Assessing neuro-oncology clinical trial impact and value: Testing a novel multi-criteria decision analysis app.

BACKGROUND: Many clinical trials are conducted globally, creating challenges in deciding which trial outcomes deserve a clinician's focus and where to direct limited resources. Determining the 'value' of a clinical trial relative to others could be useful in this context. The aim of this study was to test a novel web-based application using multi-criteria decision analysis (MCDA) to rank clinical trial value. METHODS: The MCDA tool combines seven metrics: unmet need; target population size; access; outcomes; cost; academic impact and use of results. Clinical trials were ranked according to their calculated 'value' - meaning the importance or worth of a trial. We determined face validity of the app using a set of ten published Phase 3 neuro-oncology clinical trials. A survey of neuro-oncology clinicians asked them to rank the same ten clinical trials, and to rank the seven metrics in terms of importance. RESULTS: The two highest app-ranked trials were in concordance with that of the survey respondents, and consistent with the two studies that have had the most impact on routine clinical practice in neuro-oncology. Of the seven metrics, surveyed clinicians considered patient outcomes and unmet need to be the most important when determining clinical trial value. CONCLUSIONS: The metrics app was able to rank and produce a numerical 'value' for existing phase 3 neuro-oncology clinical trials. In the future, a related app to prospectively rank future trials at the startup stage could be developed to help centers determine which should be prioritized to be conducted at their site.

Primary Tumor Resection in Patients With Metastatic Colorectal Cancer Is Associated With Reversal of Systemic Inflammation and Improved Survival.

BACKGROUND: The true survival benefit of noncurative primary tumor resection in patients with de novo metastatic colorectal cancer (mCRC) remains uncertain. The present study examined the effect of primary tumor resection on systemic inflammation and survival in patients with mCRC. MATERIALS AND METHODS: Consecutive patients with de novo mCRC who had undergone primary tumor resection were identified from a prospective database. Patients were excluded if they had undergone resection of metastases, had undergone delayed primary resection, or if blood samples were unavailable. The neutrophil/lymphocyte ratio (NLR) was used as a biomarker of systemic inflammation. Overall survival (OS) was compared between patient groups according to the pre- and postprimary resection NLR. The associations between the reversal of an elevated NLR and primary tumor bulk or performance status were explored. RESULTS: A total of 145 eligible patients were identified from the database, with a median age of 70 years. The baseline NLR was elevated (> 5) in 65 patients, 36 (55%) of whom had a low NLR after surgery. The reversal of an elevated NLR was associated with significantly improved OS (hazard ratio, 0.53; P = .017). A similar benefit was seen after excluding patients undergoing emergency primary resection. NLR reversal was more frequent in patients with larger primary tumors or good performance status. CONCLUSION: The present study is the first to demonstrate a relationship between the reversal of a systemic inflammatory response and the improved survival after primary resection in those with mCRC. A greater effect was seen in patients with large primary tumors. If validated, these observations could guide clinical decision-making in patients with mCRC at presentation.

Comparison between poor and long-term survivors with glioblastoma: review of an Australian dataset.

AIMS: Despite the largely poor prognosis for patients with glioblastoma, 5-year survival approaches 10%. In many circumstances the reasons for discrepant outcomes remain unknown. This retrospective cohort study compared clinical and socio-demographic variables between long-term and poor survivors with glioblastoma. METHODS: Data from patients with glioblastoma diagnosed from 1998-2010 were accessed from two institutions. The cohort was divided into poor (<6 months), average (6-24 months) and long-term (>24 months) survivors. Clinical and socio-demographic variables were compared. RESULTS: In total 529 patients were included; 221 (42%) were poor, 260 (49%) average and 48 (9%) long-term survivors. Those surviving >24 months were younger and significantly more likely to be in a higher socioeconomic status group; be of a better performance status; have a frontal lobe tumor; have a craniotomy (rather than a biopsy); have a macroscopic resection; have two or more operations; and participate in a clinical trial. Country of birth, regional versus city residence and public versus private hospital treatment were not associated with differential survival outcomes. An ordered logistic regression analysis showed that age, performance status, extent of resection and clinical trial participation were independently associated with survival. CONCLUSION: Reassuringly, no statistically significant socio-demographic differences exist when comparing long-term and poor survivors with glioblastoma. Patients surviving more than 2 years were significantly more likely to have participated in a clinical trial. This research could contribute towards informing further research on prognostic variables for patients with glioblastoma.