Evidence map›Paper›PMID 36379186›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2023

Health-related quality of life in the phase III ASCENT trial of sacituzumab govitecan versus standard chemotherapy in metastatic triple-negative breast cancer.

Sibylle Loibl, Delphine Loirat, Sara M Tolaney, Kevin Punie, Mafalda Oliveira, Hope S Rugo, Aditya Bardia, Sara A Hurvitz, Adam M Brufsky, Kevin Kalinsky and 11 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02574455 (An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments), which is not on this map. Cited by 29 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 6 pooled it
4.4field-weighted citation impact, top 4% 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.

NCT02574455 phase3completednot on this map

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan Versus Treatment of Physician Choice in Patients With Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

TypeinterventionalSponsorGilead SciencesRan2017 to 2020Enrolled529ConditionsBreast CancerArmsSacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 6 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  7. A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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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

21 authors at 15 institutions in 5 countries.

Sibylle LoiblHämatologisch-Onkologische Gemeinschaftspraxis Am Bethanien-Krankenhaus, Frankfurt, Germany. Electronic address: sibylle.loibl@gbg.de.
Delphine LoiratMedical Oncology Department and D3i, Institut Curie, Paris, France.
Sara M TolaneyMedical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Kevin PunieDepartment of General Medical Oncology and Multidisciplinary Breast Centre, Leuven Cancer Institute, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
Mafalda OliveiraMedical Oncology Department and Breast Cancer Group, Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Hope S RugoDepartment of Medicine, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
Aditya BardiaDepartment of Hematology and Oncology, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.
Sara A HurvitzDepartment of Medicine, Division of Hematology/Medical Oncology, David Geffen School of Medicine, University of California, Los Angeles, Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA.
Adam M BrufskyDivision of Hematology/Oncology, Magee-Womens Hospital and the Hillman Cancer Center, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Kevin KalinskyDepartment of Medicine, Columbia University Irving Medical Center, New York, USA; Department of Hematology and Medical Oncology, Winship Cancer Institute at Emory University, Atlanta, GA, USA.
Javier CortésOncology Department, International Breast Cancer Center (BCC), Pangaea Oncology, Quirónsalud, Barcelona, Spain; Department of Medicine, Faculty of Biomedical and Health Sciences, European University of Madrid, Madrid, Spain.
Joyce A O'ShaughnessyMedical Oncology, Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, TX, USA.
Véronique DierasDepartment of Medical Oncology, Centre Eugène Marquis, Rennes, France.
Lisa A CareyMedicine - Hematology/Oncology Division, University of North Carolina Lineberger Comprehensive Cancer Center, Chapel Hill, NC, USA.
Luca GianniMedical Oncology, Gianni Bonadonna Foundation, Milano, Italy.
Mahdi GharaibehDepartment of Global Value and Access, Gilead Sciences, Inc., Foster City, CA, USA.
Luciana PregerDepartment of Medical Affairs, Gilead Sciences, Inc., Foster City, CA, USA.
See PhanDepartment of Clinical Development, Gilead Sciences, Inc., Foster City, CA, USA.
Lawrence ChangDepartment of Global Value and Access, Gilead Sciences, Inc., Foster City, CA, USA.
Ling ShiEvidence Synthesis, Modeling & Communication (EMC), Evidera PPD, Waltham, MA, USA.
Martine J PiccartMedical Oncology Department, Institut Jules Bordet and l'Université Libre de Bruxelles, Brussels, Belgium.
Gilead Sciences (United States) · USCentre Eugène Marquis · FRDana-Farber Cancer Institute · USEmory University · USHarvard University · USInstitut Curie · FRKrankenhaus Bethanien · DEMagee-Womens Hospital · USTexas Oncology · USUniversidad Europea de Madrid · ESUniversité Libre de Bruxelles · BEUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · USVall d'Hebron Hospital Universitari · ES

Funding

VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA047904
6 · The paper itself

Abstract

backgroundThe antibody-drug conjugate sacituzumab govitecan (SG) prolongs progression-free survival and overall survival in patients with refractory/relapsed metastatic triple-negative breast cancer (mTNBC). Here, we investigated its effect on health-related quality of life (HRQoL).

methodsThis analysis was based on the open-label phase III ASCENT trial (NCT02574455). Adults with refractory/relapsed mTNBC who had received ≥2 prior systemic therapies (≥1 in the metastatic setting) were randomised 1:1 to SG or treatment of physician's choice (TPC; capecitabine, eribulin, vinorelbine, or gemcitabine). HRQoL was assessed on day 1 of each treatment cycle using the EORTC QLQ-C30. Score changes from baseline were analysed using linear mixed-effect models for repeated measures. Stratified Cox regressions evaluated time to first clinically meaningful change of HRQoL.

resultsThe analysis population comprised 236 patients randomised to SG and 183 to TPC. For global health status (GHS)/QoL, physical functioning, fatigue, and pain, changes from baseline were superior for SG versus TPC. Compared with TPC, SG was inferior regarding changes from baseline for nausea/vomiting and diarrhoea but non-inferior for other QLQ-C30 domains. Median time to first clinically meaningful worsening was longer for SG than for TPC for physical functioning (22.1 versus 12.1 weeks, P < 0.001), role functioning (11.4 versus 7.1 weeks, P < 0.001), fatigue (7.7 versus 6.0 weeks, P < 0.05), and pain (21.6 versus 9.9 weeks, P < 0.001).

conclusionsSG was generally associated with greater improvements and delayed worsening of HRQoL scores compared with TPC. This supports the favourable profile of SG as an mTNBC treatment.

Indexed as

ImmunoconjugatesTriple Negative Breast NeoplasmsAdultAntibodies, Monoclonal, HumanizedCamptothecinFatigueHumansPainQuality of LifeAntibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatessacituzumab govitecanAntibody–drug conjugateClinical trialEORTC QLQ-C30Phase IIIQuality of lifeSacituzumab govitecanTriple-negative breast neoplasms

Identifiers

PMID36379186
PMCPMC11195534
OpenAlexW4306711477

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.