Evidence map›Paper›PMID 33904646›Full record

Trial reportThe oncologist2021

Post Hoc Health-Related Quality of Life Analysis According to Response Among Patients with Prostate Cancer in the PROSELICA and FIRSTANA Studies.

Antoine Thiery-Vuillemin, Karim Fizazi, Oliver Sartor, Stéphane Oudard, Denise Bury, Ayse Ozatilgan, Elizabeth M Poole, Mario Eisenberger, Johann de Bono

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase III
In one paragraph

Trial report in The oncologist, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 32% 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.

NCT01308567 phase3completednot on this map

Randomized, Open Label, Multi-Center Study Comparing Cabazitaxel at 25 mg/m^2 and at 20 mg/m^2 in Combination With Prednisone Every 3 Weeks to Docetaxel in Combination With Prednisone in Patients With Metastatic Castration Resistant Prostate Cancer Not Pretreated With Chemotherapy

TypeinterventionalSponsorSanofiRan2011 to 2018Enrolled1,168ConditionsProstate CancerArmsCabazitaxel (XRP6258), Docetaxel (XRP6976), Prednisone
NCT01308580 phase3completednot on this map

Randomized, Open Label Multi-Center Study Comparing Cabazitaxel at 20 mg/m² and at 25 mg/m² Every 3 Weeks in Combination With Prednisone for the Treatment of Metastatic Castration Resistant Prostate Cancer Previously Treated With a Docetaxel-Containing Regimen

TypeinterventionalSponsorSanofiRan2011 to 2015Enrolled1,200ConditionsProstate CancerArmsCabazitaxel (XRP6258), Prednisone (or Prednisolone)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. 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

9 authors at 7 institutions in 3 countries.

Antoine Thiery-VuilleminCentre Hospitalier Régional Universitaire, Besançon, France.
Karim FizaziCancer Medicine, Institut Gustave Roussy, University of Paris Saclay, Villejuif, France.
Oliver SartorTulane University School of Medicine, New Orleans, Louisiana, USA.
Stéphane OudardGeorge Pompidou European Hospital, René Descartes University, Paris, France.
Denise BurySanofi US, Cambridge, Massachusetts, USA.
Ayse OzatilganSanofi US, Cambridge, Massachusetts, USA.
Elizabeth M PooleSanofi US, Cambridge, Massachusetts, USA.
Mario EisenbergerThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, USA.
Johann de BonoRoyal Marsden and The Institute of Cancer Research, Sutton, UK.
Sanofi (United States) · USCentre Hospitalier Universitaire de Besançon · FRHôpital Européen Georges-Pompidou · FRInstitute of Cancer Research · GBInstitut Gustave Roussy · FRSidney Kimmel Comprehensive Cancer Center · USTulane University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe phase III PROSELICA (NCT01308580) and FIRSTANA (NCT01308567) trials investigated taxane chemotherapy among men with postdocetaxel metastatic, castration-resistant prostate cancer (mCRPC) or chemotherapy-naïve mCRPC, respectively. We present a post hoc analysis of patient-reported health-related quality of life (HRQL) among patients with or without a clinical (pain, tumor, or prostate-specific antigen [PSA]) response. MATERIALS AND

methodsPROSELICA and FIRSTANA HRQL and pain data were collected and analyzed using protocol-defined Functional Assessment of Cancer Therapy-Prostate (FACT-P) and McGill-Melzack (Present Pain Intensity scale) questionnaires. Outcomes included definitive FACT-P Total Score (TS) improvements and longitudinal assessment of FACT-P TS.

resultsIn PROSELICA and FIRSTANA, the proportion of patients receiving taxane chemotherapy with a definitive FACT-P TS improvement was significantly higher among patients with versus without a pain or PSA response (pain: PROSELICA: 67% vs. 33.5%; p < .001; FIRSTANA: 75.2% vs. 45.8%; p < .001; PSA: PROSELICA: 50.3% vs. 34.2%; p < .001; FIRSTANA: 49.8% vs. 38.9%; p = .001). In PROSELICA, the proportion of patients receiving taxane chemotherapy with a definitive FACT-P TS improvement was significantly higher among patients with versus without a tumor response; the proportion was numerically higher in FIRSTANA (PROSELICA: 54.4% vs. 36.7%; p = .001; FIRSTANA: 50.6% vs. 45.3%). FACT-P TS was significantly improved or maintained for the majority of treatment cycles analyzed.

conclusionIn PROSELICA and FIRSTANA, HRQL improvements were significantly higher among patients with a pain, tumor, or PSA response versus those without, with the exception of patients with a tumor response in FIRSTANA. IMPLICATIONS FOR PRACTICE: Using data from the FIRSTANA and PROSELICA phase III clinical trials, this study demonstrated that patients with metastatic, castration-resistant prostate cancer (mCRPC) receiving docetaxel or cabazitaxel who exhibited a response (pain, tumor, prostate-specific antigen), often experienced significantly greater improvements in health-related quality of life (HRQL) compared with patients without a response. For patients with a pain response, significant HRQL improvements occurred early and were maintained. This study provides further insight into the impact of taxane chemotherapy on the HRQL of patients with mCRPC and allows for a better understanding of the relationship between treatment, response, and HRQL, supporting therapeutic decision making.

Indexed as

Antineoplastic AgentsProstatic Neoplasms, Castration-ResistantDocetaxelHumansMalePainProstate-Specific AntigenQuality of LifeTreatment OutcomeAntineoplastic AgentsDocetaxelProstate-Specific AntigenCabazitaxelDocetaxelHealth-related quality of lifeMetastatic castration-resistant prostate cancerPainProstate

Identifiers

PMID33904646
PMCPMC8265338
OpenAlexW3157026044

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.