PMID- 26370220
OWN - NLM
STAT- MEDLINE
DCOM- 20161101
LR  - 20181202
IS  - 1433-7339 (Electronic)
IS  - 0941-4355 (Print)
IS  - 0941-4355 (Linking)
VI  - 24
IP  - 4
DP  - 2016 Apr
TI  - Sotatercept (ACE-011) for the treatment of chemotherapy-induced anemia in 
      patients with metastatic breast cancer or advanced or metastatic solid tumors 
      treated with platinum-based chemotherapeutic regimens: results from two phase 2 
      studies.
PG  - 1517-25
LID - 10.1007/s00520-015-2929-9 [doi]
AB  - PURPOSE: Sotatercept may represent a novel approach to the treatment of 
      chemotherapy-induced anemia (CIA). We report the results from two phase 2 
      randomized studies examining the use of sotatercept for the treatment of CIA in 
      patients with metastatic cancer. METHODS: In study A011-08, patients with 
      metastatic breast cancer were randomized to 2:2:2:1 to receive sotatercept 0.1, 
      0.3, or 0.5 mg/kg, or placebo, respectively, every 28 days. In study 
      ACE-011-NSCL-001, patients with solid tumors treated with platinum-based 
      chemotherapy received sotatercept 15 or 30 mg every 42 days. The primary endpoint 
      for both studies was hematopoietic response, defined as a hemoglobin (Hb) 
      increase of >/=1 g/dL from baseline. RESULTS: Both studies were terminated early 
      due to slow patient accrual. Among patients treated with sotatercept in the 
      A011-08 and ACE-011-NSCL-001 studies, more patients achieved a mean Hb increase 
      of >/=1 g/dL in the combined sotatercept 0.3 mg/kg and 15 mg (66.7 %) group and 
      sotatercept 0.5 mg/kg and 30 mg (38.9 %) group versus the sotatercept 0.1 mg/kg 
      (0 %) group. No patients achieved a mean Hb increase of >/=1 g/dL in the placebo 
      group. The incidence of treatment-related adverse events (AEs) was low in both 
      studies, and treatment discontinuations due to AEs were uncommon. CONCLUSIONS: 
      Although both studies were terminated early, these results indicate that 
      sotatercept is active and has an acceptable safety profile in the treatment of 
      CIA.
FAU - Raftopoulos, Haralambos
AU  - Raftopoulos H
AD  - Monter Cancer Center, Hofstra North Shore-LIJ School of Medicine, 450 Lakeville 
      Road, Lake Success, NY, 11042, USA. harry.raftopoulos@gmail.com.
FAU - Laadem, Abderrahmane
AU  - Laadem A
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Hesketh, Paul J
AU  - Hesketh PJ
AD  - Lahey Hospital & Medical Center, Tufts University School of Medicine, Burlington, 
      MA, USA.
FAU - Goldschmidt, Jerome
AU  - Goldschmidt J
AD  - Blue Ridge Cancer Care, Blacksburg, VA, USA.
FAU - Gabrail, Nashat
AU  - Gabrail N
AD  - Gabrail Cancer Center, Canton, OH, USA.
FAU - Osborne, Cynthia
AU  - Osborne C
AD  - Texas Oncology PA, Dallas, TX, USA.
FAU - Ali, Muhammad
AU  - Ali M
AD  - Quincy Medical Group, Quincy, IL, USA.
FAU - Sherman, Matthew L
AU  - Sherman ML
AD  - Acceleron Pharma, Cambridge, MA, USA.
FAU - Wang, Ding
AU  - Wang D
AD  - Josephine Ford Cancer Institute, Detroit, MI, USA.
FAU - Glaspy, John A
AU  - Glaspy JA
AD  - UCLA Medical Center, Los Angeles, CA, USA.
FAU - Puccio-Pick, Marie
AU  - Puccio-Pick M
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Zou, Jun
AU  - Zou J
AD  - Celgene Corporation, Summit, NJ, USA.
FAU - Crawford, Jeffrey
AU  - Crawford J
AD  - Duke University Medical Center, Durham, NC, USA.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20150914
PL  - Germany
TA  - Support Care Cancer
JT  - Supportive care in cancer : official journal of the Multinational Association of 
      Supportive Care in Cancer
JID - 9302957
RN  - 0 (ACE-011)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 49DFR088MY (Platinum)
SB  - IM
MH  - Adult
MH  - Anemia/chemically induced/*drug therapy
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Breast Neoplasms/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Induction Chemotherapy/*adverse effects
MH  - Middle Aged
MH  - Platinum/adverse effects
MH  - Recombinant Fusion Proteins/administration & dosage/*therapeutic use
PMC - PMC4766217
OTO - NOTNLM
OT  - ActRIIA
OT  - Chemotherapy-induced anemia
OT  - Erythropoiesis
OT  - Sotatercept
EDAT- 2015/09/16 06:00
MHDA- 2016/11/02 06:00
PMCR- 2015/09/14
CRDT- 2015/09/16 06:00
PHST- 2015/03/23 00:00 [received]
PHST- 2015/08/31 00:00 [accepted]
PHST- 2015/09/16 06:00 [entrez]
PHST- 2015/09/16 06:00 [pubmed]
PHST- 2016/11/02 06:00 [medline]
PHST- 2015/09/14 00:00 [pmc-release]
AID - 10.1007/s00520-015-2929-9 [pii]
AID - 2929 [pii]
AID - 10.1007/s00520-015-2929-9 [doi]
PST - ppublish
SO  - Support Care Cancer. 2016 Apr;24(4):1517-25. doi: 10.1007/s00520-015-2929-9. Epub 
      2015 Sep 14.