Prospective analysis of UGT1A1 promoter polymorphism for irinotecan dose escalation in metastatic colorectal cancer patients treated with bevacizumab plus FOLFIRI as the first-line setting: study protocol for a randomized controlled trial

详细信息    查看全文

• 作者：Yung-Sung Yeh ; Hsiang-Lin Tsai ; Ching-Wen Huang ; Jui-Ho Wang ; Yi-Wen Lin…
• 关键词：UGT1A1 ; Bevacizumab ; FOLFIRI ; Dose escalation ; Metastatic colorectal cancer
• 刊名：Trials
• 出版年：2016
• 出版时间：December 2016
• 年：2016
• 卷：17
• 期：1
• 全文大小：540 KB
• 参考文献：1.Ishida H, Fujita K, Akiyama Y, Sunakawa Y, Yamashita K, Mizuno K, et al. Regimen selection for first-line FOLFIRI and FOLFOX based on UGT1A1 genotype and physical background is feasible in Japanese patients with advanced colorectal cancer. Jpn J Clin Oncol. 2011;41:617–23.CrossRef PubMed
  2.Cecchin E, Innocenti F, D'Andrea M, Corona G, De Mattia E, Biason P, et al. Predictive role of the UGT1A1, UGT1A7, and UGT1A9 genetic variants and their haplotypes on the outcome of metastatic colorectal cancer patients treated with fluorouracil, leucovorin, and irinotecan. J Clin Oncol. 2009;27:2457–65.CrossRef PubMed
  3.Saltz LB, Cox JV, Blanke C, Rosen LS, Fehrenbacher L, Moore MJ, et al. Irinotecan plus fluorouracil and leucovorin for metastatic colorectal cancer. Irinotecan Study Group. N Engl J Med. 2000;343:905–14.CrossRef PubMed
  4.Douillard JY, Cunningham D, Roth AD, Navarro M, James RD, Karasek P, et al. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: a multicentre randomised trial. Lancet. 2000;355:1041–7.CrossRef PubMed
  5.Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, et al. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004;350:2335–42.CrossRef PubMed
  6.Van Cutsem E, Köhne CH, Hitre E, Zaluski J, Chang Chien CR, Makhson A, et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med. 2009;360:1408–17.CrossRef PubMed
  7.Peeters M, Price T. Biologic therapies in the metastatic colorectal cancer treatment continuum – applying current evidence to clinical practice. Cancer Treat Rev. 2012;38:397–406.CrossRef PubMed
  8.Lu CY, Huang CW, Hu HM, Tsai HL, Huang CM, Yu FJ, et al. Prognostic advantage of irinotecan dose escalation according to uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) genotyping in patients with metastatic colorectal cancer treated with bevacizumab combined with 5-fluorouracil/leucovorin with irinotecan in a first-line setting. Transl Res. 2014;164:169–76.CrossRef PubMed
  9.Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000;92:205–16.CrossRef PubMed
  10.Marcuello E, Páez D, Paré L, Salazar J, Sebio A, del Rio E, et al. A genotype-directed phase I-IV dose-finding study of irinotecan in combination with fluorouracil/leucovorin as first-line treatment in advanced colorectal cancer. Br J Cancer. 2011;105:53–7.PubMedCentral CrossRef PubMed
  11.Wang M, Sun DF, Wang S, Qing Y, Chen S, Wu D, et al. Polymorphic expression of UDP-glucuronosyltransferase UGTlA gene in human colorectal cancer. PLoS One. 2013;8:e57045.PubMedCentral CrossRef PubMed
  12.Maitland ML, Grimsley C, Kuttab-Boulos H, Witonsky D, Kasza KE, Yang L, et al. Comparative genomics analysis of human sequence variation in the UGT1A gene cluster. Pharmacogenomics J. 2006;6:52–62.CrossRef PubMed
  13.Thomas SS, Li SS, Lampe JW, Potter JD, Bigler J. Genetic variability, haplotypes, and htSNPs for exons 1 at the human UGT1A locus. Hum Mutat. 2006;27:717.CrossRef PubMed
  14.Tang KS, Chiu HF, Chen HH, Eng HL, Tsai CJ, Teng HC, et al. Link between colorectal cancer and polymorphisms in the uridine-diphosphoglucuronosyltransferase 1A7 and 1A1 genes. World J Gastroenterol. 2005;11:3250–4.PubMedCentral CrossRef PubMed
  15.Kim KP, Hong YS, Lee JL, Bae KS, Kim HS, Shin JG, et al. A phase I study of UGT1A1 *28/*6 genotype-directed dosing of irinotecan (CPT-11) in Korean patients with metastatic colorectal cancer receiving FOLFIRI. Oncology. 2015;88:164–72.CrossRef PubMed
  16.Sunakawa Y, Ichikawa W, Fujita K, Nagashima F, Ishida H, Yamashita K, et al. UGT1A1*1/*28 and *1/*6 genotypes have no effects on the efficacy and toxicity of FOLFIRI in Japanese patients with advanced colorectal cancer. Cancer Chemother Pharmacol. 2011;68:279–84.CrossRef PubMed
  17.Maeda H, Hazama S, Shavkat A, Okamoto K, Oba K, Sakamoto J, et al. Differences in UGT1A1, UGT1A7, and UGT1A9 polymorphisms between Uzbek and Japanese populations. Mol Diagn Ther. 2014;18:333–42.PubMedCentral CrossRef PubMed
  18.Fuchs CS, Marshall J, Barrueco J. Randomized, controlled trial of irinotecan plus infusional, bolus, or oral fluoropyrimidines in first-line treatment of metastatic colorectal cancer: updated results from the BICC-C study. J Clin Oncol. 2008;26:689–90.CrossRef PubMed
  19.Ribero D, Wang H, Donadon M, Zorzi D, Thomas MB, Eng C, et al. Bevacizumab improves pathologic response and protects against hepatic injury in patients treated with oxaliplatin-based chemotherapy for colorectal liver metastases. Cancer. 2007;110:2761–7.CrossRef PubMed
  
• 作者单位：Yung-Sung Yeh (1) (2) (3)
  Hsiang-Lin Tsai (2) (4) (5) (6)
  Ching-Wen Huang (2) (5) (7)
  Jui-Ho Wang (8)
  Yi-Wen Lin (9)
  Hsiu-Chih Tang (10)
  Yung-Chuan Sung (11)
  Chang-Chieh Wu (12)
  Chien-Yu Lu (13) (14)
  Jaw-Yuan Wang (15) (2) (3) (5) (6) (7)
  
  1. Division of Trauma, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  2. Division of Gastroenterology and General Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  3. Graduate Institute of Clinical Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  4. Division of General Surgery Medicine, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  5. Graduate Institute of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  6. Department of Surgery, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  7. Division of Colorectal Surgery, Department of Surgery, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  8. Division of Colorectal Surgery, Department of Surgery, Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan
  9. Department of Surgery, Tainan Municipal Hospital, Tainan, Taiwan
  10. Colon and Rectal Surgery, Tainan Sin-Lau Hospital, Tainan, Taiwan
  11. Division of Hematology-Oncology, Department of Internal Medicine, Cathay General Hospital, Taipei, Taiwan
  12. Division of Colon and Rectal Surgery, Department of Surgery, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan
  13. Division of Gastroenterology, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan
  14. Department of Internal Medicine, Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung, Taiwan
  15. Center for Biomarkers and Biotech Drugs, Kaohsiung Medical University, Kaohsiung, Taiwan
  
• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Irinotecan is approved and widely administered to metastatic colorectal cancer (mCRC) patients; however, it can cause severe toxicities including neutropenia and diarrhea. The polymorphisms of genes encoding drug-metabolizing enzymes can play a crucial role in the increased susceptibility of cancer patients to chemotherapy toxicity. Therefore, we plan to explore the effect of the genetic polymorphism of uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1) for irinotecan detoxification in mCRC patients. This trial will compare the clinical outcomes and side effects observed in mCRC patients treated with bevacizumab plus 5-fluorouracil/leucovorin/irinotecan (FOLFIRI) with and without UGT1A1 genotyping and irinotecan dose escalation. A total of 400 mCRC patients were randomized into a study group and a control group.