Evidence map›Paper›PMID 32569568›Full record

ArticleCanadian Urological Association journal = Journal de l'Association des urologues du Canada2020

Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC.

Geoffrey Gotto, Darrel E Drachenberg, Joseph Chin, Richard Casey, Vincent Fradet, Robert Sabbagh, Bobby Shayegan, Ricardo A Rendon, Brita Danielson, Fernandes Camacho and 5 more

Open access · diamondAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Canadian Urological Association journal = Journal de l'Association des urologues du Canada, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 20% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Observational
  6. Article
  7. Article
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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

15 authors at 9 institutions in 2 countries.

Geoffrey GottoUniversity of Calgary, Calgary, AB, Canada.
Darrel E DrachenbergUniversity of Manitoba, Winnipeg, MB, Canada.
Joseph ChinLondon Health Sciences Centre-Victoria Hospital, London, ON, Canada.
Richard CaseyThe Fe/Male Health Centres, Oakville, ON, Canada.
Vincent FradetHotel Dieu du Québec (CHUQ), Quebec City, QC, Canada.
Robert SabbaghCIUSSE-CHUS - Université de Sherbrooke, Sherbrooke, QC, Canada.
Bobby ShayeganMcMaster University, Hamilton, ON, Canada.
Ricardo A RendonDalhousie University, Halifax, NS, Canada.
Brita DanielsonUniversity of Alberta, Edmonton, AB, Canada.
Fernandes CamachoDamos Inc, Toronto, ON, Canada.
Anousheh ZardanJanssen Inc., Toronto, ON, Canada.
Richard PlanteJanssen Inc., Toronto, ON, Canada.
Huong HewJanssen Inc., Toronto, ON, Canada.
Katherine ChanJanssen Inc., Toronto, ON, Canada.
Andrew FeiferTrillium Health Partners, Toronto, ON, Canada.
Dalhousie University · CAJanssen (Belgium) · BEMcMaster University · CATrillium Health Centre · CAUniversité de Sherbrooke · CAUniversity of Alberta · CAUniversity of Calgary · CAUniversity of Manitoba · CAVictoria Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAbiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castration-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Herein, we report their patient-reported outcomes (PROs).

methodsAfter a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]).

resultsAt a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients' PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P.

conclusionsCOSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.

Identifiers

PMID32569568
PMCPMC7704085
OpenAlexW3036173424

What OpenQuestion holds

Textmetadata
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Registered trials

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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.