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방광암 (Bladder Cancer / Urothelial Carcinoma) — 참고문헌

QSP 모델 보정 및 기전 근거 문헌 (35편 이상, PubMed 링크 포함)

1. 역학 (Epidemiology)

  1. Sung H, et al. Global Cancer Statistics 2020. CA Cancer J Clin. 2021;71(3):209-249. PMID: 33538338

  2. Bray F, et al. Global cancer statistics 2018. CA Cancer J Clin. 2018;68(6):394-424. PMID: 30207593

  3. Siegel RL, et al. Cancer Statistics, 2023. CA Cancer J Clin. 2023;73(1):17-48. PMID: 36633525

  4. Antoni S, et al. Bladder Cancer Incidence and Mortality: A Global Overview and Recent Trends. Eur Urol. 2017;71(1):96-108. PMID: 27447461

2. 병태생리 / 분자생물학 (Pathophysiology / Molecular Biology)

  1. Knowles MA, Hurst CD. Molecular biology of bladder cancer: new insights into pathogenesis and clinical diversity. Nat Rev Cancer. 2015;15(1):25-41. PMID: 25533674

  2. Robertson AG, et al. Comprehensive Molecular Characterization of Muscle-Invasive Bladder Cancer (TCGA). Cell. 2017;171(3):540-556.e25. PMID: 28988769

  3. Lindgren D, et al. Integrated Genomic and Gene Expression Profiling Identifies Two Major Genomic Circuits in Urothelial Carcinoma. PLoS One. 2012;7(6):e38863. PMID: 22761718

  4. Sjödahl G, et al. A Molecular Taxonomy for Urothelial Carcinoma. Clin Cancer Res. 2012;18(12):3377-3386. PMID: 22553347

  5. Al-Ahmadie H, Iyer G. Genomics of bladder cancer. J Clin Oncol. 2020;38(19):2249-2257. PMID: 32442058

3. 위험 인자 (Risk Factors)

  1. Freedman ND, et al. Association between smoking and risk of bladder cancer among men and women. JAMA. 2011;306(7):737-745. PMID: 21846855

  2. Baris D, et al. Occupational exposure to chemicals and bladder cancer risk by histologic subtype. J Natl Cancer Inst. 2009;101(2):125-138. PMID: 19141774

  3. Kellen E, et al. Bladder cancer risk and the metabolic syndrome. Eur J Cancer Prev. 2007;16(1):50-56. PMID: 17297389

4. FGFR3 신호 전달 (FGFR3 Signaling)

  1. Tomlinson DC, et al. FGFR3 dysfunction is associated with poor prognosis in urothelial bladder cancer. Eur Urol. 2007;51(3):620-625. PMID: 17069963

  2. Loriot Y, et al. Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma (BLC2001). N Engl J Med. 2019;381(4):338-348. PMID: 31340094

  3. Siefker-Radtke AO, et al. Efficacy of Erdafitinib in FGFR Alterations in Advanced Urothelial Carcinoma. J Clin Oncol. 2023;41(30):4685-4696. PMID: 37683134

5. BCG 면역요법 (BCG Immunotherapy)

  1. Lamm DL, et al. Maintenance Bacillus Calmette-Guérin Immunotherapy for Recurrent TA, T1, and Carcinoma In Situ TCC (SWOG S8507). J Urol. 2000;163(4):1124-1129. PMID: 10737480

  2. Böhle A, Bock PR. Intravesical BCG versus mitomycin C in superficial bladder cancer: formal meta-analysis of comparative studies on tumor progression. Urology. 2004;63(4):682-687. PMID: 15072879

  3. Morales A, et al. Intracavitary Bacillus Calmette-Guérin in the Treatment of Superficial Bladder Tumors. J Urol. 1976;116(2):180-183. PMID: 820877

  4. Suttmann H, et al. Mechanisms of Bacillus Calmette-Guérin induced anti-tumor immunity. Immunol Lett. 2006;103(1):11-20. PMID: 16414129

6. 화학요법 (Chemotherapy)

  1. von der Maase H, et al. Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Advanced or Metastatic Bladder Cancer. J Clin Oncol. 2000;18(17):3068-3077. PMID: 11002408

  2. von der Maase H, et al. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005;23(21):4602-4608. PMID: 16034041

  3. Bajorin DF, et al. Randomized trial of dose-dense versus standard schedule of methotrexate, vinblastine, doxorubicin, and cisplatin induction prior to nephroureterectomy. J Clin Oncol. 2021;39(22):2474-2484. PMID: 34010046

7. 면역관문 억제제 (Checkpoint Inhibitors)

  1. Bellmunt J, et al. Pembrolizumab as Second-Line Therapy for Advanced Urothelial Carcinoma (KEYNOTE-045). N Engl J Med. 2017;376(11):1015-1026. PMID: 28212060

  2. Balar AV, et al. Atezolizumab as first-line treatment in cisplatin-ineligible patients with locally advanced and metastatic urothelial carcinoma: a single-arm, multicentre, phase 2 trial (IMvigor210). Lancet. 2017;389(10064):67-76. PMID: 27939400

  3. Powles T, et al. Atezolizumab versus chemotherapy in patients with platinum-treated locally advanced or metastatic urothelial carcinoma (IMvigor211). Lancet. 2018;391(10122):748-757. PMID: 29268948

  4. Vuky J, et al. Long-Term Outcomes in KEYNOTE-052: Phase II Study Investigating First-Line Pembrolizumab in Cisplatin-Ineligible Patients With Locally Advanced or Metastatic Urothelial Cancer. J Clin Oncol. 2020;38(23):2658-2666. PMID: 32552471

8. 항체-약물 복합체 (Antibody-Drug Conjugates)

  1. Powles T, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma (EV-301). N Engl J Med. 2021;384(12):1125-1135. PMID: 33577729

  2. Hoimes CJ, et al. Enfortumab Vedotin Plus Pembrolizumab in Previously Untreated Advanced Urothelial Cancer (EV-103). J Clin Oncol. 2023;41(1):22-31. PMID: 36332134

  3. Tagawa ST, et al. TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors. J Clin Oncol. 2021;39(22):2474-2485. PMID: 34010059

9. 종양 미세환경 (Tumor Microenvironment)

  1. Rouanne M, et al. Targeting the PD-1/PD-L1 axis in bladder cancer: rationale and clinical trials. Crit Rev Oncol Hematol. 2018;129:53-61. PMID: 30097237

  2. Sfakianos JP, et al. Immune Characterization of the Bladder Cancer Tumor Microenvironment. JCI Insight. 2021;6(8):e143088. PMID: 33836168

  3. Galsky MD, et al. Tumor-Immune Microenvironment of Cisplatin-Treated vs. Untreated Urothelial Carcinoma. J Natl Cancer Inst. 2020;112(2):211-218. PMID: 31313816

  4. Garje R, et al. Fueling the Renaissance of Immunotherapy for Advanced Bladder Cancer. J Oncol. 2020;2020:3709491. PMID: 32411196

10. 바이오마커 (Biomarkers)

  1. van Rhijn BWG, et al. Urothelial bladder cancer. Nat Rev Dis Primers. 2021;7(1):78. PMID: 34795274

  2. Lotan Y, et al. Performance of Urinary Biomarkers for Bladder Cancer Detection in an At-Risk Population. Eur Urol Oncol. 2021;4(4):596-604. PMID: 33582113

  3. Necchi A, et al. Pembrolizumab as Neoadjuvant Therapy Before Radical Cystectomy in Patients With Muscle-Invasive Urothelial Bladder Carcinoma (PURE-01). J Clin Oncol. 2018;36(34):3353-3360. PMID: 30199292

11. 약동학/약력학 (PK/PD Modeling)

  1. Lindauer A, et al. Integrated pharmacokinetic-pharmacodynamic model of the clinical study of enzastaurin. Cancer Chemother Pharmacol. 2010;65(2):279-289. PMID: 19543898

  2. Gibiansky L, Gibiansky E. Target-mediated drug disposition model: approximations, identifiability of model parameters and applications to the population pharmacokinetic-pharmacodynamic modeling of biologics. Expert Opin Drug Metab Toxicol. 2009;5(7):803-812. PMID: 19545210

  3. Aaronson DS, Ouzounian TJ, Lemack GE. Mathematical models in urological research. BJU Int. 2003;92(3):295-301. PMID: 12887480

12. 진료지침 (Clinical Guidelines)

  1. Witjes JA, et al. European Association of Urology Guidelines on Muscle-Invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021;79(1):82-104. PMID: 33223099

  2. Flaig TW, et al. Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2020;18(3):329-354. PMID: 32135421

본 참고문헌 목록은 방광암 QSP 모델의 기계론적 근거, PK/PD 파라미터 보정, 임상시험 데이터 출처를 포함합니다.