Asian Pacific Journal of Cancer Prevention

Asian Pacific Journal of Cancer Prevention (아시아태평양암예방학회)
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Phase II Study on Javanica Oil Emulsion Injection (Yadanzi®) Combined with Chemotherapy in Treating Patients with Advanced Lung Adenocarcinoma

  • Lu, Yan-Yan (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Huang, Xin-En (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Cao, Jie (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Xu, Xia (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Wu, Xue-Yan (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Liu, Jin (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Xiang, Jin (Department of Research, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research) ;
  • Xu, Lin (Department of Chemotherapy, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research)
  • Published : 2013.08.30
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Abstract

Purpose: To investigate the efficacy and safety of Javanica oil emulsion injection (Yadanzi$^{(R)}$) combined with pemetrexed and platinum (PP) for treating patients with advanced lung cancer. Patients and Methods: From June 2011 to June 2013, we recruited 58 patients with advanced lung cancer, and divided them into two groups. Twenty eight patients received Yadanzi$^{(R)}$ (from ZheJiang Jiuxu Pharmaceutical Co., Ltd.) together with PP chemotherapy (combined group), while the others were given only PP chemotherapy (control group). After two cycles of treatment, efficacy and safety of treatment were evaluated. Results: The overall respnse rate [(CR+PR+SD)/(CR+PR+SD+PD)] of the combined group was higher than that of control group (89.7% vs. 86.2%, p>0.05). Regarding rate of life improvement, it was 82.8% in combined group, and 51.7% in the control group (p<0.05). In terms of side effects, leukopenia in combined group was less frequent than that in control group (p<0.05). More patients in the control group were found to suffer liver toxicity. Conclusions: Javanica oil emulsion injection combined with chemotherapy could be considered as a safe and effective regimen in treating patients with advanced lung adenocarcinoma. It can improve the quality of life and reduce the possibility of leukopenia. Further clinical trials with a large sample size should be conducted to confirm whether addition of Yadanzi$^{(R)}$ to chemotherapy could increase the response rate, reduce toxicity, enhance tolerability and improve quality of life for patients with advanced lung cancer.

Keywords

References

  1. Bunn PA Jr (2002) Chemotherapy for advanced non-small-cell lung cancer: who, what, when, why? J Clin Oncol, 20, S23-33.
  2. De Angelis V (2004). Activity, objective response, and WHO and RECIST (Response Evaluation Criteria In Solid Tumor) evaluation criteria. Suppl Tumori, 3, S7-9.
  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. Ding CX, Suo RY (2006). The Study of Chinese Medicine Brucea in Pharmacology and chemical composition. Chinese Traditional Patient Medicine, 28(1). [in chinese]
  5. Gao LL, Huang XE, Zhang Q, et al (2011). A Cisplatin and vinorelbine (NP) regimen as a postoperative adjuvant chemotherapy for completely resected breast cancers in China: final results of a phase II clinical trial. Asian Pac J Cancer Prev, 12, 77-80.
  6. Gong P, Huang XE, Chen CY, et al (2012). Comparison on complications of peripherally inserted central catheters by ultrasound guide or conventional method in cancer patients. Asian Pac J Cancer Prev, 13, 1873-5. https://doi.org/10.7314/APJCP.2012.13.5.1873
  7. Gu M, Li SY, Huang XE, et al (2013). A phase II study on continuous infusional paclitaxel and 5-Fu as first-line chemotherapy for patients with advanced esophageal cancer. Asian Pac J Cancer Prev, 13, 5587-91.
  8. Huang XE, Li CG, Li Y, et al (2011). Weekly TP regimen as a postoperative adjuvant chemotherapy for completely resected breast cancer in China: final result of a phase II trial. Asian Pac J Cancer Prev, 12, 2797-800.
  9. 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
  10. Jiang Y, Huang XE, Yan PW, et al (2010). Validation of treatment efficacy of a computer-assisted program for breast cancer patients receiving postoperative adjuvant chemotherapy.Asian Pac J Cancer Prev, 11, 1059-62.
  11. Li CG, Huang XE, Li Y, et al (2011). Clinical observations on safety and efficacy of OxyContin(R) administered by rectal route in treating cancer related pain. Asian Pac J Cancer Prev, 12, 2477-8.
  12. Li CG, Huang XE, Li Y, et al (2011). Phase II trial of irinotecan plus nedaplatin (INP) in treating patients with extensive stage small cell lung cancer. Asian Pac J Cancer Prev, 12, 487-90.
  13. Li CG, Huang XE, Xu L, et al (2012). Clinical application of serum tumor associated material (TAM) from non-small cell lung cancer patients. Asian Pac J Cancer Prev, 13, 301-4. https://doi.org/10.7314/APJCP.2012.13.1.301
  14. Li Y, Yan PW, Huang XE, et al (2011). MDR1 gene C3435T polymorphism is associated with clinical outcomes in gastric cancer patients treated with postoperative adjuvant chemotherapy. Asian Pac J Cancer Prev, 12, 2405-9.
  15. 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
  16. Liu JH, Zhao N, Zhang GJ (2012). Bioactive quassinoids from the seeds of Brucea javanica. J Nat Prod, 75, 683-8. https://doi.org/10.1021/np200920c
  17. Liu W, Li SY, Huang XE, et al (2012). Inhibition of tumor growth in vitro by a combination of extracts from rosa roxburghii tratt and fagopyrum cymosum. Asian Pac J Cancer Prev, 13, 2409-14. https://doi.org/10.7314/APJCP.2012.13.5.2409
  18. Liu YC, Zhou SB, Gao F, et al (2013). Chemotherapy and Late Course Three Dimensional Conformal Radiotherapy for Treatment of Patients with Stage III Non- small Cell Lung Cancer. Asian Pac J Cancer Prev, 14, 2663-5. https://doi.org/10.7314/APJCP.2013.14.4.2663
  19. 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
  20. Lu YY, Huang XE, Xu L, et al (2013). Potential predictors of sensitivity to pemetrexed as first-line chemotherapy for patients with advanced non-squamous NSCLCs. Asian Pac J Cancer Prev, 14, 2005-8. https://doi.org/10.7314/APJCP.2013.14.3.2005
  21. Ma YK, Hu AX, Zhou M (2004). The progress of javanica oil in clinical application. Shandong Med J, 44. [in chinese]
  22. McCulloch M, See C, Shu XJ, et al (2006). Astragalus-based Chinese herbs and platinum-based chemotherapy for advanced non-small-cell lung cancer: meta-analysis of randomized trials. J Clin Oncol, 24, 419-30. https://doi.org/10.1200/JCO.2005.03.6392
  23. Ping X, Wang J, Zhang SX, et al (1996). The bone marrow protective effect of Javanica oil emulsion in patients with chemotherapy. Henan J Oncol, 9, 71. [in chinese]
  24. Rosell R, Viteri S, Molina MA, et al (2010). Epidermal growth factor receptor tyrosine kinase inhibitors as first-line treatment in advanced nonsmall-cell lung cancer. Curr Opin Oncol, 22, 112-20. https://doi.org/10.1097/CCO.0b013e32833500d2
  25. Shu J, Li CG, Liu YC, et al (2012). Comparison of Serum Tumor Associated Material (TAM) with Conventional Biomarkers in Cancer Patients. Asian Pac J Cancer Prev, 13, 2399-403. https://doi.org/10.7314/APJCP.2012.13.5.2399
  26. Sohaib A (2012). RECIST rules. Cancer Imaging, 12, 345-6. https://doi.org/10.1102/1470-7330.2012.9011
  27. Sun MQ, Meng AF, Huang XE, et al (2013). Comparison of psychological influence on breast cancer patients between breast-conserving surgery and modified radical mastectomy. Asian Pac J Cancer Prev, 14, 149-52. https://doi.org/10.7314/APJCP.2013.14.1.149
  28. Taixiang W, Munro AJ, Guanjian L (2005). Chinese medical herbs for chemotherapy side effects in colorectal cancer patients. Cochrane Database Syst Rev, 25, CD004540.
  29. Wang Q, Wang M, He X, et al (2012). [Meta-analysis on treatment of non-small cell lung cancer with brucea javanica oil emulsion in combination with platinum-contained first-line chemotherapy]. Zhongguo Zhong Yao Za Zhi, 37, 2022-9. Chinese.
  30. 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
  31. Xu HX, Huang XE, Li Y, et al (2011). A clinical study on safety and efficacy of Aidi injection combined with chemotherapy. Asian Pac J Cancer Prev, 12, 2233-6.
  32. Xu HX, Huang XE, Qian ZY, et al (2011). Clinical observation of Endostar(R) combined with chemotherapy in advanced colorectal cancer patients. Asian Pac J Cancer Prev, 12, 3087-90.
  33. Xu JW, Li CG, Huang XE, et al (2011). Ubenimex capsule improves general performance and chemotherapy related toxicity in advanced gastric cancer cases. Asian Pac J Cancer Prev, 12, 985-7.
  34. Xu T, Xu ZC, Zou Q, Yu B, Huang XE (2012). P53 Arg72Pro polymorphism and bladder cancer risk--meta-analysis evidence for a link in Asians but not Caucasians. Asian Pac J Cancer Prev, 13, 2349-54. https://doi.org/10.7314/APJCP.2012.13.5.2349
  35. Xu X, Wang L, Xu HQ, et al (2013). Clinical Comparison between Paclitaxel Liposome (Lipusu(R)) and Paclitaxel for Treatment of Patients with Metastatic Gastric Cancer. Asian Pac J Cancer Prev, 14, 2591-4. https://doi.org/10.7314/APJCP.2013.14.4.2591
  36. Yamamoto Y, Iwase H (2012). Management for treatment-induced adverse reaction-chemotherapy. Nihon Rinsho, 70, 672-6
  37. Yan PW, Huang XE, Yan F, et al (2011). Influence of MDR1 gene codon 3435 polymorphisms on outcome of platinum-based chemotherapy for advanced non small cell lung cancer. Asian Pac J Cancer Prev, 12, 2291-4.
  38. Yin HT, Tian QZ, Guan L (2013). In vitro and in vivo evaluation of the antitumor efficiency of resveratrol against lung cancer. Asian Pac J Cancer Prev, 14, 1703-6. https://doi.org/10.7314/APJCP.2013.14.3.1703
  39. Yin HT, Zhang DG, Wu XL (2013). In vivo evaluation of curcumin-loaded nanoparticles in a A549 xenograft mice model. Asian Pac J Cancer Prev, 14, 409-12. https://doi.org/10.7314/APJCP.2013.14.1.409
  40. Yu DS, Huang XE, Zhou JN, et al (2012). A Comparative study on the value of anal preserving surgery for aged people with low rectal carcinoma in Jiangsu, China. Asian Pac J Cancer Prev, 13, 2339-40. https://doi.org/10.7314/APJCP.2012.13.5.2339
  41. Zhan YP, Huang XE, Cao J (2012). Clinical safety and efficacy of Kanglaite(R) (Coix Seed Oil) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev, 13, 5319-21. https://doi.org/10.7314/APJCP.2012.13.10.5319
  42. Zhan YP, Huang XE, Cao J (2012). Clinical study on safety and efficacy of Qinin(R) (cantharidin sodium) injection combined with chemotherapy in treating patients with gastric cancer. Asian Pac J Cancer Prev, 13, 4773-6. https://doi.org/10.7314/APJCP.2012.13.9.4773
  43. Zhang LQ, Huang XE, Wang J (2011). The cyclin D1 G870A polymorphism and colorectal cancer susceptibility: a meta-analysis of 20 populations. Asian Pac J Cancer Prev, 12, 81-5.
  44. Zhang XZ, Huang XE, Xu YL, et al (2012). Phase II study on voriconazole for treatment of Chinese patients with malignant hematological disorders and invasive aspergillosis. Asian Pac J Cancer Prev, 13, 2415-8. https://doi.org/10.7314/APJCP.2012.13.5.2415
  45. Zhou JN, Huang XE, Ye Z, et al (2009). Weekly paclitaxel/ Docetaxel combined with a paltinum in the treatment of advanced non-samll cell lung cancer: a study on efficacy, safety and pre-medication. Asian Pac J Cancer Prev, 10, 1147-50.

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