Background Randomized controlled trials (RCTs) have stringent inclusion criteria and may not fully represent patients seen in everyday clinical practice. Real-world data (RWD) can provide supportive evidence for the effectiveness of medical interventions in more heterogeneous populations than RCTs. Sunitinib is a widely used first-line treatment for patients with metastatic renal cell carcinoma (mRCC). Objective This is the first comprehensive meta-analysis to evaluate the efficacy of sunitinib using the novel approach of combining RCTs and RWD. Methods RCTs and RWD studies published between 2000 and 2017 were identified from PubMed, Ovid, MEDLINE, and EMBASE. Eligible studies contained a cohort of ≥ 50 adult patients with mRCC receiving first-line sunitinib treatment. The meta-analysis combined RWD and RCT treatment groups, adjusting for data type (RCT or RWD). Recorded outcomes were median progression-free survival (mPFS), median overall survival (mOS), and objective response rate (ORR). Publication bias was assessed via review of funnel plots for each outcome measure. A random effects model to account for study heterogeneity was applied to each endpoint. Sensitivity analyses evaluated the robustness of the overall estimates. Results Of the 3611 studies identified through medical database searches, 22 (15 RWD studies, 7 RCTs) met eligibility criteria and were analyzed. mPFS (18 studies), mOS (19 studies), and ORR (15 studies) were reported for aggregate measures based on 4815, 5321, and 4183 patients, respectively. Reported mPFS (RWD, 7.5-11.0 months; RCTs, 5.6-15.1 months) and ORR data (RWD, 14.0-34.6%; RCTs, 18.8-46.9%) were consistent with the overall confidence estimates (95% confidence interval [CI]) of 9.3 (8.6-10.2) months and 27.9% (24.2-32.0), respectively. Reported mOS showed greater variation in RWD (6.8-33.2 months) compared with RCTs (21.8-31.5 months), with an overall confidence estimate (95% CI) of 23.0 (19.2-27.6) months. Inspection of funnel plots and sensitivity analyses indicated that there was no publication bias for any efficacy endpoint. Sensitivity analyses showed no evidence of lack of robustness for mPFS, mOS, or ORR. Interpretation of these results is limited by differences in trial design, cohort characteristics, and missing data. Conclusions This novel, comprehensive meta-analysis validates sunitinib as an effective first-line treatment for patients with mRCC in both RCTs and everyday clinical practice. The methodology provides a framework for future analyses combining data from RCTs and RWD.

650 Background: Randomized controlled trials (RCTs) are the basis of approval for medical interventions, but may not fully reflect populations seen in clinical practice. Sunitinib is a widely used 1st-line treatment for patients (pts) with metastatic renal cell carcinoma (mRCC). This is the first large-scale meta-analysis to evaluate the efficacy of sunitinib using the novel approach of combining RCTs and real-world data (RWD). Methods: PubMed, Ovid, MEDLINE and EMBASE were searched from 2000-2017 for RCTs and RWD studies of sunitinib as 1st-line treatment in pts with mRCC. Eligible studies contained a cohort of ≥50 adult pts per study arm. The meta-analysis combined RWD and RCT study arms, adjusting for data type (RCT or RWD). Recorded outcomes were: median progression-free survival (mPFS), median overall survival (mOS) and objective response rate (ORR). A random effects model to account for study heterogeneity was applied to each endpoint. Sensitivity analyses evaluated the robustness of the overall estimate. Results: Of the studies that met eligibility criteria, mPFS, mOS and ORR were reported by 18, 19 and 15 studies, respectively. Combined RWD and RCT analyses are presented in the Table. Reported mPFS (RWD, 7.5–11.0; RCTs, 5.6–15.1 months) and ORR data (RWD, 14.0–34.6%; RCTs, 18.8–46.9%) were consistent with the overall estimates. Reported mOS showed greater variation in RWD (6.8–33.2 months) compared with RCTs (21.8–31.5 months). Sensitivity analyses showed no evidence of lack of robustness for mPFS, mOS or ORR. Interpretation of these results is limited by differences in trial design and cohort characteristics. Conclusions: This novel, large-scale meta-analysis validates sunitinib as an effective 1st-line treatment for pts with mRCC in both RCTs and everyday clinical practice. [Table: see text]

Aim: To evaluate how efficacy outcomes from real-world data (RWD) can support those from randomized controlled trials (RCTs), in the context of first-line tyrosine kinase inhibitor treatment of metastatic renal cell carcinoma. Patients & methods: PubMed, Ovid, MEDLINE and EMBASE were searched for RCTs and RWD studies with ≥50 adult patients per arm published in 2000–2017. Outcome measures were median progression-free survival, median overall survival and objective response rate. Results: A total of 13 RCTs and 22 RWD studies met eligibility criteria; 31, 28 and 25 studies, respectively, reported median progression-free survival, median overall survival and objective response rate. Summary outcome measures were similar in RWD and RCTs. Conclusion: RWD validates efficacy-based outcomes from RCTs and may provide supportive evidence to inform clinical decisions.

Letters display parametersof the monitor arethe limit imageswere reviewedat the workstationand 50 different images were reviewed on hard copy by sevenphysicians,only three of whom were board-certified radiologists. Gillard have not addressed is the problem of older comparisonfilms when reviewingtheir inpatients onthemonitor.On the basisof our experience,we disagree with Drs. Harrison and Gillard's findings. We will proceed toward our goal but do so by im proving the monitor qualities to match those of filmed images.The Fuji quality assurance workstationsare helpful but should not be usedasthefinal interpretation station.