Evidence map›Paper›PMID 23569312›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Phase II trial of the CDK4 inhibitor PD0332991 in patients with advanced CDK4-amplified well-differentiated or dedifferentiated liposarcoma.

Mark A Dickson, William D Tap, Mary Louise Keohan, Sandra P D'Angelo, Mrinal M Gounder, Cristina R Antonescu, Jonathan Landa, Li-Xuan Qin, Dustin D Rathbone, Mercedes M Condy and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02571829 (A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma), which is not on this map. Cited by 221 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
221citing papers in PubMed, 3 pooled it
32.7field-weighted citation impact, top 1% 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.

NCT02571829 phase2unknown statusnot on this mapstarted 2016, after this paper: background citation

A Phase II Single Arm Study Assessing Efficacy & Safety of Ribociclib in Patients With Advanced Well-Differentiated or Dedifferentiated Liposarcoma

TypeinterventionalSponsorHadassah Medical OrganizationRan2016 to 2017Enrolled30ConditionsLiposarcoma, Soft Tissue SarcomaArmsribociclib
3 · Its place in the literature

Who cites it

221 citing papers in PubMed, 3 syntheses or guidelines pooled it, 390 citations in OpenAlex.

  1. Pooled it
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  9. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial
  10. Selinexor in Advanced, Metastatic Dedifferentiated Liposarcoma: A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
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  16. Aplidin in patients with advanced dedifferentiated liposarcomas: a French Sarcoma Group Single-Arm Phase II study.Annals of oncology : official journal of the European Society for Medical Oncology · 2015
    Trial
  17. Article
  18. Review
  19. Observational
  20. Article

161 more citing papers are in PubMed but not listed here.

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

14 authors at 1 institution in 1 country.

Mark A DicksonMemorial Sloan-Kettering Cancer Center, New York, NY, USA. dicksonm@mskcc.org
William D Tap
Mary Louise Keohan
Sandra P D'Angelo
Mrinal M Gounder
Cristina R Antonescu
Jonathan Landa
Li-Xuan Qin
Dustin D Rathbone
Mercedes M Condy
Yelena Ustoyev
Aimee M Crago
Samuel Singer
Gary K Schwartz
Memorial Sloan Kettering Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
SOFT TISSUE SARCOMA PROGRAM PROJECTP01CA047179 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI LADANYI, MARC · 1989 to 2010
$17.3M
SPORE in Soft Tissue SarcomaP50CA140146 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI SPRIGGS, DAVID R · 2010 to 2014
$11.1M
NCI NIH HHS P01 CA047179NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA140146
6 · The paper itself

Abstract

purposeCDK4 is amplified in > 90% of well-differentiated (WDLS) and dedifferentiated liposarcomas (DDLS). The selective cyclin-dependent kinase 4 (CDK4)/CDK6 inhibitor PD0332991 inhibits growth and induces senescence in cell lines and xenografts. In a phase I trial of PD0332991, several patients with WDLS or DDLS experienced prolonged stable disease. We performed an open-label phase II study to determine the safety and efficacy of PD0332991 in patients with advanced WDLS/DDLS. PATIENTS AND

methodsPatients age ≥ 18 years experiencing disease progression while receiving systemic therapy before enrollment received PD0332991 200 mg orally once per day for 14 consecutive days in 21-day cycles. All were required to have CDK4 amplification by fluorescence in situ hybridization and retinoblastoma protein (RB) expression by immunohistochemistry (≥ 1+). The primary end point was progression-free survival (PFS) at 12 weeks, with 12-week PFS of ≥ 40% considered promising and ≤ 20% not promising. If ≥ nine of 28 patients were progression free at 12 weeks, PD0332991 would be considered active.

resultsWe screened 48 patients (44 of 48 had CDK4 amplification; 41 of 44 were RB positive). Of those, 30 were enrolled, and 29 were evaluable for the primary end point. Grade 3 to 4 events included anemia (17%), thrombocytopenia (30%), neutropenia (50%), and febrile neutropenia (3%). At 12 weeks, PFS was 66% (90% CI, 51% to 100%), significantly exceeding the primary end point. The median PFS was 18 weeks. There was one partial response.

conclusionTreatment with the CDK4 inhibitor PD0332991 was associated with a favorable progression-free rate in patients with CDK4-amplified and RB-expressing WDLS/DDLS who had progressive disease despite systemic therapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorCell DifferentiationCyclin-Dependent Kinase 4Disease-Free SurvivalFemaleHumansImmunohistochemistryIn Situ Hybridization, FluorescenceKaplan-Meier EstimateLiposarcomaMaleMiddle AgedAntineoplastic AgentsBiomarkers, TumorCDK4 protein, humanCyclin-Dependent Kinase 4palbociclibPiperazinesPyridinesRetinoblastoma Protein

Identifiers

PMID23569312
PMCPMC3661937
OpenAlexW2107480474

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.