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Safety of Lienal Polypeptide Injection Combined with Chemotherapy in Treating Patients with Advanced Cancer

  • Huang, Xin-En (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Wang, Lin (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Ji, Zhu-Qing (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Liu, Meng-Yan (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Qian, Ting (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Li, Li (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research)
  • Published : 2015.12.03

Abstract

Objective: To assess the safety of Liena polypeptide injection (produced by JILIN FSENS PHARMACEUTICAL CO.,LTD) combined with chemotherapy in treating patients with advanced cancers. Method: A consecutive cohort of patients with advanced cancers were treated with Liena polypeptide injection combined with chemotherapy. And chemotherapy for patients with advanced cancers were adopted from regimens suggested by NCCN guideline. Liena polypeptide injection was intravenously injected at a dosage of 2ml plus 100ml normal saline for continuous 7 days during chemotherapy as one course. After at least two courses of treatment, safety and side effects were evaluated. Results: There were 20 female and 14 male patients with advanced cancer recruited into this study, including 10 patients with breast, 8 patients with colorectal, 8 patients with lung, 4 patients with gastric, and 1 patient with esophageal cancer, as well as 1 patient with non-Hodgkin's lymphoma, 1 patient with low pharyngeal and 1 patient with urethral cancer. The median age of patients was 59 (40-82) years. Incidences of Grade 1 to 2 myelosuppression was observed in 5/34 patients, and Grade 1 to 2 elevation of hepatic enzyme was recorded in 3/34 patients. Adverse effects on the gastrointestinal tract were documented in 5/34 patients, and were Grade 1. No Grade 3-4 toxicities were diagnosed. No treatment related death was found. Conclusions: Liena polypeptide injection combined with chemotherapy was safe in treating several sites of tumors, that mainly included lung, colorectal and breast cancer. However, further study should be conducted to clarify the effectiveness of this treatment.

Keywords

Lienal polypeptide injection;chemotherapy;advanced cancer

References

  1. Alisa A, Ives A, Pathan AA, et al (2005). Analysis of CD4+ T-Cell responses to a novel alpha-fetoprotein-derived epitope in hepatocellular carcinoma patients. Clin Cancer Res, 11, 6686-94. https://doi.org/10.1158/1078-0432.CCR-05-0382
  2. Alving CR, Peachman KK, Rao M, et al (2012). Adjuvants for human vaccines. Curr Opin Immunol, 24, 310-5. https://doi.org/10.1016/j.coi.2012.03.008
  3. Arihara F, Mizukoshi E, Kitahara M, et al (2013). Increase in CD14+HLA-DR -/low myeloid-derived suppressor cells in hepatocellular carcinoma patients and its impact on prognosis. Cancer Immunol Immunother, 62, 1421-30. https://doi.org/10.1007/s00262-013-1447-1
  4. Arruebo M, Fernandez-Pacheco R, Ibarra MR, et al (2007). Magnetic nanoparticles for drug delivery. Nano Today, 2, 22-32.
  5. Belardelli F, Ferrantini M, Proietti E, et al (2002). Interferonalpha in tumor immunity and immunotherapy. Cytokine Growth Factor Rev, 13, 119-34. https://doi.org/10.1016/S1359-6101(01)00022-3
  6. Bode C, Zhao G, Steinhagen F, et al (2011). CpG DNA as a vaccine adjuvant. Expert Rev Vaccines, 10, 499-511. https://doi.org/10.1586/erv.10.174
  7. Brannon-Peppas L, Blanchette JO (2004). Nanoparticle and targeted systems for cancer therapy. Adv Drug Deliv Rev, 56, 1649-59. https://doi.org/10.1016/j.addr.2004.02.014
  8. Chen KJ, Lin SZ, Zhou L, et al (2011). Selective recruitment of regulatory T cell through CCR6-CCL20 in hepatocellular carcinoma fosters tumor progression and predicts poor prognosis. PLoS One, 6, e24671. https://doi.org/10.1371/journal.pone.0024671
  9. Chen W, Zheng R, Zeng H, et al (2014). Trend analysis of the changes of male/female, urban/rural incidences and average age of cancer patients in China 1989-2008. Chin J Oncol, 36, 796-800.
  10. Chen Z, Shen S, Peng B, et al (2009). Intratumoural GM-CSF microspheres and CTLA-4 blockade enhance the antitumour immunity induced by thermal ablation in a subcutaneous murine hepatoma model. Int J Hyperthermia, 25, 374-82. https://doi.org/10.1080/02656730902976807
  11. Cheng M, Chen Y, Xiao W, et al (2013). NK cell-based immunotherapy for malignant diseases. Cell Mol Immunol, 10, 230-52. https://doi.org/10.1038/cmi.2013.10
  12. Cheng Y, Zhang G, Li G (2013). Targeting MAPK pathway in melanoma therapy. Cancer Metastasis Rev, 32, 567-84. https://doi.org/10.1007/s10555-013-9433-9
  13. Crispe IN, Giannandrea M, Klein I, et al (2006). Cellular and molecular mechanisms of liver tolerance. Immunol Rev, 213, 101-18. https://doi.org/10.1111/j.1600-065X.2006.00435.x
  14. Ferlay J, Shin H, Bray F, et al (). GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide; IARC Cancer Base No. 10; International Agency for Research on Cancer: Lyon, France, 2010; Volume 2010, p. 29.
  15. Gao Q, Qiu SJ, Fan J, et al (2007). Intratumoral balance of regulatory and cytotoxic T cells is associated with prognosis of hepatocellular carcinoma after resection. J Clin Oncol, 25, 2586-2593. https://doi.org/10.1200/JCO.2006.09.4565
  16. Hoechst B, Voigtlaender T, Ormandy L, et al (2009). Myeloid derived suppressor cells inhibit natural killer cells in patients with hepatocellular carcinoma via the NKp30 receptor. Hepatology, 50, 799-807. https://doi.org/10.1002/hep.23054
  17. Ilkovitch D, Lopez DM (2009). The liver is a site for tumorinduced myeloid-derived suppressor cell accumulation and immunosuppression. Cancer Res, 69, 5514-21. https://doi.org/10.1158/0008-5472.CAN-08-4625
  18. Jemal A, Bray F, Center MM, et al (2011). Global cancer statistics. CA Cancer J Clin, 61, 69-90. https://doi.org/10.3322/caac.20107
  19. Kalyanaraman B, Joseph J, Kalivendi S, et al (2002). Doxorubicininduced apoptosis: implications in cardiotoxicity. Mol Cell Biochem, 234-235, 119-124. https://doi.org/10.1023/A:1015976430790
  20. Komorizono Y, Kohara K, Oketani M, et al (2003). Systemic combined chemotherapy with low dose of 5-fluorouracil, cisplatin, and interferon-alpha for advanced hepatocellular carcinoma: a pilot study. Dig Dis Sci, 48, 877-81. https://doi.org/10.1023/A:1023035109665
  21. Lin SM, Lin CJ, Hsu CW, et al (2004). Prospective randomized controlled study of interferon-alpha in preventing hepatocellular carcinoma recurrence after medical ablation therapy for primary tumors. Cancer, 100, 376-82. https://doi.org/10.1002/cncr.20004
  22. Liu L (2014). The global significance of China's cancer burden and control effort. Ann Transl Med, 2014, 2.
  23. National Bureau of Statistics of China (2011). China Population and Employment Statistics Yearbook, China Statistics Press: Beijing, China, 2012.
  24. Naumov GN, Townson JL, MacDonald IC, et al (2003). Ineffectiveness of doxorubicin treatment on solitary dormant mammary carcinoma cells or late-developing metastases. Breast Cancer Res Treat, 82, 199-206. https://doi.org/10.1023/B:BREA.0000004377.12288.3c
  25. Obi S, Yoshida H, Toune R, et al (2006). Combination therapy of intraarterial 5-fluorouracil and systemic interferon-alpha for advanced hepatocellular carcinoma with portal venous invasion. Cancer, 106, 1990-7. https://doi.org/10.1002/cncr.21832
  26. Ormandy LA, Hillemann T, Wedemeyer H, et al (2005). Increased populations of regulatory T cells in peripheral blood of patients with hepatocellular carcinoma. Cancer Res, 65, 2457-64. https://doi.org/10.1158/0008-5472.CAN-04-3232
  27. Ozols RF, Herbst RS, Colson YL, et al (2006). Clinical cancer advances 2006: major research advances in cancer treatment, prevention, and screening - a report from the American society of clinical oncology. Jpn J Clin Oncol, 25, 146-62. https://doi.org/10.1200/JCO.2006.09.7030
  28. Patt YZ, Hassan MM, Lozano RD, et al (2003). Phase II trial of systemic continuous fluorouracil and subcutaneous recombinant interferon Alfa-2b for treatment of hepatocellular carcinoma. J Clin Oncol, 21, 421-7. https://doi.org/10.1200/JCO.2003.10.103
  29. Peng XH, Qian X, Mao H, et al (2008). Targeted magnetic iron oxide nanoparticles for tumor imaging and therapy. Int J Nanomedicine, 3, 311-21.
  30. Rosenberg SA, Yang JC, Restifo NP, et al (2004). Cancer immunotherapy: moving beyond current vaccines. Nat Med, 10, 909-15. https://doi.org/10.1038/nm1100
  31. Rosenberg SA (2001). Progress in human tumour immunology and immuno-therapy. Nature, 411, 380-4. https://doi.org/10.1038/35077246
  32. Rosenberg SA, Yang JC, White DE, et al (1998). Durability of complete responses in patients with metastatic cancer treated with high-dose interleukin-2: identification of the antigens mediating response. Ann Surg, 228, 307-19. https://doi.org/10.1097/00000658-199809000-00004
  33. Rougier P, Mitry E, Barbare JC, et al (2007). Hepatocellular carcinoma (HCC): an update. Semin Oncol, 34, S12-20. https://doi.org/10.1053/j.seminoncol.2007.01.007
  34. Schuster M, Nechansky A, Kircheis R (2006) . Cancer immunotherapy. Biotechnol J, 1, 138-47. https://doi.org/10.1002/biot.200500044
  35. Serda RE (2013) . Particle platforms for cancer immunotherapy. Int J Nanomedicine, 8, 1683-96.
  36. Shurin MR, Naiditch H, Gutkin DW, et al (2012). ChemoImmunoModulation: immune regulation by the antineoplastic chemotherapeutic agents. Curr Med Chem, 19, 1792-803. https://doi.org/10.2174/092986712800099785
  37. Singh RK, Gutman M, Bucana CD, et al (1995). Interferons alpha and beta down-regulate the expression of basic fibroblast growth factor in human carcinomas. Proc Natl Acad Sci USA, 92, 4562-6. https://doi.org/10.1073/pnas.92.10.4562
  38. Sun HC, Tang ZY, Wang L, et al (2006). Postoperative interferon alpha treatment postponed recurrence and improved overall survival in patients after curative resection of HBV-related hepatocellular carcinoma: a randomized clinical trial. J Cancer Res Clin Oncol, 132, 458-65. https://doi.org/10.1007/s00432-006-0091-y
  39. Talmadge JE (1998). Pharmacodynamic aspects of peptide administration biological response modifiers. Adv Drug Deliv Rev, 33, 241-52. https://doi.org/10.1016/S0169-409X(98)00032-5
  40. Vadrot N, Legrand A, Nello E, et al (2006). Inducible nitric oxide synthase (iNOS) activity could be responsible for resistance or sensitivity to IFN-gamma-induced apoptosis in several human hepatoma cell lines. J Interferon Cytokine Res, 26, 901-13. https://doi.org/10.1089/jir.2006.26.901
  41. WHO. GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. Available online: http://globocan.iarc.fr (accessed on 17 May 2015).

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