Evidence map›Paper›PMID 31754962›Full record

Trial reportTargeted oncology2019

Adjusting Overall Survival Estimates for Treatment Switching in Metastatic, Castration-Sensitive Prostate Cancer: Results from the LATITUDE Study.

Susan Feyerabend, Fred Saad, Nolen Joy Perualila, Suzy Van Sanden, Joris Diels, Tetsuro Ito, Peter De Porre, Karim Fizazi

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Targeted oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01715285 (A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy), which is not on this 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
–field-weighted citation impact
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.

NCT01715285 phase3completednot on this map

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

TypeinterventionalSponsorJanssen Research & Development, LLCRan2013 to 2022Enrolled1,209ConditionsProstate NeoplasmsArmsAbiraterone acetate, Prednisone, Androgen deprivation therapy (ADT), Abiraterone acetate Placebo, Prednisone Placebo
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Article
  3. Article
  4. 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

8 authors.

Susan FeyerabendUrologic Oncology, Studienpraxis Urologie, Nürtingen, Germany.
Fred SaadUrologic Oncology, Centre Hospitalier de L'Université de Montréal/CRCHUM, Montréal, QC, Canada.
Nolen Joy PerualilaHealth Economics and Market Access EMEA, Janssen, Beerse, Belgium. NPeruali@its.jnj.com.ORCID http://orcid.org/0000-0001-8402-0399
Suzy Van SandenHealth Economics and Market Access EMEA, Janssen, Beerse, Belgium.
Joris DielsHealth Economics and Market Access EMEA, Janssen, Beerse, Belgium.
Tetsuro ItoHealth Economics and Market Access EMEA, Janssen, High Wycombe, Buckinghamshire, UK.
Peter De PorreClinical Oncology, Janssen Research & Development BE, Spring House, USA.
Karim FizaziGustave Roussy, University of Paris Sud, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLATITUDE was the first phase 3 trial examining the survival benefit of adding abiraterone acetate (AA) + prednisone (P) to androgen-deprivation therapy (ADT) in newly diagnosed metastatic, castration-sensitive prostate cancer (mCSPC). Due to significant improvement in overall survival after the first interim analysis, patients in the placebos + ADT arm could switch to AA + P + ADT during an open-label extension. As in other studies where switching is allowed, statistical adjustments are needed to assess the real benefit of new drugs. PATIENTS AND

methodsThis was a post hoc analysis to estimate the true survival benefit of AA + P + ADT in patients with newly diagnosed mCSPC by applying statistical adjustments commonly used to adjust for treatment switching.

resultsOf 112 patients still receiving placebos + ADT at the first interim analysis, 72 switched to AA + P + ADT during the open-label extension. Final analysis was conducted after median follow-up of 51.8 months. Compared to the placebos + ADT arm, the risk of death in the AA + P + ADT arm was 34% lower [hazard ratio (HR) = 0.663 (95% confidence interval 0.566-0.778)] by unadjusted intent-to-treat analysis, 37% lower [HR = 0.629 (95% confidence interval 0.526-0.753)] by rank preserving structure failure time modeling, and 38% lower [HR = 0.616 (95% confidence interval 0.524-0.724)] by inverse probability of censoring weights.

conclusionsAnalyses adjusting for treatment switching using two different statistical approaches confirm the improved survival benefit of adding AA + P to ADT in patients with newly diagnosed mCSPC.

trial registrationClinicalTrials.gov identifier NCT01715285.

Indexed as

Abiraterone AcetateAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsAsiaCanadaDouble-Blind MethodDrug SubstitutionEuropeHumansInternational AgenciesLatin AmericaMaleMiddle AgedNeoplasm MetastasisPrednisoneAbiraterone AcetatePrednisone

Identifiers

PMID31754962
PMCPMC6875513

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.