1臺北榮民總醫院 泌尿部；2國立陽明大學醫學院 醫學系泌尿科暨書田泌尿科學研究中心；3 國立臺灣大學醫學系藥學專業學院 藥學系暨臨床藥學研究所；4國立臺灣大學附設醫院 藥劑部，5內科部血液腫瘤科；6法商益普生股份有限公司；7艾昆緯藥品資訊股份有限公司
Hsiao-Jen Chung*1,2, Yen-Hwa Chang1,2, Yi-Hsiu Huang1,2, Tzu-Ping Lin1,2, Tzu-Chun Wei1,2, Fang-Ju Lin3,4, Huai-Hsuan Huang5, Hui-Chuan Wang6, Kai-Pei Chou7, Hung-Wei Lin7
Management of Adverse Events in Patients with Metastatic Renal Cell Carcinoma Receiving Second-line Targeted Therapy: Real-World Experience in Taiwan
1Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan; 2Department of Urology, School of Medicine, Shu-Tien Urological Institute, National Yang-Ming University, Taipei, Taiwan; 3Graduate Institute of Clinical Pharmacy & School of Pharmacy, College of Medicine, National Taiwan University, Taipei, Taiwan; 4Department of Pharmacy and 5Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan; 6Ipsen Pharma Taiwan Branch, Taipei, Taiwan, 7IQVIA Solutions Taiwan Ltd., Taipei, Taiwan
Targeted therapies, such as VEGFR or m-TOR inhibitors, have been reimbursed by Taiwan’s National Health Insurance payment scheme for metastatic renal cell carcinoma (mRCC) treatment in recent years. The safety of targeted therapy is an important issue and the occurrence of adverse events (AEs) might have a negative impact on patients’ burden and quality of life. The study aimed to understand the occurrence and the management of AEs among mRCC patients who received second-line (2L) targeted therapy.
A retrospective chart review study was conducted in the two largest public medical centers in northern Taiwan. Patients with mRCC who received targeted therapies for both first-line (1L) and 2L treatment from June 2013 to December 2017 were identified. Patients were followed up until discontinuation of targeted therapies. Occurrence of targeted therapy-related AEs and their management were analyzed. The list of AEs to be identified were based on clinical trials; the relationship between AEs and the targeted therapy were assessed based on the records on the chart.
A total of 27 eligible mRCC patients were included; the mean age was 63.1 years and 81.5% were male. Twenty-three patients (85.2%) received everolimus as the 2L treatment and four patients (14.8%) received axitinib. During the follow-up period, 10 treatment-related AEs were reported, and all of them occurred in the everolimus users. Two of the AEs led to hospitalization, including one for renal failure and the other for interstitial pneumonitis. The average hospital length of stay were 44 days and 17 days, respectively. Both events resulted in discontinuation of everolimus. The AEs identified and managed in the outpatient setting were hypertension (n=5), and hand-foot syndrome (n=2) which on average resulted in 1.2 and 9 outpatient visits, respectively. In addition, the dose of everolimus was reduced in one case due to hyperglycemia.
Based on the experience of two medical centers, most AEs of 2L mRCC targeted therapy were manageable. Only a few treatment-related AEs resulted in discontinuation, dose reduction of targeted therapy or hospitalization. The safety of targeted therapy for mRCC should be closely monitored in clinical practice.