Evidence map›Paper›PMID 23281268›Full record

Trial reportPediatric blood & cancer2013

Safety and efficacy of high-dose tamoxifen and sulindac for desmoid tumor in children: results of a Children's Oncology Group (COG) phase II study.

Stephen X Skapek, James R Anderson, D Ashley Hill, David Henry, Sheri L Spunt, William Meyer, Simon Kao, Fredric A Hoffer, Holcombe E Grier, Douglas S Hawkins and 1 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Pediatric blood & cancer, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03112031 (A Randomized Trial of Tamoxifen Combined With Amphotericin B and Fluconazole for Cryptococcal Meningitis), which is not on this map. Cited by 58 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 5% 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.

NCT03112031 phase2completednot on this mapstarted 2017, after this paper: background citation

A Randomized Trial of Tamoxifen Combined With Amphotericin B and Fluconazole for Cryptococcal Meningitis

TypeinterventionalSponsorOxford University Clinical Research Unit, VietnamRan2017 to 2018Enrolled50ConditionsMeningitis Streptococcal, Hiv, Meningitis, MeningoencephalitisArmsTamoxifen, Amphotericin B, Fluconazole
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 1 synthesis or guideline pooled it, 122 citations in OpenAlex.

  1. Guideline
  2. Sorafenib for Advanced and Refractory Desmoid Tumors.The New England journal of medicine · 2018
    Trial
  3. Review
  4. Review
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Local Treatment of Desmoid Tumors: An Update.Seminars in interventional radiology · 2024
    Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. 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

11 authors at 9 institutions in 1 country.

Stephen X SkapekDivision of Pediatric Hematology/Oncology, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, Texas 75390-9063, USA. stephen.skapek@UTSouthwestern.edu
James R Anderson
D Ashley Hill
David Henry
Sheri L Spunt
William Meyer
Simon Kao
Fredric A Hoffer
Holcombe E Grier
Douglas S Hawkins
R Beverly Raney
University of Washington · USCenter for Cancer and Blood Disorders · USChildren's National · USDana-Farber Cancer Institute · USUniversity of Iowa Hospitals and Clinics · USUniversity of Kansas Medical Center · USUniversity of Nebraska Medical Center · USUniversity of Oklahoma Health Sciences Center · USUniversity of Tennessee Health Science Center · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
QUALITY ASSURANCE REVIEW CENTER (QARC)U10CA029511 · NCI · UNIV OF MASSACHUSETTS MED SCH WORCESTER · PI FITZGERALD, THOMAS J. · 1985 to 2013
$23.4M
INTERGROUP RHABDOMYOSARCOMA STUDYU10CA024507 · NCI · VIRGINIA COMMONWEALTH UNIVERSITY · PI REAMAN, GREGORY H · 1985 to 2002
$2.0M
INTERGROUP RHABDOMYOSARCOMA STUDY STATISTICAL CENTERU10CA072989 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ANDERSON, JAMES R · 1997 to 2002
$1.4M
NCI NIH HHS CA-24507NCI NIH HHS CA-29511NCI NIH HHS CA-98543NCI NIH HHS U10 CA024507NCI NIH HHS U10 CA029511NCI NIH HHS U10 CA072989NCI NIH HHS U10 CA098413NCI NIH HHS U10 CA098543
6 · The paper itself

Abstract

backgroundDesmoid fibromatosis (desmoid tumor, DT) is a soft tissue neoplasm prone to recurrence despite complete surgical resection. Numerous small retrospective reports suggest that non-cytotoxic chemotherapy using tamoxifen and sulindac may be effective for DT. We evaluated the safety and efficacy of tamoxifen and sulindac in a prospective phase II study within the Children's Oncology Group. PROCEDURES: Eligible patients were <19 years of age who had measurable DT that was recurrent or not amenable to surgery or radiation. The primary objective was to estimate progression-free survival (PFS). Patients received tamoxifen and sulindac daily for 12 months or until disease progression or intolerable toxicity occurred. Response was assessed by magnetic resonance imaging.

resultsFifty-nine eligible patients were enrolled from 2004 to 2009; 78% were 10-18 years old. Twenty-two (38%) were previously untreated; 15 (41%) of the remaining 37 enrolling with recurrent DT had prior systemic chemotherapy and six (16%) had prior radiation. No life-threatening toxicity was reported. Twelve (40%) of 30 females developed ovarian cysts, which were asymptomatic in 11 cases. Ten patients completed therapy without disease progression or discontinuing treatment. Responses included four partial and one complete (5/59, 8%). The estimated 2-year PFS and survival rates were 36% (95% confidence interval: 0.23-0.48) and 96%, respectively. All three deaths were due to progressive DT.

conclusionsTamoxifen and sulindac caused few serious side effects in children with DT, although ovarian cysts were common. However, the combination showed relatively little activity as measured by response and PFS rates.

Indexed as

AdolescentAntineoplastic Combined Chemotherapy ProtocolsChildDesmoid TumorsDisease-Free SurvivalFemaleHumansMaleSulindacTamoxifenSulindacTamoxifen

Identifiers

PMID23281268
PMCPMC4646066
OpenAlexW2053755159

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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.