CT of XXXX metastases to the liver using modified RECIST criteria: determining the ideal number of @entity75 to measure.

@entity1 @entity75 @entity5 @entity14 @entity694
OBJECTIVE: We sought to define the ideal number of @entity75 to be measured to assess disease response in @entity1 undergoing chemotherapy for @entity694 metastases to the liver. MATERIALS AND METHODS: Thirty consecutive @entity1 were recruited for this study. @entity1 were part of a multisite, randomized, double-arm, phase 3 clinical trial involving chemotherapy with an investigational drug for metastatic @entity694 . @entity1 were recruited from U.S. and international sites. Institutional review board approval was obtained, and informed consent was obtained from all @entity1 . Our study included CT measurements of hepatic metastases. All @entity1 (n = 30) had a minimum of five @entity75 in the liver. @entity75 size was defined by Response Evaluation Criteria in @entity5 (RECIST) criteria. We calculated the @entity1 response at 2 months and at 6 months (complete response, partial response, stable disease, and progressive disease) using RECIST. @entity1 response was calculated based on the percentage increase or decrease at 2 and 6 months in the greatest diameter of the single largest lesion, two large lesions, three large lesions, four lesions, and five lesions, respectively. The concordance between five-target-lesion measurement and lesser numbers of lesions was analyzed using kappa statistics (StatView, 5.0). RESULTS: In 93.33% of @entity1 (n = 28/30), there was agreement on @entity1 response irrespective of the number of measurements made on CT. Of these 30 @entity1 , 47% had a partial response (n = 14/30), 43% had stable disease (n = 13/30), and 10% had progressive disease at 2 months (n = 3/30). At 6 months, 43% had a partial response (n = 13/30), 47% had stable disease (n = 14/30), and 10% had progressive disease (n = 3/30). Agreement in response evaluation between lesion groups for multiple measurements was high, with values of 1.0 for multiple-lesion measurements and 0.88 for single-lesion measurements at 2 months. The concordance values were the same at 6 months. CONCLUSION: In the majority of @entity1 with hepatic metastases of @entity14 , measuring the maximal diameter of the single largest lesion yielded the same treatment-response classification as measuring up to five @entity75 . This result suggests that it may be possible to reduce the number of lesions measured in clinical trials.
