Phase II trial of recombinant human endostatin in combination with concurrent chemoradiotherapy in patients with stage III non-small-cell lung cancer

Radiotherapy and Oncology

Volumn 114, Issue 2, 2015, Pages 161-166

  Bao, Yong ^a   Peng, Fang ^b   Zhou, Qi Chao ^a   Yu, Zhong Hua ^c   Li, Jian Cheng ^d   Cheng, Zhi Bin ^e   Chen, Long ^f   Hu, Xiao ^a   Chen, Yuan Yuan ^g   Wang, Jin ^g   Wang, Yan ^h   Ma, Hong Lian ^g   Xu, Zu Min ^c   Lu, Ru Biao ^a   Deng, Xiao Wu ^a   Chen, Ming ^a  

^a SUN YAT SEN UNIVERSITY CANCER CENTER   (China)

^b SUN YAT SEN UNIVERSITY   (China)

^c GUANGDONG MEDICAL UNIVERSITY   (China)

^d FUJIAN PROVINCIAL TUMOR HOSPITAL   (China)

^e THE FIFTH AFFILIATED HOSPITAL OF SUN YAT SEN UNIVERSITY   (China)

^f GUANGXI MEDICAL UNIVERSITY   (China)

^g ZHEJIANG CANCER HOSPITAL   (China)

^h GUANGZHOU GENERAL HOSPITAL OF GUANGZHOU MILITARY COMMAND   (China)

Author keywords

Angiogenesis inhibitor; Chemotherapy; Endostatin; Lung cancer; Radiotherapy

Indexed keywords

CISPLATIN; DEXAMETHASONE; DOCETAXEL; FLUORODEOXYGLUCOSE F 18; RECOMBINANT ENDOSTATIN; SEROTONIN AGONIST; ANTINEOPLASTIC AGENT; ENDOSTATIN; TAXOID;

ADULT; ADVANCED CANCER; AGED; ALLERGIC REACTION; ANEMIA; ANTIANGIOGENIC THERAPY; ARTICLE; BLEEDING; CANCER COMBINATION CHEMOTHERAPY; CANCER CONTROL; CANCER GROWTH; CANCER LOCALIZATION; CANCER MORTALITY; CANCER PATIENT; CANCER SIZE; CANCER STAGING; CANCER SURVIVAL; CHEMORADIOTHERAPY; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; COMPUTER ASSISTED RADIOTHERAPY; COMPUTER ASSISTED TOMOGRAPHY; CONTRAST ENHANCEMENT; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; ESOPHAGITIS; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; HYPERTENSION; INFECTION; LEUKOPENIA; LINEAR ACCELERATOR; LYMPHOCYTOPENIA; MALE; MEDICATION COMPLIANCE; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NON SMALL CELL LUNG CANCER; OVERALL SURVIVAL; PARESTHESIA; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PREMEDICATION; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RADIATION DOSE; RADIATION INDUCED EMESIS; RADIATION INJURY; RADIATION RESPONSE; RESPIRATORY FAILURE; SINGLE BLIND PROCEDURE; SKIN TOXICITY; THROMBOCYTOPENIA; TRACHEOESOPHAGEAL FISTULA; TREATMENT DURATION; TREATMENT REFUSAL; TREATMENT RESPONSE; VOMITING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; LUNG NEOPLASMS; MIDDLE AGED; PATHOLOGY; PROSPECTIVE STUDY; SURVIVAL RATE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CHEMORADIOTHERAPY; CISPLATIN; DISEASE-FREE SURVIVAL; ENDOSTATINS; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROSPECTIVE STUDIES; SURVIVAL RATE; TAXOIDS;

EID: 84926141704     PISSN: 01678140     EISSN: 18790887     Source Type: Journal    
DOI: 10.1016/j.radonc.2014.11.039     Document Type: Article

References (46)

1. D.G. Pfister, D.H. Johnson, and C.G. Azzoli American Society of Clinical Oncology treatment of unresectable non-small-cell lung cancer guideline: update 2003 J Clin Oncol 22 2004 330 353
2. R.O. Dillman, J. Herndon, S.L. Seagren, W.L. Eaton Jr., and M.R. Green Improved survival in stage III non-small-cell lung cancer: seven-year follow-up of cancer and leukemia group B (CALGB) 8433 trial J Natl Cancer Inst 88 1996 1210 1215
3. W.T. Sause, C. Scott, and S. Taylor Radiation Therapy Oncology Group (RTOG) 88-08 and Eastern Cooperative Oncology Group (ECOG) 4588: preliminary results of a phase III trial in regionally advanced, unresectable non-small-cell lung cancer J Natl Cancer Inst 87 1995 198 205
4. K. Furuse, M. Fukuoka, and M. Kawahara Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer J Clin Oncol 17 1999 2692 2699
5. B. Jeremic, Y. Shibamoto, L. Acimovic, and S. Milisavljevic Hyperfractionated radiation therapy with or without concurrent low-dose daily carboplatin/etoposide for stage III non-small-cell lung cancer: a randomized study J Clin Oncol 14 1996 1065 1070
6. C. Schaake-Koning, W. van den Bogaert, and O. Dalesio Effects of concomitant cisplatin and radiotherapy on inoperable non-small-cell lung cancer N Engl J Med 326 1992 524 530
7. P. Zatloukal, L. Petruzelka, and M. Zemanova Concurrent versus sequential chemoradiotherapy with cisplatin and vinorelbine in locally advanced non-small cell lung cancer: a randomized study Lung Cancer 46 2004 87 98
8. R. Rengan, A.M. Maity, J.P. Stevenson, and S.M. Hahn New strategies in non-small cell lung cancer: improving outcomes in chemoradiotherapy for locally advanced disease Clin Cancer Res 17 2011 4192 4199
9. W.J. Curran Jr., R. Paulus, and C.J. Langer Sequential vs. concurrent chemoradiation for stage III non-small cell lung cancer: randomized phase III trial RTOG 9410 J Natl Cancer Inst 103 2011 1452 1460
10. G.R. Blumenschein Jr., R. Paulus, and W.J. Curran Phase II study of cetuximab in combination with chemoradiation in patients with stage IIIA/B non-small-cell lung cancer: RTOG 0324 J Clin Oncol 29 2011 2312 2318
11. O. Arrieta, M. Blake, and M.D. de la Mata-Moya Phase II study. Concurrent chemotherapy and radiotherapy with nitroglycerin in locally advanced non-small cell lung cancer Radiother Oncol 111 2014 311 315
12. A. Sgambato, F. Casaluce, P. Maione, A. Rossi, F. Ciardiello, and C. Gridelli Cetuximab in advanced non-small cell lung cancer (NSCLC): the showdown? J Thoracic Dis 6 2014 578 580
13. R. Komaki, R. Paulus, and G.R. Blumenschein Jr. EGFR expression and survival in patients given cetuximab and chemoradiation for stage III non-small cell lung cancer: a secondary analysis of RTOG 0324 Radiother Oncol 112 2014 30 36
14. M.S. O'Reilly, T. Boehm, and Y. Shing Endostatin: an endogenous inhibitor of angiogenesis and tumor growth Cell 88 1997 277 285
15. Y. Ling, Y. Yang, and N. Lu Endostar, a novel recombinant human endostatin, exerts antiangiogenic effect via blocking VEGF-induced tyrosine phosphorylation of KDR/Flk-1 of endothelial cells Biochem Biophys Res Commun 361 2007 79 84
16. X.D. Jiang, P. Dai, Y. Qiao, J. Wu, D.A. Song, and S.Q. Li Clinical study on the recombinant human endostatin regarding improving the blood perfusion and hypoxia of non-small-cell lung cancer Clin Transl Oncol 14 2012 437 443
17. X.D. Jiang, P. Dai, J. Wu, D.A. Song, and J.M. Yu Effect of recombinant human endostatin on radiosensitivity in patients with non-small-cell lung cancer Int J Radiat Oncol Biol Phys 83 2012 1272 1277
18. X.D. Jiang, Y. Qiao, and P. Dai Preliminary clinical study of weekly recombinant human endostatin as a hypoxic tumour cell radiosensitiser combined with radiotherapy in the treatment of NSCLC Clin Transl Oncol 14 2012 465 470
19. M.B. Meng, X.D. Jiang, and L. Deng Enhanced radioresponse with a novel recombinant human endostatin protein via tumor vasculature remodeling: experimental and clinical evidence Radiother Oncol 106 2013 130 137
20. F. Peng, Z. Xu, and J. Wang Recombinant human endostatin normalizes tumor vasculature and enhances radiation response in xenografted human nasopharyngeal carcinoma models PLoS One 7 2012 e34646
21. B.H. Han, Q.Y. Xiu, and H.M. Wang A multicenter, randomized, double-blind, placebo-controlled safety study to evaluate the clinical effects and quality of life of paclitaxel-carboplatin (PC) alone or combined with Endostar for advanced non-small cell lung cancer (NSCLC) Zhonghua Zhong Liu Za Zhi 33 2011 854 859
22. J. Wang, Y. Sun, and Y. Liu Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients Zhongguo fei ai za zhi 8 2005 283 290
23. J. Folkman Antiangiogenesis in cancer therapy-endostatin and its mechanisms of action Exp Cell Res 312 2006 594 607
24. X. Hu, Y. Bao, and L. Zhang Omitting elective nodal irradiation and irradiating postinduction versus preinduction chemotherapy tumor extent for limited-stage small cell lung cancer: interim analysis of a prospective randomized noninferiority trial Cancer 118 2012 278 287
25. P. Giraud, M. Antoine, and A. Larrouy Evaluation of microscopic tumor extension in non-small-cell lung cancer for three-dimensional conformal radiotherapy planning Int J Radiat Oncol Biol Phys 48 2000 1015 1024
26. K.E. Rosenzweig, S. Sura, A. Jackson, and E. Yorke Involved-field radiation therapy for inoperable non small-cell lung cancer J Clin Oncol 25 2007 5557 5561
27. M. Chen, J.A. Hayman, R.K. Ten Haken, D. Tatro, S. Fernando, and F.M. Kong Long-term results of high-dose conformal radiotherapy for patients with medically inoperable T1-3N0 non-small-cell lung cancer: is low incidence of regional failure due to incidental nodal irradiation? Int J Radiat Oncol Biol Phys 64 2006 120 126
28. M. Nakamura, T. Koizumi, and M. Hayasaka Cisplatin and weekly docetaxel with concurrent thoracic radiotherapy for locally advanced stage III non-small-cell lung cancer Cancer Chemother Pharmacol 63 2009 1091 1096
29. M.A. Socinski, T.E. Stinchcombe, and D.T. Moore Incorporating bevacizumab and erlotinib in the combined-modality treatment of stage III non-small-cell lung cancer: results of a phase I/II trial J Clin Oncol 30 2012 3953 3959
30. J. Bussink, J.H. Kaanders, and A.J. van der Kogel Tumor hypoxia at the micro-regional level: clinical relevance and predictive value of exogenous and endogenous hypoxic cell markers Radiother Oncol 67 2003 3 15
31. M. Nordsmark, S.M. Bentzen, and V. Rudat Prognostic value of tumor oxygenation in 397 head and neck tumors after primary radiation therapy. An international multi-center study Radiother Oncol 77 2005 18 24
32. P. Sonveaux Provascular strategy: targeting functional adaptations of mature blood vessels in tumors to selectively influence the tumor vascular reactivity and improve cancer treatment Radiother Oncol 86 2008 300 313
33. R.K. Jain Normalization of tumor vasculature: an emerging concept in antiangiogenic therapy Science 307 2005 58 62
34. A. Sandler, R. Gray, and M.C. Perry Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer N Engl J Med 355 2006 2542 2550
35. J.S. Lind, S. Senan, and E.F. Smit Pulmonary toxicity after bevacizumab and concurrent thoracic radiotherapy observed in a phase I study for inoperable stage III non-small-cell lung cancer J Clin Oncol 30 2012 e104 e108
36. D.R. Spigel, J.D. Hainsworth, and D.A. Yardley Tracheoesophageal fistula formation in patients with lung cancer treated with chemoradiation and bevacizumab J Clin Oncol 28 2010 43 48
37. T.E. Stinchcombe, and J.A. Bogart Novel approaches of chemoradiotherapy in unresectable stage IIIA and stage IIIB non-small cell lung cancer Oncologist 17 2012 682 693
38. A. Abdollahi, P. Hahnfeldt, and C. Maercker Endostatin's antiangiogenic signaling network Mol Cell 13 2004 649 663
39. J. Hanai, M. Dhanabal, and S.A. Karumanchi Endostatin causes G1 arrest of endothelial cells through inhibition of cyclin D1 J Biol Chem 277 2002 16464 16469
40. A. Sudhakar, H. Sugimoto, C. Yang, J. Lively, M. Zeisberg, and R. Kalluri Human tumstatin and human endostatin exhibit distinct antiangiogenic activities mediated by alpha v beta 3 and alpha 5 beta 1 integrins Proc Natl Acad Sci U S A 100 2003 4766 4771
41. K.S. Albain, J.J. Crowley, and A.T. Turrisi 3rd Concurrent cisplatin, etoposide, and chest radiotherapy in pathologic stage IIIB non-small-cell lung cancer: a Southwest Oncology Group phase II study, SWOG 9019 J Clin Oncol 20 2002 3454 3460
42. K. Kiura, H. Ueoka, and Y. Segawa Phase I/II study of docetaxel and cisplatin with concurrent thoracic radiation therapy for locally advanced non-small-cell lung cancer Br J Cancer 89 2003 795 802
43. R. Govindan, J. Bogart, and T. Stinchcombe Randomized phase II study of pemetrexed, carboplatin, and thoracic radiation with or without cetuximab in patients with locally advanced unresectable non-small-cell lung cancer: Cancer and Leukemia Group B trial 30407 J Clin Oncol 29 2011 3120 3125
44. M.R. Mancuso, R. Davis, and S.M. Norberg Rapid vascular regrowth in tumors after reversal of VEGF inhibition J Clin Investig 116 2006 2610 2621
45. R.S. Herbst, K.R. Hess, and H.T. Tran Phase I study of recombinant human endostatin in patients with advanced solid tumors J Clin Oncol 20 2002 3792 3803
46. X. Zhao, K. Mei, and X. Cai A randomized phase II study of recombinant human endostatin plus gemcitabine/cisplatin compared with gemcitabine/cisplatin alone as first-line therapy in advanced non-small-cell lung cancer Invest New Drugs 30 2012 1144 1149