Evidence map›Paper›PMID 34754238›Full record

ArticleCancer management and research2021

Matching-Adjusted Indirect Comparison of Ribociclib Plus Fulvestrant versus Palbociclib Plus Letrozole as First-Line Treatment of HR+/HER2- Advanced Breast Cancer.

Peter A Fasching, Thomas E Delea, Yen-Shen Lu, Richard De Boer, Sara A Hurvitz, Aaron Moynahan, David Chandiwana, Brad Lanoue, Huilin Hu, Astrid Thuerigen and 1 more

Open access · goldAbstract read
In one paragraph

Article in Cancer management and research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.7field-weighted citation impact, top 27% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Observational
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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

11 authors at 8 institutions in 5 countries.

Peter A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
Thomas E DeleaPolicy Analysis Inc. (PAI), Brookline, MA, USA.
Yen-Shen LuNational Taiwan University Hospital, Taipei, Taiwan.
Richard De BoerPeter MacCallum Cancer Centre, Victoria, Australia.
Sara A HurvitzUniversity of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Aaron MoynahanPolicy Analysis Inc. (PAI), Brookline, MA, USA.
David ChandiwanaNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Brad LanoueNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Huilin HuNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Astrid ThuerigenNovartis Pharma AG, Basel, Switzerland.
Joyce O'ShaughnessyDepartment of Medical Oncology, Baylor University Medical Center, Texas Oncology and US Oncology Network, Dallas, TX, USA.
Novartis (United States) · USPolicy Analysis (United States) · USBaylor University Medical Center · USNational Taiwan University Hospital · TWNovartis (Switzerland) · CHPeter MacCallum Cancer Centre · AUUniversitätsklinikum Erlangen · DEUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCyclin-dependent kinase 4/6 inhibitors (CDK4/6i) plus endocrine therapy are recommended for first-line treatment of hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). However, not all CDK4/6i trials have reported significant overall survival (OS) benefit, and there have been no head-to-head trials. Two trials have reported OS outcomes in first-line patients: MONALEESA-3 reported significant OS benefit with first- or second-line ribociclib plus fulvestrant (RIB+FUL) versus placebo plus fulvestrant (PBO+FUL), while PALOMA-1 reported no significant OS benefit for palbociclib plus letrozole (PAL+LET) versus LET in first-line postmenopausal patients. Matched-adjusted indirect comparisons (MAICs) are an established method for comparing efficacy of treatments from different trials. We used an MAIC to compare first-line patients from MONALEESA-3 and PALOMA-1. PATIENTS AND

methodsAn unanchored MAIC of progression-free survival (PFS) and OS in first-line patients with HR+/HER2- ABC treated with RIB+FUL versus PAL+LET was conducted using individual patient data from MONALEESA-3 and aggregated data from PALOMA-1. To match patients in PALOMA-1, patients in MONALEESA-3 were limited to those with no prior endocrine therapy for ABC and no (neo) adjuvant LET ≤12 months before enrollment. PFS and OS were compared using Kaplan-Meier estimators and Cox regression.

resultsA total of 329 and 178 patients from RIB+FUL and PBO+FUL arms, respectively, of MONALEESA-3 were matched to 84 and 81 patients from PAL+LET and LET arms of PALOMA-1. After weighting, OS was significantly longer for RIB+FUL versus PAL+LET (hazard ratio [HR], 0.50; 95% CI, 0.32-0.77;

conclusionUsing MAIC to adjust for trial differences, OS comparisons favored RIB+FUL over PAL+LET as first-line treatment in postmenopausal patients with HR+/HER2- ABC. These exploratory results suggest a significant increase in OS benefit with RIB treatment compared with PAL.

Indexed as

CDK4/6 inhibitorMONALEESA-3overall survivalPALOMA-1

Identifiers

PMID34754238
PMCPMC8570288
OpenAlexW3208811501

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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.