Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors [Ovarian Cancer]

Abstract

We read with much interest the article by Therasse et al. (1) on the new Response Evaluation Criteria in Solid Tumors Group (RECIST) in the Journal. In the RECIST, the definition of progression is based on the evaluation of measurable and nonmeasurable disease. However, it is our experience that, in many randomized trials of the first-line treatment of ovarian cancer, in which progression-free survival is often the primary end point, investigators start second-line treatment based on an increase in serum CA 125 levels only, without clinical evidence of progression. This practice has led to confusion in establishing the date of progression, since such cases, in which treatment is initiated before objective progression has been documented, are handled in variable ways by different groups. Some groups count these patients as having progressive disease, others censor them, and others ignore treatment before disease progression altogether.