Evidence map›Paper›PMID 34523767›Full record

Trial reportThe oncologist2022

Patient-Reported Outcomes with Selpercatinib Among Patients with RET Fusion-Positive Non-Small Cell Lung Cancer in the Phase I/II LIBRETTO-001 Trial.

Anna Minchom, Aaron C Tan, Erminia Massarelli, Vivek Subbiah, Valentina Boni, Bruce Robinson, Lori J Wirth, Lisa M Hess, Min-Hua Jen, Jennifer Kherani and 2 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The oncologist, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
1.0field-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.

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, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. 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

12 authors at 9 institutions in 5 countries.

Anna MinchomRoyal Marsden Hospital and The Institute of Cancer Research, London, UK.
Aaron C TanNational Cancer Centre Singapore, Singapore.
Erminia MassarelliCity of Hope, Duarte, CA, USA.
Vivek SubbiahThe University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Valentina BoniSTART Madrid-Centro Integral Oncológico Clara Campal (CIOCC), Hm Hospitales Sanchinarro, Madrid, Spain.
Bruce RobinsonRoyal North Shore Hospital, Sydney, Australia.
Lori J WirthMassachusetts General Hospital, Boston, MA, USA.
Lisa M HessEli Lilly & Co., Indianapolis, IN, USA.
Min-Hua JenEli Lilly & Co., Indianapolis, IN, USA.
Jennifer KheraniLoxo Oncology, a wholly owned subsidiary of Eli Lilly & Co., Stamford, CT, USA.
Elizabeth OlekLoxo Oncology, a wholly owned subsidiary of Eli Lilly & Co., Stamford, CT, USA.
Caroline E McCoachUniversity of California at San Francisco, San Francisco, CA, USA.
Eli Lilly (United States) · USCity of Hope · USHospital Universitario HM Sanchinarro · ESLoxo Oncology at Lilly (United States) · USMassachusetts General Hospital · USNational Cancer Centre Singapore · SGRoyal Marsden Hospital · GBRoyal North Shore Hospital · AUThe University of Texas MD Anderson Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLIBRETTO-001 is an ongoing, global, open-label, phase I/II study of selpercatinib in patients with advanced or metastatic solid tumors. We report interim patient-reported outcomes in patients with RET fusion-positive non-small cell lung cancer (NSCLC). PATIENTS AND

methodsPatients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30) version 3.0 at baseline (cycle 1, day 1), approximately every other 28-day cycle until cycle 13, and every 12 weeks thereafter. Data were evaluated through cycle 13 as few patients had reached later time points. A change of ≥10 points from baseline in domain scores was considered clinically meaningful.

resultsAmong 253 selpercatinib-treated patients, 239 were categorized into subgroups by prior therapy: treatment-naïve (n = 39), one prior line of therapy (n = 64), or two or more prior lines of therapy (n = 136). The QLQ-C30 was completed by >85% of patients at each time point. Most patients overall and in each subgroup maintained or improved in all health-related quality of life (HRQoL) domains during treatment. The percentage of patients who experienced clinically meaningful improvements ranged from 61.1% to 66.7% for global health status, 33.3% to 61.1% for dyspnea, and 46.2% to 63.0% for pain. The 61.1% of patients with improved dyspnea had two or more prior lines of therapy; median time to first improvement was 3.4 months. At the first postbaseline evaluation (cycle 3), 45.9% of all patients reported a ≥10-point reduction in pain.

conclusionIn this interim analysis, the majority of patients with RET fusion-positive NSCLC remained stable or improved on all QLQ-C30 subscales at each study visit, demonstrating favorable HRQoL as measured by the QLQ-C30 during treatment with selpercatinib.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsDyspneaHumansPainPatient Reported Outcome MeasuresProto-Oncogene Proteins c-retPyrazolesPyridinesQuality of LifeProto-Oncogene Proteins c-retPyrazolesPyridinesRET protein, humanselpercatinibdyspneahealthnonpainpatientrelated quality of lifereported outcomesselpercatinibsmall cell lung cancer

Identifiers

PMID34523767
PMCPMC9714603
OpenAlexW3201409886

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.