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Complications associated with perioperative use of tyrosine kinase inhibitor in cytoreductive nephrectomy.

ABSTRACT: Recent clinical trials have investigated the benefit of combining tyrosine kinase inhibitors (TKIs) and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Our goal is to determine whether the perioperative use of TKIs increases the postoperative morbidity following CN in renal cell carcinoma patients. We identified 627 patients with Stage IV renal cell carcinoma who underwent CN from 2007-2010 utilizing the SEER-Medicare database. Eighty-two patients treated with TKIs were matched (3:1) to 246 controls. We calculated 30- and 90-day incidence rates of postoperative complications and mortality. On unadjusted analysis, TKI use prior to CN was associated with higher overall complication rate within 30 days (HR?=?2.73, 95% CI: 1.09-6.8) after surgery. On multivariate analysis, perioperative TKI use was independently associated with higher risk for postoperative complications within 30 days (HR?=?2.93, 95% CI: 1.17-7.36), as well as 90 days (HR?=?1.84, 95% CI: 1.02-3.32) after nephrectomy. A higher Charlson comorbidity index also emerged to represent an independent risk factor for postoperative complications within 30 days (HR?=?2.41, 95% CI: 1.44-4.02) and 90 days (HR?=?2.23, 95% CI: 1.51-3.29) after nephrectomy. TKI treatment was not associated with an increased postoperative mortality at 30 and 90 days after surgery. Thus, TKI treatment was associated with an increased complication rate but not overall mortality following CN. Our results suggest that renal surgeons should be aware of possibly increased complications following CN in renal cell carcinoma patients, when TKI treatment is administered.

SUBMITTER: Carvalho FLF

PROVIDER: S-EPMC6813342 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Complications associated with perioperative use of tyrosine kinase inhibitor in cytoreductive nephrectomy.

Carvalho Filipe L F FLF Zheng Chaoyi C Witmer Kenneth K O'neill John J Lynch John H JH Kowalczyk Keith J KJ

Scientific reports 20191024 1

Recent clinical trials have investigated the benefit of combining tyrosine kinase inhibitors (TKIs) and cytoreductive nephrectomy (CN) in patients with metastatic renal cell carcinoma. Our goal is to determine whether the perioperative use of TKIs increases the postoperative morbidity following CN in renal cell carcinoma patients. We identified 627 patients with Stage IV renal cell carcinoma who underwent CN from 2007-2010 utilizing the SEER-Medicare database. Eighty-two patients treated with TK ...[more]

PMID: 31649310

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Project description:Background:While living kidney donation is considered safe in healthy individuals, perioperative complications can occur due to several factors. Objective:We explored associations between the incidence of perioperative complications and donor characteristics, surgical technique, and surgeon's experience in a large contemporary cohort of living kidney donors. Design:Living kidney donors enrolled prospectively in a multicenter cohort study with some data collected retrospectively after enrollment was complete (eg, surgeon characteristics). Setting:Living kidney donor centers in Canada (n = 12) and Australia (n = 5). Patients:Living kidney donors who donated between 2004 and 2014 and the surgeons who performed the living kidney donor nephrectomies. Measurements:Operative and hospital discharge medical notes were collected prospectively, with data on perioperative (intraoperative and postoperative) information abstracted from notes after enrollment was complete. Complications were graded using the Clavien-Dindo system and further classified into minor and major. In 2016, surgeons who performed the nephrectomies were invited to fill an online survey on their training and experience. Methods:Multivariable logistic regression models with generalized estimating equations were used to compare perioperative complication rates between different groups of donors. The effect of surgeon characteristics on the complication rate was explored using a similar approach. Poisson regression was used to test rates of overall perioperative complications between high- and low-volume centers. Results:Of the 1421 living kidney donor candidates, 1042 individuals proceeded with donation, where 134 (13% [95% confidence interval (CI): 11%-15%]) experienced 142 perioperative complications (55 intraoperative; 87 postoperative). The most common intraoperative complication was organ injury and the most common postoperative complication was ileus. No donors died in the perioperative period. Most complications were minor (90% of 142 complications [95% CI: 86%-96%]); however, 12 donors (1% of 1042 [95% CI: 1%-2%]) experienced a major complication. No statistically significant differences were observed between donor groups and the rate of complications. A total of 43 of 48 eligible surgeons (90%) completed the online survey. Perioperative complication rates did not vary significantly by surgeon characteristics or by high- versus low-volume centers. Limitations:Operative and discharge reporting is not standardized and varies among surgeons. It is possible that some complications were missed. The online survey for surgeons was completed retrospectively, was based on self-report, and has not been validated. We had adequate statistical power only to detect large effects for factors associated with a higher risk of perioperative complications. Conclusions:This study confirms the safety of living kidney donation as evidenced by the low rate of major perioperative complications. We did not identify any donor or surgeon characteristics associated with a higher risk of perioperative complications. Trial registrations:NCT00319579: A Prospective Study of Living Kidney Donation (https://clinicaltrials.gov/ct2/show/NCT00319579)NCT00936078: Living Kidney Donor Study (https://clinicaltrials.gov/ct2/show/NCT00936078).

Project description:BackgroundSunitinib, a multitargeted tyrosine-kinase inhibitor, which is approved by both US and European Commission regulatory agencies for clinical use, extends survival of patients with metastatic renal-cell carcinoma and gastrointestinal stromal tumours, but concerns have arisen about its cardiac safety. We therefore assessed the cardiovascular risk associated with sunitinib in patients with metastatic gastrointestinal stromal tumours.MethodsWe retrospectively reviewed all cardiovascular events in 75 patients with imatinib-resistant, metastatic, gastrointestinal stromal tumours who had been enrolled in a phase I/II trial investigating the efficacy of sunitinib. The composite cardiovascular endpoint was cardiac death, myocardial infarction, and congestive heart failure. We also examined sunitinib's effects on left ventricular ejection fraction (LVEF) and blood pressure. We investigated potential mechanisms of sunitinib-associated cardiac effects by studies in isolated rat cardiomyocytes and in mice.FindingsEight of 75 (11%) patients given repeating cycles of sunitinib in the phase I/II trial had a cardiovascular event, with congestive heart failure recorded in six of 75 (8%). Ten of 36 (28%) patients treated at the approved sunitinib dose had absolute LVEF reductions in ejection fraction (EF) of at least 10%, and seven of 36 (19%) had LVEF reductions of 15 EF% or more. Sunitinib induced increases in mean systolic and diastolic blood pressure, and 35 of 75 (47%) individuals developed hypertension (>150/100 mm Hg). Congestive heart failure and left ventricular dysfunction generally responded to sunitinib being withheld and institution of medical management. Sunitinib caused mitochondrial injury and cardiomyocyte apoptosis in mice and in cultured rat cardiomyocytes.InterpretationLeft ventricular dysfunction might be due, in part, to direct cardiomyocyte toxicity, exacerbated by hypertension. Patients treated with sunitinib should be closely monitored for hypertension and LVEF reduction, especially those with a history of coronary artery disease or cardiac risk factors.

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Complications associated with perioperative use of tyrosine kinase inhibitor in cytoreductive nephrectomy.

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Complications associated with perioperative use of tyrosine kinase inhibitor in cytoreductive nephrectomy.

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