Evidence map›Paper›PMID 31675535›Full record

ArticleCancer treatment and research communications2020

A phase I study of weekly doxorubicin and oral topotecan for patients with relapsed or refractory small cell lung cancer (SCLC): A Fred and Pamela Buffet Cancer Center Clinical Trials Network study.

Vinicius Ernani, Rahat Jahan, Lynette M Smith, Alissa S Marr, Sarah E Kimbrough, Mary E Kos, Jolene Tijerina, Shannon Pivovar, Imayavaramban Lakshmanan, Marsha Ketcham and 7 more

Open access · hybridAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Cancer treatment and research communications, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 41% 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, 4 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
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

17 authors at 1 institution in 1 country.

Vinicius ErnaniDepartment of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
Rahat JahanDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Lynette M SmithDepartment of Biostatistics, University of Nebraska Medical Center, Omaha, NE, United States.
Alissa S MarrDepartment of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
Sarah E KimbroughEarly Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.
Mary E KosEarly Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.
Jolene TijerinaEarly Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.
Shannon PivovarEarly Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.
Imayavaramban LakshmananDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Marsha KetchamEarly Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States.
Sanchita RauthDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Kavita MallyaDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Mohd W NasserDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Maneesh JainDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Anne KessingerDepartment of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States.
Surinder K BatraDepartment of Biochemistry and Molecular Biology, University of Nebraska Medical Center, Omaha, NE, United States.
Apar Kishor GantiDepartment of Medicine, VA Nebraska Western Iowa Health Care System, Omaha, NE, United States; Department of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, United States; Early Phase Therapeutic Clinical Trials Unit, Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, United States. Electronic address: aganti@unmc.edu.
University of Nebraska Medical Center · US

Funding

UNMC/EPPLEY CANCER CENTER SUPPORT GRANTP30CA036727 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI Steven H Caplan · 1985 to 2026
$55.0M
NCI NIH HHS P30 CA036727
6 · The paper itself

Abstract

backgroundRelapsed/refractory small cell lung cancer (SCLC) has a poor prognosis, with no good options. We evaluated a novel combination of topotecan and doxorubicin, providing sequential topoisomerase I and II inhibition, in this setting. MATERIALS AND

methodsAdult patients (>19 years) with relapsed/refractory SCLC, who had received at least one prior chemotherapy regimen were eligible. Patients received escalating doses of oral topotecan on days 1-5 of each three week cycle (maximum - 5 cycles). The dosing cohorts were: 0.85 mg/m

resultsTwenty-two patients were enrolled, of which 20 were evaluable. Median age was 61 years; 74% were male and 95% were Caucasian. Hematologic side effects were the most common adverse events. There were no therapy-related Grade 5 toxicities. Incidence of DLT based on cohorts were: DL2: 1/6 (Grade 4 thrombocytopenia), DL3: 1/6 (AST elevation) and DL4: 2/4 (Grade 4 thrombocytopenia). Response rate was 20% (4/20) and disease control rate (SD + PR) was 36%. The median progression free and overall survival were 3.6 months and 6 months, respectively.

conclusionsThe combination of topotecan and doxorubicin was safe and effective in relapsed/refractory SCLC. The maximum tolerated dose of oral topotecan was 1.35 mg/m

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsAspartate AminotransferasesChemical and Drug Induced Liver InjuryDose-Response Relationship, DrugDoxorubicinDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansLung NeoplasmsMaleMaximum Tolerated DoseMiddle AgedAspartate AminotransferasesDoxorubicinTopotecanDoxorubicinPhase 1 clinical trialSmall cell lung cancerTopoisomerase1Topoisomerase 2Topotecan

Identifiers

PMID31675535
PMCPMC7315624
OpenAlexW2980116994

What OpenQuestion holds

Textmetadata
LicenceTDM
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.