Evidence map›Paper›PMID 34169003›Full record

SynthesisFrontiers in oncology2021

A Systematic Review and Meta-Analysis of Randomized Controlled Trials With Novel Hormonal Therapies for Non-Metastatic Castration-Resistant Prostate Cancer: An Update From Mature Overall Survival Data.

Martina Maggi, Stefano Salciccia, Francesco Del Giudice, Gian Maria Busetto, Ugo G Falagario, Giuseppe Carrieri, Matteo Ferro, Angelo Porreca, Giovanni Battista Di Pierro, Vittorio Fasulo and 4 more

Open access · goldAbstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Frontiers in oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
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  7. Article
  8. 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

14 authors at 5 institutions in 1 country.

Martina MaggiDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Stefano SalcicciaDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Francesco Del GiudiceDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Gian Maria BusettoDepartment of Urology and Renal Transplantation, University of Foggia, Policlinico Riuniti, Foggia, Italy.
Ugo G FalagarioDepartment of Urology and Renal Transplantation, University of Foggia, Policlinico Riuniti, Foggia, Italy.
Giuseppe CarrieriDepartment of Urology and Renal Transplantation, University of Foggia, Policlinico Riuniti, Foggia, Italy.
Matteo FerroDepartment of Urology, European Institute of Oncology (IEO), Milan, Italy.
Angelo PorrecaDepartment of Urology, Veneto Institute of Oncology (IOV) IRCCS, Padua, Italy.
Giovanni Battista Di PierroDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Vittorio FasuloDepartment of Urology, Istituto Clinico Humanitas IRCCS-Clinical and Research Hospital, Milan, Rozzano, Italy.
Viviana FrantellizziDepartment Of Maternal-Infant And Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Giuseppe De VincentisDepartment Of Maternal-Infant And Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Ettore De BerardinisDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Alessandro SciarraDepartment of Maternal-Infant and Urological Sciences, Sapienza Rome University, Policlinico Umberto I, Rome, Italy.
Policlinico Umberto I · ITUniversity of Foggia · ITEuropean Institute of Oncology · ITIRCCS Humanitas Research Hospital · ITIstituti di Ricovero e Cura a Carattere Scientifico · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo get better insight into the management of non-metastatic castration-resistant prostate cancer (M0 CRPC), in this meta-analysis and review we aimed to present an updated evaluation of the efficacy and safety of novel hormonal therapies (nHT) for M0 CRPC according to final analyses with mature overall survival (OS) and safety data.

methodsWe analyzed metastasis-free survival (MFS), OS, time to prostate-specific antigen (PSA) progression, second-line therapies data, adverse events (AEs), including all AEs, serious AEs (SAEs), AEs leading to discontinuation of trial regimen, AEs leading to death, fatigue, dizziness, cardiovascular events, and fractures; moreover, we evaluated the impact of PSA doubling time (PSA-DT), Eastern Cooperative Oncology Group (ECOG) score, use of bone-targeted therapy, lymph lodes (LN) status, and prior HT on final OS data. A comparison among the placebo arms of the included trials in terms of survival and safety profiles was assessed.

resultsAccording to the pooled analysis with updated and mature OS data, OS was significantly improved with nHT compared to placebo (hazard ratio (HR)= 0.74, 95% confidence interval (CI)= 0.66-0.84). nHT significantly improved OS over placebo across all pre-specified subgroups. Subgroup analysis revealed a greater OS benefit in patients with PSA-DT >6 months than ≤6 months (HR= 0.69 versus HR= 0.75), ECOG 0 than 1 (HR= 0.70 versus HR= 0.80), N1 disease than N0 (HR= 0.61 versus HR= 0.78), and in those receiving bone-targeted therapy (HR= 0.65 versus HR= 0.74), and a comparable OS by number of prior HT (HR= 0.75 versus HR= 0.76, for HT= 1 and ≥2); yet, differences between pre-specified subgroups were not significant (all p> 0.05). Overall, the nHT arm was significantly associated with higher rates of AEs, when compared with the placebo arm. The long-term analysis showed a worse safety profile with nHT than the interim analysis.

conclusionsAccording to final analyses, nHT have shown to improve OS over placebo in the setting of high-risk M0 CRPC. The long-term analysis showed a worse safety profile with nHT than the interim analysis, whit distinct profiles among different nHT. The lack of survival data regarding second-line therapies remains a major issue.

Indexed as

adverse eventshormonal therapymetastasisnon-metastatic castration-resistant prostate canceroverall survivalprostate neoplasm

Identifiers

PMID34169003
PMCPMC8217817
OpenAlexW3172577062

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.