研究背景
腎細胞癌(Renal cell carcinoma)為發源於腎臟的惡性腫瘤，在我國的發生率有逐年上升的趨勢。近年來，隨著藥物的發展，轉移型的腎細胞癌主要是以標靶治療中的酪胺酸酶抑制劑(tyrosine kinase inhibitor, TKI)來進行治療，其中sunitinib於2010年1月於我國核准健保給付，現在已是腎細胞癌治療中重要的藥物，但是缺乏我國相關的使用資料。
研究方法
本研究為觀察性回溯性研究，利用我國2004年至2013年全民健保資料庫，分析因腎細胞癌被處方sunitinib者的處方型態。以研究對象被處方全身性治療的日期為指標日期，比較sunitinib以及其他使用者之差異。在處方型態部分，會分析資料庫中所有sunitinib使用者之基本資料、指標日期前接受的治療、初次處方劑量以及sunitinib治療結束後選擇的藥物。最後，會將sunitinib使用者使用sunitinib的期間每90天為一觀察區間(period)，計算每個病人每期內的sunitinib使用量，作為sunitinib使用劑量的參考，並進一步分析使用高低劑量者之特質差異。
研究結果
於2010年1月1日後，一共有1069名晚期腎細胞癌病人開始使用全身性治療，其中719名(67.26%)為sunitinib使用者。其他350名病人，大多是使用傳統的interferon-α(佔142名，13.32%)。
所有腎細胞癌病人中，共828名病人有sunitinib的使用紀錄。大多數的病人都是2010年1月1日後才開始使用，只有3名於健保核准給付前即開始。828名使用者中有87.20%在使用sunitinib前沒有接受過任何全身性治療，而其他有接受過全身性治療的病人中，則以interferon-α的使用比例最高。Sunitinib的初次處方劑量中，有一半以上因為資料缺乏的關係無法取得精確劑量，但是大多數有劑量資料的病人(18.60%)使用的是仿單所建議的較低劑量37.5 mg，每天服用一次，而完全遵照仿單建議者只佔13.53%。使用sunitinib的期間，有許多病人在第一觀察區間中被處方的劑量並沒有達到仿單建議的標準。進一步分析後發現，使用較低劑量者的年齡較高(p<0.0001)、女性比例較高(p=0.0030)、且National Cancer Institute(NCI) cormorbidity index共病症風險較高(p=0.0001)。
結論
本研究分析的期間，sunitinib是我國晚期腎細胞癌最常被使用的第一線藥品，但是實際使用的劑量卻有偏低的情形。劑量偏低是否為副作用的考量以及治療效果是否會有所差異還需要進一步的研究。

Background
Renal cell carcinoma (RCC) is a kind of malignancy originated within the kidneys, which has an increasing incidence in Taiwan. In these years, some new drugs were approved for RCC treatment, while tyrosine kinase inhibitors (TKI) are recommended as the standard treatment for advanced RCC patients. Among all TKIs, sunitinib was listed in reimbursement scheme of the National Health Insurance for RCC on 2010/1/1, but there is no utilization information in Taiwan population.

Methods
A retrospective study was conducted using the National Health Insurance claims database spanning the period from 2004 to 2013, to analyze the prescribing pattern of sunitinib in advancde RCC patients. Advanced RCC was defined as those who had registered for catastrophic illness for kidney cancer, and started systemic therapy after 2010/1/1. Then the characteristics of sunitinib users are cmaompared to non-users. As for sunitinib prescribing pattern, this study analyzed the baseline characteristics, treatment before and after sunitinib, drug interaction, initianl dosage and dosage change during sunitinib therapy. To analyze the dosage change of sunitinib, this study used 90 days as a period after sunitinib started, then calculated the sum of sunitinib dosage prescribed in every period. Furthermore, the characteristic difference between patients on high dosage and low dosage was analyzed.

Results
There were 1069 advanced RCC patients started systemic treatment after 2010/1/1, and 719 (67.26%) of them were sunitinib users. As for other 350 patients, most of them were using interferon-α (142 patients, 13.32%).
In all RCC patients, 828 patients were prescribrd with sunitinib. Most of them started sunitinib after 2010/1/1, only 3 started in 2009. 87.20% of these sunitinib users had not received other systemic therapy before sunitinib. As for others previously treated users, most of them received interferon-α. More than half of the sunitinib prescriptions did not document dosage and frequency, but most of the complete initial prescriptions (18.60%) were recorded with lower dose (37.5 mg once daily), only 13.53% initial prescriptions adhered to the dosage recommendation on the package insert. During the sunitinib treatment, lots of the sunitinib users did not receive recommended dosage. After further analysis, patients using lower dosage were older (p<0.0001), more female (p=0.0030) and higher score in NCI cormorbidity index (p=0.0001).

Conclusions
Sunitinib was the most commonly used systemic therapy in advanced RCC patients in Taiwan. However, the actual prescribed dosage was lower than recommendation. Whether the lower dosage is due to intolerance and the effectiveness of the lower dose require further research.

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