Re: New Guidelines to Evaluate the Response to Treatment in Solid Tumors (Ovarian Cancer)

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Abstract
The Gynaecologic Cancer Intergroup (GCIG) believes that definitions for response and progression of ovarian cancer according to serum CA 125 levels should be incorporated into ovarian cancer clinical trial protocols for relapse therapy. Although the GCIG is convinced of the value of the definition of progression that incorporates both Response Evaluation Criteria in Solid Tumors (RECIST) and CA 125 criteria and which should be used to define date of progression (1,2), the response definition as defined by Rustin (3) could benefit from further simplification. On the basis of the available data and extensive discussions among the cooperative groups within the GCIG, we recommend that the following definition of response be used in ovarian cancer trials so that response can be measured by either RECIST or CA 125 criteria. If the response is evaluable by both criteria, then the date of response will be the date of the earlier of the two events.

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