Abstract NTOC-104: BEYOND RECIST1.1 : THE NEED FOR ALTERNATIVE DISEASE MEASUREMENT CRITERIA FOR CLINICAL TRIALS IN OVARIAN CANCER

BACKGROUND AND PURPOSE: The majority of ovarian cancer patients respond initially to platinum combination chemo therapy, however at least 70% will relapse and eventually die from recurrent platinum-resistant disease. Thus upon relapse, there is a high degree of interest in participation in clinical trials of novel treatments. However, the pattern of presentation of recurrent disease skews toward “non-measurable” by RECIST solid tumor response criteria, with a majority of patients presenting with diffuse, non-nodular disease and hence being excluded from participating in most trials. Yet these excluded patients may be the ones who would see most benefit from the tested drugs since drug efficacy would not be confounded with issues of penetration into bulky tumors. In addition, in cases where patients present with apparently isolated tumors that are amenable to measurement, the patient is currently forced to choose between surgical excision of the tumor, which retrospective studies suggest extends survival in appropriately selected cases, and keeping the tumor as measurable disease required for entry into a clinical trial. Finally, the current rapid development of targeted therapies, immunotherapies, and combinations means there are potentially many more trial opportunities than can be filled by the relatively small number of ovarian cancer patients, potentially slowing the translation from preclinical findings to actual patient treatment. Here we review the salient facts demonstrating the need for greater clinical trial access for patients with non-RECIST tumor presentation, issues of measuring tumor response, as well as some potential solutions. METHODS: We used a literature search and an online patient survey to assess the impact that the RECIST requirements have on clinical trial participation by ovarian cancer patients. We also reviewed the literature for potential alternative approaches to tumor assessment that would be novel to either solid tumor trials as a whole or ovarian cancer specifically. CONCLUSIONS: Expanding clinical trial access to ovarian cancer patients whose tumors do not meet RECIST requirements should accelerate progress in a way that benefits all stakeholders: patients, pharmaceutical companies, and researchers. Viable alternatives exist and more are under development. Ovarian cancer patients are eager to see these put into practice and are willing to help move this effort forward by participating in relevant validation trials. Adapting clinical trial structure and response criteria to accommodate non-measurable disease in ovarian cancer should be a high priority. Citation Format: Shirley Pepke and Trudy Rucker. BEYOND RECIST1.1 : THE NEED FOR ALTERNATIVE DISEASE MEASUREMENT CRITERIA FOR CLINICAL TRIALS IN OVARIAN CANCER [abstract]. In: Proceedings of the 11th Biennial Ovarian Cancer Research Symposium; Sep 12-13, 2016; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2017;23(11 Suppl):Abstract nr NTOC-104.