Evidence map›Paper›PMID 33184097›Full record

Trial reportESMO open2020

Impact of clinical versus radiographic progression on clinical outcomes in metastatic castration-resistant prostate cancer.

Arpit Rao, Howard I Scher, Peter De Porre, Margaret K Yu, Anil Londhe, Keqin Qi, Michael J Morris, Charles Ryan

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in ESMO open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 37% 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

5 citing papers in PubMed, 7 citations in OpenAlex.

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

8 authors at 4 institutions in 2 countries.

Arpit RaoDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA. Electronic address: raoa@umn.edu.
Howard I ScherDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Weill Cornell Medical College, New York, United States.
Peter De PorreOncology Development, Janssen Research & Development, Beerse, Belgium.
Margaret K YuJanssen Research & Development, Los Angeles, California, USA.
Anil LondheOncology Development, Janssen Research & Development, Titusville, New Jersey, USA.
Keqin QiOncology Development, Janssen Research & Development, Titusville, New Jersey, USA.
Michael J MorrisDepartment of Medicine, Memorial Sloan-Kettering Cancer Center, New York, New York, USA; Weill Cornell Medical College, New York, United States.
Charles RyanDivision of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, Minnesota, USA.
Janssen (United States) · USMemorial Sloan Kettering Cancer Center · USUniversity of Minnesota · USJanssen (Belgium) · BE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectivesUnequivocal clinical progression (UCP)-a worsening of clinical status with or without radiographic progression (RAD)-represents a distinct mode of disease progression in metastatic prostate cancer. We evaluated the prevalence, risk factors and the impact of UCP on survival outcomes.

methodsA post-hoc analysis of the COU-AA-302, a randomised phase 3 study of abiraterone plus prednisone (AAP) versus prednisone was performed. Baseline characteristics were summarised. Cox proportional-hazards model and Kaplan-Meier method were used for survival and time to event analyses, respectively. Iterative multiple imputation method was used for correlation between clinicoradiographic progression-free survival (crPFS) and overall survival (OS).

resultsOf 736 patients with disease progression, 280 (38%) had UCP-only and 124 (17%) had UCP plus RAD. Prognostic index model high-risk group was associated with increased likelihood of UCP (p<0.0001). Median OS was 25.7 months in UCP-only and 33.0 months for RAD-only (HR 1.39; 95% CI 1.16 to 1.66; p=0.0003). UCP adversely impacted OS in both treatment groups. Lowest OS was seen in patients with prostate specific antigen (PSA)-non-response plus UCP-only progression (median OS 22.6 months (95% CI 20.7 to 24.4)). Including UCP events lowered estimates of treatment benefit-median crPFS was 13.3 months (95% CI 11.1 to 13.8) versus median rPFS of 16.5 months (95% CI 13.8 to 16.8) in AAP group. Finally, crPFS showed high correlation with OS (r=0.67; 95% CI 0.63 to 0.71).

conclusionsUCP is a common and clinically relevant phenomenon in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with AAP or prednisone. UCP is prognostic and associated with inferior OS and post-progression survival. A combination of PSA-non-response and UCP identifies patients with poorest survival. When included in PFS analysis, UCP diminishes estimates of treatment benefit. Continued study of UCP in mCRPC is warranted.

Indexed as

Prostatic Neoplasms, Castration-ResistantAbiraterone AcetateAntineoplastic Combined Chemotherapy ProtocolsHumansMalePrednisoneProportional Hazards ModelsAbiraterone AcetatePrednisoneabirateronemetastatic castration-resistant prostate cancerno longer clinically benefiting (NLCB)survivalunequivocal clinical progression

Identifiers

PMID33184097
PMCPMC7662417
OpenAlexW3102492229

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.