Evidence map›Paper›PMID 34373957›Full record

ArticleSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2022

Risk factors of skeletal-related events in patients with bone metastatic castration-resistant prostate cancer undergoing treatment with zoledronate.

Hirotaka Miyashita, Christina Cruz, Vaibhav Patel

Registry-linked trialAbstract readControlled Clinical Trial
PubMed Publisher
In one paragraph

Article in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00321620 (A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.4field-weighted citation impact, top 38% 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.

NCT00321620 phase3completednot on this map

A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer

TypeinterventionalSponsorAmgenRan2006 to 2012Enrolled1,904ConditionsBone MetastasesArmszoledronic acid, denosumab
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 4 citations in OpenAlex.

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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

3 authors at 2 institutions in 1 country.

Hirotaka MiyashitaDepartment of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, NY, USA. Miyashita.hirotaka@gmail.com.ORCID http://orcid.org/0000-0002-0433-9779
Christina CruzDepartment of Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel, New York, NY, USA.
Vaibhav PatelDivision of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Mount Sinai Beth Israel · USIcahn School of Medicine at Mount Sinai · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSkeletal-related events (SREs) are related to morbidity and mortality in patients with bone metastatic prostate cancer, and preventive strategies based on patient risk assessment are recommended. However, potentiating factors for SREs in patients with bone metastatic prostate cancer are not well elucidated.

methodsWe analyzed the clinical data from a controlled arm of a clinical trial comparing denosumab with zoledronate in patients with bone metastatic, castration resistant prostate cancer (ClinicalTrial.gov ID: NCT00321620) available at Project Data Sphere, a broad-access research platform. The primary endpoint was the first SRE after the inclusion to the trial, and the time to the first SRE was analyzed using Cox proportional hazards model based on patients' baseline characteristics including age, race, ECOG performance status (PS), Gleason score, TNM stage at diagnosis, metastasis pattern, and urine and serum laboratory data.

resultsSeven hundred ten patients without documented history of osteopenia or osteoporosis whose data was available in the zoledronate arm of the trial were analyzed. The median age of the patients was 71 years old, the median follow-up was 225 days, and 295 patients (42%) had at least one SRE during this period. The univariate analysis showed that history of SREs, Gleason score ≥ 7, elevated serum alkaline phosphatase (ALP), and high urine N-telopeptide cross-links/creatinine ratio (NTx/Cre) are significant baseline risk factors for SREs. Patients with the characteristics of history of SREs, Gleason score ≥ 7 and elevated serum ALP also showed a significantly higher hazard ratio of SREs in multivariate analysis.

conclusionsThe incidence of SREs in patients with bone metastatic prostate cancer may be higher in those with history of SREs, Gleason ≥ 7, and elevated serum ALP.

Indexed as

Bone NeoplasmsProstatic NeoplasmsProstatic Neoplasms, Castration-ResistantAgedBone and BonesHumansMaleRisk FactorsZoledronic AcidZoledronic AcidAlkaline phosphataseBone metastasisCastration resistant prostate cancerGleason scoreSkeletal-related events

Identifiers

PMID34373957
OpenAlexW3191353647

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.