科研之友
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摘要
This article is an original meta-analysis based on 14 published or presented phase III trials. The aim was to explore whether different adjuvant treatment-approaches (cytokines [CK], vaccines [VAX], or other) may differentially influence patients%26apos; outcomes in surgically resected renal cell carcinoma (RCC). This may have implications with regard to the relative impact of the mechanisms of action, given the awaited results of the currently ongoing trials with targeted agents. With this perspective, a sensitivity analysis was conducted to determine whether significant %26quot;qualitative%26quot; or %26quot;quantitative%26quot; interaction exist according to different strategies. Although the limitations of such approach, the encountered heterogeneity and data not reaching statistical significance, an effect in favor of 5-year relapse-free survival (RFS) in the qualitative interaction between different adjuvant treatment strategies (particularly between VAX and CK or other types of treatment) was observed, suggesting that the nature of the therapeutic intervention itself may impact outcome. %26lt;br%26gt;Background: Although data from ongoing trials with targeted agents are awaited, we used a meta-analytical approach to explore whether cytokines (CK), vaccines (VAX), or other therapies may differentially influence patients%26apos; outcomes. Materials and Methods: The objective was to determine whether significant interactions exist according to treatment (CK vs. VAX vs. other), in the context of a literature-based meta-analysis. Fourteen trials (3380 patients) were identified, with 10 randomized clinical trials (RCTs) (2257 patients) providing data for the primary outcome-5-year relapse-free survival (RFS). The primary selected end point was 5-year RFS; secondary end points were 5- and 2-year overall survival (OS) and 2-year RFS. Event-based relative risk (RR) ratios with 95% confidence intervals (CI) were extracted and cumulated according to a random-effect model from articles/presentations. Testing for heterogeneity was performed as well. Results: Although not statistically significant, an effect in favor of a qualitative interaction according to treatment was found for 5-year RFS, with a likely detrimental effect in CK (P = .42) in contrast to that found in VAX subpopulation (P = .76). For the secondary end points, a similar effect in favor of a quantitative significant interaction according to treatment was found for 5-year OS, regardless of the approach adopted, with a different magnitude of treatment effect. In addition, a borderline significant (P = .05) detrimental effect in terms of 2-year OS against the use of adjuvant treatment was determined in the CK subpopulation (RR, 1.24; 95% CI, 0.99, 1.54). Conclusion: The effect in favor of a qualitative interaction according to the adopted strategy is intriguing and suggests potential implications for trial design with targeted agents.
- 出版日期2013-12
