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Phase II Study of Pemetrexed as Second or Third Line Combined Chemotherapy in Patients with Colorectal Cancer

  • Wu, Xue-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) ;
  • You, Shan-Xi (Department of Oncology, The No.4 Hospital of Taizhou of Jiangsu Province) ;
  • Lu, Yan-Yan (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) ;
  • 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)
  • 발행 : 2013.03.30

초록

Purpose: To investigate the safety and efficacy of pemetrexed combined with chemotherapy as second or third line in patients with stage IV colorectal cancer (CRC). Patients and Methods: This trial was conducted to evaluate the effectiveness and safety of pemetrexed given to patients with recurrent or metastatic colorectal carcinoma who previously received 5-FU-based chemotherapy. All patients were required to have a histological diagnosis of colorectal adenocarcinoma with measurable metastatic disease and prior chemotherapy. Patients received pemetrexed at a dose of 500 $mg/m^2$ by 10 minute infusion on day 1, repeated every 21 days. Doses were modified depending on nadir counts. Combined chemotherapy included Oxaliplatin, Irinotecan and cis-platinum. Results: Thirty patients were enrolled and twenty-nine were evaluable for response. One patient did not have repeat radiological testing to determine response because he went off study after only one cycle of treatment for economic reasons. For 29 evaluable patients, 1 partial response, 6 stable disease and 22 progressive disease were recorded. Response rate was 3.45% (1/29). All responses occurred in patients receiving a starting dose of pemetrexed 500 $mg/m^2$. Median time to progression for all eligible patients was 2.5 months. The most common toxicities experienced were mild to moderate fever, hepatic damage, myelosuppression, nausea, vomiting, constipation, abdominal pain, diarrhea, and skin rash. Conclusion: Pemetrexed at 500 $mg/m^2$ given every three weeks combined with chemotherapy is associated with moderate response and good tolerability in patients with stage IV CRC.

키워드

참고문헌

  1. Atkins JN, Jacobs SA, Wieand HS, et al (2005). Pemetrexed/oxaliplatin for first-line treatment of patients with advanced colorectal cancer, a phase II trial of the National Surgical Adjuvant Breast and Bowel Project Foundation Research Program. Clin Colorectal Cancer, 5, 181-7. https://doi.org/10.3816/CCC.2005.n.029
  2. Conti JA, Kemeny N, Saltz L et al (1996). Irinotecan is an active agent in untreated patients with metastatic colorectal cancer. J Clin Oncol, 14, 709-15.
  3. Cripps C, Burnell M, Jolivet J, et al (1999). Phase II study of first-line LY231514 (multi-targeted antifolate) in patients with locally advanced or metastatic colorectal cancer, an NCIC Clinical Trials Group study. Ann Oncol, 10, 1175-9. https://doi.org/10.1023/A:1008372529239
  4. Cunningham D, Pyrhonen S, James RD, et al (1998). Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer. Lancet, 352, 1413-8. https://doi.org/10.1016/S0140-6736(98)02309-5
  5. De Gramont A, Figer A, Seymour M, et al (1998). Randomized trial of leucovorin and 5-fluorouracil with or without oxaliplatin in advanced colorectal cancer. Proc Am Soc Clin Oncol, 17, 257a (Abstr).
  6. Findlay M,Van Cutsem E, KochaW, et al (1997). A randomized phase II study of capecitabine in patients with advanced colorectal cancer. Proc Am Soc Clin Oncol, 16, 227a (Abstr).
  7. 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.
  8. 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
  9. 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.
  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. John W, Picus J, Blanke CD, et al (2000). Activity of multitargeted antifolate (pemetrexed disodium, LY231514) in patients with advanced colorectal carcinoma, results from a phase II study. Cancer, 88, 1807813.
  12. 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
  13. 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.
  14. 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.
  15. Li Y, Yan PW, Huang XE, Li CG (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.
  16. 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
  17. Nogue M, Segui MA, Batiste E et al (1996). Phase II study of oral Tegafur (TF) and low-dose oral leucovorin in advanced colorectal cancer. Proc Am Soc Clin Oncol, 15, 200 (Abstr).
  18. Shih C, Gosset L, Gates S, et al (1996). LY231514 and its polyglutamates exhibit potent inhibition against both human dihydrofolate reductase(DHFR) and thymidylate synthase (TS), Multiple folate enzyme inhibition. Ann Oncol, 7, 85. https://doi.org/10.1093/annonc/7.suppl_1.85
  19. 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
  20. Sudoh J, Gemma A (2008). [Pemetrexed]. Gan To Kagaku Ryoho, 35, 1033-8.
  21. 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.
  22. 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.
  23. 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.
  24. 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
  25. 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.
  26. 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.
  27. Yu DS, Huang XE, Zhou JN (2012). 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
  28. 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.
  29. 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
  30. 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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