Abstract
6522 Background: No studies have examined differences in imaging assessment of drug response for unresectable pancreatic cancer between investigators and independent central review panels. This study reports such discrepancies. Methods: 133 patients in two multi-center, randomized Phase II drug trials had their response assessed by measurement of tumor size or new lesions on serial CT scans. Protocols specified techniques for tumor measurement and defined responses as complete (CR) or partial responses (PR), stable (SD) or progressive disease (PD). Objective responses were confirmed by repeat imaging evaluations after an interval > 4 weeks. Cases of PR or SD withdrawn from the study <8 weeks after enrollment were scored as non-evaluable (NE). The same images were then blindly reviewed by protocol trained radiologists at an Independent Core Lab. Cases of discordance in the interpretation of best response between investigators and reviewers were then blindly re-reviewed by an independent adjudicator. Results: In 50/133 cases (38%), there was sufficient discrepancy between investigators and reviewers to result in a change in overall response. In 10 cases (8%), investigators reported responses inconsistent with protocol standards for their tumor measurements. In 40 cases (30%), reviewers disagreed with the radiological findings of the investigators. In 47 of the 50 cases, the films were available for a second review by the adjudicator who confirmed the reviewers’ assessment of response in 39/47 (83%) of cases. Discrepancies in assessment of response were not randomly distributed. Investigators reported significantly more confirmed objective responses (CR + PR) than reviewers even after investigators’ response coding errors were corrected. As shown in Table 1 , investigators reported favorable responses in 21/133 (16%) cases compared with 6/133 (5%) responses noted by reviewers (p=0.01). Conclusions: The results support the use of independent review of trial data when the endpoint of the trial (response rate) is based on imaging data. [Table: see text]
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