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.
Purpose As the survival of head and neck cancer (HNC) improves, survivors increasingly confront non-cancer–related deaths. This nationwide population-based study aimed to investigate non-cancer–related deaths in HNC survivors.
Materials and Methods Data from the Korean Central Cancer Registry were obtained to characterize causes of death, mortality patterns, and survival in patients with HNC between 2006 and 2016 (n=40,890). Non-cancer-related mortality relative to the general population was evaluated using standardized mortality ratios (SMRs). The 5- and 10-year cause-specific competing risks probabilities of death (cumulative incidence function, CIF) and subdistribution hazards ratios (sHR) from the Fine-Gray models were estimated.
Results Comorbidity-related mortality was frequent in older patients, whereas suicide was predominant in younger patients. The risk of suicide was greater in patients with HNC than in the general population (SMR, 3.1; 95% confidence interval [CI], 2.7 to 3.5). The probability of HNC deaths reached a plateau at 5 years (5-year CIF, 33.9%; 10-year CIF, 39.5%), whereas the probability of non-HNC deaths showed a long-term linear increase (5-year, CIF 5.6%; 10-year CIF, 11.9%). Patients who were male (sHR, 1.56; 95% CI, 1.41 to 1.72), diagnosed with early-stage HNC (localized vs. distant: sHR, 1.86; 95% CI, 1.58 to 2.21) and older age (65-74 vs. 0-44: sHR, 6.20; 95% CI, 4.92 to 7.82; ≥ 75 vs. 0-44: sHR, 9.81; 95% CI, 7.76 to 12.39) had an increased risk of non-cancer mortality.
Conclusion Non-HNC–related deaths continue increasing. HNC survivors are at increased risk of suicide in the younger and comorbidity-related death in the older. Better population-specific surveillance awareness and survivorship plans for HNC survivors are warranted.
Citations
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Time‐varying association of second primary malignancy and long‐term survival outcomes in patients with head and neck cancer Xiaoke Zhu, Yu Heng, Jian Zhou, Hanqing Lin, Liang Zhou, Ming Zhang, Pengyu Cao, Lei Tao International Journal of Cancer.2023; 153(1): 94. CrossRef
Purpose
Though regular surveillance of hepatocellular carcinoma (HCC) for high-risk patients is widely recommended, its rate and effectiveness are not clear. The aim of this study is to investigate the actual rate of HCC surveillance and its related factors and to clarify its impact on survival in a Korean HCC cohort.
Materials and Methods
From 2012 to 2015, 319 newly diagnosed HCC patients were prospectively enrolled at a tertiary hospital. Patient interviews based on a structured questionnaire survey were conducted. Surveillance was defined as liver imaging test ≥ 2 times with at least 3-month interval within 2 years prior to HCC diagnosis.
Results
Surveillance rate was 39.8%. Of the HCC patients with high-risk factors, only 182 (57.1%) had knowledge for the need for regular surveillance, and 141 (44.2%) had the accurate information about the method (ultrasound-based study). Surveillance group showed a higher proportion of early HCC (p < 0.001) and a longer overall survival (p < 0.001) compared to non-surveillance group. The multivariable Cox regression analysis indicated Child-Pugh class A, history of anti-viral therapy, low serum α-fetoprotein level, non-advanced Barcelona Clinic Liver Cancer stage as independent predictors of overall survival, while regular surveillance was not (p=0.436).
Conclusion
Less than half of the newly diagnosed Korean HCC patients were under surveillance and the accurate perception for the need of HCC surveillance was insufficient. Of those under surveillance, most patients were diagnosed with early stage HCC, which led to the improved survival. Comprehensive efforts to optimize the surveillance program for the target population are warranted.
Citations
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Factors associated with the survival outcomes of patients with untreated hepatocellular carcinoma: An analysis of nationwide data Min Jung Kwon, Soy Chang, Ji Hoon Kim, Ji Won Han, Jeong Won Jang, Jong Young Choi, Seung Kew Yoon, Pil Soo Sung Frontiers in Oncology.2023;[Epub] CrossRef
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