Author(s)
Chung JS1, Hong SH2, Chung HS3, Seo IY4, Kwon TG5, Jeong H6, Chung JI7, Jeon SH8, Park JY9, Ha H10, Chung BH11, Song W12, Kim YJ13, Kim SH14, Lee JS14
1National Cancer Center, Gyeonggi, Korea, Republic of (South), 2The Catholic University of Korea Seoul St. Mary's Hospital, Seoul, Korea, Republic of (South), 3Chonnam National University Hospital, Hwasun, Korea, Republic of (South), 4Wonkwang University Hospital, Iksan, Korea, Republic of (South), 5Kyungpook National University Chil-gok Hospital, Dae-gu, Korea, Republic of (South), 6Seoul National University, Seoul, Korea, Republic of (South), 7Inje University Busan Paik Hospital, Busan, Korea, Republic of (South), 8KyungHee University Hospital, Seoul, Korea, Republic of (South), 9Korea University Ansan Hospital, Gyeonggi, Korea, Republic of (South), 10Pusan National University Hospital, Busan, Korea, Republic of (South), 11Gangnam Severance Hospital, Seoul, Korea, Republic of (South), 12Ewha Womans University Mokdong Hospital, Seoul, Korea, Republic of (South), 13Pfizer Pharmaceuticals Korea Ltd., seoul, South Korea, 14Pfizer Pharmaceuticals Korea Ltd., Seoul, Korea, Republic of (South)
OBJECTIVES: This aimed to describe AEs of advanced RCC patients treated with targeted therapies in real world setting in Korea. METHODS: Data for this analysis was derived from an outcomes research on advanced RCC patients, which was a nationwide, multi-centered, and 1 year-prospective observational study conducted from Oct 2016~Oct 2019 at 12 hospitals. Advanced RCC patients aged≥19 years, treated with 1st – line targeted therapy, newly experiencing one of the AEs(fatigue, hand-foot syndrome, mucosal inflammation, diarrhea, gastro-intestinal symptoms, hypertension, and anorexia), and taught for self-management of AEs from a medical team were enrolled. Patients who were hospitalized, treated with immunotherapy or other systemic chemotherapy were excluded. During the 1year observation period, data were collected at baseline, 6month, and 12month. RESULTS: Total 77patients(aged mean 62 years, 73% male) were enrolled, then 47 and 60 patients were followed-up at 6 and 12month, respectively. At baseline, 96% patients were clear cell RCC, 65% metastasized to lung, 100% were ≤1 Eastern Cooperative Oncology Group Performance Status(ECOG), 40% had a cancer operation, and 8% experienced radiotherapy. At Baseline of this study, 82% patients remained in stable disease(SD), 8% had partial response(PR), and 9% achieved complete responses(CR). During the study, response rates to the therapy were 60% SD, 34% PR, and 6% CR at 6month and 40% SD, 40% PR, and 15% CR at 12month. As to AEs, total 216 cases of AEs were reported at baseline and 15 new cases were presented during 1year. Fatigue(23.1%) was the most frequent followed by anorexia(14.8%) and diarrhea(13.0%). A greater part of occurred AEs(82%) were grade 1 or 2. 18% of cases were grade 3 and no AE was grade 4. CONCLUSIONS:AEs occurring while treating with the targeted therapy in real world practice were observed as manageable in this study. Self-managements of those AEs are required for better health-outcomes.
