Evidence map›Paper›PMID 28334439›Full record

Trial reportCancer2017

A phase 2 trial of dasatinib in patients with locally advanced or stage IV mucosal, acral, or vulvovaginal melanoma: A trial of the ECOG-ACRIN Cancer Research Group (E2607).

Kevin Kalinsky, Sandra Lee, Krista M Rubin, Donald P Lawrence, Anthony J Iafrarte, Darell R Borger, Kim A Margolin, Mario M Leitao, Ahmad A Tarhini, Henry B Koon and 6 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00700882 (A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas), which is not on this map. Cited by 60 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 2 pooled it
8.6field-weighted citation impact, top 2% 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.

NCT00700882 phase2completednot on this map

A Phase II Trial of Dasatinib in KIT-Positive Patients With Unresectable Locally Advanced or Stage IV Mucosal, Acral and Vulvovaginal Melanomas

TypeinterventionalSponsorEastern Cooperative Oncology GroupRan2009 to 2020Enrolled81ConditionsMelanoma (Skin)Armsdasatinib
3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 2 syntheses or guidelines pooled it, 123 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Review
  13. Review
  14. Article
  15. Article
  16. Anorectal mucosal melanoma.Seminars in colon & rectal surgery · 2023
    Article
  17. Review
  18. The c-Src/LIST Positive Feedback Loop Sustains Tumor Progression and Chemoresistance.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2023
    Article
  19. Review
  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

16 authors at 12 institutions in 1 country.

Kevin KalinskyColumbia University Medical Center, New York, New York.ORCID http://orcid.org/0000-0002-1583-3553
Sandra LeeDana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts.
Krista M RubinMassachusetts General Hospital, Boston, Massachusetts.
Donald P LawrenceMassachusetts General Hospital, Boston, Massachusetts.
Anthony J IafrarteMassachusetts General Hospital, Boston, Massachusetts.
Darell R BorgerMassachusetts General Hospital, Boston, Massachusetts.
Kim A MargolinCity of Hope, Duarte, California.ORCID http://orcid.org/0000-0002-5718-7422
Mario M LeitaoMemorial Sloan Kettering Cancer, New York, New York.
Ahmad A TarhiniUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Henry B KoonCase Western Reserve University, Cleveland, Ohio.
Andrew L PecoraHackensack Medical Center, Hackensack, New Jersey.
Anthony J JaslowskiSaint Vincent Hospital, Green Bay, Wisconsin.
Gary I CohenGreater Baltimore Medical Center, Baltimore, Maryland.
Timothy M KuzelRush University Medical Center, Chicago, Illinois.
Christopher D LaoUniversity of Michigan Comprehensive Cancer Center.
John M KirkwoodUniversity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Massachusetts General Hospital · USUniversity of Pittsburgh Medical Center · USCase Western Reserve University · USCity of Hope · USColumbia University Irving Medical Center · USGreater Baltimore Medical Center · USHackensack University Medical Center · USHarvard University · USMemorial Sloan Kettering Cancer Center · USRush University Medical Center · USSaint Vincent Hospital · USUniversity of Michigan · US

Funding

NRG Oncology Network Group Operations Center - GY9 BIQSFP Reports/BudgetsU10CA180868 · NCI · NRG ONCOLOGY FOUNDATION, INC. · PI Quynh-Thu Xuan Le, ROBERT S. MANNEL · 2014 to 2026
$206.8M
Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
Statistics CoreU10CA180822 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI James J. Dignam, GREG YOTHERS · 2014 to 2026
$146.4M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
Wisconsin NCI Community Oncology Research Program (WiNCORP)UG1CA189956 · NCI · MARSHFIELD CLINIC RESEARCH FOUNDATION · PI ADEDAYO A ONITILO, Kurt Oettel · 2014 to 2026
$32.3M
Therapuetic Immune Targeting of EphA2 Expressed by Melanoma & Its Tumor-AssociateP50CA121973 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 2008 to 2018
$22.9M
NCI NCTN-Network Lead Academic Participating Site at UPMC Hillman Cancer CenterUG1CA233184 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI ADAM M BRUFSKY, John Munn Kirkwood · 2019 to 2026
$7.7M
CWRU Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteU10CA180853 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERDS, AARON THOMAS, MACHTAY, MITCHELL · 2014 to 2018
$6.2M
NCTN Lead Academic Participating Site at Dana-Farber/Partners Cancer CareU10CA180867 · NCI · DANA-FARBER CANCER INST · PI BURSTEIN, HAROLD JOHN, KIBEL, ADAM S · 2014 to 2018
$6.2M
NCI NIH HHS P50 CA121973NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA180791NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180801NCI NIH HHS U10 CA180802NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180822NCI NIH HHS U10 CA180828NCI NIH HHS U10 CA180844NCI NIH HHS U10 CA180853NCI NIH HHS U10 CA180867NCI NIH HHS U10 CA180868NCI NIH HHS U10 CA180888NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189956NCI NIH HHS UG1 CA233184
6 · The paper itself

Abstract

backgroundKIT-directed tyrosine kinase inhibitors such as imatinib have demonstrated benefits in KIT-mutant (KIT+) mucosal, acral, vulvovaginal, and chronically sun-damaged (CSD) melanoma. Dasatinib has superior preclinical activity in comparison with other tyrosine kinase inhibitors against cells with the most common KIT mutation, exon 11

methodsPatients received 70 mg of oral dasatinib twice daily. The primary objective for this 2-stage phase 2 trial was response rate. Stage I was open to KIT+ and wild-type KIT (KIT-) mucosal, acral, and CSD melanoma (n = 57). Stage II accrued only KIT+ tumors (n = 30). To enrich the trial for KIT+ tumors, vulvovaginal melanoma was added, and CSD melanoma was removed from eligibility. Secondary objectives included progression-free survival (PFS), overall survival (OS), and safety.

resultsFrom May 2009 to December 2010, the first stage enrolled 57 patients. Among the evaluable patients, 3 of 51 (5.9%) achieved a partial response: all were KIT-. Stage II closed early because of slow accrual (November 2011 to December 2015). In stage II, 4 of 22 evaluable patients (18.2%) had a partial response; the median duration was 4.2 months. The median PFS was 2.1 months (n = 73; 95% confidence interval [CI], 1.5-2.9 months). The median OS was 7.5 months (95% CI, 6.0-11.9 months). In exploratory analyses, no differences were seen in PFS or OS with the KIT status or subtype. Dasatinib was discontinued because of adverse events in 9 of 75 patients (12%).

conclusionsThe dasatinib response rate among KIT+ melanoma patients was low. In view of its clinical activity, it is recommended that imatinib remain the KIT tyrosine kinase inhibitor of choice for unresectable KIT+ melanoma. Cancer 2017;123:2688-97. © 2017 American Cancer Society.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDasatinibDisease-Free SurvivalFemaleHumansMaleMelanomaMiddle AgedMucous MembraneMutationNeoplasm MetastasisNeoplasm StagingProto-Oncogene Proteins c-kitAntineoplastic AgentsDasatinibProto-Oncogene Proteins c-kitacraldasatinibKIT mutationmelanomamucosalvulvovaginal

Identifiers

PMID28334439
PMCPMC5498223
OpenAlexW2599316103

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

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 Socratic graph.