Evidence map›Paper›PMID 36861085›Full record

ArticleTherapeutic advances in medical oncology2023

Quality of life with ribociclib

Hope S Rugo, Victoria Harmer, Joyce O'Shaughnessy, Komal Jhaveri, Sara M Tolaney, Fatima Cardoso, Aditya Bardia, Vikalp Kumar Maheshwari, Sandeep Tripathi, Sina Haftchenary and 2 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in Therapeutic advances in medical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
2.8field-weighted citation impact, top 9% 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.

NCT01958021 phase3completednot on this map

A Randomized Double-blind, Placebo-controlled Study of LEE011 in Combination With Letrozole for the Treatment of Postmenopausal Women With Hormone Receptor Positive, HER2 Negative, Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2023Enrolled668ConditionsAdvanced, Metastatic Breast CancerArmsRibociclib, Letrozole, Placebo
NCT02246621 phase3active not recruitingnot on this map

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

TypeinterventionalSponsorEli Lilly and CompanyRan2014 to 2026Enrolled493ConditionsBreast CancerArmsAbemaciclib, Anastrozole, Letrozole, Placebo
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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

12 authors at 11 institutions in 6 countries.

Hope S RugoUniversity of California San Francisco Helen Diller Family Comprehensive Cancer Center, 1825 4th St, 3rd Floor BCC, San Francisco, CA 94158, USA.
Victoria HarmerImperial College Healthcare NHS Trust, London, UK.
Joyce O'ShaughnessyTexas Oncology-Baylor University Medical Center and The US Oncology Research Network, Dallas, TX, USA.
Komal JhaveriMemorial Sloan Kettering Cancer Center, New York, NY, USA.
Sara M TolaneyDana-Farber Cancer Institute, Boston, MA, USA.
Fatima CardosoBreast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, Portugal.
Aditya BardiaMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.ORCID https://orcid.org/0000-0003-4885-1157
Vikalp Kumar MaheshwariNBS CONEXTS at Novartis Pharmaceuticals, Hyderabad, India.
Sandeep TripathiNovartis Pharmaceuticals, Hyderabad, India.
Sina HaftchenaryNovartis Pharmaceuticals Canada, Montreal, QC, Canada.
Purnima PathakNovartis Services Inc, East Hanover, NJ, USA.
Peter A FaschingUniversity Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, and Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany.
Novartis (India) · INChampalimaud Foundation · PTDana-Farber Cancer Institute · USHarvard University · USImperial College Healthcare NHS Trust · GBMemorial Sloan Kettering Cancer Center · USNovartis (Canada) · CANovartis (United States) · USTexas Oncology · USUniversitätsklinikum Erlangen · DEUniversity of California, San Francisco · US

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

Background: A cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) + endocrine therapy is recommended as first-line treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer (ABC). Quality of life (QoL) is an important endpoint that affects treatment decisions. Understanding the relevance of CDK4/6i treatment on QoL is gaining importance given use in earlier treatment lines for ABC and an emerging role in treating early breast cancer in which QoL may be more impactful. In the absence of head-to-head trial data, a matching-adjusted indirect comparison (MAIC) permits comparative efficacy between trials. Objective: In this analysis, patient-reported QoL for MONALEESA-2 [ribociclib + aromatase inhibitor (AI)] and MONARCH 3 (abemaciclib + AI) was compared using MAIC with a focus on individual domains. Design: An anchored MAIC of QoL comparing ribociclib + AI Methods: Individual patient data from MONALEESA-2 and published aggregated data from MONARCH 3 were included in this analysis. Time to sustained deterioration (TTSD) was calculated as the time from randomization to a ⩾10-point deterioration with no later improvement above this threshold. Results: Patients from the ribociclib ( Conclusions: This MAIC indicates that ribociclib + AI is associated with better symptom-related QoL than abemaciclib + AI for postmenopausal patients with HR+/HER2- ABC treated in the first-line setting. Trial registration: NCT01958021 (MONALEESA-2) and NCT02246621 (MONARCH 3).

Indexed as

abemaciclibCDK4/6 inhibitorMONALEESA-2MONARCH 3quality of liferibociclib

Identifiers

PMID36861085
PMCPMC9969464
OpenAlexW4321795635

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.