Background The objective of this case cohort study was to describe our experience in the care of patients with immune checkpoint inhibitor-related acute interstitial nephritis (ICI-AIN) including rechallenge. Methods A descriptive case series of patients that received an ICI and had an AKI (defined as a $1.5-fold increase in serum creatinine) as an immune-related adverse event (irAE), with biopsy-proven or clinically suspected ICI-AIN from January 1, 2014 to December 1, 2018 at Mayo Clinic, Rochester. We studied details regarding diagnosis, clinical course, management, and outcomes of rechallenge of immunotherapy. Complete response (CR) was defined as return of kidney function back to baseline or ,0.3 mg/dl above baseline creatinine; partial response (PR) was defined as creatinine .0.3 mg/dl from baseline, but less than twofold above the baseline by the end of steroid course. Results A total of 14 cases of biopsy-proven (35%) or clinically suspected (65%) ICI-AIN was identified. All patients had their ICI withheld and 12 patients received steroids. Steroid regimens were highly variable. The starting equivalent dose of prednisone was higher in those that had a CR versus a PR (median 0.77 mg/kg versus 0.66 mg/kg). Proton pump inhibitors (PPIs) were used in 11 patients and were stopped in eight (73%) patients at the time of the AKI event. A CR was seen in five (63%) of the eight patients who discontinued PPIs. Rechallenge was attempted in four of the 14 patients: three were successful with no recurrence of AKI, but one patient had recurrent AKI and fatal pneumonitis. Conclusions Careful review, withholding ICI and concomitant known AIN-inducing medications, along with prompt initial steroid management were the key in complete renal kidney recovery. A kidney biopsy should be strongly considered. Rechallenge of immunotherapy after a kidney irAE, although challenging, is possible and would need careful evaluation on an individual basis.
BackgroundThe impact of using adjuvant chemotherapy following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with appendiceal adenocarcinoma is not known. The aim of this study was to assess the impact of adjuvant chemotherapy following complete cytoreduction in patients with appendiceal adenocarcinoma.MethodsRetrospective medical record review of all patients with appendiceal adenocarcinoma treated at our institution between 2006 and 2015. Kaplan‐Meier plots were used to summarize overall survival (OS) and relapse‐free survival over time, and log‐rank tests and Cox proportional hazards models were used to test for differences in survival between groups.ResultsA total of 103 patients with appendiceal adenocarcinoma received care at our institution during the study period. Complete cytoreduction (cytoreductive score 0‐1) was achieved in 68 patients (66%). Of these 68 patients, 26 received adjuvant chemotherapy. The most common regimens were capecitabine (n = 11), capecitabine plus oxaliplatin (n = 7), and 5‐FU plus oxaliplatin (n = 6). Tumor histopathology and grade, and the ability to achieve complete cytoreduction were significant predictors of overall survival. The median OS for non–low‐grade and well‐differentiated tumor patients who received adjuvant chemotherapy following complete cytoreduction was 9.03 years, compared to 2.88 years for patients who did not receive adjuvant chemotherapy (P = .02). Among low‐grade and well‐differentiated tumor patients who underwent complete cytoreduction, there was no statistically significant difference in OS between those who received adjuvant chemotherapy and those who did not.ConclusionAdjuvant chemotherapy seems to have benefit in appendiceal cancer patients with non–low‐grade or well‐differentiated tumor type but not in low‐grade or well‐differentiated tumors.
BACKGROUND: Clinical practice guidelines (CPGs) are evidence-based guidelines that serve as a standard of care in oncology practice, reimbursements, and quality improvement initiatives. To our knowledge, the extent of financial conflicts of interest (FCOIs) in National Comprehensive Cancer Network (NCCN) guidelines have not been systemically evaluated. The current study evaluated the extent of FCOIs in the NCCN CPGs for the most common malignancies in the United States. METHODS: The authors examined the latest 2019 versions of the NCCN CPGs for the 10 most common cancers by incidence in the United States. Using disclosure lists, they catalogued the FCOIs for the panelists under various categories outlined in the CPG. The authors also tabulated the companies and institutions involved in each panel disclosure. An "episode" describes 1 instance of participation of a panelist in 1 company in 1 category of each guideline. "Affiliation" describes an industrial, commercial, or institutional affiliation reported by a panelist in each episode. RESULTS: Of the 491 panelists on the CPG panel, 483 (98.3%) completed FCOI disclosures. A total of 224 (46.4%) reported at least 1 FCOI episode. A total of 1103 episodes were disclosed with an average of 4.9 episodes reported per panelist with FCOIs. Acting as part of scientific advisory boards, as a consultant, or as an expert witness was the most common FCOI category (19.9%). A total of 191 companies were associated with 1103 episodes of FCOI. The top companies were Bristol-Myers Squibb, Merck, Genentech, and AstraZeneca. Among cancers, the prevalence of FCOIs was highest for lung cancer (56%), bladder cancer (52%), pancreatic cancer (52%), non-Hodgkin lymphoma (50%), kidney cancer (49%), colorectal cancer (43%), breast cancer (42%), melanoma (40%), prostate cancer (38%), and uterine cancer (32%). Among the panelists with FCOIs, 26%, 17%, and 57%, respectively, reported 1, 2, and >3 episodes. There were 127 episodes noted among the CPG chairs and/or vice chairs who reported FCOIs (mean, 6.4 episodes). The chairs and/or vice chairs of CPGs for uterine cancer, pancreatic cancer, melanoma, and prostate cancer were not found to have any FCOIs. CONCLUSIONS: FCOIs are very prevalent among NCCN CPG panelists. In nearly one-half of the CPGs, the majority of the panelists had at least 1 FCOI. Greater than one-half of the CPG chairs and/or vice chairs reported multiple FCOIs. Further research studies are necessary to determine the impact of these FCOIs.
e13573 Background: UpToDate is an evidence based clinical resource designed to provide current clinical information. It is a widely used clinical practice tool providing evidenced based recommendations for diagnosis, management, and therapy. The extent of COI among the UpToDate authors has not been well studied. Our study evaluated the extent of COI of UpToDate authors involved in medical management recommendations for the 10 most common cancers in United States. Methods: We examined the latest November 2020 version of the UpToDate clinical management recommendations for 10 most common cancers. Using disclosure lists, we catalogued COIs for participants in each work group. The categories included: Category I- Grant/Research/Clinical Trial Support; Category II- Consultant/Scientific Advisory Boards/Expert witness; Category III- Speakers Bureau; Category IV- Equity Ownership/Stock Options/Patent holder/Employment/Other Financial Interest; and Category V- Spouse/Domestic Partner/Dependent Potential Conflict. We cataloged the companies/institutions involved in each disclosure. An “episode” describes 1 instance of participation of an individual in 1 company in 1 category for each cancer section. Results: There was a total of 207 authors including section and deputy editors of oncology management section. All authors completed their COI disclosures (100%). 128 (62%) of a total of 207 individuals reported COIs. A total of 1343 episodes were disclosed. We found that each author had an average of 10.49 episodes overall. Authors involved in Category I, II, III, IV & V were 6.3%, 13.5%, 3.2%, 4.7% and 1.6% respectively. 29.36% authors were involved both in Category I and II. A total of 672 company affiliations were associated with COI disclosure. AstraZeneca (6.10%), Merck (4.31%) and Novartis (2.68%) were the companies most frequently reported. The guideline with the maximum episodes (223) was prostate cancer. Conclusions: COIs are prevalent among authors of UpToDate clinical management recommendations. More than ½ of the participants disclosed at least 1 COI, but there appears to be a substantial number of experienced experts without COIs. Further research studies are necessary to determine the impact of these COIs on clinical practice patterns and resource utilization. Distribution of COI and total episodes.[Table: see text]
Introduction There is ongoing controversy concerning the potential influence of industry and financial conflict of interest (FCOI) in the development of clinical practice guidelines (CPG). The influence of industry in renal guideline development has been discussed in the past with emphasis on the National Kidney foundation (NKF) and Kidney and Dialysis Outcomes Quality Initiative guidelines. In this study we evaluate the self-reported FCOI among guideline panel members in Kidney Disease: Improving Global Outcomes (KDIGO) CPGs. Methods We examined 10 of the most recent KDIGO CPGs developed between 2009 and 2018. Using disclosure lists, we catalogued FCOIs for panelists for each individual CPG. The categories were Advisor/Consultant, Honoraria, Travel Stipend, Grant/Research Support, Speaker, Equity Interest, Employee, Board of Trustees, Royalties, Advisory Board, Employment, Ownership, Data Monitoring Committee, Expert Testimony, and Development of Education Materials. We also reviewed FCOIs for members of evidence review team (ERT). We also catalogued the company involved in each disclosure. One conflict describes 1 instance of participation of an individual in 1 category in each guideline. “Company” describes a commercial, industry, or institute affiliation reported in each episode. Results One hundred two (66.4%) of the total 151 panelists reported FCOI. A total of 662 conflicts were disclosed. Being a consultant or advisor was the most common category. One hundred fifty-one companies were associated with FCOI disclosure. One company was most frequently reported, involving 60 (9%) of 662 conflicts. Of the 52 members in the ERT, there was 1 instance of FCOI. Conclusion FCOI is prevalent in KDIGO guidelines with almost two thirds of the panelists self-reporting FCOI. The evidence review team had only 1 instance of FCOI.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
customersupport@researchsolutions.com
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.