Core Outcome Measures in Effectiveness Trials

Outcome reporting in neoadjuvant surgical trials: a systematic review of the literature and proposals for new standards

General Information

Abstract:
BACKGROUND: The use of neoadjuvant therapy before surgery for gastrointestinal cancer is increasing; however, patients may not complete both treatment components. Understanding completion rates of each treatment stage is necessary for treatment evaluation and to inform decision-making. This study evaluates reporting for recent neoadjuvant surgical trials, focusing on treatment progression and other key outcomes. METHODS: Systematic literature searches identified randomized and nonrandomized phase II and III studies evaluating neoadjuvant treatment and surgery for esophageal, stomach, and colorectal cancer, and colorectal liver metastases. Rates of reporting of failure to complete neoadjuvant treatment, nonprogression to surgery after neoadjuvant treatment, and nonresection at planned surgery were assessed. For each measure, reporting was categorized as "full," "partial," and "absent" according to predefined criteria, and reasons for nonprogression at each stage of treatment were examined to inform proposed standards. RESULTS: Of 9854 abstracts, 123 papers were reviewed and 62 articles were included, reporting outcomes for 9126 patients. Details of noncompletion of neoadjuvant treatment and nonprogression to surgery were completely absent in 21 (33.9%) and 19 (30.6%) studies, respectively. Reporting of nonresection at planned surgery was also deficient, with 21 (33.9%) studies providing no information about this outcome. Reasons for noncompletion and nonprogression were similar and included disease progression, treatment toxicity, and patient choice. Common reasons for nonresection were locally advanced disease and the discovery of unsuspected metastases. CONCLUSIONS: Reports of recent neoadjuvant surgical trials often fail to include treatment progression and other key outcomes. These findings support the need for minimum reporting standards.

Authors:
Blencowe, N. S. Chana, P. Whistance, R. N. Stevens, D. Wong, N. A. Falk, S. J. Blazeby, J. M.

Publication

Journal:
J Natl Cancer Inst
Volume:
106
Issue:
9
Pages:
-
Year:
2014
DOI:
Further Study Information

Date:
Funding source(s):

Health Area

Disease Category
Cancer
Gastroenterology

Disease Name
Gastrointestinal cancer

Target Population

Age Range
-

Sex
Unknown


Nature / type of Intervention
Unknown

Method(s)

Unknown

Stakeholders Involved

Unknown

Study Type

Systematic review of outcomes measured in trials

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