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.
Sung Gu Kang, Eu Chang Hwang, Seung Il Jung, Ho Song Yu, Ho Seok Chung, Taek Won Kang, Dong Deuk Kwon, Jun Eul Hwang, Jun Seok Kim, Joon Hwa Noh, Jae Hyung You, Myung Ki Kim, Tae Hoon Oh, Ill Young Seo, Seung Baik, Chul-Sung Kim, Seok Ho Kang, Jun Cheon
Cancer Res Treat. 2016;48(4):1293-1301. Published online March 23, 2016
Purpose The purpose of this study is to evaluate the effect of diabetes mellitus (DM) and preoperative glycemic control on prognosis in Korean patients with upper tract urothelial carcinoma (UTUC) who underwent radical nephroureterectomy (RNU). Materials and Methods A total of 566 patients who underwent RNU at six institutions between 2004 and 2014 were reviewed retrospectively. Kaplan-Meier and Cox regression analyses were performed to assess the association between DM, preoperative glycemic control, and recurrence-free, cancer-specific, and overall survival.
Results The median follow-up period was 33.8 months (interquartile range, 41.4 months). A total of 135 patients (23.8%) had DM and 67 patients (11.8%) had poor preoperative glycemic control. Patients with poor preoperative glycemic control had significantly shorter median recurrence-free, cancer-specific, and overall survival than patients with good preoperative glycemic control and non-diabetics (all, p=0.001). In multivariable Cox regression analysis, DM with poor preoperative glycemic control showed association with worse recurrence-free survival (hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.31 to 3.90; p=0.003), cancer-specific survival (HR, 2.96; 95% CI, 1.80 to 4.87; p=0.001), and overall survival (HR, 2.13; 95% CI, 1.40 to 3.22; p=0.001). Conclusion Diabetic UTUC patients with poor preoperative glycemic control had significantly worse oncologic outcomes than diabetic UTUC patients with good preoperative glycemic control and non-diabetics. Further investigation is needed to elucidate the exact mechanism underlying the impact of glycemic control on UTUC treatment outcome.
Citations
Citations to this article as recorded by
Identifying ways to improve diabetes management during cancer treatments (INDICATE): protocol for a qualitative interview study with patients and clinicians Laura Ashley, Saifuddin Kassim, Ian Kellar, Lisa Kidd, Frances Mair, Mike Matthews, Mollie Price, Daniel Swinson, Johanna Taylor, Galina Velikova, Jonathan Wadsley BMJ Open.2022; 12(2): e060402. CrossRef
Annular-shaped stenosis in the ureter: Caution should be taken Jie Ming, Yue Wang, Ziliang Su, Chunyang Wang Urologic Oncology: Seminars and Original Investigations.2022; 40(6): 274.e7. CrossRef
Glycosylated haemoglobin and prognosis in 10,536 people with cancer and pre-existing diabetes: a meta-analysis with dose-response analysis Suping Ling, Michael Sweeting, Francesco Zaccardi, David Adlam, Umesh T. Kadam BMC Cancer.2022;[Epub] CrossRef
Malnutrition management of hospitalized patients with diabetes/hyperglycemia and cancer cachexia Rosa Burgos Peláez, José Pablo Suárez Llanos, Jose Manuel García Almeida, Pilar Matía Martín, Samara Palma Milla, Alejandro Sanz Paris, Ana Zugasti Murillo, Ana Artero-Fullana, Alfonso Calañas Continente, M.ª Jesús Chinchetru, Katherine García Malpartida, Nutrición Hospitalaria.2022;[Epub] CrossRef
The Impact of Diabetes on the Prognosis of Upper Tract Urothelial Carcinoma After Radical Nephroureterectomy: A Systematic Review and Meta-Analysis Xiaoshuai Gao, Liang Zhou, Jianzhong Ai, Wei Wang, Xingpeng Di, Liao Peng, Banghua Liao, Xi Jin, Hong Li, Kunjie Wang Frontiers in Oncology.2021;[Epub] CrossRef
The Prognostic Value of Lymphovascular Invasion in Patients With Upper Tract Urinary Carcinoma After Surgery: An Updated Systematic Review and Meta-Analysis Lijin Zhang, Bin Wu, Zhenlei Zha, Hu Zhao, Jun Yuan, Yejun Feng Frontiers in Oncology.2020;[Epub] CrossRef
The impact of preoperative glycated hemoglobin levels on outcomes in oral squamous cell carcinoma Ze Yun Tay, Huang‐Kai Kao, Kuang‐Hsu Lien, Shao‐Yu Hung, Yenlin Huang, Ngan‐Ming Tsang, Kai‐Ping Chang Oral Diseases.2020; 26(7): 1449. CrossRef