Cancer Research and Treatment

Original Articles

Genitourinary cancer

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 Shin, Jae Lyun Lee, Tae Gyun Kwon, Byoung Young Shim, Ho Seok Chung, Sang-Hee Kim, Se Hoon Park; Cancer Res Treat. 2023;55(2):643-651. Published online November 28, 2022; DOI: https://doi.org/10.4143/crt.2022.883

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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 years), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range, 4.36 to 15.95 mg) with a median administration period of 5.6 months (range, 15 to 750 days). Eighty-three percentage 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 was 12.4 months (95% confidence interval [CI], 9.6 to 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.

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Axitinib

Reactions Weekly.2024; 1991(1): 45. CrossRef

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Selection Criteria for Active Surveillance of Patients with Prostate Cancer in Korea: A Multicenter Analysis of Pathology after Radical Prostatectomy: Chang Wook Jeong, Sung Kyu Hong, Seok Soo Byun, Seong Soo Jeon, Seong Il Seo, Hyun Moo Lee, Hanjong Ahn, Dong Deuk Kwon, Hong Koo Ha, Tae Gyun Kwon, Jae Seung Chung, Cheol Kwak, Hyung Jin Kim; Cancer Res Treat. 2018;50(1):265-274. Published online April 14, 2017; DOI: https://doi.org/10.4143/crt.2016.477

Abstract PDF Supplementary Material PubReader ePub

Purpose
Korean patients with prostate cancer (PC) typically present with a more aggressive disease than patients in Western populations. Consequently, it is unclear if the current criteria for active surveillance (AS) can safely be applied to Korean patients. Therefore, this study was conducted to define appropriate selection criteria for AS for patients with PC in Korea.
Materials and Methods
We conducted a multicenter retrospective study of 2,126 patients with low risk PC who actually underwent radical prostatectomy. The primary outcome was an unfavorable disease, which was defined by non-organ confined disease or an upgrading of the Gleason score to ≥ 7 (4+3). Predictive variables of an unfavorable outcome were identified by multivariate analysis using randomly selected training samples (n=1,623, 76.3%). We compared our selected criteria to various Western criteria for the primary outcome and validated our criteria using the remaining validation sample (n=503, 23.7%).
Results
A non-organ confined disease rate of 14.9% was identified, with an increase in Gleason score ≥ 7 (4+3) of 8.7% and a final unfavorable disease status of 20.8%. The following criteria were selected: Gleason score ≤ 6, clinical stage T1-T2a, prostate-specific antigen (PSA) ≤ 10 ng/mL, PSA density < 0.15 ng/mL/mL, number of positive cores ≤ 2, and maximum cancer involvement in any one core ≤ 20%. These criteria provided the lowest unfavorable disease rate (11.7%) when compared to Western criteria (13.3%-20.7%), and their validity was confirmed using the validation sample (5.9%).
Conclusion
We developed AS criteria which are appropriate for Korean patients with PC. Prospective studies using these criteria are now warranted.

Citations

Citations to this article as recorded by

Outcomes of active surveillance for Japanese patients with prostate cancer (PRIAS‐JAPAN)
Takuma Kato, Ryuji Matsumoto, Akira Yokomizo, Yoichiro Tohi, Hiroshi Fukuhara, Yoichi Fujii, Keiichiro Mori, Takuma Sato, Junichi Inokuchi, Katsuyoshi Hashine, Shinichi Sakamoto, Hidefumi Kinoshita, Koji Inoue, Toshiki Tanikawa, Takanobu Utsumi, Takayuki
BJU International.2024; 134(4): 652. CrossRef
Has Active Surveillance for Prostate Cancer Become Safer? Lessons Learned from a Global Clinical Registry
Chris Bangma, Paul Doan, Lin Zhu, Sebastiaan Remmers, Daan Nieboer, Jozien Helleman, Monique J. Roobol, Mikio Sugimoto, Byung Ha Chung, Lui Shiong Lee, Mark Frydenberg, Laurence Klotz, Michael Peacock, Antoinette Perry, Anders Bjartell, Antti Rannikko, Mi
European Urology Oncology.2024;[Epub] CrossRef
Establishment of Prospective Registry of Active Surveillance for Prostate Cancer: The Korean Urological Oncology Society Database
Gyoohwan Jung, Jung Kwon Kim, Seong Soo Jeon, Jae Hoon Chung, Cheol Kwak, Chang Wook Jeong, Hanjong Ahn, Jae Young Joung, Tae Gyun Kwon, Sung Woo Park, Seok-Soo Byun
The World Journal of Men's Health.2023; 41(1): 110. CrossRef
The Role of Magnetic Resonance Imaging (MRI) and MRI-Targeted Biopsy for Active Surveillance
Chang Wook Jeong
Journal of Urologic Oncology.2023; 21(2): 97. CrossRef
Incidence and mortality projections for major cancers among Korean men until 2034, with a focus on prostate cancer
Sahyun Pak, Kyu-Won Jung, Eun-Hye Park, Young Hwii Ko, Young-Joo Won, Jae Young Joung
Investigative and Clinical Urology.2022; 63(2): 175. CrossRef
Role of single nucleotide polymorphisms of the HSD3B1 gene (rs6203 and rs33937873) in the prediction of prostate cancer risk
Yasmine Amrousy, Hesham Haffez, Doaa Abdou, Hanaa Atya
Molecular Medicine Reports.2022;[Epub] CrossRef
A single-center long-term experience of active surveillance for prostate cancer: 15 years of follow-up
Sang Hun Song, Jung Kwon Kim, Hakmin Lee, Sangchul Lee, Sung Kyu Hong, Seok-Soo Byun
Investigative and Clinical Urology.2021; 62(1): 32. CrossRef
The clinical impact of strict criteria for active surveillance of prostate cancer in Korean population: Results from a prospective cohort
Jungyo Suh, Hyeong Dong Yuk, Minyong Kang, Bum Sik Tae, Ja Hyeon Ku, Hyeon Hoe Kim, Cheol Kwak, Chang Wook Jeong
Investigative and Clinical Urology.2021; 62(4): 430. CrossRef
Comparison of Characteristics, Follow-up and Outcomes of Active Surveillance for Prostate Cancer According to Ethnicity in the GAP3 Global Consortium Database
Kerri Beckmann, Aida Santaolalla, Jozien Helleman, Peter Carroll, Byung Ha Chung, Lui Shiong Lee, Antoinette Perry, Jose Rubio-Briones, Mikio Sugimoto, Bruce Trock, Riccardo Valdagni, Prokar Dasgupta, Mieke Van Hemelrijck, Oussama Elhage, Bruce Trock, Beh
European Urology Open Science.2021; 34: 47. CrossRef
Patients with Biopsy Gleason Score 3 + 4 Are Not Appropriate Candidates for Active Surveillance
Juhyun Park, Sangjun Yoo, Min Chul Cho, Chang Wook Jeong, Ja Hyeon Ku, Cheol Kwak, Hyeon Hoe Kim, Hyeon Jeong
Urologia Internationalis.2020; 104(3-4): 199. CrossRef
Current status and progress of focal therapy in Asia
Takumi Shiraishi, Osamu Ukimura
Current Opinion in Urology.2018; 28(6): 529. CrossRef
The MMP2 rs243865 polymorphism increases the risk of prostate cancer: A meta-analysis
Kun Liu, Shuo Gu, Xuzhong Liu, Qing Sun, Yunyan Wang, Junsong Meng, Zongyuan Xu
Oncotarget.2017; 8(42): 72933. CrossRef

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