Evidence map›Paper›PMID 36514034›Full record

Trial reportBMC cancer2022

Patient-reported outcomes in individuals with advanced gastrointestinal stromal tumor treated with ripretinib in the fourth-line setting: analysis from the phase 3 INVICTUS trial.

Patrick Schöffski, Suzanne George, Michael C Heinrich, John R Zalcberg, Sebastian Bauer, Hans Gelderblom, César Serrano, Robin L Jones, Steven Attia, Gina D'Amato and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03353753 (A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies), which is not on this 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
1.2field-weighted citation impact, top 22% 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.

NCT03353753 phase3completednot on this map

A Phase 3, INterVentional, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of DCC-2618 In Patients With AdvanCed Gastrointestinal Stromal TUmorS Who Have Received Treatment With Prior Anticancer Therapies

TypeinterventionalSponsorDeciphera Pharmaceuticals, LLCRan2018 to 2022Enrolled129ConditionsGastrointestinal Stromal TumorsArmsDCC-2618, Placebo Oral Tablet
3 · Its place in the literature

Who cites it

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

  1. Pooled it
  2. Review
  3. Article
  4. Article
  5. Article
  6. Article
  7. KIT ATP-Binding Pocket/Activation Loop Mutations in GI Stromal Tumor: Emerging Mechanisms of Kinase Inhibitor Escape.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Article
  8. Article
  9. Review
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

18 authors at 15 institutions in 8 countries.

Patrick SchöffskiGeneral Medical Oncology, University Hospitals Leuven, Herestraat 49, B-3000, Leuven, Belgium. patrick.schoffski@uzleuven.be.
Suzanne GeorgeDana-Farber Cancer Institute, 450 Brookline Ave, 02215, Boston, MA, USA.
Michael C HeinrichVA Portland Veterans Health Care System, 3710 SW US Veterans Hospital Rd., 97239, Portland, OR, USA.
John R ZalcbergMonash University and Alfred Health, 553 St Kilda Road, VIC, 3004, Melbourne, Australia.
Sebastian BauerDepartment of Medical Oncology, University Hospital Essen, Sarcoma Center/West German Cancer Center, University Duisburg-Essen, Hufelandstraße 55, D - 45147, Essen, Germany.
Hans GelderblomLeiden University Medical Center, Albinusdreef 2, 2333 ZA, Leiden, Netherlands.
César SerranoCentro Cellex, Vall d'Hebron Institute of Oncology, Carrer de Natzaret, 115-117, 08035, Barcelona, Spain.
Robin L JonesRoyal Marsden and Institute of Cancer Research, 15 Cotswold Rd, SM2 5NG, London, UK.
Steven AttiaMayo Clinic, 4500 San Pablo Road S, 32224, Jacksonville, FL, USA.
Gina D'AmatoSylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Ave, 33136, Miami, FL, USA.
Ping ChiMemorial Sloan Kettering Cancer Center, 1275 York Ave, 10065, New York, NY, USA.
Peter ReichardtSarcoma Center, Helios Klinikum Berlin-Buch, Schwanebecker Ch 50, 13125, Berlin, Germany.
Claus BeckerDeciphera Pharmaceuticals, LLC, 200 Smith St., 02451, Waltham, MA, USA.
Kelvin ShiDeciphera Pharmaceuticals, LLC, 200 Smith St., 02451, Waltham, MA, USA.
Julie MeadeDeciphera Pharmaceuticals, LLC, 200 Smith St., 02451, Waltham, MA, USA.
Rodrigo Ruiz-SotoDeciphera Pharmaceuticals, LLC, 200 Smith St., 02451, Waltham, MA, USA.
Jean-Yves BlayCentre Leon Berard, 28 Prom. Léa et Napoléon Bullukian, 69008, Lyon, France.
Margaret von MehrenFox Chase Cancer Center, 333 Cottman Ave, 19111, Philadelphia, PA, USA.
Deciphera Pharmaceuticals (United States) · USCentre Léon Bérard · FRCIBBIM-Nanomedicine · ESDana-Farber Cancer Institute · USEssen University Hospital · DEFox Chase Cancer Center · USHelios Hospital Berlin-Buch · DEInstitute of Cancer Research · GBKU Leuven · BELeiden University Medical Center · NLMayo Clinic in Florida · USMemorial Sloan Kettering Cancer Center · USMonash University · AUOHSU Knight Cancer InstituteSylvester Comprehensive Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
SPORE in Soft Tissue SarcomaP50CA140146 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI LADANYI, MARC · 2010 to 2014
$11.1M
Novel models for functional profiling of germline SDH variants associated with cancerR21CA263400 · NCI · OREGON HEALTH & SCIENCE UNIVERSITY · PI HEINRICH, MICHAEL C · 2021 to 2022
$320k
BLRD VA I01 BX000338BLRD VA I01 BX005358NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA140146NCI NIH HHS R21 CA263400
6 · The paper itself

Abstract

backgroundRipretinib is a novel switch-control kinase inhibitor that inhibits KIT and PDGFRA signaling. In the INVICTUS phase 3 trial, ripretinib increased median progression-free survival and prolonged overall survival vs. placebo in ≥ fourth-line advanced GIST. Here, we report prespecified analysis of quality of life (QoL) as assessed by patient-reported outcome (PRO) measures and an exploratory analysis evaluating the impact of alopecia on QoL.

methodsIn the INVICTUS trial (NCT03353753), QoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30; physical function, role function, overall health, and overall QoL) and the EuroQoL 5-Dimension 5-Level (EQ-5D-5 L; visual analogue scale). Analysis of covariance (ANCOVA) models compared changes in scores from baseline to treatment cycle 2, day 1 within and between ripretinib and placebo. Within the ripretinib arm, repeated measures models assessed the impact of alopecia on QoL.

resultsPatients receiving ripretinib maintained QoL (as assessed by the EORTC QLQ-C30 and EQ-5D-5 L PRO measures) from baseline to cycle 2, day 1 whereas QoL declined with placebo, resulting in clinically significant differences between treatments (nominal P < 0.01). The most common treatment-emergent adverse event with ripretinib was alopecia; however, QoL was similarly maintained out to treatment cycle 10, day 1 in patients receiving ripretinib who developed alopecia and those who did not.

conclusionPRO assessments in the INVICTUS trial suggest that patients on ripretinib maintain their QoL out to C2D1, unlike patients receiving placebo. Longitudinal QoL was maintained for patients receiving ripretinib out to cycle 10, day 1 (approximately 8 months; past the point of median progression-free survival with ripretinib [6.3 months]), even if the patients developed alopecia.

trial registrationClinicalTrials.gov Identifier: NCT03353753 ; first posted: November 27, 2017.

Indexed as

Gastrointestinal Stromal TumorsAlopeciaHumansNaphthyridinesPatient Reported Outcome MeasuresQuality of LifeUreaNaphthyridinesripretinibUreaAlopeciaGastrointestinal stromal tumorsPatient-reported outcome measuresQuality of lifeRipretinib

Identifiers

PMID36514034
PMCPMC9746146
OpenAlexW4311825954

What OpenQuestion holds

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LicenceCC BY
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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.