6473288
OTO - NOTNLM
OT  - Breast neoplasms
OT  - Dose-dense chemotherapy
OT  - Pegfilgrastim
COIS- Pegteograstim was supplied by the GC Pharma.
EDAT- 2018/09/22 06:00
MHDA- 2019/08/08 06:00
PMCR- 2019/04/01
CRDT- 2018/09/22 06:00
PHST- 2018/06/30 00:00 [received]
PHST- 2018/09/18 00:00 [accepted]
PHST- 2018/09/22 06:00 [pubmed]
PHST- 2019/08/08 06:00 [medline]
PHST- 2018/09/22 06:00 [entrez]
PHST- 2019/04/01 00:00 [pmc-release]
AID - crt.2018.383 [pii]
AID - crt-2018-383 [pii]
AID - 10.4143/crt.2018.383 [doi]
PST - ppublish
SO  - Cancer Res Treat. 2019 Apr;51(2):812-818. doi: 10.4143/crt.2018.383. Epub 2018 
      Sep 19.