Internet based second opinion pathology in a large chemotherapy trial for ovarian cancer – results of a standardized review process

Background: It has been suggested that specialized pathology review prior to randomization should become standard procedure in study protocols, because a considerable number of patients in clinical trials of ovarian carcinoma may have histopathological diagnoses in conflict with inclusion criteria. We hypothesized that our new, internet-based high throughput infrastructure would be capable of providing specialized second opinion pathology within 10 days.

Design: Patients scheduled for the AGO OVAR17 ovarian carcinoma chemotherapy trial were registered for expert pathologic case review prior to randomization. All original slides were requested from local pathologist, scanned and uploaded to a secured internet server. Five pathologists specialized in gynecologic pathology from Austria, Switzerland and Germany were available online. If necessary, immunohistochemistry was available through a collaborating pathology lab.

Results: 880 patients with an original diagnosis of ovarian epithelial carcinoma were registered through our internet platform for second opinion pathology review from 10/2011 – 07/2013. In 2.5% (n = 22) of cases, a major diagnostic discrepancy of potential clinical relevance was found leading to exclusion from the chemotherapy trial. Ovarian borderline tumors and ovarian metastasis were the leading discrepant diagnosis. The average time from patient registration until completion of pathology review was 5.2 days.

Conclusion: Our results show that the use of a new internet-based infrastructure makes specialized case review prior to patient randomization feasible within less than 10 working days. Our new approach might further improve quality of patient care through minimization of overtreatment, especially of patients with ovarian borderline tumors and inadequate treatment of patients with ovarian metastases.