1. Blauvelt A, Leonardi CL, Gooderham M, et al. Efficacy and Safety of Continuous Risankizumab Therapy vs Treatment Withdrawal in Patients With Moderate to Severe Plaque Psoriasis: A Phase 3 Randomized Clinical Trial. JAMA Dermatology 2020; 156(6): 649-658.
2. 喜開悅 75mg 針筒裝注射劑(SKYRIZI 75mg /0.83ml Pre-filled syringe) 醫療 科技評估報告: 財團法人醫藥品查驗中心; 2019.
3. TNM classification 8th edition - The Radiology Assistant.
https://radiologyassistant.nl/chest/lung-cancer/tnm-classification-8th-edition.
Accessed October 26, 2020.
4. Non-Small Cell Lung Cancer Treatment (PDQ® )–Patient Version. National Institutes of Health ： National Cancer Institute.
https://www.cancer.gov/types/lung/patient/non-small-cell-lung-treatment-pdq.
Accessed October 26, 2020.
5. Zhang Q, Wu C, Ding W, et al. Prevalence of ROS1 fusion in Chinese patients with non‐small cell lung cancer. Thoracic cancer 2019; 10(1): 47-53.
6. Park S, Ahn B-C, Lim SW, et al. Characteristics and outcome of ROS1-positive non–small cell lung cancer patients in routine clinical practice. Journal of Thoracic Oncology 2018; 13(9): 1373-1382.
7. Mehta A, Saifi M, Batra U, Suryavanshi M, Gupta K. Incidence of ROS1-Rearranged Non-Small-Cell Lung Carcinoma in India and Efficacy of Crizotinib in Lung Adenocarcinoma Patients. Lung Cancer: Targets and Therapy 2020; 11: 19.
8. Simon GR, Costa RR, Gandara DR. Pharmacogenomics in Lung Cancer:
Predictive Biomarkers for Chemotherapy. In: IASLC Thoracic Oncology:
Elsevier; 2018:466-478. e463.
9. Chen YF, Hsieh MS, Wu SG, et al. Clinical and the prognostic characteristics of lung adenocarcinoma patients with ROS1 fusion in comparison with other driver mutations in East Asian populations. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2014;
9(8): 1171-1179.
10. Khalifa J, Amini A, Popat S, Gaspar LE, Faivre-Finn C. Brain metastases from NSCLC: radiation therapy in the era of targeted therapies. Journal of Thoracic Oncology 2016; 11(10): 1627-1643.
11. DEMPKE WC, Edvardsen K, Lu S, Reinmuth N, Reck M, Inoue A. Brain metastases in NSCLC–are TKIs changing the treatment strategy? Anticancer research 2015; 35(11): 5797-5806.
12. Patil T, Smith DE, Bunn PA, et al. The incidence of brain metastases in stage IV ROS1-rearranged non–small cell lung cancer and rate of central nervous system progression on crizotinib. Journal of Thoracic Oncology 2018; 13(11):
1717-1726.
13. Remon J, Besse B. Brain metastases in oncogene-addicted non-small cell lung cancer patients: incidence and treatment. Frontiers in oncology 2018; 8: 88.
14. How Is Lung Cancer Diagnosed and Treated?. Centers for Disease Control and Prevention. https://www.cdc.gov/cancer/lung/basic_info/diagnosis_treatment.htm.
Accessed October 26, 2020.
15. NCCN Clinical Practice Guideline in Oncology: Non-Small Cell Lung Cancer, Version 8.2020 — September 15, 2020. National Comprehensive Cancer Network. https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf.
Accessed October 23, 2020.
16. Hanna NH, Schneider BJ, Temin S, et al. Therapy for Stage IV Non–Small-Cell Lung Cancer Without Driver Alterations: ASCO and OH (CCO) Joint Guideline Update. Journal of Clinical Oncology 2020.
17. Lung cancer: diagnosis and management. NICE National Institute for Health and Care Excellence. https://www.nice.org.uk/guidance/ng122. Accessed October 23, 2020.
18. Systemic anti-cancer therapy: management options for people with non-squamous (adenocarcinoma, large cell undifferentiated) carcinoma and non-small-cell carcinoma (non-otherwise specified) – October 2020 update.NICE National Institute for Health and Care Excellence.
https://www.nice.org.uk/guidance/ng122/resources/systemic-anticancer-therapy-management-options-for-people-with-nonsquamous-adenocarcinomalarge-cell-un differentiated-carcinoma-and-nonsmallcell-carcinoma-nonotherwise-specified-pd f-6722110909. Accessed October 23, 2020.
19. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up.
https://www.esmo.org/content/download/347819/6934778/1/ESMO-CPG-mNSC LC-15SEPT2020.pdf. Accessed November 30, 2020.
20. Lecia V Sequist JWN. Personalized, genotype-directed therapy for advanced non-small cell lung cancer. UpToDate.
https://www.uptodate.com/contents/personalized-genotype-directed-therapy-for-a dvanced-non-small-cell-lung-cancer. Accessed October 26, 2020.
21. 中文仿單：羅思克® 膠囊 100 毫克、膠囊 200 毫克(衛部藥輸字第 027864 號、
衛 部 藥 輸 字 第 027865 號 ). .
https://info.fda.gov.tw/MLMS/ShowFile.aspx?LicId=52027865&Seq=001&Type
=9. Accessed October 22, 2020.
22. ATC/DDD Index 2020. WHO Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_index/. Accessed October 27, 2020.
23. 西藥、醫療器材、特定用途化粧品許可證查詢. 衛生福利部食品藥物管理署.
https://info.fda.gov.tw/MLMS/H0001.aspx. Accessed October 27, 2020.
24. Aguiar JP, Cardoso Borges F, Murteira R, et al. [safety] Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma. International journal of clinical pharmacy 2018; 40(4): 852-861.
25. 健 保 用 藥 品 項 查 詢 . 衛 生 福 利 部 中 央 健 康 保 險 署 . https://www1.nhi.gov.tw/QueryN/Query1.aspx. Accessed October 27, 2020.
26. Pharmaceutical Benefits Advisory Committee. Public Summary Document-Entrectinib: Capsule 200 mg; Rozlytrek® . https://www.pbs.gov.au/pbs/industry/listing/elements/pbac-meetings/psd/2020-03 /entrectinib-capsule-200-mg-rozlytrek. Accessed October 22, 2020.
27. National Institute for Health and Care Excellence. Technology appraisal guidance-Entrectinib for treating ROS1-positive advanced non-small-cell lung cancer. https://www.nice.org.uk/guidance/ta643. Accessed October 22, 2020.
28. Drilon A, Siena S, Dziadziuszko R, et al. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. The Lancet Oncology 2020; 21(2): 261-270.
29. Chu P, Antoniou M, Bhutani MK, Aziez A, Daigl M. Matching-adjusted indirect comparison: entrectinib versus crizotinib in ROS1 fusion-positive non-small cell lung cancer. Journal of comparative effectiveness research 2020; 9(15): 861-876.
30. Braud FGD, Niger M, Damian S, et al. Alka-372-001: First-in-human, phase I study of entrectinib – an oral pan-trk, ROS1, and ALK inhibitor – in patients with advanced solid tumors with relevant molecular alterations. Journal of Clinical Oncology 2015; 33(15_suppl): 2517-2517.
31. Patel MR, Bauer TM, Liu SV, et al. STARTRK-1: Phase 1/2a study of entrectinib, an oral Pan-Trk, ROS1, and ALK inhibitor, in patients with advanced solid tumors with relevant molecular alterations. Journal of Clinical Oncology 2015;
33(15_suppl): 2596-2596.
32. STARTRK-1.NCT02097810.Clinical trial.gov.
https://www.clinicaltrials.gov/ct2/show/NCT02097810?term=NCT02097810&dr aw=2&rank=1. Accessed November 9, 2020.
33. STARTRK-2.NCT02568267.Clinical trial.gov https://www.clinicaltrials.gov/ct2/show/NCT02568267?term=NCT02568267&dr aw=2&rank=1. Accessed November 9, 2020.
34. Wu YL, Yang JC, Kim DW, et al. Phase II Study of Crizotinib in East Asian Patients With ROS1-Positive Advanced Non-Small-Cell Lung Cancer. Journal of clinical oncology : official journal of the American Society of Clinical Oncology 2018; 36(14): 1405-1411.
35. National Institute for Health and Care Excellence. Technology appraisal guidance-Crizotinib for treating ROS1-positive advanced non-small-cell lung cancer. https://www.nice.org.uk/guidance/ta529. Accessed November 6, 2020.
36. Soria J-C, Tan DS, Chiari R, et al. First-line ceritinib versus platinum-based chemotherapy in advanced ALK-rearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study. The Lancet 2017;
389(10072): 917-929.
37. Shaw AT, Kim D-W, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. New England Journal of Medicine 2013;
368(25): 2385-2394.
38. Shaw AT, Riely GJ, Bang YJ, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Annals of oncology : official journal of the European Society for Medical Oncology 2019; 30(7): 1121-1126.
39. entrectinib (Rozlytrek). Scottish Medicines Consortium.
https://www.scottishmedicines.org.uk/medicines-advice/entrectinib-rozlytrek-full -smc2294/. Accessed October 27, 2020.
40. 102 年 癌 症 登 記 年 報 . 衛 生 福 利 部 國 民 健 康 署 . https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=5191. Published 2016. Accessed October 29, 2020.
41. Bellone M, Zaniolo O, Martinelli E, Marcelli G, Orfanos P, Pradelli L. PCN152 COST-UTILITY AUC MODEL ADAPTED TO ITALIAN CLINICAL PRACTICE FOR EVALUATION OF ENTRECTINIB VERSUS STANDARD OF CARE IN ROS1+ NSCLC PATIENTS. Value in Health 2019; 22: S465.
42. 106 年 癌 症 登 記 報 告 . 衛 生 福 利 部 國 民 健 康 署 . https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=12235. Published 2020. Accessed October 29, 2020.
43. 108 年各類癌症健保前 10 大醫療支出統計(109.07.23 新增). 衛生福利部中央
健 康 保 險 署 .
https://www.nhi.gov.tw/Content_List.aspx?n=AE8F3C1B6EC35217&topn=23C6 60CAACAA159D. Accessed November 19, 2020.
44. 103 年 癌 症 登 記 年 報 . 衛 生 福 利 部 國 民 健 康 署 . https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=7330. Published 2017. Accessed October 29, 2020.
45. 104 年 癌 症 登 記 年 報 . 衛 生 福 利 部 國 民 健 康 署 . https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=8084. Published 2017. Accessed October 29, 2020.
46. 105 年 癌 症 登 記 報 告 . 衛 生 福 利 部 國 民 健 康 署 . https://www.hpa.gov.tw/Pages/Detail.aspx?nodeid=269&pid=10227. Published 2018. Accessed October 29, 2020.
47. Sasaki H, Suzuki A, Tatematsu T, et al. Prognosis of recurrent non-small cell lung cancer following complete resection. Oncol Lett 2014; 7(4): 1300-1304.
48. Drilon A, Siena S, Dziadziuszko R, et al. Entrectinib in ROS1 fusion-positive non-small-cell lung cancer: integrated analysis of three phase 1-2 trials. The Lancet Oncology 2020; 21(2): 261-270.
49. Shaw AT, Riely GJ, Bang YJ, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Annals of Oncology 2019; 30(7): 1121-1126.
50. ATC/DDD Index 2020. World Health Organization Collaborating Centre for Drug Statistics Methodology. https://www.whocc.no/atc_ddd_index/. Accessed November 13, 2020.
51. 藥品給付規定-第九節 抗癌瘤藥物(109.10.26 更新). 衛生福利部中央健康保
險 署 .
https://www.nhi.gov.tw/Content_List.aspx?n=E70D4F1BD029DC37&topn=3FC 7D09599D25979. Accessed November 18, 2020.
52. 癌症期別與治療分析年度報告-民國 106 年長表申報 16 種癌症 特定因子 (SSF) 分 布 統 計 表 . 台 灣 癌 症 登 記 中 心 . http://tcr.cph.ntu.edu.tw/uploadimages/Y106_SSF.pdf. Accessed November 20, 2020.
53. Solomon B, Varella-Garcia M, Camidge DR. ALK gene rearrangements: a new therapeutic target in a molecularly defined subset of non-small cell lung cancer.
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer 2009; 4(12): 1450-1454.
54. Entrectinib: Capsule 200 mg; Rozlytrek® . Pharmaceutical Benefits Advisory Committee.
https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2020-0 3/entrectinib-capsule-200-mg-rozlytrek. Published 2020. Accessed October 27, 2020.
55. Landi L, Chiari R, Tiseo M, et al. Crizotinib in <em>MET</em>-Deregulated or
<em>ROS1</em>-Rearranged Pretreated Non–Small Cell Lung Cancer (METROS): A Phase II, Prospective, Multicenter, Two-Arms Trial. Clinical Cancer Research 2019; 25(24): 7312-7319.
56. Moro-Sibilot D, Cozic N, Pérol M, et al. Crizotinib in c-MET- or ROS1-positive NSCLC: results of the AcSé phase II trial. Annals of oncology : official journal of the European Society for Medical Oncology 2019; 30(12): 1985-1991.
57. Shaw AT, Ou S-HI, Bang Y-J, et al. Crizotinib in ROS1-Rearranged Non–
Small-Cell Lung Cancer. New England Journal of Medicine 2014; 371(21):
1963-1971.
附錄
附錄一、療效文獻搜尋紀錄
資料庫 搜索日期 項次 搜索條件 篇數
PubMed 2020/11/04
#1 "Entrectinib"OR"Rozlytrek" 132
#2
"Lung Neoplasms"[Mesh] OR
"Carcinoma, Non-Small-Cell Lung"[Mesh]
235497
#3
lung[All Fields] AND (neoplasms[All Fields] OR cancer[All Fields] OR
neoplasm[All Fields] OR carcinoma[All Fields])
EMBASE 2020/11/04
#1 'entrectinib'/exp OR entrectinib 545
#2 lung AND cancer 565803
#3 lung AND 'carcinoma' 180866
#4 lung AND 'malignant neoplasm' 37438
#5 #2 OR #3 OR #4 603384
#6 #1 AND #5 330
#7 #6 AND [systematic review]/lim 14
#8 #6 AND [meta analysis]/lim 5
#9 #6 AND [controlled clinical trial]/lim 45
#10 #7 OR #8 OR #9 59
#11 #10 AND 'ros*' 47
納入篇數 2
Cochrane
Library 2020/11/04
#1 "non small-cell lung cancer" 12272
#2 Entrectinib 11
#3 #1 AND #2 7
納入篇數 0
附錄二、經濟評估文獻搜尋紀錄
資料庫 搜索日期 項次 搜索條件 篇數
CRD 2020.11.06 Results for: (entrectinib) OR (Rozlytrek)
0 INAHTA 2020.11.06 (entrectinib) OR (Rozlytrek) 0
Cochrane 2020.11.06
#1 "non-small cell lung cancer" 12,272
#2 "entrectinib" OR "Rozlytrek" 11
#3 "Cost-consequence analysis" OR
"cost-benefit analysis" OR
"cost-effectiveness analysis" OR
"cost-utility analysis" OR "Cost studies"
0
Pubmed 2020.11.06
#1 "non-small cell lung cancer" 58,649
#2 (entrectinib) OR (Rozlytrek) 132
#3 "Cost-consequence analysis" OR
"cost-benefit analysis" OR
"cost-effectiveness analysis" OR
"cost-utility analysis" OR "Cost studies"
428,400
#4 #1 AND #2 AND #3 2
Embase 2020.11.06
#1 "non-small cell lung cancer" 136,300
#2 (entrectinib) OR (Rozlytrek) 546
#3 "Cost-consequence analysis" OR
"cost-benefit analysis" OR
"cost-effectiveness analysis" OR
"cost-utility analysis" OR "Cost studies"
235,936
#4 #1 AND #2 AND #3 3