Evidence map›Paper›PMID 33930659›Full record

Trial reportESMO open2021

Patient-reported outcomes from STARTRK-2: a global phase II basket study of entrectinib for ROS1 fusion-positive non-small-cell lung cancer and NTRK fusion-positive solid tumours.

L Paz-Ares, F Barlesi, S Siena, M-J Ahn, A Drilon, A Conley, C Rolfo, J Wolf, T Seto, R Doebele and 5 more

Open access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in ESMO open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.5field-weighted citation impact, top 6% 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

20 citing papers in PubMed, 36 citations in OpenAlex.

  1. Review
  2. Rare, Yet Targetable: New Perspectives on Ampullary Carcinomas.International journal of molecular sciences · 2026
    Review
  3. Article
  4. Review
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  10. Review
  11. International journal of molecular sciences · 2024
    Review
  12. Review
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  15. Review
  16. Review
  17. Current oncology (Toronto, Ont.) · 2022
    Review
  18. Diagnosis and management of TRK fusion cancer.The American journal of managed care · 2022
    Review
  19. Review
  20. 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

15 authors at 14 institutions in 8 countries.

L Paz-AresMedical Oncology Department, Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Clinical Research Unit, Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazaresr@seom.org.
F BarlesiMedical Oncology Department, Gustave Roussy Cancer Campus, Villejuif, France.
S SienaMedical Oncology Department, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy; Department of Oncology and Hemato-Oncology, Università degli Studi di Milano, Milan, Italy.
M-J AhnSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
A DrilonDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, USA; Weill Cornell Medical College, New York, USA.
A ConleyDepartment of Sarcoma Medical Oncology, MD Anderson Cancer Center, University of Texas, Houston, USA.
C RolfoMarlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, USA.
J WolfDepartment I of Internal Medicine, Center for Integrated Oncology, University Hospital of Cologne, Cologne, Germany.
T SetoDepartment of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
R DoebeleDivision of Medical Oncology, University of Colorado, Aurora, USA.
A KapreDepartment of Patient-Centered Outcomes Research, Genentech, Inc., South San Francisco, USA.
D ChenProduct Development Oncology, Genentech, Inc., South San Francisco, USA.
S McCallumMedication Safety and Risk Management, Genentech, Inc., South San Francisco, USA.
S OsbornePDMA Operations (Biometrics), F. Hoffmann-La Roche Ltd, Basel, Switzerland.
G DemetriDepartment of Oncologic Pathology, Dana-Farber Cancer Institute and Ludwig Center at Harvard Medical School, Boston, USA.
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITHarvard University · USHospital Universitario 12 De Octubre · ESInstitut Gustave Roussy · FRMedication Management (United States) · USMemorial Sloan Kettering Cancer Center · USNational Hospital Organization Kyushu Cancer Center · JPPatient-Centered Outcomes Research Institute · USSamsung Medical Center · KRThe University of Texas MD Anderson Cancer Center · USUniversity Hospital Cologne · DEUniversity of Colorado Anschutz Medical Campus · USUniversity of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer CenterZimmer Biomet (Switzerland) · CH

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundPatient-reported outcomes (PROs) are increasingly relevant endpoints in clinical trials, contributing to our understanding of risk-benefit profiles, in addition to efficacy and safety data. We investigated the impact of entrectinib on patient-reported symptoms, functioning, and health-related quality of life. PATIENTS AND

methodsSTARTRK-2 is a phase II basket study in patients with locally advanced/metastatic neurotrophic receptor tyrosine kinase 1/2/3 (NTRK1/2/3) and ROS proto-oncogene 1 (ROS1) fusion-positive solid tumours. PROs (prespecified secondary endpoint) were evaluated using the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (QLQ-C30), lung cancer module (QLQ-LC13), and colorectal cancer module (QLQ-CR29), and the EuroQoL 5-Dimension 3-Level instruments, completed before cycle 1 day 1 and each subsequent 4-week cycle of entrectinib dosing, and the end of treatment. Adverse events and treatment-related symptoms were assessed in the safety analysis (SA)-PRO population. Tumour-related symptoms, functioning, and global health status were assessed in the efficacy analysis (EA)-PRO population. Data cut-offs: 31 October 2018 NTRK cohort; 01 May 2019 ROS1 cohort.

resultsSA-PRO populations comprised patients with NTRK fusion-positive solid tumours (N = 88) or ROS1 fusion-positive non-small-cell lung cancer (N = 180) who received one or more doses of entrectinib, completed PRO questionnaires on cycle 1 day 1 and answered one or more questions on-study. EA-PRO populations (N = 71) and (N = 145), respectively, comprised SA-PRO patients with measurable baseline disease. Moderate-to-high baseline global health status scores were maintained in EA-PRO populations during treatment. Role and physical functioning scores were moderate-to-high at baseline, with trends towards clinical improvement during treatment. Both cohorts reported low-to-moderate symptom burden at baseline, which was maintained or trended towards clinically meaningful improvement. Symptoms commonly associated with cancer treatment (e.g. nausea, fatigue) remained stable or improved during treatment. All SA-PRO patients experienced one or more adverse events, most frequently constipation or diarrhoea.

conclusionsPRO findings were consistent with the favourable safety profile of entrectinib, and further reinforce the positive benefit-risk profile of this treatment, indicating minimal overall treatment burden.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsBenzamidesHumansIndazolesPatient Reported Outcome MeasuresProtein-Tyrosine KinasesProto-Oncogene MasProto-Oncogene ProteinsQuality of LifeBenzamidesentrectinibIndazolesMAS1 protein, humanProtein-Tyrosine KinasesProto-Oncogene MasProto-Oncogene ProteinsROS1 protein, humanentrectinibNTRKpatient-reported outcomesROS1tyrosine kinase inhibitor

Identifiers

PMID33930659
PMCPMC8100628
OpenAlexW3159801410

What OpenQuestion holds

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LicenceCC BY
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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.