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The myth of measurable disease in ovarian cancer.

There are well-documented and serious limitations associated with analyzing measurable disease in ovarian cancer as a sole primary endpoint in clinical trials, as this focus requires the presence of individual tumor masses of sufficient size and distinctive shape to image. An alternative highly rational strategy adds the routine monitoring of validated serum tumor markers (e.g., CA-125), which can more adequately define changes in “tumor volume” associated with small nonvisualized macroscopic and diffuse microscopic cancer. In a commentary written more than 5 years ago, this author noted the serious limitations associated with employing changes in “measurable disease” by physical examination or radiographic imaging to define nonoverall survival endpoints in ovarian cancer trials (1). In recognition of the serious inadequacy of this approach, the Gynecologic Cancer Intergroup, a highly regarded international consortium of clinical investigators, has officially modified its criteria for the evaluation of efficacy in ovarian cancer randomized trials to include well-characterized changes in a validated serum tumor marker (CA-125) as an acceptable objective endpoint for progression-free survival in these studies (2). Despite this fact, many ovarian cancer trials continue to examine endpoints that are based solely on changes in “measurable disease” as evidence of a regimen’s biological activity, and mandate that “disease progression” be documented by findings observed on radiographic studies. An unfortunate, and disquieting result of this trial design perspective is that treating physicians who quite rationally elect to remove a patient from an ovarian cancer study based on a marked (and confirmed) rise in the serum CA-125 level in the absence of changes on abdominal