Evidence map›Paper›PMID 27124835›Full record

Trial reportJAMA oncology2016

Progression-Free Survival Among Patients With Well-Differentiated or Dedifferentiated Liposarcoma Treated With CDK4 Inhibitor Palbociclib: A Phase 2 Clinical Trial.

Mark A Dickson, Gary K Schwartz, Mary Louise Keohan, Sandra P D'Angelo, Mrinal M Gounder, Ping Chi, Cristina R Antonescu, Jonathan Landa, Li-Xuan Qin, Aimee M Crago and 3 more

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

Trial report in JAMA oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01209598 (A Phase II Study Of PD0332991), which is not on this map. Cited by 191 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed, 2 pooled it
19.2field-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.

NCT01209598 phase2completednot on this map

A Phase II Study Of PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2010 to 2016Enrolled90ConditionsSarcoma, LiposarcomaArmsPalbociclib 200mg, Palbociclib 125mg
3 · Its place in the literature

Who cites it

191 citing papers in PubMed, 2 syntheses or guidelines pooled it, 315 citations in OpenAlex.

  1. Pooled it
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  7. First-Line Anlotinib Treatment for Soft-Tissue Sarcoma in Chemotherapy-Ineligible Patients: An Open-Label, Single-Arm, Phase 2 Clinical Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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  10. 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
  11. 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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131 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

13 authors at 3 institutions in 1 country.

Mark A DicksonDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Gary K SchwartzColumbia University Medical Center, New York, New York.
Mary Louise KeohanDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Sandra P D'AngeloDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Mrinal M GounderDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Ping ChiDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Cristina R AntonescuDepartment of Pathology, Memorial Sloan-Kettering Cancer Center, New York, New York.
Jonathan LandaDepartment of Radiology, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Li-Xuan QinDepartment of Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, New York.
Aimee M CragoDepartment of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Samuel SingerDepartment of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Andrew KoffDepartment of Cell Biology, Memorial Sloan-Kettering Cancer Center, New York, New York.
William D TapDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York8Weill Cornell Medical College, New York, New York.
Memorial Sloan Kettering Cancer Center · USCornell University · USColumbia University Irving Medical 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

importanceMore than 90% of well-differentiated or dedifferentiated liposarcomas (WD/DDLS) have CDK4 amplification. The selective CDK4 and CDK6 inhibitor palbociclib inhibits growth and induces senescence in liposarcoma cell lines and xenografts. Our prior phase 2 study demonstrated that treatment with palbociclib (200 mg daily for 14 days every 21 days) resulted in clinical benefit in WD/DDLS but moderate hematologic toxic effects. It is important to understand whether palbociclib at a new dose and schedule-125 mg daily for 21 days every 28 days-results in clinical benefit and manageable toxic effects.

objectiveTo determine the progression-free survival (PFS) at 12 weeks of patients with WD/DDLS treated with palbociclib (PD0332991). DESIGN, SETTING, AND

participantsIn this phase 2, nonrandomized, open-label clinical trial conducted at the Memorial Sloan Kettering Cancer Center, 60 patients 18 years and older with advanced WD/DDLS and measurable disease by RECIST 1.1 were enrolled from December 2011 to January 2014 and followed to March 2015. Patients received oral palbociclib at 125 mg daily for 21 days in 28-day cycles. MAIN OUTCOMES AND MEASURES: Primary end point was PFS. Secondary end points included response rate and toxic effects.

resultsOverall, 30 patients were enrolled in the initial cohort and 30 more in an expansion cohort. Median (range) age was 61.5 (35-87) years; 31 patients (52%) were male; median (range) Eastern Cooperative Oncology Group score was 0 (0-1). Progression-free survival at 12 weeks was 57.2% (2-sided 95% CI, 42.4%-68.8%), and the median PFS was 17.9 weeks (2-sided 95% CI, 11.9-24.0 weeks). There was 1 complete response. Toxic effects were primarily hematologic and included neutropenia (grade 3, n = 20 [33%]; grade 4, n = 2 [3%]) but no neutropenic fever. CONCLUSIONS AND RELEVANCE: In patients with advanced WD/DDLS, treatment with palbociclib was associated with a favorable PFS and occasional tumor response. This dose and schedule appears active and may have less toxic effects than 200 mg for 14 days.

trial registrationclinicaltrials.gov Identifier: NCT01209598.

Indexed as

Dose-Response Relationship, DrugAdultAgedAged, 80 and overCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Disease-Free SurvivalFemaleHumansLiposarcomaMaleMiddle AgedPiperazinesProtein Kinase InhibitorsPyridinesCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6palbociclibPiperazinesProtein Kinase InhibitorsPyridines

Identifiers

PMID27124835
PMCPMC4991028
OpenAlexW2343607850

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.