DOI QR코드

DOI QR Code

Clinical Study on Safety and Efficacy of JiSaiXin (Recombinant Human Granulocyte Colony Stimulating Factor Injection Manufactured in China) for Chinese Undergoing Chemotherapy

  • Wang, Lin (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University and Jiangsu Institute of Cancer Research) ;
  • Huang, Xin-En (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University and Jiangsu Institute of Cancer Research)
  • Published : 2015.02.04

Abstract

Objectives: To assess safety and efficacy of JiSaiXin (Recombinant Human Granulocyte Colony Stimulating Factor Injection manufactured in China, G-CSF) 150ug per day for three days and whether this regimen could reduce the incidence of febrile neutropenia caused by chemotherapy. Method: From July 2014 to December 2014 patients treated by chemotherapy in our hospital were randomly divided into two groups: Group A with prophylactic use of G-CSF (JiSaiXin) 24 hours after chemotherapy for consecutive 3 days; and Group B with G-CSF (JiSaiXin) after neutropenia. Routine blood tests were performed 7 days and 14 days after chemotherapy. Results: A total of 100 patients fulfilled study criteria, and the incidence of severe neutropenia (grade III/IV) and the incidence of febrile neutropenia in Group A were lower than those in Group B. Nine patients were found severe neutropenia (grade III/IV) in Group B, but one in Group A, three febrile neutropenia in Group B, but 0 in Group A. Conclusions: This study suggested that prophylactic use of G-CSF (JiSaiXin) 150ug per day 24 hours after chemotherapy for consecutive 3 days is safe and could be effective for preventing febrile neutropenia in patients with chemotherapy.

Keywords

References

  1. Caggiano V, Weiss RV, Rickert TS, et al (2005). 1ncidence, cost, and mortality of neutropenia hospitalization associated with chemotherapy.Cancer, 103, 1916-24. https://doi.org/10.1002/cncr.20983
  2. Cui L, Liu XX, one more author, et al (2014). Phase II study on dose escalating schedule of paclitaxel concurrent with radiotherapy in treating patients with locally advanced non-small cell lung cancer. Asian Pac J Cancer Prev, 15, 1699-702. https://doi.org/10.7314/APJCP.2014.15.4.1699
  3. Deng QQ, Huang XE, Ye LH, et al (2013). Phase II trial of Loubo(R) (lobaplatin) and pemetrexed for patients with metastatic breast cancer not responding to anthracycline or taxanes. Asian Pac J Cancer Prev, 14, 413-7. https://doi.org/10.7314/APJCP.2013.14.1.413
  4. Gong JP, Yang L, one more author, et al (2014). Outcomes based on risk assessment of anastomotic leakage after rectal cancer surgery. Asian Pac J Cancer Prev, 15, 707-12. https://doi.org/10.7314/APJCP.2014.15.2.707
  5. Hou ZB, Lu KJ, one more author, et al (2014). In vitro and in vivo antitumor evaluation of berbamine for lung cancer treatment. Asian Pac J Cancer Prev, 15, 1767-9. https://doi.org/10.7314/APJCP.2014.15.4.1767
  6. Huang XE, Cao J, one more author, et al (2014). Leucogen tablets at 60 mg three times per day are safe and effective to control febrile neutropenia. Asian Pac J Cancer Prev, 15, 8495-7. https://doi.org/10.7314/APJCP.2014.15.19.8495
  7. Huang XE, Tian GY, Cao J, et al (2013). Pemetrexed as a component of first-, second- and third-line chemotherapy in treating patients with metastatic lung adenocarcinoma. Asian Pac J Cancer Prev, 14, 6663-7. https://doi.org/10.7314/APJCP.2013.14.11.6663
  8. Huang XE, Wei GL, Huo JG, et al (2013). Intrapleural or intraperitoneal lobaplatin for treatment of patients with malignant pleural effusion or ascites. Asian Pac J Cancer Prev, 14, 2611-4. https://doi.org/10.7314/APJCP.2013.14.4.2611
  9. Kuderer NM, Dale DC, Crawford J, et al (2007). Impact of primary prophylaxis with granulocyte colony-stimulating factor on febrile neutropenia and mortality in adult cancer patients receiving chemotherapy: a systematic review. J Clin Oncol, 25, 3158-67. https://doi.org/10.1200/JCO.2006.08.8823
  10. Kuderer NM, Dale DC, Crawford J, et al (2006). Mortality, morbidity, and cost associated with febrile neutropenia in adult cancer patients. Cancer, 106, 2258-66. https://doi.org/10.1002/cncr.21847
  11. Lal A, Bhurgri Y, Rizvi N, et al (2008). Factors influencing in-hospital length of stay and mortality in cancer patients suffering from ferile neutropenia. Asian Pac J Cancer Prev, 9, 303-8.
  12. Liu J, Huang XE, Feng JF et al (2014). Further study on pemetrexed based chemotherapy in treating patients with advanced gastric cancer (AGC). Asian Pac J Cancer Prev, 15, 6587-90. https://doi.org/10.7314/APJCP.2014.15.16.6587
  13. Liu J, Huang XE, Tian GY, et al (2013). Phase II Study on safety and efficacy of Yadanzi(R) (Javanica oil emulsion injection) combined with chemotherapy for patients with gastric cancer. Asian Pac J Cancer Prev, 14, 2009-12. https://doi.org/10.7314/APJCP.2013.14.3.2009
  14. Lu YY, Huang XE, et al (2014). Clinical observations on associations between the UGT1A1 genotype and severe toxicity of irinotecan. Asian Pac J Cancer Prev, 15, 3335-41. https://doi.org/10.7314/APJCP.2014.15.7.3335
  15. Smith TC, Khatcheressian J, Lvman GH, et al (2006). Update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline, J Clin Onco1, 24, 3187-205. https://doi.org/10.1200/JCO.2006.06.4451
  16. Tan HTK, Hurley D, Daniel G, et al (2011). Comparative effectiveness of colony-stimulating factors for febrile neutropenia: a retrospective study. Curr Med Res Opin, 27, 79-6. https://doi.org/10.1185/03007995.2010.536527
  17. Tian GY, Miu M, Huang XE, et al (2014). Systematic analysis of pemetrexed-based chemoradiotherapy for patients with locally advanced or metastatic esophageal cancer. Asian Pac J Cancer Prev, 15, 8475-8. https://doi.org/10.7314/APJCP.2014.15.19.8475
  18. Weycker D, Malin J, Glass A, et al (2007). Economic burden of chemotherapy-related febrile neutropenia. J Support Oncol, 5, 44-5.
  19. Weycker DMJ, Barron R, Edelsberg J, et al (2011). Comparative effectiveness of filgrastim, pegfilgrastim, and sargramostim as prophylaxis against hospitalization for neutropenic complications in patients with cancer receiving chemotherapy. Am J Clin Oncol, 35, 267-74.
  20. Wu XY, Huang XE, You SX, et al (2013). Phase II study of pemetrexed as second or third line combined chemotherapy in patients with colorectal cancer. Asian Pac J Cancer Prev, 14, 2019-22. https://doi.org/10.7314/APJCP.2013.14.3.2019
  21. Xu C, Lv PH, one more author, et al (2014). Safety and efficacy of sequential transcatheter arterial chemoembolization and portal vein embolization prior to major hepatectomy for patients with HCC. Asian Pac J Cancer Prev, 15, 703-6. https://doi.org/10.7314/APJCP.2014.15.2.703
  22. Yan HA, Shen K, Huang XE (2013). Clinical study on mannan peptide combined with TP regimen in treating patients with non-small cell lung cancer. Asian Pac J Cancer Prev, 14, 4801-4. https://doi.org/10.7314/APJCP.2013.14.8.4801
  23. Zhang Jing, Yu Shiying , et al (2014). The current G-CSF use in cancer patients with chemotherapy. Chinese-German J Clin Oncol, 13, 6.

Cited by

  1. Clinical Application of Serum Tumor Abnormal Protein (TAP) in Colorectal Cancer Patients vol.16, pp.8, 2015, https://doi.org/10.7314/APJCP.2015.16.8.3425
  2. Safety and Efficacy of a Mouth-Rinse with Granulocyte Colony Stimulating Factor in Patients with Chemotherapy-Induced Oral Mucositis vol.17, pp.1, 2016, https://doi.org/10.7314/APJCP.2016.17.1.413
  3. A Clinical Study on Juheli (Recombinant Human Interleukin - 11) in the Second Prevention of Chemotherapy Induced Thrombocytopenia vol.17, pp.2, 2016, https://doi.org/10.7314/APJCP.2016.17.2.485