Evidence map›Paper›PMID 29126389›Full record

Trial reportBMC cancer2017

Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter "real life" study.

Luca Cindolo, Clara Natoli, Cosimo De Nunzio, Michele De Tursi, Maurizio Valeriani, Silvana Giacinti, Salvatore Micali, Mino Rizzo, Giampaolo Bianchi, Eugenio Martorana and 14 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

12 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Article
  7. Article
  8. Article
  9. Article
  10. Effectiveness, safety and cost of abiraterone acetate in patients with metastatic castration-resistant prostate cancer: a real-world data analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Observational
  11. Article
  12. 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

24 authors at 11 institutions in 2 countries.

Luca CindoloDepartment of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy. lucacindolo@virgilio.it.ORCID http://orcid.org/0000-0002-0712-2719
Clara NatoliDepartment of Medical, Oral and Biotechnological Sciences, Centro Scienze dell'Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy.
Cosimo De NunzioDepartment of Urology, "Sant'Andrea" Hospital , Sapienza University", Rome, Italy.
Michele De TursiDepartment of Medical, Oral and Biotechnological Sciences, Centro Scienze dell'Invecchiamento e Medicina Traslazionale (CeSI-MeT), Chieti, Italy.
Maurizio ValerianiRadiation therapy Unit, "Sant'Andrea" Hospital, "Sapienza University", Rome, Italy.
Silvana GiacintiOncology Unit, "Sant'Andrea" Hospital, "Sapienza University", Rome, Italy.
Salvatore MicaliDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy.
Mino RizzoDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy.
Giampaolo BianchiDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy.
Eugenio MartoranaDepartment of Urology, University of Modena & Reggio Emilia, Baggiovara Hospital, Via Giardini, 1355, Baggiovara, Italy.
Marcello ScarciaEnte Ecclesiastico Ospedale "F. Miulli", S.P. per Santeramo Km 4.100, Acquaviva delle Fonti, Italy.
Giuseppe Mario LudovicoEnte Ecclesiastico Ospedale "F. Miulli", S.P. per Santeramo Km 4.100, Acquaviva delle Fonti, Italy.
Pierluigi BoveDepartment Of Experimental Medicine and Surgery, Azienda Policlinico Tor Vergata, Rome, Italy.
Anastasia LaudisiUOSD of Medical Oncology Azienda Policlinico Tor Vergata, Rome, Italy.
Oscar SelvaggioDepartment of Urology, University of Foggia, V.le L. Pinto, Foggia, Italy.
Giuseppe CarrieriDepartment of Urology, University of Foggia, V.le L. Pinto, Foggia, Italy.
Maida BadaDepartment of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy.
Pietro CastellanDepartment of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy.
Stefano BoccasileUrology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, Bari, Italy.
Pasquale DitonnoUrology and Andrology Unit II, Department of Emergency and Organ Transplantation, University of Bari, Piazza G. Cesare 11, Bari, Italy.
Paolo ChiodiniMedical Statistics Unit, University of Campania "Luigi Vanvitelli", via L. Armanni 5, Naples, Italy.
Paolo VerzeDepartment of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy.
Vincenzo MironeDepartment of Neurosciences, Sciences of Reproduction and Odontostomatology, Urology Unit, University of Naples "Federico II", Naples, Italy.
Luigi SchipsDepartment of Urology, ASL Abruzzo2, Via dei Vestini, Chieti, Italy.
University of Modena and Reggio Emilia · ITAgenzia Sanitaria Regionale Abruzzo · ITAzienda Ospedaliera Sant'Andrea · ITOspedale Generale Regionale Francesco Miulli · ITPoliclinico Tor Vergata · ITUniversity of Bari Aldo Moro · ITUniversity of Chieti-Pescara · ITUniversity of Foggia · ITUniversity of Naples Federico II · ITParco Nazionale d'Abruzzo · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the safety and efficacy of abiraterone acetate (AA) in the "real life" clinical practice for men with chemotherapy-naïve metastatic castration-resistant prostate.

methodsA consecutive series of patients with mCRPC in 9 Italian tertiary centres treated with AA was collected. Demographics, clinical parameters, treatment outcomes and toxicity were recorded. The Brief Pain Inventory scale Q3 was tracked and patient treatment satisfaction was evaluated. Survival curves were estimated by the method of Kaplan-Meier and Cox regression and compared by the log-rank test statistic.

resultsWe included 145 patients (mean age 76.5y). All patients were on androgen deprivation therapy. Patients had prior radiotherapy, radical prostatectomy, both treatments or exclusive androgen deprivation therapy in 17%, 33%, 9% and 40%, respectively. 57% of the patients had a Gleason score higher more than 7 at diagnosis. 62% were asymptomatic patients. The median serum total PSA at AA start was 17 ng/mL (range 0,4-2100). The median exposure to AA was 10 months (range 1-35). The proportion of patients achieving a PSA decline ≥50% at 12 weeks was 49%. Distribution of patient satisfaction was 32% "greatly improved", 38% "improved", 24% "not changed", 5.5% "worsened". Grade 3 and 4 toxicity was recorded in 17/145 patients 11.7% (70% cardiovascular events, 30% critical elevation of AST/ALT levels). At the last follow-up, median progression free and overall survival were 17 and 26.5 months, respectively. Both outcomes significantly correlated with the presence of pain, patient satisfaction, PSA baseline and PSA decline.

conclusionsThe AA is effective and well tolerated in asymptomatic or slightly symptomatic mCRPC in a "real life" setting. The survival outcomes are influenced by the presence of pain, patient satisfaction, baseline PSA and PSA decline.

trial registrationThe study was retrospectively registered at ISRCTN as DOI: 10.1186/ISRCTN 52513758 in date April the 30th 2016.

Indexed as

Abiraterone AcetateAgedAged, 80 and overDisease-Free SurvivalDisease ProgressionDrug-Related Side Effects and Adverse ReactionsHumansKaplan-Meier EstimateMaleMiddle AgedNeoplasm MetastasisProstatectomyProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantRisk FactorsTreatment OutcomeAbiraterone AcetateProstate-Specific AntigenAbiraterone acetateAndrogen deprivation therapyAndrogen receptorCastration-resistant prostate cancerProstate cancer

Identifiers

PMID29126389
PMCPMC5681753
OpenAlexW2767843503

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.