Evidence map›Paper›PMID 28039155›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone.

C Massard, J Mateo, Y Loriot, C Pezaro, L Albiges, N Mehra, A Varga, D Bianchini, C J Ryan, D P Petrylak and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01511536 (A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.8field-weighted citation impact, top 6% 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.

NCT01511536 phase1 / phase2completednot on this map

A Phase I/II Study of Cabazitaxel Combined With Abiraterone Acetate and Prednisone in Patients With Metastatic Castrate-Resistant Prostate Cancer (CRPC) Whose Disease Has Progressed After Docetaxel Chemotherapy

TypeinterventionalSponsorSanofiRan2012 to 2014Enrolled38ConditionsProstate CancerArmsCabazitaxel XRP6258, Abiraterone acetate, Prednisone 5 mg
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 7 institutions in 3 countries.

C MassardDepartment of Drug Development, Gustave Roussy Cancer Campus, University of Paris Sud, Villejuif, France.
J MateoThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
Y LoriotDepartment of Medical Oncology, Gustave Roussy Cancer Campus, University of Paris Sud, Villejuif, France.
C PezaroThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
L AlbigesDepartment of Medical Oncology, Gustave Roussy Cancer Campus, University of Paris Sud, Villejuif, France.
N MehraThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
A VargaDepartment of Drug Development, Gustave Roussy Cancer Campus, University of Paris Sud, Villejuif, France.
D BianchiniThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
C J RyanHelen Diller Family Comprehensive Cancer Center, University of California, San Francisco, USA.
D P PetrylakComprehensive Cancer Center Yale School of Medicine, New Haven.
G AttardThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
L ShenSanofi Genzyme, Cambridge, USA.
K FizaziDepartment of Medical Oncology, Gustave Roussy Cancer Campus, University of Paris Sud, Villejuif, France.
J de BonoThe Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK.
Royal Marsden NHS Foundation Trust · GBUniversité Paris-Sud · FRInstitute of Cancer Research · GBInstitut Gustave Roussy · FRSanofi (United States) · USUniversity of California, San Francisco · USYale Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Abiraterone and cabazitaxel improve survival in patients with metastatic castration-resistant prostate cancer (mCRPC). We conducted an open-label phase I/II trial of cabazitaxel plus abiraterone to assess the antitumor activity and tolerability in patients with progressive mCRPC after docetaxel (phase I), and after docetaxel and abiraterone (phase II) (NCT01511536). Patients and methods: The primary objectives were to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of cabazitaxel plus abiraterone (phase I), and the prostate-specific antigen (PSA) response defined as a ≥ 50% decrease confirmed ≥3 weeks later with this combination (phase II). Results: Ten patients were enrolled in the phase I component; nine were evaluable. No DLTs were identified. The MTD was established as the approved doses for both drugs (cabazitaxel 25 mg/m2 every 3 weeks and abiraterone 1000 mg once daily). Daily abiraterone treatment did not impact on cabazitaxel clearance. Twenty-seven patients received cabazitaxel plus abiraterone plus prednisone (5 mg twice daily) in phase II. The median number of cycles administered (cabazitaxel) was seven (range: 1-28). Grade 3-4 treatment-emergent adverse events included asthenia (in 5 patients; 14%), neutropenia (in 5 patients; 14%) and diarrhea (in 3 patients; 8%). Nine patients (24%) required dose reductions of cabazitaxel. Of 26 evaluable patients, 12 achieved a PSA response [46%; 95% confidence interval (CI): 26.6-66.6%]. Median PSA-progression-free survival was 6.9 months (95% CI: 4.1-10.3 months). Of 14 patients with measurable disease at baseline, 3 (21%) achieved a partial response per response evaluation criteria in solid tumors. Conclusions: The combination of cabazitaxel and abiraterone has a manageable safety profile and shows antitumor activity in patients previously treated with docetaxel and abiraterone.

Indexed as

AgedAndrostenesAntineoplastic Combined Chemotherapy ProtocolsDisease-Free SurvivalDisease ProgressionDocetaxelHumansKaplan-Meier EstimateMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalProstate-Specific AntigenProstatic Neoplasms, Castration-ResistantTaxoidsabirateroneAndrostenescabazitaxelDocetaxelProstate-Specific AntigenTaxoidsabirateronecabazitaxelcombinationprostate cancer

Identifiers

PMID28039155
PMCPMC5378222
OpenAlexW2533072646

What OpenQuestion holds

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LicenceCC BY-NC
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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.