Evidence map›Paper›PMID 35405438›Full record

Observational studyESMO open2022

Real-world experience of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: long-term results of the prospective ABItude study.

G Procopio, V E Chiuri, M Giordano, A R Alitto, R Maisano, R Bordonaro, S Cinieri, S Rossetti, S De Placido, M Airoldi and 13 more

Open access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in ESMO open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 29% 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

4 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Abiraterone and enzalutamide in the first line therapy of metastatic castration resistant prostate cancer.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2024
    Article
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

23 authors at 20 institutions in 1 country.

G ProcopioDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
V E ChiuriMedical Oncology Department, Ospedale Vito Fazzi, Lecce, Italy.
M GiordanoMedical Oncology Division, ASST-Lariana, Como, Italy.
A R AlittoDepartment of Diagnostic Imaging, Radiation Oncology and Hematology, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy.
R MaisanoDepartment of Oncology, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
R BordonaroMedical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy.
S CinieriMedical Oncology Unit, Antonio Perrino Hospital, Brindisi, Italy.
S RossettiDepartment of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.
S De PlacidoDepartment of Clinical Medicine and Surgery, University of Naples 'Federico II', Naples, Italy.
M AiroldiOncology Unit 2, Città della Salute e della Scienza di Torino, Turin, Italy.
L GalliDepartment of Medical Oncology, A.O.U. Pisana, Pisa, Italy.
D GasparroMedical Oncology Unit, Department of General & Specialistic Medicine, University Hospital of Parma, Parma, Italy.
G M LudovicoDepartment of Urology, Ospedale F. Miulli, Acquaviva delle Fonti, Bari, Italy.
P F GuglielminiOncology Unit, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.
C CarellaMedical Oncology Unit, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy.
P NovaDepartment of Medical Oncology, ASST Brianza, Presidio Vimercate, Vimercate, Italy.
M AgliettaDepartment of Oncology, University of Turin, Turin, Italy; Candiolo Cancer Institute-FPO-IRCCS, Candiolo, Italy.
L SchipsDepartment of Medical, Oral and Biotechnological Sciences, G. D'Annunzio University of Chieti, Urology Unit, SS. Annunziata Hospital, Chieti, Italy.
P BeccagliaJanssen-Cilag SpA, Cologno Monzese, Italy. Electronic address: pbeccagl@its.jnj.com.
A SciarraDepartment of Urology, Sapienza Rome University Policlinico Umberto I, Rome, Italy.
L LiviRadiation Oncology Unit and Department of Clinical and Experimental Biomedical Sciences 'Mario Serio', Azienda Ospedaliera Universitaria Careggi, University of Florence, Florence, Italy.
D SantiniDepartment of Medical Oncology, University Campus Biomedico, Rome, Italy.
ABItude Study Group
Azienda Ospedaliera Citta' della Salute e della Scienza di Torino · ITAzienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITIstituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · ITOspedale A. Perrino · ITOspedale Garibaldi · ITOspedale Generale Regionale Francesco Miulli · ITOspedale Vito Fazzi · ITPoliclinico Umberto I · ITUniversità Campus Bio-Medico · ITUniversity of Chieti-Pescara · ITUniversity of Naples Federico II · ITUniversity of Parma · ITUniversity of Pisa · ITAgostino Gemelli University Polyclinic · ITAzienda ospedaliera "Bianchi-Melacrino-Morelli" · ITAzienda Ospedaliera di Desio e Vimercate · ITAzienda Ospedaliero-Universitaria Careggi · ITAzienda Socio Sanitaria Territoriale Lariana · ITCandiolo Cancer Institute · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLimited real-world data exist on the effectiveness and safety of abiraterone acetate plus prednisone (abiraterone hereafter) in the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) naive to chemotherapy. Most of the few available studies had a retrospective design and included a small number of patients. In the interim analysis of the ABItude study, abiraterone showed good clinical effectiveness and safety profile in the chemotherapy-naive setting over a median follow-up of 18 months. PATIENTS AND

methodsWe evaluated clinical and patient-reported outcomes (PROs) of chemotherapy-naive mCRPC patients treated with abiraterone as for clinical practice in the Italian, observational, prospective, multicentric ABItude study. mCRPC patients were enrolled at abiraterone start (February 2016-June 2017) and followed up for 3 years; clinical endpoints and PROs, including quality of life (QoL) and pain, were prospectively collected. Kaplan-Meier curves were estimated.

resultsOf the 481 patients enrolled, 454 were assessable for final study analyses. At abiraterone start, the median age was 77 years, with 58.6% elderly patients and 69% having at least one comorbidity (57.5% cardiovascular diseases). Visceral metastases were present in 8.4% of patients. Over a median follow-up of 24.8 months, median progression-free survival (any progression reported by the investigators), time to abiraterone discontinuation, and overall survival were, respectively, 17.3 months [95% confidence interval (CI) 14.1-19.4 months], 16.0 months (95% CI 13.1-18.2 months), and 37.3 months (95% CI 36.5 months-not estimable); 64.2% of patients achieved ≥50% reduction in prostate-specific antigen. QoL assessed by Functional Assessment of Cancer Therapy-Prostate, the European Quality of Life 5 Dimensions 3 Level, and European Quality of Life Visual Analog Scale remained stable during treatment. Median time to pain progression according to Brief Pain Inventory data was 31.1 months (95% CI 24.8 months-not estimable). Sixty-two patients (13.1%) had at least one adverse drug reaction (ADR) and 8 (1.7%) one serious ADR.

conclusionWith longer follow-up, abiraterone therapy remains safe, well tolerated, and active in a large unselected population.

Indexed as

Abiraterone AcetateProstatic Neoplasms, Castration-ResistantAgedAntineoplastic Combined Chemotherapy ProtocolsHumansMalePainPrednisoneProspective StudiesQuality of LifeRetrospective StudiesAbiraterone AcetatePrednisoneabiraterone acetatemetastatic castration-resistant prostate cancerprospective studyreal-world evidence

Identifiers

PMID35405438
PMCPMC9058899
OpenAlexW4223447282

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.