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Article

Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer

  • Authors:
    • Yang Chen
    • Yiqi Du
    • Ping Li
    • Fei Wu
    • Yan Fu
    • Zhaoshen Li
    • Yongzhang Luo
  • View Affiliations / Copyright

    Affiliations: National Engineering Laboratory for Antitumor Protein Therapeutics, School of Life Sciences, Tsinghua University, Beijing 100084, P.R. China, Department of Gastroenterology, Changhai Hospital, Second Military Medical University, Shanghai 200433, P.R. China
  • Pages: 586-590
    |
    Published online on: March 27, 2014
       https://doi.org/10.3892/mco.2014.271
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Abstract

Pancreatic cancer is one of the most lethal and resistant to treatment of solid tumors. Combination therapies with various types of drugs against pancreatic cancer have been extensively investigated. Endostatin is a potent endogenous inhibitor of angiogenesis, which may be administered in combination with various chemotherapeutic agents in the treatment of several types of cancer. To the best of our knowledge, this phase I trial was the first clinical study to determine the tolerance, safety and efficacy of M2ES, a novel polyethylene glycosylated recombinant human endostatin, administered concurrently with full-dose gemcitabine in patients with inoperable, locally advanced or metastatic pancreatic adenocarcinoma. a total of 16 patients were treated with gemcitabine (1,000 mg̸m2 on days 1, 8 and 15) and M2ES (5-45 mg̸m2 on days 1, 8, 15 and 21) of each 28-day cycle. In 15 evaluable patients, the stable disease rate (SDR) was 40% (95% CI: 11.9‑68.1%). In particular, a 75% SDR was observed in 3 out of 4 patients with a M2ES dose level of 7.5 mg/m2. The most noticeable M2ES-related adverse events observed during the trial were grade 2 liver function abnormalities (6.3%) and grade 1 skin rash (6.3%). No dose-limiting toxicity was observed in any patients from all the dose levels. Therefore, there was no increased toxicity associated with the addition of M2ES to gemcitabine and this combination was well tolerated.
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1 

Yeo CJ and Cameron JL: Prognostic factors in ductal pancreatic cancer. Langenbecks Arch Surg. 383:129–133. 1998. View Article : Google Scholar : PubMed/NCBI

2 

Dunphy EP: Pancreatic cancer: a review and update. Clin J Oncol Nurs. 12:735–741. 2008. View Article : Google Scholar : PubMed/NCBI

3 

O’Reilly MS, Boehm T, Shing Y, et al: Endostatin: An endogenous inhibitor of angiogenesis and tumor growth. Cell. 88:277–285. 1997.

4 

Folkman J: Antiangiogenesis in cancer therapy - endostatin and its mechanisms of action. Exp Cell Res. 312:594–607. 2006. View Article : Google Scholar : PubMed/NCBI

5 

Shi HB, Huang YJ, Zhou H, et al: Nucleolin is a receptor that mediates antiangiogenic and antitumor activity of endostatin. Blood. 110:2899–2906. 2007. View Article : Google Scholar : PubMed/NCBI

6 

Zhuo W, Luo C, Wang X, Song X, Fu Y and Luo Y: Endostatin inhibits tumour lymphangiogenesis and lymphatic metastasis via cell surface nucleolin on lymphangiogenic endothelial cells. J Pathol. 222:249–260. 2010. View Article : Google Scholar

7 

Chen Y, Wang S, Lu X, Zhang H, Fu Y and Luo Y: Cholesterol sequestration by nystatin enhances the uptake and activity of endostatin in endothelium via regulating distinct endocytic pathways. Blood. 117:6392–6403. 2011. View Article : Google Scholar : PubMed/NCBI

8 

Kulke MH, Bergsland EK, Ryan DP, et al: Phase II study of recombinant human endostatin in patients with advanced neuroendocrine tumors. J Clin Oncol. 24:3555–3561. 2006. View Article : Google Scholar : PubMed/NCBI

9 

Wang J, Sun Y, Liu Y, et al: Results of randomized, multicenter, double-blind phase III trial of rh-endostatin (YH-16) in treatment of advanced non-small cell lung cancer patients. Chin J Lung Cancer. 8:283–290. 2005.(In Chinese).

10 

Roberts MJ, Bentley MD and Harris JM: Chemistry for peptide and protein PEGylation. Adv Drug Deliv Rev. 54:459–476. 2002. View Article : Google Scholar : PubMed/NCBI

11 

Weis SM and Cheresh DA: Tumor angiogenesis: molecular pathways and therapeutic targets. Nat Med. 17:1359–1370. 2011. View Article : Google Scholar : PubMed/NCBI

12 

Huang P, Chubb S, Hertel LW, Grindey GB and Plunkett W: Action of 2′,2′-difluorodeoxycytidine on DNA synthesis. Cancer Res. 51:6110–6117. 1991.

13 

Plunkett W, Huang P, Xu YZ, Heinemann V, Grunewald R and Gandhi V: Gemcitabine: metabolism, mechanisms of action, and self-potentiation. Semin Oncol. 22:3–10. 1995.PubMed/NCBI

14 

Burris HA III, Moore MJ, Andersen J, et al: Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a randomized trial. J Clin Oncol. 15:2403–2413. 1997.PubMed/NCBI

15 

Rocha Lima CM and Centeno B: Update on pancreatic cancer. Curr Opin Oncol. 14:424–430. 2002.

16 

Guchelaar HJ, Richel DJ and van Knapen A: Clinical, toxicological and pharmacological aspects of gemcitabine. Cancer Treat Rev. 22:15–31. 1996. View Article : Google Scholar : PubMed/NCBI

17 

Trotti A, Colevas AD, Setser A, et al: CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment. Semin Radiat Oncol. 13:176–181. 2003. View Article : Google Scholar : PubMed/NCBI

18 

Therasse P, Arbuck SG, Eisenhauer EA, 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. 92:205–216. 2000. View Article : Google Scholar

19 

Eisenhauer EA, Therasse P, Bogaerts J, et al: New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 45:228–247. 2009. View Article : Google Scholar

20 

Berlin JD, Catalano P, Thomas JP, Kugler JW, Haller DG and Benson AB III: Phase III study of gemcitabine in combination with fluorouracil versus gemcitabine alone in patients with advanced pancreatic carcinoma: Eastern Cooperative Oncology Group Trial E2297. J Clin Oncol. 20:3270–3275. 2002. View Article : Google Scholar

21 

Colucci G, Labianca R, Di Costanzo F, et al: Randomized phase III trial of gemcitabine plus cisplatin compared with single-agent gemcitabine as first-line treatment of patients with advanced pancreatic cancer: the GIP-1 study. J Clin Oncol. 28:1645–1651. 2010. View Article : Google Scholar : PubMed/NCBI

22 

Louvet C, Labianca R, Hammel P, et al; GERCOR; GISCAD. Gemcitabine in combination with oxaliplatin compared with gemcitabine alone in locally advanced or metastatic pancreatic cancer: results of a GERCOR and GISCAD phase III trial. J Clin Oncol. 23:3509–3516. 2005. View Article : Google Scholar : PubMed/NCBI

23 

Dugan E, Truax R, Meadows KL, et al: Phase I dose escalation study of gemcitabine plus irinotecan in advanced solid tumors. Anticancer Res. 29:5149–5153. 2009.PubMed/NCBI

24 

Moore MJ, Goldstein D, Hamm J, et al: Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J Clin Oncol. 25:1960–1966. 2007. View Article : Google Scholar

25 

Duffy A, Kortmansky J, Schwartz GK, et al: A phase I study of erlotinib in combination with gemcitabine and radiation in locally advanced, non-operable pancreatic adenocarcinoma. Ann Oncol. 19:86–91. 2008. View Article : Google Scholar : PubMed/NCBI

26 

Ardavanis A, Kountourakis P, Karagiannis A, Doufexis D, Tzovaras AA and Rigatos G: Biweekly gemcitabine (GEM) in combination with erlotinib (ERL): an active and convenient regimen for advanced pancreatic cancer. Anticancer Res. 29:5211–5217. 2009.PubMed/NCBI

27 

Scheithauer W, Schull B, Ulrich-Pur H, et al: Biweekly high-dose gemcitabine alone or in combination with capecitabine in patients with metastatic pancreatic adenocarcinoma: a randomized phase II trial. Ann Oncol. 14:97–104. 2003. View Article : Google Scholar : PubMed/NCBI

28 

Eder JP, Supko JG, Clark JW, et al: Phase I clinical trial of recombinant human endostatin administered as a short intravenous infusion repeated daily. J Clin Oncol. 20:3772–3784. 2002. View Article : Google Scholar : PubMed/NCBI

29 

Herbst RS, Hess KR, Tran HT, et al: Phase I study of recombinant human endostatin in patients with advanced solid tumors. J Clin Oncol. 20:3792–3803. 2002. View Article : Google Scholar : PubMed/NCBI

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Copy and paste a formatted citation
Spandidos Publications style
Chen Y, Du Y, Li P, Wu F, Fu Y, Li Z and Luo Y: Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. Mol Clin Oncol 2: 586-590, 2014.
APA
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., & Luo, Y. (2014). Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. Molecular and Clinical Oncology, 2, 586-590. https://doi.org/10.3892/mco.2014.271
MLA
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., Luo, Y."Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer". Molecular and Clinical Oncology 2.4 (2014): 586-590.
Chicago
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., Luo, Y."Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer". Molecular and Clinical Oncology 2, no. 4 (2014): 586-590. https://doi.org/10.3892/mco.2014.271
Copy and paste a formatted citation
x
Spandidos Publications style
Chen Y, Du Y, Li P, Wu F, Fu Y, Li Z and Luo Y: Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. Mol Clin Oncol 2: 586-590, 2014.
APA
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., & Luo, Y. (2014). Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer. Molecular and Clinical Oncology, 2, 586-590. https://doi.org/10.3892/mco.2014.271
MLA
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., Luo, Y."Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer". Molecular and Clinical Oncology 2.4 (2014): 586-590.
Chicago
Chen, Y., Du, Y., Li, P., Wu, F., Fu, Y., Li, Z., Luo, Y."Phase I trial of M2ES, a novel polyethylene glycosylated recombinant human endostatin, plus gemcitabine in advanced pancreatic cancer". Molecular and Clinical Oncology 2, no. 4 (2014): 586-590. https://doi.org/10.3892/mco.2014.271
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