Dataset Information

Adjuvant Antiangiogenic Agents in Post-nephrectomy Renal Cell Carcinoma: A Systematic Review and Meta-analysis.

ABSTRACT: Context:The role of antiangiogenic agents in advanced renal cell carcinoma (RCC) is well established. However, it is still not clear whether this benefit can be extrapolated to the adjuvant setting. Objective:To determine the efficacy and safety of antiangiogenic agents in patients with RCC and a high risk of relapse after nephrectomy. Evidence acquisition:We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) evaluating the use of any oral antiangiogenic agent compared to placebo in post-nephrectomy RCC patients. Prespecified data elements were extracted from each trial. Outcomes of interest included overall survival (OS) and disease-free survival (DFS). The overall effect was pooled using the DerSimonian and Laird random-effects models. Evidence synthesis:Three RCTs comparing antiangiogenics to placebo among 3693 patients met our inclusion criteria and were used in meta-analyses. Overall, antiangiogenics did not improve DFS (hazard ratio [HR] 0.92, 95% confidence interval [CI] 0.78-1.07) or OS (HR 0.99, 95% CI 0.79-1.25). These results persisted when restricting the analysis to patients with clear cell carcinoma and patients with highest risk of relapse. Similarly, sunitinib did not show any improvement in the entire cohort for either DFS (HR 0.89, 95% CI 0.67-1.19) or OS (HR 1.11, 95% CI 0.90-1.37). Conclusions:In this meta-analysis, antiangiogenics did not improve OS and DFS over placebo in high-risk RCC after nephrectomy. Further studies are needed to identify the patient population that might derive a benefit from antiangiogenics in the adjuvant setting. Patient summary:In this article, we found that there is currently insufficient evidence to support the use of oral antiangiogenics in nonmetastatic renal cell carcinoma after nephrectomy. In addition, the use of oral antiangiogenics was associated with a 2.7-fold higher rate of significant side effects compared to placebo.

SUBMITTER: Sonbol MB

PROVIDER: S-EPMC6192050 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Adjuvant Antiangiogenic Agents in Post-nephrectomy Renal Cell Carcinoma: A Systematic Review and Meta-analysis.

Sonbol Mohamad B MB Firwana Belal B Hilal Talal T Wang Zhen Z Almader-Douglas Diana D Joseph Richard W RW Ho Thai H TH

European urology oncology 20180315 2

<h4>Context</h4>The role of antiangiogenic agents in advanced renal cell carcinoma (RCC) is well established. However, it is still not clear whether this benefit can be extrapolated to the adjuvant setting.<h4>Objective</h4>To determine the efficacy and safety of antiangiogenic agents in patients with RCC and a high risk of relapse after nephrectomy.<h4>Evidence acquisition</h4>We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RC ...[more]

PMID: 30345423

Similar Datasets

Project description:Introduction: Cryoablation has been considered as the most efficacious ablative alternative to partial nephrectomy (PN) for selected patients. Our objective is to assess the existing evidence relating to the safety and efficacy of cryoablation compared with PN for clinical T1 renal masses. Materials and Methods: A comprehensive search of PMC, EMBASE, and the Cochrane Library was conducted to identify studies containing comparison of cryoablation and PN. By utilizing those included studies, a systematic review and cumulative meta-analyses were performed to assess the safety and efficacy between cryoablation and PN for T1 renal masses. Results: 17 retrospective studies providing available data were included in our study. Significant differences were found about all oncological variables including all-cause death, cancer-specific death, metastasis and local-recurrence (p < 0.001, p = 0.03, p < 0.001, and p < 0.001, respectively) between the PN group and the cryoablation group. The mean difference between two groups for percent estimated glomerular filtration rate decrease and creatinine increase was -4.84 and 0.15 respectively (p < 0.001 and p = 0.006, respectively). The incidences of overall and postoperative complications in the PN group were significantly higher than that in the cryoablation group (p = 0.001 and p < 0.001, respectively), but the result about intraoperative complications didn't show a significant difference between the two groups (p = 0.53). Conclusions: Comparing with PN, cryoablation for clinical T1 renal tumors is associated with poorer oncological outcomes, but the existing disadvantages are accompanied by lower rate of overall and postoperative complications and superior renal functional preservation. For patients with imperative indications for nephron-sparing surgery who can't risk more invasive PN, cryoablation could be an attractive option. Owing to the inherent limitations of eligible studies, conclusions drawn from our meta-analyses should be interpreted cautiously and be confirmed further with well-designed randomized controlled trials with extensive follow-up length.

Project description:Objective: The purpose of this meta-analysis was to systematically assess the influence of three-dimensional (3D) printing technology in laparoscopic partial nephrectomy (LPN) of complex renal tumors. Methods: A systematic literature review was performed in June 2020 using the Web of Science, PubMed, Embase, the Cochrane library, the China National Knowledge Infrastructure (CNKI), and the Wanfang Databases to identify relevant studies. The data relative to operation time, warm ischemic time, intraoperative blood loss, positive surgical margin, reduction in estimated glomerular filtration rate (eGFR), and complications (including artery embolization, hematoma, urinary fistula, transfusion, hematuria, intraoperative bleeding, and fever) were extracted. Two reviewers independently assessed the quality of all included studies, and the eligible studies were included and analyzed using the Stata 12.1 software. A subgroup analysis was performed stratifying patients according to the complexity of the tumor and surgery type or to the nephrometry score. Results: One randomized controlled trial (RCT), two prospective controlled studies (PCS), and seven retrospective comparative studies (RCS) were analyzed, involving a total of 647 patients. Our meta-analysis showed that there were significant differences in operation time, warm ischemic time, intraoperative blood loss, reduction in eGFR, and complications between the LPN with 3D-preoperative assessment (LPN-3DPA) vs. LPN with conventional 2D preoperative assessment (LPN-C2DPA) groups. Positive surgical margin did not differ significantly. Conclusion: The LPN-3DPA group showed shorter operation time and warm ischemic time, as well as less intraoperative blood loss, reduction in eGFR, fewer complications for patients with complex renal tumor. Therefore, LPN assisted by three-dimensional printing technology should be a preferable treatment of complex renal tumor when compared with conventional LPN. However, further large-scale RCTs are needed in the future to confirm these findings.

Project description:ImportanceGirentuximab is a chimeric monoclonal antibody that binds carbonic anhydrase IX, a cell surface glycoprotein ubiquitously expressed in clear cell renal cell carcinoma (ccRCC). Its safety and activity in phase 2 studies prompted investigation into its use as adjuvant monotherapy in participants with high-risk ccRCC.ObjectiveTo evaluate the safety and efficacy of adjuvant girentuximab on disease-free survival (DFS) and overall survival (OS) in patients with localized completely resected high-risk ccRCC.Design, setting, and participantsThe ARISER trial (Adjuvant Rencarex Immunotherapy Phase 3 Trial to Study Efficacy in Nonmetastatic RCC) was a randomized, double-blind, placebo-controlled phase 3 clinical trial that took place between June 10, 2004, and April 2, 2013, at 142 academic medical centers in 15 countries in North and South America and Europe. Eligible adult patients had undergone partial or radical nephrectomy for histologically confirmed ccRCC and fell into 1 of the following high-risk groups: pT3/pT4Nx/N0M0 or pTanyN+M0 or pT1b/pT2Nx/N0M0 with nuclear grade 3 or greater. Patients were assigned via central computerized double-blind 1:1 randomization to receive either a single loading dose of girentuximab, 50 mg (week 1), followed by weekly intravenous infusions of girentuximab, 20 mg (weeks 2-24), or placebo, stratified by risk group and region. The data were analyzed from March 31, 2012, to April 2, 2013.Main outcomes and measuresCo-primary end points were DFS and OS, based on imaging studies assessed by independent radiological review committee. Secondary end points included safety, assessed as the rate and grade of adverse events.ResultsA total of 864 patients (66% male; median [interquartile range] age, 58 [51-65] years) were randomized to girentuximab (n = 433) or placebo (n = 431). Compared with placebo, participants treated with girentuximab had no statistically significant DFS (hazard ratio, 0.97; 95% CI, 0.79-1.18) or OS advantage (hazard ratio, 0.99; 95% CI, 0.74-1.32). Median DFS was 71.4 months (interquartile range, 3 months to not reached) for girentuximab and never reached for placebo group. Median OS was never reached regardless of treatment. Drug-related adverse events occurred in 185 patients (21.6%), reported comparably between arms. Serious adverse events occurred in 72 patients (8.4%), reported comparably between arms. One drug-related serious adverse event occurred in a patient receiving placebo.Conclusions and relevanceGirentuximab had no clinical benefit as adjuvant treatment for patients with high-risk ccRCC. The surprisingly long DFS and OS in these patients represent a challenge to adjuvant ccRCC drug development.Trial registrationclinicaltrials.gov Identifier: NCT00087022.

Dataset Information

Adjuvant Antiangiogenic Agents in Post-nephrectomy Renal Cell Carcinoma: A Systematic Review and Meta-analysis.

Publications

Adjuvant Antiangiogenic Agents in Post-nephrectomy Renal Cell Carcinoma: A Systematic Review and Meta-analysis.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets