Protective effect of ulinastatin in patients with non-small cell lung cancer after radiation therapy: a randomized, placebo-controlled study

Medical Oncology

Volumn 32, Issue 1, 2015, Pages 1-8

  Bao, Pengtao ^a,b   Zhao, Weiguo ^b   Li, Yun ^b   Liu, Yu ^b   Zhou, Yi ^b   Liu, Changting ^a  

^a CHINESE PLA GENERAL HOSPITAL   (China)

^b 309TH HOSPITAL OF PLA   (China)

Author keywords

Inflammatory cytokines; Non small cell lung cancer; Radiation induced lung injury; Ulinastatin

Indexed keywords

INTERLEUKIN 6; PLACEBO; TRANSFORMING GROWTH FACTOR BETA1; TUMOR NECROSIS FACTOR ALPHA; ULINASTATIN; GLYCOPROTEIN; TRYPSIN INHIBITOR;

ADULT; AGED; ARTICLE; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER SURVIVAL; CLINICAL EFFECTIVENESS; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DYSPNEA; FEMALE; FOLLOW UP; FORCED EXPIRATORY VOLUME; FORCED VITAL CAPACITY; HUMAN; INTENSITY MODULATED RADIATION THERAPY; LUNG FUNCTION; MAJOR CLINICAL STUDY; MALE; NON SMALL CELL LUNG CANCER; RADIATION DOSE; RADIATION INDUCED LUNG INJURY; RADIATION INJURY; RADIATION PROTECTION; RANDOMIZED CONTROLLED TRIAL; THORAX PAIN; TREATMENT DURATION; TREATMENT RESPONSE; CARCINOMA, NON-SMALL-CELL LUNG; KAPLAN MEIER METHOD; LUNG NEOPLASMS; MIDDLE AGED; MORTALITY; RADIATION PNEUMONITIS;

ADULT; AGED; CARCINOMA, NON-SMALL-CELL LUNG; DOUBLE-BLIND METHOD; FEMALE; GLYCOPROTEINS; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; RADIATION PNEUMONITIS; TRYPSIN INHIBITORS;

EID: 84920114074     PISSN: 13570560     EISSN: 1559131X     Source Type: Journal    
DOI: 10.1007/s12032-014-0405-x     Document Type: Article

References (40)

1. Coggle JE, Lambert BE, Moores SR. Radiation effects in the lung. Environ Health Perspect. 1986;70:261–91.
2. Spiro SG, Douse J, Read C, Janes S. Complications of lung cancer treatment. Semin Respir Crit Care Med. 2008;29(3):302–17.
3. Yamashita H, Nakagawa K, Nakamura N, Koyanagi H, Tago M, Igaki H, et al. Exceptionally high incidence of symptomatic grade 2–5 radiation pneumonitis after stereotactic radiation therapy for lung tumors. Radiat Oncol. 2007;2:21.
4. Westbury CB, Yarnold JR. Radiation fibrosis–current clinical and therapeutic perspectives. Clin Oncol. 2012;24(10):657–72.
5. McDonald S, Rubin P, Phillips TL, Marks LB. Injury to the lung from cancer therapy: clinical syndromes, measurable endpoints, and potential scoring systems. Int J Radiat Oncol Biol Phys. 1995;31(5):1187–203.
6. Abratt RP, Morgan GW. Lung toxicity following chest irradiation in patients with lung cancer. Lung Cancer. 2002;35(2):103–9.
7. Fan M, Marks LB, Hollis D, Bentel GG, Anscher MS, Sibley G, et al. Can we predict radiation-induced changes in pulmonary function based on the sum of predicted regional dysfunction? J Clin Oncol. 2001;19(2):543–50.
8. Marks LB, Fan M, Clough R, Munley M, Bentel G, Coleman RE, et al. Radiation-induced pulmonary injury: symptomatic versus subclinical endpoints. Int J Radiat Biol. 2000;76(4):469–75.
9. Ding NH, Li JJ, Sun LQ. Molecular mechanisms and treatment of radiation-induced lung fibrosis. Curr Drug Targets. 2013;14(11):1347–56.
10. Otani K, Nishiyama K, Ito Y, Kawaguchi Y, Inaji H. Steroid treatment increases the recurrence of radiation-induced organizing pneumonia after breast-conserving therapy. Cancer Med. 2014;3(4):947–53.
11. Wynn TA. Cellular and molecular mechanisms of fibrosis. J Pathol. 2008;214(2):199–210.
12. Chen Y, Williams J, Ding I, Hernady E, Liu W, Smudzin T, et al. Radiation pneumonitis and early circulatory cytokine markers. Semin Radiat Oncol. 2002;12(1 Suppl. 1):26–33.
13. Jackson IL, Zhang X, Hadley C, Rabbani ZN, Zhang Y, Marks S, et al. Temporal expression of hypoxia-regulated genes is associated with early changes in redox status in irradiated lung. Free Radic Biol Med. 2012;53(2):337–46.
14. Yuan ST, Ellingrod VL, Schipper M, Stringer KA, Cai X, Hayman JA, et al. Genetic variations in TGFbeta1, tPA, and ACE and radiation-induced thoracic toxicities in patients with non-small-cell lung cancer. J Thorac Oncol. 2013;8(2):208–13.
15. Minami-Shimmyo Y, Ohe Y, Yamamoto S, Sumi M, Nokihara H, Horinouchi H, et al. Risk factors for treatment-related death associated with chemotherapy and thoracic radiotherapy for lung cancer. J Thorac Oncol. 2012;7(1):177–82.
16. Kim JY, Kim YS, Kim YK, Park HJ, Kim SJ, Kang JH, et al. The TGF-beta1 dynamics during radiation therapy and its correlation to symptomatic radiation pneumonitis in lung cancer patients. Radiat Oncol. 2009;4:59.
17. Yang HJ, Youn H, Seong KM, Yun YJ, Kim W, Kim YH, et al. Psoralidin, a dual inhibitor of COX-2 and 5-LOX, regulates ionizing radiation (IR)-induced pulmonary inflammation. Biochem Pharmacol. 2011;82(5):524–34.
18. Ogata T, Yamazaki H, Teshima T, Kihara A, Suzumoto Y, Inoue T, et al. Early administration of IL-6RA does not prevent radiation-induced lung injury in mice. Radiat Oncol. 2010;5:26.
19. Redlich CA, Gao X, Rockwell S, Kelley M, Elias JA. IL-11 enhances survival and decreases TNF production after radiation-induced thoracic injury. J Immunol. 1996;157(4):1705–10.
20. Kanai T, Ishiwata T, Kobayashi T, Sato H, Takizawa M, Kawamura Y, et al. Ulinastatin, a urinary trypsin inhibitor, for the initial treatment of patients with Kawasaki disease: a retrospective study. Circulation. 2011;124(25):2822–8.
21. Hiyama A, Takeda J, Kotake Y, Morisaki H, Fukushima K. A human urinary protease inhibitor (ulinastatin) inhibits neutrophil extracellular release of elastase during cardiopulmonary bypass. J Cardiothorac Vasc Anesth. 1997;11(5):580–4.
22. Inoue K, Takano H. Urinary trypsin inhibitor as a therapeutic option for endotoxin-related inflammatory disorders. Expert Opin Investig Drugs. 2010;19(4):513–20.
23. Chen CC, Wang SS, Lee FY. Action of antiproteases on the inflammatory response in acute pancreatitis. JOP. 2007;8(4 Suppl.):488–94.
24. Fang Y, Xu P, Gu C, Wang Y, Fu XJ, Yu WR, et al. Ulinastatin improves pulmonary function in severe burn-induced acute lung injury by attenuating inflammatory response. J Trauma. 2011;71(5):1297–304.
25. Song Z, Chen G, Lin G, Jia C, Cao J, Ao G. The ultra-early protective effect of ulinastatin on rabbit acute lung injury induced by paraquat. BMC Emerg Med. 2013;13(Suppl. 1):S7.
26. Wang N, Liu X, Zheng X, Cao H, Wei G, Zhu Y, et al. Ulinastatin is a novel candidate drug for sepsis and secondary acute lung injury, evidence from an optimized CLP rat model. Int Immunopharmacol. 2013;17(3):799–807.
27. Katoh H, Ishikawa H, Hasegawa M, Yoshida Y, Suzuki Y, Ohno T, et al. Protective effect of urinary trypsin inhibitor on the development of radiation-induced lung fibrosis in mice. J Radiat Res. 2010;51(3):325–32.
28. Shigetomi H, Onogi A, Kajiwara H, Yoshida S, Furukawa N, Haruta S, et al. Anti-inflammatory actions of serine protease inhibitors containing the Kunitz domain. Inflamm Res. 2010;59(9):679–87.
29. Bao P, Gao W, Li S, Zhang L, Qu S, Wu C, et al. Effect of pretreatment with high-dose ulinastatin in preventing radiation-induced pulmonary injury in rats. Eur J Pharmacol. 2009;603(1–3):114–9.
30. Suresh K, Chandrashekara S. Sample size estimation and power analysis for clinical research studies. J Hum Reprod Sci. 2012;5(1):7–13.
31. Bradley JD, Ieumwananonthachai N, Purdy JA, Wasserman TH, Lockett MA, Graham MV, et al. Gross tumor volume, critical prognostic factor in patients treated with three-dimensional conformal radiation therapy for non-small-cell lung carcinoma. Int J Radiat Oncol Biol Phys. 2002;52(1):49–57.
32. Suntharalingam M, Paulus R, Edelman MJ, Krasna M, Burrows W, Gore E, et al. Radiation therapy oncology group protocol 02-29: a phase II trial of neoadjuvant therapy with concurrent chemotherapy and full-dose radiation therapy followed by surgical resection and consolidative therapy for locally advanced non-small cell carcinoma of the lung. Int J Radiat Oncol Biol Phys. 2012;84(2):456–63.
33. Schuetze SM, Zhao L, Chugh R, Thomas DG, Lucas DR, Metko G, et al. Results of a phase II study of sirolimus and cyclophosphamide in patients with advanced sarcoma. Eur J Cancer. 2012;48(9):1347–53.
34. Zhao W, Robbins ME. Inflammation and chronic oxidative stress in radiation-induced late normal tissue injury: therapeutic implications. Curr Med Chem. 2009;16(2):130–43.
35. Kobayashi H, Gotoh J, Fujie M, Terao T. Characterization of the cellular binding site for the urinary trypsin inhibitor. J Biol Chem. 1994;269(32):20642–7.
36. Kobayashi H, Shinohara H, Takeuchi K, Itoh M, Fujie M, Saitoh M, et al. Inhibition of the soluble and the tumor cell receptor-bound plasmin by urinary trypsin inhibitor and subsequent effects on tumor cell invasion and metastasis. Cancer Res. 1994;54(3):844–9.
37. Hirano T, Manabe T. Human urinary trypsin inhibitor, urinastatin, prevents pancreatic injuries induced by pancreaticobiliary duct obstruction with cerulein stimulation and systemic hypotension in the rat. Arch Surg. 1993;128(12):1322–9; discussion 9.
38. Fujino N, Kubo H, Suzuki T, He M, Yamada M, Takahashi T, et al. Administration of a specific inhibitor of neutrophil elastase attenuates pulmonary fibrosis after acute lung injury in mice. Exp Lung Res. 2012;38(1):28–36.
39. Kouvaris JR, Kouloulias VE, Vlahos LJ. Amifostine: the first selective-target and broad-spectrum radioprotector. Oncologist. 2007;12(6):738–47.
40. Antonadou D, Petridis A, Synodinou M, Throuvalas N, Bolanos N, Veslemes M, et al. Amifostine reduces radiochemotherapy-induced toxicities in patients with locally advanced non-small cell lung cancer. Semin Oncol. 2003;30(6 Suppl 18):2–9.