Evidence map›Paper›PMID 31504118›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2019

Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial.

J M Weiss, T Csoszi, M Maglakelidze, R J Hoyer, J T Beck, M Domine Gomez, A Lowczak, R Aljumaily, C M Rocha Lima, R V Boccia and 21 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2019. 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 98 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT02499770 phase1 / phase2completednot on this map

Phase 1b/2a Safety and Pharmacokinetic Study of G1T28 in Patients With Extensive Stage Small Cell Lung Cancer (SCLC) Receiving Etoposide and Carboplatin

TypeinterventionalSponsorG1 Therapeutics, Inc.Ran2015 to 2019Enrolled122ConditionsSmall Cell Lung CancerArmsCarboplatin, Placebo, Trilaciclib, Etoposide
NCT05862610 phase2not yet recruitingnot on this mapstarted 2023, after this paper: background citation

A Prospective, Randomized, Controlled Phase II Clinical Study of Trilaciclib Combined With Standard Treatment Project As a Neoadjuvant Treatment For Triple Negative Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2027Enrolled150ConditionsBreast NeoplasmArmsTrilaciclib plus chemotherapy, Chemotherapy
3 · Its place in the literature

Who cites it

98 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Efficacy and safety of trilaciclib to prevent chemotherapy-induced myelosuppression in advanced solid tumors: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Pooled it
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  16. The Five-Decade Journey of Small Cell Lung Cancer.Cancer communications (London, England) · 2026
    Review
  17. Neutropenic events associated with new anticancer treatments, from pathophysiology to practice: a scoping review-NEW Group (Neutropenic Events Working Group).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
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38 more citing papers are in PubMed but not listed here.

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

31 authors.

J M WeissDivision of Hematology and Oncology, Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, USA.
T CsosziOncology, Hetenyi Geza Korhaz, Onkologiai Kozpont, Szolnok, Hungary.
M MaglakelidzeDepartment of Oncology, Research Institute of Clinical Medicine, Tbilisi, Georgia, USA.
R J HoyerDepartment of Oncology, Memorial Hospital, University of Colorado Health, Colorado Springs, USA.
J T BeckDepartment of Medical Oncology and Hematology, Highlands Oncology Group, Fayetteville, USA.
M Domine GomezDepartment of Oncology, University Hospital Fundacion Jimenez Diaz, IIS-FJD, Madrid, Spain.
A LowczakDepartment of Pulmonology, Faculty of Health and Science, University of Warmia and Mazury in Olsztyn, Poland.
R AljumailyStephenson Cancer Center, University of Oklahoma, Oklahoma City, USA.
C M Rocha LimaGibbs Cancer Center and Research Institute, Spartanburg, USA.
R V BocciaCenter for Cancer and Blood Disorders, Bethesda, USA.
W HannaHematology/Oncology, University of Tennessee Medical Center, Knoxville, USA.
P NikolinakosUniversity Cancer & Blood Center, LLC, Athens, Greece.
V K ChiuDepartment of Hematology/Oncology, University of New Mexico Comprehensive Cancer Center, Albuquerque, USA.
T K OwonikokoDepartment of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, USA.
S R SchusterUniversity of Colorado, Fort Collins, USA.
M A HusseinDepartment of Oncology, Florida Cancer Specialists, Leesburg, USA.
D A RichardsDepartment of Oncology, US Oncology Research, Tyler, USA.
P SawryckiDepartment of Cancer Chemotherapy, Provincial Hospital, Toruń, Poland.
I BulatARENSIA Oncology Unit, Institute of Oncology, Chisinau, Moldova.
J T HammDepartment of Medical Oncology, Norton Health Care, Louisville, USA.
L L HartDrug Development Program, Floridia Cancer Specialists, Fort Myers, USA.
S AdlerClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
J M AntalClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
A Y LaiClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
J A SorrentinoClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
Z YangClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
R K MalikClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
S R MorrisClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
P J RobertsClinical Research, G1 Therapeutics, Inc., Research Triangle Park, USA.
K H DragnevDepartment of Hematology/Oncology, Norris Cotton Cancer Center Dartmouth-Hitchcock Medical Center, Lebanon, USA. Electronic address: konstantin.h.dragnev@hitchcock.org.
G1T28-02 Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChemotherapy-induced damage of hematopoietic stem and progenitor cells (HSPC) causes multi-lineage myelosuppression. Trilaciclib is an intravenous CDK4/6 inhibitor in development to proactively preserve HSPC and immune system function during chemotherapy (myelopreservation). Preclinically, trilaciclib transiently maintains HSPC in G1 arrest and protects them from chemotherapy damage, leading to faster hematopoietic recovery and enhanced antitumor immunity. PATIENTS AND

methodsThis was a phase Ib (open-label, dose-finding) and phase II (randomized, double-blind placebo-controlled) study of the safety, efficacy and PK of trilaciclib in combination with etoposide/carboplatin (E/P) therapy for treatment-naive extensive-stage small-cell lung cancer patients. Patients received trilaciclib or placebo before E/P on days 1-3 of each cycle. Select end points were prespecified to assess the effect of trilaciclib on myelosuppression and antitumor efficacy.

resultsA total of 122 patients were enrolled, with 19 patients in part 1 and 75 patients in part 2 receiving study drug. Improvements were seen with trilaciclib in neutrophil, RBC (red blood cell) and lymphocyte measures. Safety on trilaciclib+E/P was improved with fewer ≥G3 adverse events (AEs) in trilaciclib (50%) versus placebo (83.8%), primarily due to less hematological toxicity. No trilaciclib-related ≥G3 AEs occurred. Antitumor efficacy assessment for trilaciclib versus placebo, respectively, showed: ORR (66.7% versus 56.8%, P = 0.3831); median PFS [6.2 versus 5.0 m; hazard ratio (HR) 0.71; P = 0.1695]; and OS (10.9 versus 10.6 m; HR 0.87; P = 0.6107).

conclusionTrilaciclib demonstrated an improvement in the patient's tolerability of chemotherapy as shown by myelopreservation across multiple hematopoietic lineages resulting in fewer supportive care interventions and dose reductions, improved safety profile, and no detriment to antitumor efficacy. These data demonstrate strong proof-of-concept for trilaciclib's myelopreservation benefits. CLINICAL TRAIL NUMBER: NCT02499770.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCarboplatinCisplatinCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6Double-Blind MethodEtoposideFemaleFollow-Up StudiesHumansLung NeoplasmsMaleCarboplatinCDK4 protein, humanCDK6 protein, humanCisplatinCyclin-Dependent Kinase 4Cyclin-Dependent Kinase 6EtoposidePaclitaxelPyrimidinesPyrrolestrilaciclibanemiaCDK4/6myelopreservationneutropeniasmall-cell lung cancertrilaciclib

Identifiers

PMID31504118
PMCPMC6857609

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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.