Elodie Klajer1, Louis Garnier2, Morgan Goujon2, Friederike Schlurmann-Constans3, Benoite Mery4, Thierry Nguyen Tan Hon2, Guillaume Mouillet5, Fabien Calcagno2, Antoine Thiery-Vuillemin6. 1. Department of Medical Oncology, CHRU Jean Minjoz, Besançon cedex, France; Université de Franche-Comté, Besançon cedex, France. Electronic address: elodie.klajer@gmail.com. 2. Department of Medical Oncology, CHRU Jean Minjoz, Besançon cedex, France. 3. Department of Medical Oncology, CHIC Quimper, Quimper, France. 4. Department of Medical Oncology, Lucien Neuwirth Cancer Institute, St Priest en Jarez, France. 5. Department of Medical Oncology, CHRU Jean Minjoz, Besançon cedex, France; Methodology and Quality of Life in Oncology Unit, CHRU Jean Minjoz, Besançon cedex, France. 6. Department of Medical Oncology, CHRU Jean Minjoz, Besançon cedex, France; Université de Franche-Comté, Besançon cedex, France; INSERM, Besançon cedex France.
Abstract
BACKGROUND: Patients with severe renal impairment or undergoing hemodialysis are usually excluded from clinical trials. Available data regarding safety and activity of systemic therapies (ST) in hemodialyzed patients are scarce. METHODS: Clinical data were searched through PubMed database until April 2020 according to PRISMA criteria. Efficacy, safety and pharmacokinetic (PK) assessment of ST were reported. RESULTS: Among 270 references, 56 reports were evaluated in full text: 41 were included for efficacy and 42 for safety analysis (sunitinib n = 68, bevacizumab n = 6, everolimus n = 28, temsirolimus n = 17, sorafenib n = 55, axitinib n = 13, pazopanib n = 13, nivolumab n = 18, cabozantinib n = 0, lenvatinib n = 0, and ipilimumab n = 0). Twelve of the reports included PK assessment among dialyzed patients. Hemodialysis did not seem to modify the expected efficacy and safety of each compound among patients undergoing hemodialysis. PK assessments were not modified in comparison with a population not undergoing dialysis. CONCLUSION: Targeted and Immune therapies seem to be effective and can be used among patients undergoing hemodialysis. Due to frailty and comorbidities associated to chronic hemodialysis enhanced vigilance for these therapies within this specific population is recommended. Dedicated prospective clinical trials would definitely help to obtain data with a higher level of evidence.
BACKGROUND:Patients with severe renal impairment or undergoing hemodialysis are usually excluded from clinical trials. Available data regarding safety and activity of systemic therapies (ST) in hemodialyzed patients are scarce. METHODS: Clinical data were searched through PubMed database until April 2020 according to PRISMA criteria. Efficacy, safety and pharmacokinetic (PK) assessment of ST were reported. RESULTS: Among 270 references, 56 reports were evaluated in full text: 41 were included for efficacy and 42 for safety analysis (sunitinib n = 68, bevacizumab n = 6, everolimus n = 28, temsirolimus n = 17, sorafenib n = 55, axitinib n = 13, pazopanib n = 13, nivolumab n = 18, cabozantinib n = 0, lenvatinib n = 0, and ipilimumab n = 0). Twelve of the reports included PK assessment among dialyzed patients. Hemodialysis did not seem to modify the expected efficacy and safety of each compound among patients undergoing hemodialysis. PK assessments were not modified in comparison with a population not undergoing dialysis. CONCLUSION: Targeted and Immune therapies seem to be effective and can be used among patients undergoing hemodialysis. Due to frailty and comorbidities associated to chronic hemodialysis enhanced vigilance for these therapies within this specific population is recommended. Dedicated prospective clinical trials would definitely help to obtain data with a higher level of evidence.