Background: Apatinib, a vascular endothelial growth factor receptor (VEGFR) blocker, has demonstrated encouraging antitumor activities and tolerable toxicities in various cancer types. Recurrent or metastatic adenoid cystic carcinoma of the head and neck (R/MACCHN) carries a poor prognosis, and treatment options are currently limited. This study was conducted to explore the antitumor activity and safety of apatinib in patients with R/MACCHN. Methods: In this phase II single-arm, prospective study, patients aged 15–75 years with incurable R/MACCHN received apatinib at a 500 mg dose once daily until intolerance or progression occurred. The primary endpoint was the 6-month progression-free survival (PFS) rate based on RECIST version 1.1. The secondary endpoints included response rate, overall survival (OS), and safety. Efficacy was assessed in all dosed patients with at least one post-baseline tumor assessment. Results: Among 68 patients treated with apatinib, 65 were evaluable for efficacy analysis, with a median follow-up time of 25.8 months. The 6-month, 12-month, and 24-month PFS rates were 92.3% [95% confidence interval (CI): 83–97.5%], 75.2% (95% CI: 61.5–84.0%) and 44.7% (95% CI: 32.3–57.5%), respectively. The objective response rate (ORR) and disease control rate (DCR), as assessed by investigators, were 46.2% (95% CI: 33.7–59.0%) and 98.5% (95% CI: 91.7–100.0%), respectively. The median duration of response was 17.7 months [interquartile range (IQR) 14.0–20.9]. The 12-month and 24-month OS rates were 92.3% (95% CI: 83.0–97.5%) and 82.3% (95% CI: 70–90.4%), respectively. The most common adverse events of grades 3–4 were hypertension (5.9%), proteinuria (9.2%), and hemorrhage (5.9%). One patient developed a fatal hemorrhage. Conclusion: An encouraging PFS, a high ORR, and a manageable safety profile were observed in this study. It seems that the administration of apatinib in R/MACCHN is likely to have a clinically meaningful therapeutic benefit and warrants further investigation. This study was prospectively registered in ClinicalTrials.gov (NCT02775370; date of registration: 17 May 2016; date of first patient enrollment: 25 May 2016)
Improving the level of arteriovenous fistula (AVF) self‐care behavior by people receiving hemodialysis is an effective way to reduce the occurrence of complications and mortality. The aim of this study was to assess the self‐care behavior of Chinese patients undergoing hemodialysis with arteriovenous fistula. The assessment of self‐care behaviors with arteriovenous fistula in hemodialysis (ASBHD‐AVF, Portuguese version) was translated into Chinese using Brislin's translation model. The content validity was evaluated by six experts. Then we involved 301 hemodialysis patients with AVF to explore the construct validity of the Chinese version of ASBHD‐AVF. Ultimately 216 patients from eight dialysis centers of general hospitals in China were recruited to evaluate the patients’ self‐care behavior about AVF. Measures included demographic questionnaire, and the Chinese ASBHD‐AVF. The Chinese ASBHD‐AVF that included 12 items has a good internal consistency (α = 0.865) and content validity (CVI = 0.979). Principal component analysis generated two factors which explained 53.525% of the total variance. About 69.9% of hemodialysis patients’ AVF self‐care behavior were at a low or moderate level. The level of self‐care behavior and knowledge need to be improved. Nurses should give specific guidance according to the patients’ own characteristics and different influence factors, in order to improve the recipients’ self‐care behavior.
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