Evidence map›Paper›PMID 26033180›Full record

Trial reportAnnals of surgical oncology2015

Surgical downstaging in an open-label phase II trial of denosumab in patients with giant cell tumor of bone.

Piotr Rutkowski, Stefano Ferrari, Robert J Grimer, Paul D Stalley, Sander P D Dijkstra, Andrzej Pienkowski, Gualter Vaz, Jay S Wunder, Leanne L Seeger, Amy Feng and 2 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of surgical oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 96 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 2 pooled it
14.2field-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.

NCT00680992 phase2completednot on this map

An Open-label, Multi-center, Phase 2 Study of Denosumab in Subjects With Giant Cell Tumor of Bone

TypeinterventionalSponsorAmgenRan2008 to 2018Enrolled535ConditionsCancer, Giant Cell Tumors, Giant Cell Tumor of Bone, Benign Giant Cell TumorsArmsDenosumab
NCT03259152 phase3unknown statusnot on this mapstarted 2016, after this paper: background citation

Clinical, Pathologic Characteristics and Its Mechansim of Denosumab Treated Giant Cell Tumor of Bone

TypeinterventionalSponsorHebei Medical University Third HospitalRan2016 to 2019Enrolled30ConditionsGiant Cell Tumor of BoneArmsDenosumab
NCT03358212 unknown statusnot on this mapstarted 2018, after this paper: background citation

Safety and Efficacy of Post-operative Denosumab Strategy for Giant Cell Tumor of Bone Treatment in China:Correlation Between Recurrence and Drug Withdrawl

Typeobservational_patient_registrySponsorPeking University People's HospitalRan2018 to 2021Enrolled100ConditionsGiant Cell Tumor of BoneArmsDenosumab
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 2 syntheses or guidelines pooled it, 184 citations in OpenAlex.

  1. Management of giant cell tumors of the distal radius: a systematic review and meta-analysis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2023
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36 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

12 authors at 9 institutions in 8 countries.

Piotr RutkowskiDepartment of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Center and Institute of Oncology, Roentgen Str 5, 02-781, Warsaw, Poland, rutkowskip@coi.waw.pl.
Stefano Ferrari
Robert J Grimer
Paul D Stalley
Sander P D Dijkstra
Andrzej Pienkowski
Gualter Vaz
Jay S Wunder
Leanne L Seeger
Amy Feng
Zachary J Roberts
Bruce A Bach
Amgen (United States) · USThe Maria Sklodowska-Curie National Research Institute of Oncology · PLCentre Léon Bérard · FRIstituto Ortopedico Rizzoli · ITLeiden University Medical Center · NLMount Sinai Hospital · CARoyal Orthopaedic Hospital · GBRoyal Prince Alfred Hospital · AUUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurgical resection with curative intent for giant cell tumor of bone (GCTB) may be associated with severe morbidity. This interim analysis evaluated reduction in surgical invasiveness after denosumab treatment in patients with resectable GCTB.

methodsPatients with primary or recurrent GCTB, for whom the initially planned surgery was associated with functional compromise or morbidity, received denosumab 120 mg subcutaneously every 4 weeks (additional doses on days 8 and 15 of the first cycle). Planned and actual GCTB-related surgical procedures before and after denosumab treatment were reported. Patients were followed for surgical outcome, adverse events, and recurrence following resection.

resultsOverall, 222 patients were evaluable for surgical downstaging (54 % were women; median age 34 years). Lesions (67 % primary and 33 % recurrent) were located in the axial (15 %) and appendicular skeleton (85 %). At the data cutoff date, most patients had not yet undergone surgery (n = 106; 48 %) or had a less morbid procedure (n = 84; 38 %) than originally planned. Median (interquartile range) time on denosumab was 19.5 (12.4-28.6) months for the 106 patients who had not undergone surgery and were continuing on monthly denosumab. Native joint preservation was 96 % (n = 24/25) for patients with planned joint/prosthesis replacement and 86 % (n = 30/35) for patients with planned joint resection/fusion. Of the 116 patients who had surgery (median postsurgical follow-up 13.0 [8.5-17.9] months), local recurrence occurred in 17 (15 %) patients.

conclusionFor patients with resectable GCTB, neoadjuvant denosumab therapy resulted in beneficial surgical downstaging, including either no surgery or a less morbid surgical procedure.

Indexed as

AdultBone Density Conservation AgentsBone NeoplasmsCombined Modality TherapyDenosumabFemaleFollow-Up StudiesGiant Cell Tumor of BoneHumansMaleNeoplasm Recurrence, LocalNeoplasm StagingPrognosisProspective StudiesBone Density Conservation AgentsDenosumab

Identifiers

PMID26033180
PMCPMC4531146
OpenAlexW1507649428

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.