Originally published as JCO Early Release 10.1200/JCO.2008.18.3269 on May 4 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Google Scholar Articles by Hillman, S. L. Articles by Sargent, D. J. PubMed PubMed Citation Articles by Hillman, S. L. Articles by Sargent, D. J. Social Bookmarking                            What's this?

Evaluation of the Optimal Number of Lesions Needed for Tumor Evaluation Using the Response Evaluation Criteria in Solid Tumors: A North Central Cancer Treatment Group Investigation

From the Mayo Clinic and Mayo Foundation, Rochester, MN; Allegheny Cancer Center, Pittsburgh, PA; The University of North Carolina at Chapel Hill, Chapel Hill, NC; and the Toledo Community Hospital Oncology Program Community Clinical Oncology Program, Toledo, OH.

Corresponding author: Shauna Hillman, MS, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: hillman.shauna{at}mayo.edu.

Purpose In February 2000, the criteria for measuring tumor shrinkage as an indicator of antitumor activity were redefined by the Response Evaluation Criteria in Solid Tumors (RECIST). This resulted in simplifying bidimensional to unidimensional measurement of lesions. Under RECIST, all lesions, up to 10, must be measured. Scanning and measuring multiple lesions is costly, time-consuming, and a disincentive to participation in clinical trials. We investigated whether fewer than 10 lesions can be measured without compromising the accuracy of assessing a regimen's activity.

Patients and Methods Thirty-two North Central Cancer Treatment Group trials including 2,374 patients were analyzed. Twelve studies were conducted before RECIST; 20 were conducted post-RECIST. Agreement between objective status by cycle, confirmed response, overall response rate, and time to progression (TTP) was evaluated based on all 10 versus the largest one through five lesions.

Results The median number of lesions reported on RECIST trials did not differ from pre-RECIST trials (median = 2.0). One lesion at baseline was reported in 49% of patients, two lesions in 28% of patients, three lesions in 12% of patients, four lesions in 6% of patients, and five lesions in 5% of patients in post-RECIST trials. Utilizing the largest two lesions produced excellent concordance with that using all lesions for all end points. In no trial did the overall response rate differ by more than 3% when two versus all lesions were considered. Evaluating more than two lesions did not significantly improve agreement.

Conclusion Based on these trials, the assessment of more than two lesions did not alter the conclusions regarding a treatment's efficacy as judged by response rate or TTP.

This study was conducted as a collaborative trial of the North Central Cancer Treatment Group and Mayo Clinic and was supported in part by Public Health Service Grant No. CA-25224.

Presented in part in oral format at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31 to June 3, 2003.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				R. M. Goldberg, D. J. Sargent, R. F. Morton, E. Green, H. K. Sanoff, H. McLeod, and J. Buckner NCCTG Study N9741: Leveraging Learning from an NCI Cooperative Group Phase III Trial Oncologist, October 1, 2009; 14(10): 970 - 978. [Abstract] [Full Text] [PDF]