Evidence map›Paper›PMID 24957683›Full record

Trial reportLung cancer (Amsterdam, Netherlands)2014

A phase II trial of the Src-kinase inhibitor saracatinib after four cycles of chemotherapy for patients with extensive stage small cell lung cancer: NCCTG trial N-0621.

Julian R Molina, Nathan R Foster, Thanyanan Reungwetwattana, Garth D Nelson, Andrew V Grainger, Preston D Steen, Philip J Stella, Randolph Marks, John Wright, Alex A Adjei

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Lung cancer (Amsterdam, Netherlands), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–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.

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

28 citing papers in PubMed.

  1. Trial
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  5. Dual Drug Repurposing: The Example of Saracatinib.International journal of molecular sciences · 2024
    Review
  6. Review
  7. Article
  8. Review
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  11. Article
  12. Article
  13. Article
  14. Historical retrospective of theMolecular and clinical oncology · 2020
    Review
  15. Article
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  17. Article
  18. Article
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  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

10 authors.

Julian R MolinaDivision of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States. Electronic address: molina.julian@mayo.edu.
Nathan R FosterDivision of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States.
Thanyanan ReungwetwattanaDivision of Medical Oncology, Department of Internal Medicine, Ramathibodi Hospital, Bangkok, Thailand.
Garth D NelsonDivision of Biomedical Statistics and Informatics, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States.
Andrew V GraingerColumbus Oncology & Hematology, Inc., 810 Jasonway Avenue, Suite A, Columbus, OH 43214l, United States.
Preston D SteenMeritCare Hospital CCOP, 820 4(th) Street North, Fargo, ND 58102, United States.
Philip J StellaSt. Joseph Mercy Cancer Center, 5301 McAuley Drive, Suite C-139, Ypsilanti, MI 48197, United States.
Randolph MarksDivision of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States.
John WrightCTEP Program, National Cancer Institute, Executive Plaza North, Suite 7115A, Rockville, MD 20852-7426, United States.
Alex A AdjeiRoswell Park Cancer Institute, Elm and Carlton Street, Buffalo, NY 14263, United States.

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180882
6 · The paper itself

Abstract

introductionTo assess the efficacy and the Src-kinase inhibitor saracatinib (AZD-0530) after four cycles of platinum-based chemotherapy for extensive stage small cell lung cancer (SCLC).

methodsPatients with at least stable disease received saracatinib at a dose of 175 mg/day by mouth until disease progression, unacceptable toxicity, or patient refusal. The primary endpoint was the 12-week progression-free survival (PFS) rate from initiation of saracatinib treatment. Planned interim analysis in first 20 patients, where 13 or more patients alive and progression-free at 12-weeks would allow continued enrollment to 40 total patients.

resultsAll 23 evaluable patients received platinum based standard chemotherapy. Median age was 58 years (range: 48-82). 96% of patients had a performance status of 0/1. Median of two cycles given (range: 1-34). All 23 (100%) patients have ended treatment, most for disease progression (19/23). The 12-week PFS rate was 26% (6/23; 95% CI: 10-48%). From start of standard chemotherapy, median PFS was 4.7 months (95% CI: 4.5-5.1) and median OS was 11.2 months (95% CI: 9.9-13.8). Eight (35%) and three (13%) patients experienced at least one grade 3/4 or grade 4 AE, respectively. Commonly occurring grade 3/4 adverse events were thrombocytopenia (13%), fatigue (9%), nausea (9%), and vomiting (9%).

conclusionsSaracatinib at a dose of 175 mg/day by mouth is well tolerated. However, the PFS rate observed at the pre-planned interim analysis did not meet the criteria for additional enrollment.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBenzodioxolesDisease ProgressionFemaleFollow-Up StudiesHumansLung NeoplasmsMaleMiddle AgedNeoplasm StagingProtein Kinase InhibitorsQuinazolinesRetreatmentAntineoplastic AgentsBenzodioxolesProtein Kinase InhibitorsQuinazolinessaracatinibsrc-Family KinasesC-SrcExtensive stageMaintenanceSaracatinibSmall cell lung cancer

Identifiers

PMID24957683
PMCPMC5652328

What OpenQuestion holds

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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.