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Cancer Research and Treatment > Accepted Articles
doi: https://doi.org/10.4143/crt.2022.883    [Accepted]
Real-World Study Evaluating Safety and Effectiveness of Axitinib in Korean Patients with Renal Cell Carcinoma after Failure of One Prior Systemic Therapy
Sang Joon Shin1 , Jae Lyun Lee2, Tae Gyun Kwon3, Byoung Young Shim4, Ho Seok Chung5, Sang-Hee Kim6, Se Hoon Park7
1Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea
2Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
3Department of Urology, School of Medicine Kyungpook National University, Daegu, Korea
4Department of Medical Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
5Department of Urology, Chonnam National University Medical School, Gwangju, Korea
6Oncology Medical Affair, Pfizer Pharmaceuticals Korea Ltd., Seoul, Korea
7Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
Correspondence  Se Hoon Park ,Tel: 82-2-3410-1767, Fax: 82-2-3410-1754, Email: hematoma@skku.edu
Received: July 21, 2022;  Accepted: November 26, 2022.  Published online: November 28, 2022.
ABSTRACT
Purpose
This post-marketing surveillance (PMS)study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world.
Materials and Methods
In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected.
Results
Between 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed. Median age was 65 years (range: 30 to 84), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range: 4.36-15.95 mg) with a median administration period of 5.6 months (range: 15-750 days). 83% of patients experienced any grade of adverse events, 71% of which were related to study treatment, including diarrhea (36%), hypertension (21%), stomatitis (17%), decreased appetite (14%), palmar-plantar erythrodysesthesia syndrome (12%), and asthenia (11%). Most adverse events were generally well tolerated and manageable, with 13% of grade >3. Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival (PFS) was 12.4 months [95% CI: 9.6, 18.9]. Objective responses were observed in 30% of patients (95% CI: 21 to 39) with 4% of complete response and 26% of partial response.
Conclusion
No new safety signal was found in the present PMS study of Korean RCC patients. Axitinib showed consistent outcomes in terms of effectiveness and safety confirming that the drug is a valid option for second-line therapy in patients with advanced RCC in a real-world setting.
Key words: Carcinoma, Renal Cell, Axitinib, Post marketing surveillance
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