http://www.nice.org.uk/guidance/ta316 (Accessed 2015/12/8)
15. Scottish Medicines Consortium. Enzalutamide (Xtandi)http://www.scottishmedicines.org.uk/SMC_Advice/Advice/911_13_enzalutamide
_Xtandi/enzalutamide_Xtandi (Accessed 2015/12/8)
16. Scottish Medicines Consortium. Enzalutamide (Xtandi)http://www.scottishmedicines.org.uk/SMC_Advice/Advice/1066_15_enzalutamid e_Xtandi/enzalutamide_Xtandi (Accessed 2015/12/8)
17. SIGN 50: Scottish Intercollegiate Guidelines Network, Critical appraisal: Notes and checklists.
http://www.sign.ac.uk/methodology/checklists.html (Accessed
2015/12/24)18. Scher HI, Fizazi K, Saad F, et al. Increased survival with enzalutamide in prostate cancer after chemotherapy. N Engl J Med. 2012;367(13): 1187-1197.
19. Fizazi K, Scher HI, Miller K, et al. Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial. Lancet Oncol.
2014; 15(10): 1147-1156.
20. Ning YM, Pierce W, Maher VE, et al. Enzalutamide for treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel: U.S. foodand drugadministrationdrug approval summary. Clinical cancer research. 2013; 19, 6067-6073.
21. Tan PS, Haaland B, Montero AJ, et al. Hormonal Therapeutics Enzalutamide and Abiraterone Acetate in the Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC) Post-docetaxel-an Indirect Comparison. Clin Med Insights Oncol. 2014; 8: 29-36.
22. Beer TM, Armstrong AJ, Rathkopf DE, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014; 371(5): 424-433.
23. Loriot Y, Miller K, Sternberg CN, et al. Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial. Lancet Oncol. 2015;16(5): 509-521.
24. Moher D, Cook DJ, Eastwood S, et al. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. The Lancet. 1999; 354:1896-1900.
25. Fizazi K, Scher HI, Molina A, et al. Abiraterone acetate for treatment of
metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study.
Lancet Oncol. 2012;13:983-92.
26. Jansen JP, Trikalinos T, Cappelleri JC, et al. Indirect treatment
comparison/network meta-analysis study questionnaire to assess relevance and credibility to inform health care decision making: an ISPOR-AMCP-NPC Good
Practice Task Force report. Value Health. 2014; 17(2):157-73.
27. Ryan CJ, Smith MR, de Bono JS, et al. Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48.
28. Rathkopf DE, Smith MR, de Bono JS, et al. Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302). Eur Urol.
2014;Nov;66(5):815-25.
29. Ryan CJ, Smith MR, Fizazi K, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic
castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol.
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附錄
附錄一「全民健康保險藥物給付項目及支付標準」藥品給付規定內容(最新版)：
第 9 節 抗癌瘤藥物 Antineoplastics drugs (摘錄)
9.3.Docetaxel：（87/7/1、92/11/1、93/8/1、95/8/1、96/1/1、99/6/1、100/1/1、101/9/1）
1.乳癌：
(1)局部晚期或轉移性乳癌。
(2)與 anthracycline 合併使用於腋下淋巴結轉移之早期乳癌之術後輔助性 化學治療。(99/6/1)
(3)早期乳癌手術後，經診斷為三陰性反應且無淋巴轉移的病人，得作為 與 cyclophosphamide 併用 doxorubicin 的化學輔助療法。(101/9/1）
2.非小細胞肺癌：局部晚期或轉移性非小細胞肺癌。
3.前列腺癌：於荷爾蒙治療失敗之轉移性前列腺癌。
4.頭頸癌：限局部晚期且無遠端轉移之頭頸部鱗狀細胞癌且無法手術切除 者，與 cisplatin 及 5-fluorouracil 併用，作為放射治療前的引導治療，限 使用 4 個療程。(100/1/1)
9.19.Estramustine sod. phosphate monohydrate (如 Estracyt)：(91/4/1) 限晚期前列腺癌病患且符合下列條件之一者使用：
1.經荷爾蒙治療無效。
2.經診斷對單獨使用荷爾蒙治療，具有預後療效不佳因素的初次治療病患。
9.39.Flutamide；buserelin：（90/8/1、101/7/1）
1.晚期（包括 T3、淋巴腺轉移、器官轉移）之腫瘤。
2.攝護腺癌病人接受根除性攝護腺切除手術治療後，PSA 逐漸升高有局部 復發或遠處轉移之情況。
3.癌症臨床期別為 T2、T3，準備接受根除性攝護腺切除手術治療或其他定 效治療，包括 irradiation 之前為求 tumor volume reduction，作為 neoadjuvant 治療之目的。
9.40.Bicalutamide：（89/10/1、101/7/1）
限用於與 LHRH 類似劑療法或手術去勢療法併用於進展性攝護腺癌。
9.49.Abiraterone (如 Zytiga）（103/12/1）
1.治療藥物或手術去勢抗性的轉移性前列腺癌（ECOG 分數須≦2）且已使 用過 docetaxel 2 個療程以上且治療無效者。
2.需與 prednisone 或 prednisolone 併用。
3.須經事前審查核准後使用，每 3 個月需再次申請。
附錄二 療效評估文獻搜尋策略 (Literature search via PubMed/Cochrane Library)
1. PubMed 文獻資料庫搜尋策略與結果 (23 Dec. 2015)
No. Query Results
#1 ("MDV 3100"[Supplementary Concept] OR "MDV 3100"[All Fields]
OR "enzalutamide"[All Fields]) OR Xtandi[All Fields] OR ("MDV 3100"[Supplementary Concept] OR "MDV 3100"[All Fields] OR
"mdv3100"[All Fields])
654
#2 ("MDV 3100"[Supplementary Concept] OR "MDV 3100"[All Fields]
OR "enzalutamide"[All Fields]) OR Xtandi[All Fields] AND (("secondary"[Subheading] OR "secondary"[All Fields] OR
"metastatic"[All Fields]) AND ("prostatic neoplasms"[MeSH Terms]
OR ("prostatic"[All Fields] AND "neoplasms"[All Fields]) OR
"prostatic neoplasms"[All Fields] OR ("prostate"[All Fields] AND
"cancer"[All Fields]) OR "prostate cancer"[All Fields]))
320
#3 #2 AND ("randomized controlled trial"[Publication Type] OR
"randomized controlled trials as topic"[MeSH Terms] OR "randomized controlled trial"[All Fields] OR "randomised controlled trial"[All Fields])
28
#4 Search enzalutamide [TI] AND abiraterone acetate [TI] 12
#5 Search comparison [TI] 285510
#6 Search indirect comparison[TI] 160
#7 Search #4 AND #5 2
#8 Search #4 AND #6 1
2. Embase 文獻資料庫搜尋策略與結果 (23 Dec. 2015)
No. Query Results
#5 enzalutamide:ti AND 'andabiraterone acetate':ti AND comparison:ti 0
#4 'enzalutamide'/exp OR enzalutamide AND 'metastatic prostate cancer' AND 'randomized controlled trial'
39
#3 'enzalutamide'/exp OR enzalutamide AND 'metastatic prostate cancer'
194
#2 enzalutamide:ti 419
#1 'enzalutamide'/exp OR enzalutamide 1967
3. Cochrane Library 文獻資料庫搜尋策略與結果 (23 Dec. 2015)
No. Query Results
#1 'enzalutamide in Title, Abstract, Keywords in Cochrane Reviews' 0
#2 'enzalutamide AND 'randomized controlled trial' in Title, Abstract, Keywords in Trials'
25
#3
'enzalutamide AND abiraterone AND comparison in Title, Abstract, Keywords in Trials'4
附錄三 經濟評估文獻搜尋紀錄
資料庫 查詢日期 關鍵字 篇數 篩選後篇數
PubMed 2015.11.27 #1 (Xtandi) OR enzalutamide
#2 ((mCRPC) OR (metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed on or after docetaxel therapy)) OR (metastatic
castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated)
#3 ((((cost effectiveness) OR cost utility) OR cost benefit) OR cost minimization) OR economic evaluation
((#1) AND #2) AND #3
5 0
Cochrane Library
2015.11.27 (Xtandi) OR enzalutamide 2 0 INAHTA 2015.11.27 (Xtandi) OR enzalutamide 0 0 CRD 2015.11.27 (Xtandi or enzalutamide) AND (cost
effectiveness or cost utility or cost benefit or cost minimization or economic evaluation )
0 0
Embase 2015.11.27 (Xtandi or enzalutamide) AND (cost effectiveness or cost utility or cost benefit or cost minimization or economic evaluation )
4 0