U.S. flag An official website of the United States government.
Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

i

Comparison of Survival Outcomes Among Cancer Patients Treated in and out of Clinical Trials



Details

  • Personal Author:
  • Description:
    Background: Clinical trials test the efficacy of a treatment in a select patient population. We examined whether cancer clinical trial patients were similar to nontrial, "real-world" patients with respect to presenting characteristics and survival. Methods: We reviewed the SWOG national clinical trials consortium database to identify candidate trials. Demographic factors, stage, and overall survival for patients in the standard arms were compared with nontrial control subjects selected from the Surveillance, Epidemiology, and End Results program. Multivariable survival analyses using Cox regression were conducted. The survival functions from aggregate data across all studies were compared separately by prognosis (>/=50% vs <50% average 2-year survival). All statistical tests were two-sided. Results: We analyzed 21 SWOG studies (11 good prognosis and 10 poor prognosis) comprising 5190 patients enrolled from 1987 to 2007. Trial patients were younger than nontrial patients (P < .001). In multivariable analysis, trial participation was not associated with improved overall survival for all 11 good-prognosis studies but was associated with better survival for nine of 10 poor-prognosis studies (P < .001). The impact of trial participation on overall survival endured for only 1 year. Conclusions: Trial participation was associated with better survival in the first year after diagnosis, likely because of eligibility criteria that excluded higher comorbidity patients from trials. Similar survival patterns between trial and nontrial patients after the first year suggest that trial standard arm outcomes are generalizable over the long term and may improve confidence that trial treatment effects will translate to the real-world setting. Reducing eligibility criteria would improve access to clinical trials. [Description provided by NIOSH]
  • Subjects:
  • Keywords:
  • ISSN:
    0027-8874
  • Document Type:
    Text
  • Funding:
    Grant
  • Genre:
    Journal Article
  • Place as Subject:
  • CIO:
    National Institute for Occupational Safety and Health (NIOSH)
  • Topic:
    Workplace Safety & Health
  • Location:
    North America
  • Volume:
    106
  • Issue:
    3
  • NIOSHTIC Number:
    nn:20057199
  • Citation:
    J Natl Cancer Inst 2014 Mar; 106(3):dju002
  • Contact Point Address:
    Joseph M. Unger, PhD, MS, SWOG Statistical Center, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, M3-C102, PO Box 19024, Seattle, WA 98109-1024
  • Email:
    junger@fhcrc.org
  • Federal Fiscal Year:
    2014
  • Performing Organization:
    University of Washington
  • Peer Reviewed:
    True
  • Start Date:
    20050701
  • Source Full Name:
    Journal of the National Cancer Institute
  • End Date:
    20250630
  • Collection(s):
  • Main Document Checksum:
    urn:sha-512:b3538663ce15830063c3a9750e100c3ca8a16adb3bbd1672fbca3ff28f6085c1a6e2d018f2570917c6ddcf3a75156dedda4f4bcc275656069c41fe82128036ce
  • Download URL:
  • File Type:
    Filetype[PDF - 1.10 MB ]
PREVIOUS
ON THIS PAGE
Details
CDC STACKS serves as an archival repository of CDC-published products including scientific findings, journal articles, guidelines, recommendations, or other public health information authored or co-authored by CDC or funded partners.

As a repository, CDC STACKS retains documents in their original published format to ensure public access to scientific information.
BACK TO TOP