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| DC 欄位 | 值 | 語言 |
|---|---|---|
| dc.contributor.advisor | 林家齊(Chia-Chi Lin) | |
| dc.contributor.author | Hsiao-I Hung | en |
| dc.contributor.author | 洪曉怡 | zh_TW |
| dc.date.accessioned | 2023-03-19T22:27:05Z | - |
| dc.date.copyright | 2022-10-05 | |
| dc.date.issued | 2022 | |
| dc.date.submitted | 2022-08-30 | |
| dc.identifier.citation | Ando, K., Manabe, R., Kishino, Y., Kusumoto, S., Yamaoka, T., Tanaka, A., Ohmori, T., & Sagara, H. (2021). Comparative Efficacy and Safety of Lorlatinib and Alectinib for ALK-Rearrangement Positive Advanced Non-Small Cell Lung Cancer in Asian and Non-Asian Patients: A Systematic Review and Network Meta-Analysis. Cancers (Basel), 13(15). https://doi.org/10.3390/cancers13153704 Crinò, L., Ahn, M. J., De Marinis, F., Groen, H. J., Wakelee, H., Hida, T., Mok, T., Spigel, D., Felip, E., Nishio, M., Scagliotti, G., Branle, F., Emeremni, C., Quadrigli, M., Zhang, J., & Shaw, A. T. (2016). Multicenter Phase II Study of Whole-Body and Intracranial Activity With Ceritinib in Patients With ALK-Rearranged Non-Small-Cell Lung Cancer Previously Treated With Chemotherapy and Crizotinib: Results From ASCEND-2. J Clin Oncol, 34(24), 2866-2873.https://doi.org/10.1200/jco.2015.65.5936 D.R. Camidge, H. R. K., M.-J. Ahn, J.C.-H. Yang, J.-Y. Han, J.-S. Lee, M.J. Hochmair, J.Y.-C. Li, G.-C. Chang, K.H. Lee, C. Gridelli, A. Delmonte, R. Garcia Campelo, D.-W. Kim, A. Bearz, F. Griesinger, A. Morabito, E. Felip, R. Califano, S. Ghosh, et al. (2018). Brigatinib versus Crizotinib in ALK-Positive Non–Small-Cell Lung Cancer. The new england journal of medicine, 379 (21), 2027-2039. Hida, T., Nokihara, H., Kondo, M., Kim, Y. H., Azuma, K., Seto, T., Takiguchi, Y., Nishio, M., Yoshioka, H., Imamura, F., Hotta, K., Watanabe, S., Goto, K., Satouchi, M., Kozuki, T., Shukuya, T., Nakagawa, K., Mitsudomi, T., Yamamoto, N., Asakawa, T., Asabe, R., Tanaka, T., & Tamura, T. (2017). Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet, 390(10089), 29-39. https://doi.org/10.1016/s0140-6736(17)30565-2 Ito, K., Yamanaka, T., Hayashi, H., Hattori, Y., Nishino, K., Kobayashi, H., Oya, Y., Yokoyama, T., Seto, T., Azuma, K., Fukui, T., Kozuki, T., Nakamura, A., Tanaka, K., Hirano, K., Yokoi, T., Daga, H., Sakata, S., Fujimoto, D., Mori, M., Maeno, K., Aoki, T., Tamura, A., Miura, S., Watanabe, S., Akamatsu, H., Hataji, O., Suzuki, K., Hontsu, S., Azuma, K., Bessho, A., Kubo, A., Okuno, M., Nakagawa, K., & Yamamoto, N. (2021). Sequential therapy of crizotinib followed by alectinib for non-small cell lung cancer harbouring anaplastic lymphoma kinase rearrangement (WJOG9516L): A multicenter retrospective cohort study. Eur J Cancer, 145, 183-193. https://doi.org/10.1016/j.ejca.2020.12.026 Katayama, R., Shaw, A. T., Khan, T. M., Mino-Kenudson, M., Solomon, B. J., Halmos, B., Jessop, N. A., Wain, J. C., Yeo, A. T., Benes, C., Drew, L., Saeh, J. C., Crosby, K., Sequist, L. V., Iafrate, A. J., & Engelman, J. A. (2012). Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers. Sci Transl Med, 4(120), 120ra117. https://doi.org/10.1126/scitranslmed.3003316 Kim, D. W., Tiseo, M., Ahn, M. J., Reckamp, K. L., Hansen, K. H., Kim, S. W., Huber, R. M., West, H. L., Groen, H. J. M., Hochmair, M. J., Leighl, N. B., Gettinger, S. N., Langer, C. J., Paz-Ares Rodríguez, L. G., Smit, E. F., Kim, E. S., Reichmann, W., Haluska, F. G., Kerstein, D., & Camidge, D. R. (2017). Brigatinib in Patients With Crizotinib-Refractory Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer: A Randomized, Multicenter Phase II Trial. J Clin Oncol, 35(22), 2490-2498. https://doi.org/10.1200/jco.2016.71.5904 Leora Horn, M., MS; Ziping Wang, MD; Gang Wu, MD; Elena Poddubskaya, MD; Tony Mok, MD; Martin Reck, MD; Heather Wakelee, MD; Alberto A. Chiappori, MD; Dae Ho Lee, MD, PhD; Valeriy Breder, MD, PhD; Sergey Orlov, MD; Irfan Cicin, MD; Ying Cheng, MD; Yunpeng Liu, MD; Yun Fan, MD; Jennifer G. Whisenant, PhD; Yi Zhou, PhD; Vance Oertel, MS; Kim Harrow, MBA; Chris Liang, PhD; Li Mao, MD;Giovanni Selvaggi, MD; Yi-Long Wu, MD. (2021). Ensartinib vs Crizotinib for Patients With Anaplastic Lymphoma Kinase−Positive Non–Small Cell Lung Cancer A Randomized Clinical Trial. JAMA Oncology, Published online (September), E1-E9. Mok, T., Camidge, D. R., Gadgeel, S. M., Rosell, R., Dziadziuszko, R., Kim, D. W., Pérol, M., Ou, S. I., Ahn, J. S., Shaw, A. T., Bordogna, W., Smoljanović, V., Hilton, M., Ruf, T., Noé, J., & Peters, S. (2020). Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study. Ann Oncol, 31(8), 1056-1064. https://doi.org/10.1016/j.annonc.2020.04.478 Peters, S., Camidge, D. R., Shaw, A. T., Gadgeel, S., Ahn, J. S., Kim, D. W., Ou, S. H. I., Pérol, M., Dziadziuszko, R., Rosell, R., Zeaiter, A., Mitry, E., Golding, S., Balas, B., Noe, J., Morcos, P. N., & Mok, T. (2017). Alectinib versus crizotinib in untreated ALK-positive non–small-cell lung cancer [Article]. New England Journal of Medicine, 377(9), 829-838. https://doi.org/10.1056/NEJMoa1704795 Shaw, A. T., Bauer, T. M., de Marinis, F., Felip, E., Goto, Y., Liu, G., Mazieres, J., Kim, D. W., Mok, T., Polli, A., Thurm, H., Calella, A. M., Peltz, G., & Solomon, B. J. (2020). First-Line Lorlatinib or Crizotinib in Advanced ALK-Positive Lung Cancer. N Engl J Med, 383(21), 2018-2029. https://doi.org/10.1056/NEJMoa2027187 Soda, M., Choi, Y. L., Enomoto, M., Takada, S., Yamashita, Y., Ishikawa, S., Fujiwara, S., Watanabe, H., Kurashina, K., Hatanaka, H., Bando, M., Ohno, S., Ishikawa, Y., Aburatani, H., Niki, T., Sohara, Y., Sugiyama, Y., & Mano, H. (2007). Identification of the transforming EML4-ALK fusion gene in non-small-cell lung cancer. Nature, 448(7153), 561-566. https://doi.org/10.1038/nature05945 Solomon, B. J., Besse, B., Bauer, T. M., Felip, E., Soo, R. A., Camidge, D. R., Chiari, R., Bearz, A., Lin, C. C., Gadgeel, S. M., Riely, G. J., Tan, E. H., Seto, T., James, L. P., Clancy, J. S., Abbattista, A., Martini, J. F., Chen, J., Peltz, G., Thurm, H., Ou, S. I., & Shaw, A. T. (2018). Lorlatinib in patients with ALK-positive non-small-cell lung cancer: results from a global phase 2 study. Lancet Oncol, 19(12), 1654-1667. https://doi.org/10.1016/s1470-2045(18)30649-1 Solomon, B. J., Mok, T., Kim, D. W., Wu, Y. L., Nakagawa, K., Mekhail, T., Felip, E., Cappuzzo, F., Paolini, J., Usari, T., Iyer, S., Reisman, A., Wilner, K. D., Tursi, J., & Blackhall, F. (2014). First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med, 371(23), 2167-2177. https://doi.org/10.1056/NEJMoa1408440 Sun, Y., Ren, Y., Fang, Z., Li, C., Fang, R., Gao, B., Han, X., Tian, W., Pao, W., Chen, H., & Ji, H. (2010). Lung adenocarcinoma from East Asian never-smokers is a disease largely defined by targetable oncogenic mutant kinases. J Clin Oncol, 28(30), 4616-4620. https://doi.org/10.1200/jco.2010.29.6038 Yang, C. Y., Yang, J. C., & Yang, P. C. (2020). Precision Management of Advanced Non-Small Cell Lung Cancer. Annu Rev Med, 71, 117-136. https://doi.org/10.1146/annurev-med-051718-013524 Yang, J. C., Ou, S. I., De Petris, L., Gadgeel, S., Gandhi, L., Kim, D. W., Barlesi, F., Govindan, R., Dingemans, A. C., Crino, L., Lena, H., Popat, S., Ahn, J. S., Dansin, E., Golding, S., Bordogna, W., Balas, B., Morcos, P. N., Zeaiter, A., & Shaw, A. T. (2017). Pooled Systemic Efficacy and Safety Data from the Pivotal Phase II Studies (NP28673 and NP28761) of Alectinib in ALK-positive Non-Small Cell Lung Cancer. J Thorac Oncol, 12(10), 1552-1560. https://doi.org/10.1016/j.jtho.2017.06.070 Zhou, C., Kim, S. W., Reungwetwattana, T., Zhou, J., Zhang, Y., He, J., Yang, J. J., Cheng, Y., Lee, S. H., Bu, L., Xu, T., Yang, L., Wang, C., Liu, T., Morcos, P. N., Lu, Y., & Zhang, L. (2019). Alectinib versus crizotinib in untreated Asian patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer (ALESIA): a randomised phase 3 study. Lancet Respir Med, 7(5), 437-446. https://doi.org/10.1016/s2213-2600(19)30053-0 | |
| dc.identifier.uri | http://tdr.lib.ntu.edu.tw/jspui/handle/123456789/84815 | - |
| dc.description.abstract | 背景 肺癌是世界上最常見的癌症之一，同時也是造成癌症死亡的主要原因。其中80-85%屬於非小細胞肺癌（NSCLC），當中又以肺腺癌和鱗狀上皮細胞肺癌為主。 大多數的非小細胞肺癌，尤其是腺癌當中60-70%至少有一個致癌驅動基因突變（Oncogenic driver mutation），包括表皮生長因子受體（EGFR）, 間變性淋巴瘤激酶（ALK）和跨膜受體蛋白酪氨酸激酶（ROS1）基因重排等驅動基因突變。 在這些突變中，ALK 佔東亞人的 5-7%。而在標靶藥物出現之前，ALK陽性的病人和其他的非小細胞肺癌一樣，在第一線所使用的標準抗癌治療為含鉑劑之合併化療（Platinum-based doublet）。 方法 通過系統性回顧和統合分析，比較新一代和第一代ALK酪胺酸激酶抑制劑的療效和安全性，並比較新一代 ALK 酪胺酸激酶抑制劑在先前未接受治療並帶有ALK基因突變的晚期非小細胞肺癌中的療效和安全性。 結果 對新一代和第一代ALK酪胺酸激酶抑制劑的六項臨床隨機試驗的結果，針對了客觀腫瘤緩解率（ORR）、無惡化存活期（PFS）、整體存活期（OS）、藥物毒性（AE）和亞組伴隨腦轉移的無惡化存活期（CNS with/without brain metastasis）進行了統合分析。 如先前已發表的研究結果所示，大多數新一代 ALK 抑製劑的分析結果優於第一代 ALK 酪胺酸激酶抑制劑。但在本統合分析中第二代及第三代抑製劑之間除了無惡化存活期及3-5級的藥物毒性不良反應之外，在療效（ORR、OS、subgroup PFS with/without brain metastasis in the baseline）則無統計顯著差異。 | zh_TW |
| dc.description.abstract | Background Lung cancer is the leading cause of cancer-related death in the world. 80 to 85 % of lung cancer are non-small cell lung cancer (NSCLC), including adenocarcinoma and squamous cell carcinoma. A majority of NSCLC, especially adenocarcinoma 60-70% of them have at least one oncogenic driver mutation, including mutations of the EGFR gene (epidermal growth factor receptor), rearrangements of the ALK (anaplastic lymphoma kinase) and ROS1 genes (c-ros oncogene 1), etc. Among these mutations, ALK accounts for 5-7% of east Asians (Yang et al., 2020). Before the advent of targeted therapy, the standard first-line treatment for ALK-positive NSCLC, like other NSCLC, was the platinum-based doublet chemotherapy. Methods To compare the efficacy and safety of the newer generation ALK inhibitors with crizotinib and compare newer ALK inhibitors in previously untreated advanced NSCLC through systematic review and meta-analysis. Results The six randomized controlled trials (RCTs) of newer generation inhibitors versus the first-generation inhibitor were analyzed for outcome, including overall response rate (ORR), progression free survival (PFS), overall survival (OS), adverse event (AE), and subgroup PFS with/without brain metastasis. As shown in the results of the published studies, most newer generation ALK inhibitors had favorable outcomes comparing with those of the first-generation ALK inhibitor in this meta-analysis. However, there were no significant differences in the efficacy (ORR, OS, and subgroup PFS with/without brain metastasis in the baseline) between the second and third newer generation inhibitors except PFS and toxicity (AE in grade 3-5). | en |
| dc.description.provenance | Made available in DSpace on 2023-03-19T22:27:05Z (GMT). No. of bitstreams: 1 U0001-2406202211292800.pdf: 3716475 bytes, checksum: 3140a03bb3b7dd81d2331718f952ef76 (MD5) Previous issue date: 2022 | en |
| dc.description.tableofcontents | 口試委員會審定書......... I 誌謝.................... II CHINESE ABSTRACT ...... III ABSTRACT....... V TABLE OF CONTENTS...... VII LIST OF FIGURES ....... IX LIST OF TABLES ........ IX CHAPTER 1 INTRODUCTION ................ 1 CHAPTER 2 METHODS...................... 3 2.1 LITERATURE SEARCH STRATEGIES....... 3 2.2 QUALITY ASSESSMENT ................ 3 2.3 META-ANALYSIS AND STATISTICS....... 4 CHAPTER 3 RESULTS .......... 5 3.1 SYSTEMATIC REVIEW ...... 5 3.2 RISK OF BIAS ........... 5 3.3 META-ANALYSIS .......... 6 3.3.1 Objective response rate (ORR) ....... 6 3.3.2 Progression-free survival (PFS) ..... 6 3.3.3 Overall survival (OS) ............... 7 3.3.4 Adverse event (AE) in any grade ..... 7 3.3.5 Adverse event (AE) in grade 3-5 ..... 8 3.4 SUBGROUP META-ANALYSIS ................ 8 3.4.1 PFS with brain metastasis in the baseline ........ 8 3.4.2 PFS without brain metastasis in the baseline ..... 9 CHAPTER 4 DISCUSSION ...... 10 CHAPTER 5 CONCLUSION ...... 11 APPENDIX: PROTOCOL ........ 22 1. STUDY SYNOPSIS ......... 23 2. INTRODUCTION ........... 30 2.1 BACKGROUND .............30 2.2 RATIONALE ............. 31 2.3 ALECTINIB ............. 32 2.4 LORLATINIB ............ 33 3. STUDY ENDPOINT ......... 34 3.1 PRIMARY ENDPOINT ...... 34 3.2 SECONDARY ENDPOINT .... 34 4. STUDY DESIGN ............34 4.1 SCHEMA ................ 34 4.2 STUDY OVERVIEW ........ 34 5. SUBJECT ELIGIBILITY .... 35 5.1 INCLUSION CRITERIA .... 35 5.2 EXCLUSION CRITERIA .... 36 6. STUDY TREATMENT ........ 38 6.1 PATIENT COMPLIANCE .... 38 6.2 ALECTINIB ............. 38 6.3 LORLATINIB ............ 39 7. DOSE MODIFICATIONS ..... 39 8. STUDY PROCEDURES ....... 40 8.1 SCREEN ................ 40 8.2 TREATMENT PERIOD ...... 40 8.3 END OF TREATMENT ...... 41 8.4 POST TREATMENT OF FOLLOW UP ...... 41 8.5 SURVIVAL FOLLOW UP ............... 41 8.6 DISCONTINUATION OF STUDY ......... 42 8.7 VISIT SCHEDULE ................... 43 9. CRITERIA FOR EVALUATION ........... 45 9.1 SAFETY ASSESSMENT ................ 45 9.2 EFFICACY ASSESSMENT .............. 45 9.3 OTHER ASSESSMENTS ................ 45 10. SAFETY MONITORING AND REPORTING .. 46 10.1 ADVERSE EVENTS .................. 46 10.2 SERIOUS ADVERSE EVENTS ...........46 11. STATISTICAL METHODS .............. 47 11.1 HYPOTHESIS ...................... 47 11.2 SAMPLE SIZE ESTIMATION .......... 47 11.3 FULL ANALYSIS SET ............... 48 11.3.1 Safety Analysis ............... 48 11.3.2 Efficacy Analysis ............. 49 12. ETHICS ........................... 50 12.1 INFORMED CONSENT FORM ........... 50 12.2 SOURCE DOCUMENTS AND CASE REPORT FORM .................... 51 APPENDIX A: LIST OF ABBREVIATIONS ............................. 52 APPENDIX B: OVERALL LESION RESPONSE AT EACH ASSESSMENT ........ 54 APPENDIX C: ECOG PERFORMANCE SCALE ............................ 55 REFERENCE ............................. 56 LIST OF FIGURES FIGURE 1 QUALITY ASSESSMENT ..................... 15 FIGURE 2 QUALITY ASSESSMENT ..................... 16 FIGURE 3 STUDY SELECTION FLOW DIAGRAM ........... 17 FIGURE 4 OBJECTIVE RESPONSE RATE ................ 18 FIGURE 5 PROGRESSION FREE SURVIVAL .............. 18 FIGURE 6 OVERALL SURVIVAL ....................... 19 FIGURE 7 ADVERSE EVENT IN ANY GRADE ............. 19 FIGURE 8 ADVERSE EVENT IN GRADE 3-5 ............. 20 FIGURE 9 PROGRESSION FREE SURVIVAL WITH BRAIN METASTASIS IN BASELINE.............. 20 FIGURE 10 PROGRESSION FREE SURVIVAL WITHOUT BRAIN METASTASIS IN BASELINE ...................... 21 LIST OF TABLES TABLE 1 STUDIES CHARACTERISTICS ..................... 12 TABLE 2 META-ANALYSIS LIST .......................... 14 TABLE 3 ALECTINIB DOSE REDUCTION SCHEDULE ........... 39 TABLE 4 LORLATINIB DOSE REDUCTION SCHEDULE .......... 40 | |
| dc.language.iso | en | |
| dc.title | 酪胺酸激脢用在間變性淋巴瘤激脢融合基因陽性非小細胞肺癌之系統性回顧、統合分析及臨床試驗計畫書 | zh_TW |
| dc.title | ALK Inhibitors in ALK Fusion Positive Non-Small Cell Lung Cancer: A Systematic Review, Meta-Analysis and Clinical Trial Protocol | en |
| dc.type | Thesis | |
| dc.date.schoolyear | 110-2 | |
| dc.description.degree | 碩士 | |
| dc.contributor.oralexamcommittee | 何肇基(Chao-Chi Ho),張基晟(Gee-Chen Chang) | |
| dc.subject.keyword | 非小細胞肺癌,間變性淋巴瘤激脢,酪胺酸激酶抑制劑,系統性回顧,統合分析, | zh_TW |
| dc.subject.keyword | Non-small cell lung cancer,Anaplastic lymphoma kinase,Tyrosine Kinase Inhibitor,systematic review,meta-analysis, | en |
| dc.relation.page | 58 | |
| dc.identifier.doi | 10.6342/NTU202201089 | |
| dc.rights.note | 同意授權(限校園內公開) | |
| dc.date.accepted | 2022-08-30 | |
| dc.contributor.author-college | 醫學院 | zh_TW |
| dc.contributor.author-dept | 臨床醫學研究所 | zh_TW |
| dc.date.embargo-lift | 2022-10-05 | - |
| 顯示於系所單位： | 臨床醫學研究所 | |
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