Evidence map›Paper›PMID 33123968›Full record

Trial reportAdvances in therapy2021

Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, Placebo-Controlled Phase II Study.

Lowell L Hart, Renata Ferrarotto, Zoran G Andric, J Thaddeus Beck, Janakiraman Subramanian, Davorin Z Radosavljevic, Bojan Zaric, Wahid T Hanna, Raid Aljumaily, Taofeek K Owonikoko and 5 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Advances in therapy, 2021. 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 53 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 4 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.

NCT02514447 phase1 / phase2completednot on this map

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

TypeinterventionalSponsorG1 Therapeutics, Inc.Ran2015 to 2021Enrolled123ConditionsSmall Cell Lung CancerArmsTrilaciclib, Placebo, Topotecan
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

53 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. 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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  3. Small Cell Lung Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2021
    Guideline
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  12. 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
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  18. Trilaciclib use in extensive-stage small cell lung cancer (ES-SCLC): are clinical benefits seen in the real-world setting?Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
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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

15 authors.

Lowell L HartMedical Oncology, Florida Cancer Specialists, Fort Myers, FL, USA. lhart@flcancer.com.
Renata FerrarottoDepartment of Thoracic and Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Zoran G AndricMedical Oncology Department, Clinical Hospital Center Bezanijska Kosa, Belgrade, Serbia.
J Thaddeus BeckDepartment of Medical Oncology and Hematology, Highlands Oncology Group, Rogers, MI, USA.
Janakiraman SubramanianDepartment of Medicine, Saint Luke's Hospital, Kansas City, MO, USA.
Davorin Z RadosavljevicInstitute for Oncology and Radiology of Serbia, Belgrade, Serbia.
Bojan ZaricFaculty of Medicine, Institute for Pulmonary Diseases of Vojvodina, University of Novi Sad, Sremska Kamenica, Serbia.
Wahid T HannaHematology/Oncology, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.
Raid AljumailyStephenson Cancer Center, University of Oklahoma, Oklahoma City, OK, USA.
Taofeek K OwonikokoDepartment of Hematology and Medical Oncology, Emory University, Atlanta, GA, USA.
Didier VerhoevenDepartment of Medical Oncology, AZ Klina Brasschaat, University of Antwerp, Antwerp, Belgium.
Jie XiaoG1 Therapeutics, Inc., Research Triangle Park, NC, USA.
Shannon R MorrisG1 Therapeutics, Inc., Research Triangle Park, NC, USA.
Joyce M AntalG1 Therapeutics, Inc., Research Triangle Park, NC, USA.
Maen A HusseinDepartment of Oncology, Florida Cancer Specialists, Leesburg, FL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMultilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation).

methodsIn this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m

resultsThirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms.

conclusionsCompared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC improves the patient experience of receiving chemotherapy, as demonstrated by a reduction in chemotherapy-induced myelosuppression, improved safety profile, improved quality of life and no detrimental effects on antitumor efficacy.

trial registrationClinicalTrials.gov: NCT02514447.

Indexed as

Lung NeoplasmsSmall Cell Lung CarcinomaAntineoplastic Combined Chemotherapy ProtocolsDouble-Blind MethodHumansPyrimidinesPyrrolesQuality of LifeTopotecanPyrimidinesPyrrolesTopotecantrilaciclibAnemiaChemotherapyMyelopreservationMyelosuppressionNeutropeniaPatient-reported outcomesSmall cell lung cancerTopotecanTrilaciclib

Identifiers

PMID33123968
PMCPMC7854399

What OpenQuestion holds

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LicenceCC BY-NC
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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.