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Ongoing Colorectal Cancer Adjuvant Trials in Japan

  • Published:
Current Colorectal Cancer Reports

Abstract

In Japan, oral fluoropyrimidines have been used widely as adjuvant therapy for colorectal cancers. The 2009 Japanese guideline recommends uracil-tegafur (UFT) and capecitabine, in addition to 5-fluorouracil (5-FU)/leucovorin (LV), as adjuvant therapy for colorectal cancer. At present, seven studies are being conducted in Japan; all are evaluating the efficacy of oral fluoropyrimidines. The SACURA and Japanese Foundation for Multidisciplinary Treatment of Cancer (JFMC)38-0901 trials are investigating the efficacy of UFT and UFT plus polysaccharide K compared with surgery alone for stage II colorectal cancer. The Japan Clinical Oncology Group (JCOG)-0205 trial is evaluating the equivalence of UFT/LV and infusional 5-FU/LV for the treatment of stage III colorectal cancer. The ACTS-CC trial is evaluating the noninferiority of S-1 compared with UFT/LV, whereas the JFMC35-C1 (ACTS-RC) trial is designed to evaluate the superiority of oral S-1 compared with UFT/LV in stage II and III rectal cancer patients. The JFMC37-0801 and JFMC33-0502 trials are evaluating the optimal duration of adjuvant chemotherapy with either capecitabine or UFT/LV.

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References

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  1. Japanese Society for Cancer of the Colon and Rectum (JSCCR): JSCCR Guidelines 2009 for the Treatment of Colorectal Cancer. Tokyo: Kanehara & Co., Ltd.; 2009.

    Google Scholar 

  2. Japanese Society for Cancer of the Colon and Rectum: Japanese Classification of Colorectal Carcinoma Second English Edition. Tokyo: Kanehara & Co., Ltd.; 2009.

    Google Scholar 

  3. Gunderson LL, Jessup JM, Sargent DJ, et al.: Revised tumor and node categorization for rectal cancer based on surveillance, epidemiology, and end results and rectal pooled analysis outcomes. J Clin Oncol 2010, 28:256–263.

    Article  PubMed  Google Scholar 

  4. Benson AB 3rd, Schrag D, Somerfield MR, et al.: American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer. J Clin Oncol 2004, 22:3408–3419.

    Article  PubMed  Google Scholar 

  5. Van Cutsem E, Oliveira J; ESMO Guidelines Working Group: Primary colon cancer: ESMO clinical recommendations for diagnosis, adjuvant treatment and follow-up. Ann Oncol 2009, 20(Suppl 4):49–50.

    PubMed  Google Scholar 

  6. National Comprehensive Cancer Network: NCCN Clinical Practice Guidelines in Oncology. Available at http://www.nccn.org/professionals/physician_gls/f_guidelines.asp. Accessed March 2010.

  7. The Colorectal Cancer Chemotherapy Study Group of Japan: Five-year results of a randomized controlled trial of adjuvant chemotherapy for curatively resected colorectal carcinoma. Jpn J Clin Oncol 1995, 25:91–103.

    Google Scholar 

  8. Kodaira S, Kikuchi K, Yasutomi M, et al.: Postoperative adjuvant chemotherapy with mitomycinC and UFT for curatively resected rectal cancer. Results from the Cooperative Project No.7 Group of the Japanese foundation for Multidisciplinary Treatment of Cancer. Int J Clin Oncol 1998, 3:357–364.

    Article  Google Scholar 

  9. Kato T, Ohashi Y, Nakazato H, et al.: Efficacy of oral UFT as adjuvant chemotherapy to curative resection of colorectal cancer: multicenter prospective randomized trial. Langenbecks Arch Surg 2002, 286:575–581.

    Google Scholar 

  10. Hamaguchi T, Shirao K, Moriya Y, et al.; NSAS-CC group: Adjuvant chemotherapy with uracil-tegafur (UFT) for stage III colorectal cancer: final results of randomized trials by the National Surgical Adjuvant Study of Colorectal Cancer (NSAS-CC) [abstract]. J Clin Oncol 2007, 25(18S):4049.

    Google Scholar 

  11. Twelves C, Wong A, Nowacki MP, et al.: Capecitabine as adjuvant treatment for stage III colon cancer. N Engl J Med 2005, 352:2696–2704.

    Article  CAS  PubMed  Google Scholar 

  12. Lembersky BC, Wieand HS, Petrelli NJ, et al.: Oral uracil and tegafur plus leucovorin compared with intravenous fluorouracil and leucovorin in stage II and III carcinoma of the colon: results from National Surgical Adjuvant Breast and Bowel Project Protocol C-06. J Clin Oncol 2006, 24:2059–2064.

    Article  CAS  PubMed  Google Scholar 

  13. Akasu T, Moriya Y, Ohashi Y, et al.; National Surgical Adjuvant Study of Colorectal Cancer: Adjuvant chemotherapy with uracil-tegafur for pathological stage III rectal cancer after mesorectal excision with selective lateral pelvic lymphadenectomy: a multicenter randomized controlled trial. Jpn J Clin Oncol 2006, 36:237–244.

    Article  PubMed  Google Scholar 

  14. Sakamoto J, Ohashi Y, Hamada C, et al.; Meta-Analysis Group of the Japanese Society for Cancer of the Colon and Rectum; Meta-Analysis Group in Cancer: Efficacy of oral adjuvant therapy after resection of colorectal cancer: 5-year results from three randomized trials. J Clin Oncol 2004, 22:484–492.

    PubMed  Google Scholar 

  15. Sakamoto J, Hamada C, Yoshida S, et al.: An individual patient data meta-analysis of adjuvant therapy with uracil-tegafur (UFT) in patients with curatively resected rectal cancer. Br J Cancer 2007, 96:1170–1177.

    Article  CAS  PubMed  Google Scholar 

  16. ClinicalTrials.gov: Tegafur-Uracil or Observation in Treating Patients With Stage II Colorectal Cancer That Has Been Completely Removed by Surgery. Available at http://clinicaltrials.gov/ct2/show/NCT00392899?term=colon+japan&rank=2. Accessed March 2010.

  17. Watanabe T, Wu TT, Catalano PJ, et al.: Molecular predictors of survival after adjuvant chemotherapy for colon cancer. N Engl J Med 2001, 344:1196–1206.

    Article  CAS  PubMed  Google Scholar 

  18. UMIN-CTR database: Randomized Phase III Trial Comparing Surgery-alone to UFT+PSK in Stage II Rectal Cancer (JFMC38-0901). Available at https://center.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000001843&language=J. Accessed March 2010.

  19. Ohwada S, Ikeya T, Yokomori T, et al.: Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study. Br J Cancer 2004, 90:1003–1010.

    Article  CAS  PubMed  Google Scholar 

  20. Sakamoto J, Morita S, Oba K, et al.; Meta-Analysis Group of the Japanese Society for Cancer of the Colon Rectum: Efficacy of adjuvant immunochemotherapy with polysaccharide K for patients with curatively resected colorectal cancer: a meta-analysis of centrally randomized controlled clinical trials. Cancer Immunol Immunother 2006, 55:404–411.

    Article  CAS  PubMed  Google Scholar 

  21. UMIN-CTR database: Randomized Phase III Trial Comparing Adjuvant Oral UFT/LV to 5-FU/L-LV in Stage III Colorectal Cancer (JCOG-0205-MF). Available at https://center.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000000265&language=J. Accessed March 2010.

  22. • Coleman MP, Quaresma M, Berrino F, et al.; CONCORD Working Group: Cancer survival in five continents: a worldwide population-based study (CONCORD). Lancet Oncol 2008, 9:730–756. This study shows that cancer survival varies widely among countries. It provides survival estimates for 1.9 million adults diagnosed with a first, primary, invasive cancer of the breast (women), colon, rectum, and prostate.

    Article  PubMed  Google Scholar 

  23. •• Sakuramoto S, Sasako M, Yamaguchi T, et al.: Adjuvant chemotherapy for gastric cancer with S-1, an oral fluoropyrimidine. N Engl J Med 2007, 357:1810–1820. This article presents the results of a large randomized controlled study of gastric cancer patients in Japan. The study demonstrated the efficacy of S-1, an oral fluoropyrimidine, as adjuvant therapy for gastric cancer patients.

    Article  CAS  PubMed  Google Scholar 

  24. ClinicalTrials.gov: Tegafur-Uracil and Leucovorin or S-1 in Treating Patients With Stage III Colon Cancer That Has Been Completely Removed by Surgery. Available at http://clinicaltrials.gov/ct2/show/NCT00660894?term=colon+japan&rank=4. Accessed March 2010.

  25. UMIN-CTR database: A Randomized Controlled Study Comparing S-1 With UFT as Postoperative Adjuvant Chemotherapy in Rectal Cancer. (JFMC35-C1:ACTS-RC). Available at https://center.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000000475&language=J. Accessed March 2010.

  26. UMIN-CTR database: An Open-Label Randomized Phase III Study of Capecitabine(6 months) versus Capecitabine(12 months) as Adjuvant Chemotherapy for Stage III(Dukes’C)Colon Cancer Patients. (JFMC37-0801). Available at https://center.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000001662&language=J. Accessed March 2010.

  27. UMIN-CTR database: Phase III Comparative Clinical Trial of Treatment Schedules for Oral UFT/LV Therapy as Postoperative Adjuvant Chemotherapy for Stage IIB/III Colorectal Cancer (JFMC33-0502). Available at https://center.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000000304&language=J. Accessed March 2010.

  28. • André T, Boni C, Navarro M, et al.: Improved overall survival with oxaliplatin, fluorouracil, and leucovorin as adjuvant treatment in stage II or III colon cancer in the MOSAIC trial. J Clin Oncol 2009, 27:3109–3116. This study showed the efficacy of oxaliplatin-containing therapy (FOLFOX therapy) as adjuvant therapy for colon cancer patients.

    Article  PubMed  Google Scholar 

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Acknowledgments

The author thanks Riyo Kakimoto for technical and secretarial support.

This study was supported by a Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science, and Technology of Japan, and by a grant from the Ministry of Health, Labor and Welfare of Japan.

Disclosure

Dr. Watanabe has received research funding from Yakult Honsha Co., Ltd.; Taiho Pharmaceutical Co., Ltd.; Chugai Pharmaceutical Co., Ltd.; Bristol Myers Co., Ltd.; and Merck Serono Co., Ltd.

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Authors and Affiliations

  1. Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo, 173-8605, Japan

    Toshiaki Watanabe

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  1. Toshiaki Watanabe
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Correspondence to Toshiaki Watanabe.

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Watanabe, T. Ongoing Colorectal Cancer Adjuvant Trials in Japan. Curr Colorectal Cancer Rep 6, 168–174 (2010). https://doi.org/10.1007/s11888-010-0056-z

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