Evidence map›Paper›PMID 26370220›Full record

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

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.

Haralambos Raftopoulos, Abderrahmane Laadem, Paul J Hesketh, Jerome Goldschmidt, Nashat Gabrail, Cynthia Osborne, Muhammad Ali, Matthew L Sherman, Ding Wang, John A Glaspy and 3 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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. It is linked to 2 registered trials, which are not on this map. Cited by 37 papers.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed
4.0field-weighted citation impact, top 6% 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.

NCT00931606 phase2terminatednot on this map

A Phase 2, Double-blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients With Metastatic Breast Cancer

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2009 to 2010Enrolled30ConditionsChemotherapy Induced AnemiaArmsSotatercept, Placebo
NCT01284348 phase2terminatednot on this map

An Open-Label Randomized, Phase 2A, Dose-Ranging Study of Sotatercept (ACE-011) for Chemotherapy-Induced Anemia in Subjects With Advanced or Metastatic Solid Tumors Treated With Platinum-Based Chemotherapeutic Regimens

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2011 to 2012Enrolled26ConditionsAnemia, Carcinoma, Non-Small-Cell Lung, Carcinoma, Small-Cell Lung, Bladder CancerArmsSotatercept 15 mg, Sotatercept 30 mg
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 65 citations in OpenAlex.

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  15. Pathogenesis and treatment of multiple myeloma bone disease.The Japanese dental science review · 2021
    Review
  16. Review
  17. Article
  18. Review
  19. Review
  20. Experimental Drugs for Chemotherapy- and Cancer-Related Anemia.Journal of experimental pharmacology · 2021
    Review
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

13 authors at 11 institutions in 2 countries.

Haralambos RaftopoulosMonter Cancer Center, Hofstra North Shore-LIJ School of Medicine, 450 Lakeville Road, Lake Success, NY, 11042, USA. harry.raftopoulos@gmail.com.
Abderrahmane LaademCelgene Corporation, Summit, NJ, USA.
Paul J HeskethLahey Hospital & Medical Center, Tufts University School of Medicine, Burlington, MA, USA.
Jerome GoldschmidtBlue Ridge Cancer Care, Blacksburg, VA, USA.
Nashat GabrailGabrail Cancer Center, Canton, OH, USA.
Cynthia OsborneTexas Oncology PA, Dallas, TX, USA.
Muhammad AliQuincy Medical Group, Quincy, IL, USA.
Matthew L ShermanAcceleron Pharma, Cambridge, MA, USA.
Ding WangJosephine Ford Cancer Institute, Detroit, MI, USA.
John A GlaspyUCLA Medical Center, Los Angeles, CA, USA.
Marie Puccio-PickCelgene Corporation, Summit, NJ, USA.
Jun ZouCelgene Corporation, Summit, NJ, USA.
Jeffrey CrawfordDuke University Medical Center, Durham, NC, USA.
Bristol-Myers Squibb (Switzerland) · CHAcceleron Pharma (United States) · USDuke Medical Center · USFord Motor Company (United States) · USGabrail Cancer Center · USHofstra University · USLahey Hospital and Medical Center · USMountain Blue Cancer Care Center · USQuincy Medical Center · USTexas Oncology · USUCLA Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeSotatercept 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.

methodsIn 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.

resultsBoth 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.

conclusionsAlthough both studies were terminated early, these results indicate that sotatercept is active and has an acceptable safety profile in the treatment of CIA.

Indexed as

AdultAnemiaAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDouble-Blind MethodFemaleHumansInduction ChemotherapyMiddle AgedPlatinumRecombinant Fusion ProteinsPlatinumRecombinant Fusion ProteinssotaterceptActRIIAChemotherapy-induced anemiaErythropoiesisSotatercept

Identifiers

PMID26370220
PMCPMC4766217
OpenAlexW1836492536

What OpenQuestion holds

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Registered trials

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.