Scientific evidence underlying National Comprehensive Cancer Network Clinical Practice Guidelines.

Abstract

6020 Background: The National Comprehensive Cancer Network (NCCN) guidelines are the most comprehensive, recognized, and widely used standard for clinical policy in oncology by clinicians and payors in the United States. However, the level of scientific evidence on which these guidelines are based, has not been systematically investigated. Objectives: We performed this study to describe the distribution of categories of evidence and consensus (EC) among the 10 most common cancers in the US with regards to recommendations for staging, initial and salvage therapy, and surveillance practice. Methods: We obtained the latest versions (September 1, 2009) of relevant guidelines from the NCCN. The definitions for various categories of EC used by NCCN panel members were as follows: Category 1 (high level evidence such as randomised controlled trials with uniform consensus), Category 2A (lower level of evidence with uniform consensus), Category 2B (lower level of evidence without a uniform consensus but with no major disagreement) and Category 3 (any level of evidence but with major disagreement). Results: Of the 983 recommendations found in the 10 sets of guidelines, the proportions of Category 1, 2A, 2B and 3 EC were 5%, 85%, 9% and 1%, respectively. Recommendations with any Category 1 EC were found in breast (19%), non-Hodgkin lymphoma (8%), kidney (7%), melanoma (6%), and lung (6%) guidelines. Colorectal, pancreatic, urinary bladder, and uterine guidelines did not have any recommendations with category 1 EC. 8% of all therapeutic recommendations were derived from category 1 EC with the majority (83%) of these pertaining to initial therapy. Guidelines with the highest proportions of therapeutic recommendations based on category 1 EC were breast (30%), lung (10%), and kidney (10%) cancers. No category 1 EC formed basis for any recommendations on screening or surveillance. Conclusions: Recommendations issued in the current NCCN guidelines are largely developed from lower levels of evidence but with uniform expert opinion. Our study underscores both the urgent need and available opportunities to expand evidence base in oncology which forms the platform for clinical practice guidelines. No significant financial relationships to disclose.