PMID- 29573207
OWN - NLM
STAT- MEDLINE
DCOM- 20190906
LR  - 20240314
IS  - 2045-7634 (Electronic)
IS  - 2045-7634 (Linking)
VI  - 7
IP  - 5
DP  - 2018 May
TI  - An open-label, dose-ranging study of Rolontis, a novel long-acting myeloid growth 
      factor, in breast cancer.
PG  - 1660-1669
LID - 10.1002/cam4.1388 [doi]
AB  - This randomized, open-label, active-controlled study investigated the safety and 
      efficacy of three doses of Rolontis (eflapegrastim), a novel, long-acting myeloid 
      growth factor, versus pegfilgrastim in breast cancer patients being treated with 
      docetaxel and cyclophosphamide (TC). The primary efficacy endpoint was duration 
      of severe neutropenia (DSN) during the first cycle of treatment. Patients who 
      were candidates for adjuvant/neoadjuvant TC chemotherapy were eligible for 
      participation. TC was administered on Day 1, followed by 45, 135, or 270 mug/kg 
      Rolontis or 6 mg pegfilgrastim on Day 2. Complete blood counts were monitored 
      daily when the absolute neutrophil count (ANC) fell to <1.5 x 10(9) /L. Up to 
      four cycles of TC were investigated. The difference in DSN (time from ANC 
      <0.5 x 10(9) /L to ANC recovery >/=2.0 x 10(9) /L) between the Rolontis and 
      pegfilgrastim groups was -0.28 days (confidence interval [CI]: -0.56, -0.06) at 
      270 mug/kg, 0.14 days (CI: -0.28, 0.64) at 135 mug/kg, and 0.72 days (CI: 0.19, 
      1.27) at 45 mug/kg. Noninferiority to pegfilgrastim was demonstrated at 135 mug/kg 
      (P = 0.002) and 270 mug/kg (P < .001), with superiority demonstrated at 270 mug/kg 
      (0.03 days; P = 0.023). The most common treatment-related adverse events (AEs) 
      were bone pain, myalgia, arthralgia, back pain, and elevated white blood cell 
      counts, with similar incidences across groups. All doses of Rolontis were well 
      tolerated, and no new or significant treatment-related toxicities were observed. 
      In Cycle 1, Rolontis demonstrated noninferiority at the 135 mug/kg dose and 
      statistical superiority in DSN at the 270 mug/kg dose when compared to 
      pegfilgrastim.
CI  - (c) 2018 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
FAU - Vacirca, Jeffrey L
AU  - Vacirca JL
AD  - New York Cancer Specialists, East Setauket, New York.
FAU - Chan, Arlene
AU  - Chan A
AD  - Breast Cancer Research Centre WA and Curtin University, Perth, Western Australia, 
      Australia.
FAU - Mezei, Klara
AU  - Mezei K
AD  - Szabolcs-Szatmar Bereg County Hospital and University Teaching Hospital, 
      Nyiregyhaza, Hungary.
FAU - Adoo, Clarence S
AU  - Adoo CS
AD  - Arizona Center for Cancer Care, Glendale, Arizona.
FAU - Papai, Zsuzsanna
AU  - Papai Z
AD  - State Health Center, Budapest, Hungary.
FAU - McGregor, Kimberly
AU  - McGregor K
AD  - Samaritan Hematology and Oncology Associates, Corvalis, Oregon.
FAU - Okera, Meena
AU  - Okera M
AD  - Adelaide Cancer Centre, Kurralta Park, South Australia, Australia.
FAU - Horvath, Zsolt
AU  - Horvath Z
AD  - University of Debrecen, Debrecen, Hungary.
FAU - Landherr, Laszlo
AU  - Landherr L
AD  - Uzsoki Hospital, Budapest, Hungary.
FAU - Hanslik, Jerzy
AU  - Hanslik J
AD  - Szpital Rejonowy Dzienny Oddzial Chemioterapii, Raciborzu, Poland.
FAU - Hager, Steven J
AU  - Hager SJ
AD  - California Cancer Associates for Research and Excellence, Fresno, California.
FAU - Ibrahim, Emad N
AU  - Ibrahim EN
AD  - Emad Ibrahim MD, Inc., Redlands, California.
FAU - Rostom, Makharadze
AU  - Rostom M
AD  - Cancer Center of Adjara Autonomous Republic, Batumi, Georgia.
FAU - Bhat, Gajanan
AU  - Bhat G
AD  - Spectrum Pharmaceuticals, Irvine, California.
FAU - Choi, Mi Rim
AU  - Choi MR
AD  - Spectrum Pharmaceuticals, Irvine, California.
FAU - Reddy, Guru
AU  - Reddy G
AD  - Spectrum Pharmaceuticals, Irvine, California.
FAU - Tedesco, Karen L
AU  - Tedesco KL
AD  - New York Oncology Hematology (US Oncology/McKesson Specialty Health), Albany, New 
      York.
FAU - Agajanian, Richy
AU  - Agajanian R
AD  - The Oncology Institute of Hope and Innovation, Downey, California.
FAU - Lang, Istvan
AU  - Lang I
AD  - National Institute of Oncology, Budapest, Hungary.
FAU - Schwartzberg, Lee S
AU  - Schwartzberg LS
AD  - West Cancer Center, Memphis, Tennessee.
LA  - eng
SI  - ClinicalTrials.gov/NCT01724866
PT  - Comparative Study
PT  - Controlled Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20180323
PL  - United States
TA  - Cancer Med
JT  - Cancer medicine
JID - 101595310
RN  - 0 (Antineoplastic Agents)
RN  - 15H5577CQD (Docetaxel)
RN  - 3A58010674 (pegfilgrastim)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - PVI5M0M1GW (Filgrastim)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/administration & dosage/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/administration & dosage
MH  - Breast Neoplasms/*drug therapy
MH  - Cyclophosphamide/*administration & dosage/adverse effects
MH  - Docetaxel/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Female
MH  - Filgrastim/administration & dosage/adverse effects/*analogs & derivatives
MH  - Humans
MH  - Middle Aged
MH  - Neutropenia/chemically induced/epidemiology
MH  - Polyethylene Glycols/*administration & dosage/adverse effects
PMC - PMC5943466
OTO - NOTNLM
OT  - Breast cancer
OT  - Rolontis
OT  - eflapegrastim
OT  - neutropenia
EDAT- 2018/03/25 06:00
MHDA- 2019/09/07 06:00
PMCR- 2018/03/23
CRDT- 2018/03/25 06:00
PHST- 2017/10/20 00:00 [received]
PHST- 2017/12/19 00:00 [revised]
PHST- 2018/01/18 00:00 [accepted]
PHST- 2018/03/25 06:00 [pubmed]
PHST- 2019/09/07 06:00 [medline]
PHST- 2018/03/25 06:00 [entrez]
PHST- 2018/03/23 00:00 [pmc-release]
AID - CAM41388 [pii]
AID - 10.1002/cam4.1388 [doi]
PST - ppublish
SO  - Cancer Med. 2018 May;7(5):1660-1669. doi: 10.1002/cam4.1388. Epub 2018 Mar 23.