Real-World Study Evaluating Safety and Effectiveness of Axitinib in Korean Patients with Renal Cell Carcinoma after Failure of One Prior Systemic Therapy.

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.

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.

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.

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.

Cancer research and treatment. 2022 Nov 28 [Epub ahead of print]

Sang Joon Shin, Jae Lyun Lee, Tae Gyun Kwon, Byoung Young Shim, Ho Seok Chung, Sang-Hee Kim, Se Hoon Park

Division of Medical Oncology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea., Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Department of Urology, School of Medicine Kyungpook National University, Daegu, Korea., Department of Medical Oncology, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea., Department of Urology, Chonnam National University Medical School, Gwangju, Korea., Oncology Medical Affair, Pfizer Pharmaceuticals Korea Ltd., Seoul, Korea., Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.