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Phase II Study on Pemetrexed-based Chemotherapy in Treating Patients with Metastatic Gastric Cancer not Responding to Prior Palliative Chemotherapy

  • Wei, Guo-Li (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) ;
  • Huo, Jie-Ge (Jiangsu Province Hospital on Integration of Chinese and Western Medicine) ;
  • Wang, Xiao-Ning (Jiangsu Province Hospital on Integration of Chinese and Western Medicine) ;
  • Tang, Jin-Hai (Department of General Surgery, the Affiliated Jiangsu Cancer Hospital of Nanjing Medical University & Jiangsu Institute of Cancer Research)
  • Published : 2013.05.30

Abstract

Purpose: This study was to determine the efficacy and safety of pemetrexed based chemotherapy in treating patients with metastatic gastric cancer who failed to respond to first and (or) second line chemotherapy. Patients and Methods: Metastatic gastric cancer patients who failed first and (or) second line chemotherapy, were enrolled. All patients were recruited from Jiangsu Cancer Hospital & Research Institute, and were treated with pemetrexed $500mg/m2$ (intravenous; on day 1), and a platinum (or irinotecan) every 3 weeks until disease progression, or intolerable toxicity. Evaluation on efficacy was conducted after two cycles of chemotherapy using the Response Evaluation Criteria for Solid Tumors. Toxicity was recorded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Results: From Jun 2011 to May 2013, 23 patients were enrolled. All eligible 23 patients completed at least 2 cycles of chemotherapy with pemetrexed based chemotherapy, and were evaluable. Their median age was 55 years (range 40 to 78 years). Seventeen patients were male and 6 female. Three patients (13%) achieved partial response, five patients (22%) stable, 15 patients (65%) with disease progression, and none with complete response. Grade 2 neutrophil suppression occurred in 4.3%, grade 3 in 13% of patients, and no grade 4 was reported. Thrombocytopenia was encountered as follows: 4.3% grade 2, 4.3% grade 3 and 4.3% grade 4. Incidence of anemia was 34.8% in grade 2, 8.7% grade 3 and 0% grade 4. Only 4.3% of patients required packed red blood cell infusion. Elevated transaminase were 4.3% in grade 2 and 0% in grade 3 or 4. Other toxicity included oral mucositis. Conclusions: Pemetrexed based chemotherapy is mildly effective in treating patients with metastatic gastric cancer with tolerable toxicity.

Keywords

Metastatic gastric cancer;pemetrexed;phase II study

References

  1. Adjei AA (2004). Pemetrexed (ALIMTA), a novel multitargeted antineoplastic agent. Clin Cancer Res, 10, S4276-80. https://doi.org/10.1158/1078-0432.CCR-040010
  2. Ajani JA (2005). Evolving chemotherapy for advanced gastric cancer. Oncologist, 10, 49-58. https://doi.org/10.1634/theoncologist.10-90003-49
  3. Bajetta E, Celio L, Buzzoni R, et al (2003). Phase II study of pemetrexed disodium (alimta ) administered with oral folic acid in patients with advanced gastric cancer. Ann Oncol, 14, 1543-8. https://doi.org/10.1093/annonc/mdg406
  4. Celio L, Buzzoni R, Longarini R, et al (2002). Pemetrexed in gastric cancer: clinical experience and future perspectives. Semin Oncol, 29, 63-8. https://doi.org/10.1053/sonc.2002.37475
  5. Celio L, Sternberg CN, Labianca R, et al (2009). Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: a multi-institutional phase II study. Ann Oncol, 20, 1062-1067. https://doi.org/10.1093/annonc/mdn766
  6. Chen JS, Chao Y, Bang YJ, et al (2010). A phase I/II and pharmacogenomic study of pemetrexed and cisplatin in patients with unresectable, advanced gastric carcinoma. Anticancer Drugs, 21, 777-84. https://doi.org/10.1097/CAD.0b013e32833cfbca
  7. 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
  8. 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.
  9. 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
  10. 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.
  11. 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.
  12. 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
  13. 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.
  14. Karpeh MS, Kelsen DP, Tepper JE (2001). Cancer of the stomach. In DeVita VTJr, Hellman S, Rosenberg SA (eds): Cancer: Principles and Practice of Oncology, 6th edition. Philadelphia, PA: Lippincott, Williams and Wilkins, 1092-126.
  15. Kim JH, Lee KW, Jung Y, et al (2005). Cytotoxic effects of pemetrexed in gastric cancer cells. Cancer Sci, 96, 365-71. https://doi.org/10.1111/j.1349-7006.2005.00058.x
  16. Kim YH, Chung HC, Kang WK, et al (2008). Pemetrexed and cisplatin in patients with advanced gastric cancer: a Korean cancer study group multicenter phase II study. Cancer Chemother Pharmacol, 62, 263-70. https://doi.org/10.1007/s00280-007-0600-y
  17. 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.
  18. 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
  19. 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.
  20. 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.
  21. 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
  22. 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
  23. 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
  24. 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
  25. Martin M (2006). Clinical experience with pemetrexed in breast cancer. Semin Oncol, 33, S15-18.
  26. Ohtsu A (2008). Chemotherapy for metastatic gastric cancer:past, present, and future. J Gastroenterol, 43, 256-64. https://doi.org/10.1007/s00535-008-2177-6
  27. Parkin DM, Bray F, Ferlay J et al (2005). Global cancer statistics, 2002. CA Cancer J Clin, 55, 74-108. https://doi.org/10.3322/canjclin.55.2.74
  28. Parkin DM, Bray FI, Devesa SS (2001). Cancer burden in the year 2000. The global picture. Eur J Cancer, 37, S4-66.
  29. Pozzo C, Barone C (2008). Is there an optimal chemotherapy regimen for the treatment of advanced gastric cancer that will provide a platform for the introduction of new bio-logical agents? Oncologist, 13, 794-806. https://doi.org/10.1634/theoncologist.2008-0082
  30. Rollins KD, Lindley C (2005). Pemetrexed: a multitargeted antifolate. Clin Ther, 27, 1343-82. https://doi.org/10.1016/j.clinthera.2005.09.010
  31. Ross P, Nicolson M, Cunningham D, et al (2002). Prospective randomized trial comparing mitomycin, cisplatin, and protracted venous-infusion fluorouracil (PVI 5-FU) with epirubicin, cisplatin, and PVI 5-FU in advanced esophagogastric cancer. J Clin Oncol, 20, 1996-2004. https://doi.org/10.1200/JCO.2002.08.105
  32. 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
  33. Sun JM, Lee KW, Kim JH, et al (2009). Efficacy and toxicity of pemetrexed as a third-line treatment for non-small cell lung cancer. Jpn J Clin Oncol, 39, 27-32.
  34. 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
  35. Wagner AD, Unverzagt S, Grothe W, et al (2010). Chemotherapy for advanced gastric cancer. Cochrane Database Syst Rev, 3, CD004064.
  36. 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
  37. 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.
  38. 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.
  39. 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.
  40. 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
  41. 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
  42. Yan PW, Huang XE, Jiang Y, et al (2010). A clinical comparison on safety and efficacy of Paclitaxel/Epirubicin (NE) with Fluorouracil/Epirubicin/Cyclophosphamide (FEC) as postoperative adjuvant chemotherapy in breast cancer. Asian Pac J Cancer Prev, 11, 1115-8.
  43. 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.
  44. 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
  45. 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
  46. 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
  47. 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
  48. 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
  49. Zhang LQ, Huang XE, Wang J (2011). The cyclin D1 G870A polymorphism and colorectal cancer susceptibility: a metaanalysis of 20 populations. Asian Pac J Cancer Prev, 12, 81-5.
  50. 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
  51. 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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