PMID- 35920783
OWN - NLM
STAT- MEDLINE
DCOM- 20221004
LR  - 20221209
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 27
IP  - 10
DP  - 2022 Oct 1
TI  - Results of NC-6300 (Nanoparticle Epirubicin) in an Expansion Cohort of Patients 
      with Angiosarcoma.
PG  - 809-e765
LID - 10.1093/oncolo/oyac155 [doi]
AB  - BACKGROUND: NC-6300 is a novel epirubicin (EPI) drug conjugated polymeric micelle 
      developed using cutting-edge micellar nanoparticle technology. The nanoparticle 
      epirubicin conjugates EPI to a polymer via a pH-sensitive linker which enables 
      the selective EPI release into tumor. Tumor activity was observed in a 
      monotherapy phase Ib trial, where two of two patients with angiosarcoma achieved 
      a partial response. To further explore the activity of NC-6300 in angiosarcoma, 
      an expansion cohort was undertaken. METHODS: Ten patients with angiosarcoma were 
      enrolled in the expansion cohort. Patients were dosed using the recommended dose 
      of 150 mg/m2 intravenously (IV) once every 3 weeks. The primary endpoint was 
      progression-free survival. RESULTS: The most common adverse events (AEs) of any 
      grade, regardless of the causal relationship with NC-6300, were neutropenia 
      (90%), fatigue, and thrombocytopenia (60% each) and nausea (50%). The most common 
      grades 3 and 4 AEs were neutropenia (80%), thrombocytopenia (40%), and anemia and 
      leukopenia (20% each). The median progression-free survival (mPFS) for all 
      subjects was 5.4 months. The mPFS was 3.8 months in subjects with prior 
      anthracycline treatment and 8.2 months in subjects without prior anthracycline 
      treatment. CONCLUSION: NC-6300 was well tolerated, showing promising activity in 
      angiosarcoma patients without prior anthracycline treatment. NC-6300 warrants 
      further investigation (ClinicalTrials.gov Identifier: NCT03168061).
CI  - (c) The Author(s) 2022. Published by Oxford University Press.
FAU - Riedel, Richard F
AU  - Riedel RF
AUID- ORCID: 0000-0001-5412-8710
AD  - Duke Cancer Institute, Duke University Medical Center, Durham, NC, USA.
FAU - Chua, Victoria
AU  - Chua V
AD  - Sarcoma Oncology Research Center, Santa Monica, CA, USA.
FAU - Moradkhani, Ania
AU  - Moradkhani A
AD  - Sarcoma Oncology Research Center, Santa Monica, CA, USA.
FAU - Krkyan, Natalie
AU  - Krkyan N
AD  - Sarcoma Oncology Research Center, Santa Monica, CA, USA.
FAU - Ahari, Amir
AU  - Ahari A
AD  - Sarcoma Oncology Research Center, Santa Monica, CA, USA.
FAU - Osada, Atsushi
AU  - Osada A
AD  - NanoCarrier Co., Ltd., Tokyo, Japan.
FAU - Chawla, Sant P
AU  - Chawla SP
AD  - Sarcoma Oncology Research Center, Santa Monica, CA, USA.
LA  - eng
SI  - ClinicalTrials.gov/NCT03168061
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Anthracyclines)
RN  - 0 (Antibiotics, Antineoplastic)
RN  - 0 (Micelles)
RN  - 0 (NC 6300)
RN  - 0 (Polymers)
RN  - 0 (Proteins)
RN  - 3Z8479ZZ5X (Epirubicin)
SB  - IM
MH  - Anthracyclines
MH  - Antibiotics, Antineoplastic/therapeutic use
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - Epirubicin/adverse effects/analogs & derivatives
MH  - *Hemangiosarcoma/chemically induced/drug therapy
MH  - Humans
MH  - Micelles
MH  - *Nanoparticles
MH  - *Neutropenia/chemically induced
MH  - Polymers
MH  - Proteins
MH  - *Thrombocytopenia/chemically induced
PMC - PMC9526480
OTO - NOTNLM
OT  - NC-6300
OT  - angiosarcoma
OT  - epirubicin
OT  - metastatic
OT  - nanoparticle
OT  - soft tissue sarcoma
OT  - unresectable
EDAT- 2022/08/04 06:00
MHDA- 2022/10/05 06:00
PMCR- 2022/08/03
CRDT- 2022/08/03 10:43
PHST- 2022/02/24 00:00 [received]
PHST- 2022/06/21 00:00 [accepted]
PHST- 2022/08/04 06:00 [pubmed]
PHST- 2022/10/05 06:00 [medline]
PHST- 2022/08/03 10:43 [entrez]
PHST- 2022/08/03 00:00 [pmc-release]
AID - 6654611 [pii]
AID - oyac155 [pii]
AID - 10.1093/oncolo/oyac155 [doi]
PST - ppublish
SO  - Oncologist. 2022 Oct 1;27(10):809-e765. doi: 10.1093/oncolo/oyac155.