ABSTRACT
We compared the performance of six prognostic scores (Royal Marsden Hospital, MDACC: MD Anderson Clinical Center and MDACC + NLR: neutrophil-to-lymphocyte ratio, MD Anderson - immune checkpoint inhibitors (MDA-ICI), GRIm: Gustave Roussy Immune Score and LIPI: Lung Immune Prognostic Index) in predicting overall survival (OS) in phase I trial patients treated with immune checkpoint inhibitors (ICI). Medical records of patients with advanced solid tumors enrolled in ICI phase I trials between 2015 and 2018 at Institut Universitaire du Cancer de Toulouse-Oncopole were reviewed. The performance of prognostic scores on OS was compared using different criteria. A total of 259 patients were included. Median age was 63 years (range: 18-83). Main primary cancers were melanoma (19%), head and neck (16%), lung (13%) and bladder (10%). With a median follow-up of 15 months (95% confidence interval [CI] = [11.6;17.5]), median OS was 12.5 months (95% CI = [10.3;16.0]). All scores were associated with OS. The MDACC, LIPI and GRIm scores performed better than the others. Concordance of risk group assignment between the scoring systems was poor. According to our results, the MDACC, GRIm and LIPI scores better suited to ICI phase I settings. Adequate scoring would allow better patient selection in early ICI trials, especially during the critical period of dose escalation, and in proof-of-concept expansion cohorts.
ABSTRACT
The rapid evolution of cancer immunotherapies has increased demand for timely introduction of new therapies and subsequently increased the demand on leading cancer research institutions worldwide. As a leader in cancer therapy research, Roche created the immunotherapy Centers of Research Excellence (imCORE) Network, a worldwide research network designed to more closely connect members in an open environment of shared information, expertise, and decisions. This network is dedicated to increasing the understanding of the underlying science in order to prioritize and accelerate the most promising new treatment options for patients. The network consists of two key pillars, Roche-sponsored clinical trials operational excellence and the imCORE network scientific collaborations. This paper focuses on the Roche-sponsored trial clinical operational excellence aspects of the network. This special contribution introduces the rationale, design, and success factors of sponsored trials within the imCORE Network, including critical components and examples of tangible improvements to clinical trial operations between the company sponsor and the trial sites. Pivotal success factors have included relationship architecture and management, transparent communication channels, open information-sharing, and the development of new processes and tools to overcome historical inefficiencies and challenges of all sizes. The shared dedication of stakeholders to cancer therapy innovation, operational improvement of clinical trials, and a durable, sustainable worldwide research collaborative has made this component of imCORE effective to date. The authors share this experience with the broader research community for the first time, in the same spirit of collective advancement of care for patients with cancer.