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2. Crum CP. Epithelial carcinoma of the ovary, fallopian tube, and peritoneum:
Pathogenesis. UpToDate.
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Clinical features and diagnosis. UpToDate.
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2020.5. Salani R. Epithelial carcinoma of the ovary, fallopian tube, and peritoneum:
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10. 西藥、醫療器材、含藥化妝品許可證查詢. 衛生福利部食品藥物管理署.
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12. 藥 品 給 付 規 定 . 衛 生 福 利 部 中 央 健 康 保 險 署 . https://www.nhi.gov.tw/Content_List.aspx?n=E70D4F1BD029DC37&topn=3
FC7D09599D25979. Accessed Feb 14th 2020.
13. Lynparza for Newly Diagnosed Ovarian Cancer - Details. pan-Canadian
Oncology Drug Review.
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Published Dec 5th, 2019. Accessed Feb 15th, 2020.
14. Lynparza for Ovarian Cancer (2nd line) - Details. pan-Canadian Oncology Drug Review. https://www.cadth.ca/lynparza-ovarian-cancer-2nd-line-details.
Published Sep 29th, 2016. Accessed Feb 15th, 2020.
15. Lynparza for Ovarian Cancer (Resubmission) - Details. pan-Canadian
Oncology Drug Review.
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16. Recommendations made by the PBAC - November 2019 - First time decisions not to recommend. Pharmaceutical Benefits Advisory Committee.
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Published Dec 20, 2019. Accessed Feb 15th, 2020.
17. Olaparib: Tablet 150 mg, Tablet 100 mg; Lynparza™ - March 2018.
Pharmaceutical Benefits Advisory Committee.
http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2018-03/fi les/olaparib-psd-march-2018.pdf. Published March 2018. Accessed Feb 15th,
2020.18. Olaparib for maintenance treatment of BRCA mutation-positive advanced ovarian, fallopian tube or peritoneal cancer after response to first-line platinum-based chemotherapy. National Institute for Health and Care Excellence. https://www.nice.org.uk/guidance/ta598. Published August 28th, 2019. Accessed, Feb 15th, 2020.
19. Olaparib for maintenance treatment of relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancer. National Institute for Health and Care Excellence. https://www.nice.org.uk/guidance/ta620. Published Jan 15th, 2020.
Accessed Feb 15th, 2020.
20. olaparib 100mg and 150mg film-coated tablets (Lynparza® ). Scottish
Medicined Consortium.
https://www.scottishmedicines.org.uk/medicines-advice/olaparib-lynparza-full
-smc2209/. Published Dec 9th, 2019. Accessed Feb 15th, 2020.
21. olaparib, 50mg, hard capsules (Lynparza® ) Scottish Medicined Consortium.
https://www.scottishmedicines.org.uk/medicines-advice/olaparib-lynparza-res
ubmission-104715/. Published Nov 7th, 2016. Accessed Feb 15th, 2020.
22. Wiggans AJ, Cass GK, Bryant A, Lawrie TA, Morrison J. Poly (ADP‐ribose) polymerase (PARP) inhibitors for the treatment of ovarian cancer. Cochrane Database of Systematic Reviews 2015; (5).
23. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. New England Journal of Medicine 2018; 379(26): 2495-2505.
24. Wu L, Zhu J, Yin R, et al. Olaparib maintenance therapy in patients (pts) with a BRCA1 and/or BRCA2 mutation (BRCAm) and newly diagnosed advanced ovarian cancer (OC): SOLO1 China cohort. Annals of Oncology 2019; 30:
ix79.
25. Pujade-Lauraine E, Ledermann JA, Selle F, et al. Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2017; 18(9):
1274-1284.
26. Friedlander M, Gebski V, Gibbs E, et al. Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. The Lancet Oncology 2018; 19(8): 1126-1134.
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1579-1589.
31. Chao A, Chang TC, Lapke N, et al. Prevalence and clinical significance of BRCA1/2 germline and somatic mutations in Taiwanese patients with ovarian cancer. Oncotarget 2016; 7(51): 85529-85541.
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http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2016-11/fi les/olaparib-psd-november-2016.pdf. Published November 2016. Accessed
Feb 15th, 2020.35. Secord AA, Barnett JC, Ledermann JA, Peterson BL, Myers ER, Havrilesky LJ. Cost-effectiveness of BRCA1 and BRCA2 mutation testing to target PARP inhibitor use in platinum-sensitive recurrent ovarian cancer. International journal of gynecological cancer : official journal of the International Gynecological Cancer Society 2013; 23(5): 8460852.
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附錄
附錄一 美國 NCCN 指引對持續或復發之上皮卵巢癌、輸卵管腫瘤或原發性腹膜癌建議可接受的復發性治療選項（依對含鉑化療反應區分）
對含鉑藥物敏感疾病之復發性治療
偏好選項 其他建議選項 在特定情況下可用的選項
細胞毒性治療
• carboplatin, gemcitabine 合併治 療加或不加上 bevacizumab
*
• carboplatin, liposomal
doxorubicin 合併治療加或不加上 bevacizumab
• carboplatin, paclitaxel 合併治療 加或不加上 bevacizumab
*
• cisplatin, gemcitabine 合併治療 標靶治療(單獨使用)
• bevacizumab
• niraparib
†
• olaparib
‡
• rucaparib§
細胞毒性治療
• carboplatin, docetaxel 合併治療
• carboplatin, paclitaxel (每週)合併治療
• capecitabine • ifosfamide • irinotecan
• niraparib, bevacizumab 合併治療
• pazopanib 荷爾蒙治療
•芳香環酶抑制劑
(anastrozole, exemestane, letrozole)
• leuprolide • megestrol • tamoxifen
細胞毒性治療 針對黏液性瘤：
• 5-FU, leucovorin, oxaliplatin 合併治療加或不加上 bevacizumab
• capecitabine, oxaliplatin 合併治療加或不加上 bevacizumab
• carboplatin, 白蛋白結合型 paclitaxel 合併治療 (用於對紫杉醇 taxane 類藥品過敏的病人)
• carboplatin, paclitaxel 合併治療 (用於年齡超過 70 歲的病人)
• irinotecan, cisplatin 合併治療 (用於亮細胞瘤) 標靶治療(單獨使用)
• entrectinib 或 larotrectinib (用於 NTRK 基因融合陽性之腫瘤)
• trametinib (用於低度惡性漿液性瘤) 荷爾蒙治療
• fulvestrant (用於低度惡性漿液性瘤) 免疫療法
• pembrolizumab (用於 MSI-high 或 dMMR 固態腫瘤病人)
縮寫：NRTK= neurotrophic receptor tyrosine kinase; MSI= microsatellite instability; dMMR=mismatch repair-deficient
* 若病人對加上 bevacizumab 的化療組合有反應，可持續使用 bevacizumab 作為維持治療，直到疾病惡化或出現無法接受的毒性。
† 針對經三線以上化學治療且腫瘤具同源重組缺陷(定義包括 1.致病性或懷疑致病性 BRCA 突變,或 2.基因不穩定)之病人，對最近一次含鉑化療反應超過 6 個月後惡化，
可使用 niraparib。
‡ 針對致病性生殖細胞 BRCA 突變之晚期卵巢癌病人，經三線以上化學治療後，可治療性使用 olaparib。
§ 針對致病性生殖細胞和/或體細胞 BRCA 突變之晚期卵巢癌病人，經兩線以上化學治療後，可治療性使用 rucaparib。
對含鉑藥物具有抗性疾病之復發性治療
偏好選項 其他建議選項 在特定情況下可用的選項
細胞毒性治療
• cyclophosphamide (口服), bevacizumab 合併治療
• docetaxel
• etoposide
• gemcitabine
• liposomal doxorubicin
• liposomol doxorubicin, bevacizumab 合併治療
• paclitaxel (每週)
• paclitaxel (每週), bevacizumab 合併治療
• topotecan
• topotecan, bevacizumab 合併治療 標靶治療(單獨使用)
• bevacizumab
• niraparib
*
• olaparib
†
• rucaparib
‡
細胞毒性治療
• capecitabine •oxaliplatin
• cyclophosphamide •paclitaxel
• doxorubicin •白蛋白結合型 paclitaxel
• ifosfamide • pemetrexed
• irinotecan • melphalan • vinorelbine
• sorafenib, topotecan 合併治療 標靶治療
• pazopanib 荷爾蒙治療
•芳香環酶抑制劑
(anastrozole, exemestane, letrozole)
• leuprolide • megestrol • tamoxifen
免疫療法
• pembrolizumab (用於 MSI-high 或 dMMR 固態腫 瘤病人)
荷爾蒙治療
• fulvestrant (用於低度惡性漿液性瘤) 標靶治療(單獨使用)
• entrectinib 或 larotrectinib (用於 NTRK 基因融合 陽性之腫瘤)
• trametinib (用於低度惡性漿液性瘤)
縮寫：NRTK= neurotrophic receptor tyrosine kinase; MSI= microsatellite instability; dMMR=mismatch repair-deficient
* 針對經三線以上化學治療且腫瘤具同源重組缺陷(定義包括 1.致病性或懷疑致病性 BRCA 突變,或 2.基因不穩定)之病人，對最近一次含鉑化療反應超過 6 個月後惡化，
可使用 niraparib。
† 針對致病性生殖細胞 BRCA 突變之晚期卵巢癌病人，經三線以上化學治療後，可治療性使用 olaparib。
‡ 針對致病性生殖細胞和/或體細胞 BRCA 突變之晚期卵巢癌病人，經兩線以上化學治療後，可治療性使用 rucaparib。
附錄二 療效評估文獻回顧搜尋策略 1. Cochrane Library
搜尋時間 搜尋策略 期刊篇數
#1 2020/2/15 "olaparib" (Title Abstract Keyword) 1 納入篇數：0
2. PubMed
搜尋時間 搜尋策略 期刊篇數
#1 2020/2/15 "olaparib"[Supplementary Concept] OR
"olaparib"[All Fields] 1,258
#2 2020/2/15 "Ovarian Neoplasms/drug therapy"[Mesh] OR
"Ovarian Neoplasms/therapy"[Mesh] 34,897
#3 2020/2/15
#1 AND #2 AND ("Systematic Review"
[Publication Type] OR "Meta-Analysis"
[Publication Type] OR "Randomized Controlled Trial" [Publication Type] OR
"randomized"[tiab] OR "randomised"[tiab])
36
納入篇數：3
3. Embase
搜尋時間 搜尋策略 期刊篇數
#1 2020/2/15 'ovary cancer'/exp 117,227
#2 2020/2/15 olaparib:ab,ti 2,469
#3 2020/2/15
#1 AND #2 AND ([systematic review]/lim OR [meta analysis]/lim OR [randomized controlled trial]/lim) AND [english]/lim AND
[humans]/lim
104
#4 2020/2/15
#1 AND #2 AND ([systematic review]/lim OR [meta analysis]/lim OR [randomized controlled trial]/lim) AND [english]/lim AND
[humans]/lim AND [article]/lim
22
納入篇數：3 (其中 2 篇與 Pubmed 搜尋結果重複)
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
PubMed 2020/3/3
1 "ovarian neoplasms"[MeSH Terms] OR "ovarian
cancer"[All Fields] 97,736 2 BRCA[All Fields] AND ("mutation"[MeSH Terms]
OR "mutation"[All Fields]) 3,261
3 "olaparib"[Supplementary Concept] OR "olaparib"[All
Fields] 1,271
4
"economics"[Subheading] OR "economics"[All Fields]
OR "cost" [All Fields] OR "costs and cost analysis"[MeSH Terms] OR ("costs"[All Fields] AND
"cost"[All Fields] AND "analysis"[All Fields]) OR
"costs and cost analysis"[All Fields]
848,733
5 #1 AND #2 AND #3 AND #4 7 Cochrane
Library 2020/3/3 1 (ovarian cancer) and (BRCA mutation) and (olaparib)
and cost 3
Embase 2020/3/3
1 ovarian cancer 164,122
BRCA mutation 7,768
2 olaparib 4,761
3 cost 883,012
5 #1 AND #2 AND #3 AND #4 25 CRD 2020/3/3 1 (ovarian cancer) AND (olaparib) AND (cost) IN HTA 0 INAHTA 2020/3/3 1 (ovarian cancer) and (olaparib) and cost 0
附錄四 Olaparib 納入給付後對健保財務影響（新發/復發卵巢癌）敏感度分析 評估年度