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A Randomized Trial Comparing Postoperative Adjuvant Chemotherapy with Cisplatin and 5-Fluorouracil Versus Preoperative Chemotherapy for Localized Advanced Squamous Cell Carcinoma of the Thoracic Esophagus (JCOG9907)

  • Thoracic Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Patients with esophageal carcinoma receiving postoperative chemotherapy showed superior disease-free survival than those receiving surgery alone in a Japan Clinical Oncology Group trial (JCOG9204). The purpose of this study was to evaluate optimal perioperative timing—that is, before or after surgery—for providing chemotherapy in patients with locally advanced esophageal squamous cell carcinoma.

Methods

Eligible patients with clinical stage II or III, excluding T4, squamous cell carcinoma were randomized to undergo surgery followed (group 1) or preceded (group 2) by chemotherapy consisting of two courses of cisplatin plus 5-fluorouracil. The primary end point was progression-free survival.

Results

We randomized 330 patients, with 166 assigned to group 1 and 164 to group 2, between May 2000 and May 2006. The planned interim analysis was conducted after completion of patient accrual. Progression-free survival did not reach the stopping boundary, but overall survival in group 2 was superior to that of group 1 (P = 0.01). Therefore, the Data and Safety Monitoring Committee recommended early publication. Updated analyses showed the 5-year overall survival to be 43% in group 1 and 55% in group 2 (hazard ratio 0.73, 95% confidence interval 0.54–0.99, P = 0.04), where the median follow-up of censored patients was 61.6 months. Concerning operative morbidity, renal dysfunction after surgery in group 2 was slightly higher than in group 1.

Conclusions

Preoperative chemotherapy with cisplatin plus 5-fluorouracil can be regarded as standard treatment for patients with stage II/III squamous cell carcinoma.

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References

  1. Ando N, Iizuka T, Ide H, et al. Surgery plus chemotherapy compared with surgery alone for localized squamous cell carcinoma of the thoracic esophagus: a Japan Clinical Oncology Group Study—JCOG 9204. J Clin Oncol. 2003;21:4592–6.

    Article  PubMed  Google Scholar 

  2. Urba SG, Orringer MB, Turrisi A, Iannettoni M, Forastiere A, Strawderman M. Randomized trial of preoperative chemoradiation versus surgery alone in patients with locoregional esophageal carcinoma. J Clin Oncol. 2001;19:305–13.

    PubMed  CAS  Google Scholar 

  3. Burmeister BH, Smithers BM, Gebski V, et al. Surgery alone versus chemoradiotherapy followed by surgery for resectable cancer of the esophagus: a randomized controlled phase III trial. Lancet Oncol. 2005;6:659–68.

    Article  PubMed  Google Scholar 

  4. Tepper J, Krasna MJ, Niedzwiecki D, et al. Phase III trial of trimodality therapy with cisplatin, fluorouracil, radiotherapy, and surgery compared with surgery alone for esophageal cancer: CALGB 9781. J Clin Oncol. 2008;26:1086–92.

    Article  PubMed  CAS  Google Scholar 

  5. Medical Research Council Oesophageal Cancer Working Party. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002;359:1727–33.

    Article  Google Scholar 

  6. Allum WH, Stenning SP, Bancewicz J, Clark PI, Langley RE. Long-term results of a randomized trial of surgery with or without preoperative chemotherapy in esophageal cancer. J Clin Oncol. 2009;27:5062–7.

    Article  PubMed  Google Scholar 

  7. Kelsen DP, Ginsberg R, Pajak TF, et al. Chemotherapy followed by surgery compared with surgery alone for localized esophageal cancer. N Engl J Med. 1998;339:1979–84.

    Article  PubMed  CAS  Google Scholar 

  8. Kelsen DP, Winter KA, Gunderson LL, et al. Long-term results of RTOG Trial 8911 (USA Intergroup 113): a random assignment trial comparison of chemotherapy followed by surgery compared with surgery alone for esophageal cancer. J Clin Oncol. 2007;25:3719–25.

    Article  PubMed  Google Scholar 

  9. Leichman L, Bodnar LM, Arshad II. Esophageal carcinoma. In: Pollock RE (ed): UICC manual of clinical oncology. 8th ed. New York: Wiley-Liss, 2004. p. 429–46.

    Google Scholar 

  10. Sobin LH, Wittekind C. TNM classification of malignant tumors. 6th ed. New York: Wiley-Liss; 2002. p. 60–5.

    Google Scholar 

  11. Kitajima M, Kitagawa Y. Surgical treatment of esophageal cancer—the advent of the era of individualization. N Engl J Med. 2002;347:1705–9.

    Article  PubMed  Google Scholar 

  12. Fujita H, Kakegawa T, Yamana H, et al. Mortality and morbidity rates, postoperative course, quality of life, and prognosis after extended radical lymphadenectomy for esophageal cancer. Comparison of three-field lymphadenectomy with two-field lymphadenectomy. Ann Surg. 1995;222:654–62.

    Article  PubMed  CAS  Google Scholar 

  13. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205–16.

    Article  PubMed  CAS  Google Scholar 

  14. National Cancer Institute. Cancer therapy evaluation program, common toxicity criteria. Version 2.0. Bethesda, MD: National Cancer Institute;1999. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm. Accessed 9 Nov, 2009.

  15. Japanese Society for Esophageal Diseases. Guideline for clinical and pathological studies on carcinoma of the esophagus (ed 9). Esophagus. 2004;1:61–88.

    Google Scholar 

  16. Stahl M, Walz MK, Stuschke M, et al. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009;27:851–6.

    Article  PubMed  CAS  Google Scholar 

  17. Gebski V, Burmeister B, Smithers BM, Foo K, Zalcberg J, Simes J. Survival benefits from neoadjuvant chemoradiotherapy or chemotherapy in oesophageal carcinoma: a meta-analysis. Lancet Oncol. 2007;8:226–34.

    Article  PubMed  CAS  Google Scholar 

  18. Ando N, Ozawa S, Kitagawa Y, Shinozawa Y, Kitajima M. Improvement in the results of treatment of advanced squamous esophageal carcinoma over fifteen consecutive years. Ann Surg. 2000;232:225–32.

    Article  PubMed  CAS  Google Scholar 

  19. Altorki N, Kent M, Ferrara C, Port J. Three-field lymph node dissection for squamous cell and adenocarcinoma of the esophagus. Ann Surg. 2002;236:177–83.

    Article  PubMed  Google Scholar 

Download references

Acknowledgment

We thank A. Kimura and N. Murata for data management, T. Shibata for statistical support, and A. Takashima for help preparing the document. We appreciate Prof. J. Patrick Barron, Department of International Medical Communications, Tokyo Medical University, for his review. This work was supported by the Grant-in-Aid for Cancer Research (14S-3, 14S-4, 17S-3, 17S-5, 20S-3, 20S-6) from the Ministry of Health, Labor and Welfare of Japan.

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Authors and Affiliations

  1. Department of Surgery, Tokyo Dental College Ichikawa General Hospital, Ichikawa, Japan

    Nobutoshi Ando MD, FACS

  2. Esophageal Surgery Division, National Cancer Center Hospital Tokyo, Tokyo, Japan

    Hoichi Kato MD & Hiroyasu Igaki MD

  3. Department of Thoracic Surgery, Aichi Cancer Center Hospital, Nagoya, Japan

    Masayuki Shinoda MD

  4. Department of Surgery, Keio University School of Medicine, Tokyo, Japan

    Soji Ozawa MD, FACS

  5. Department of Surgery, Tochigi Cancer Center, Utsunomiya, Japan

    Hideaki Shimizu MD

  6. Institute of Gastroenterology, Tokyo Women’s Medical University, Tokyo, Japan

    Tsutomu Nakamura MD

  7. Department of Surgery, Niigata Cancer Center Hospital, Niigata, Japan

    Hiroshi Yabusaki MD

  8. Department of Surgery, Kanagawa Cancer Center, Yokohama, Japan

    Norio Aoyama MD

  9. Department of Surgery, Shikoku Cancer Center, Matsuyama, Japan

    Akira Kurita MD

  10. Department of Surgery, Iwate Medical University School of Medicine, Morioka, Japan

    Kenichiro Ikeda MD

  11. Department of Surgery, Niigata University Medical and Dental Hospital, Niigata, Japan

    Tatsuo Kanda MD

  12. Department of Surgery, National Hospital Organization, Osaka National Hospital, Osaka, Japan

    Toshimasa Tsujinaka MD

  13. Japan Clinical Oncology Group Data Center, Tokyo, Japan

    Kenichi Nakamura MD & Haruhiko Fukuda MD

Authors
  1. Nobutoshi Ando MD, FACS
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  2. Hoichi Kato MD
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  3. Hiroyasu Igaki MD
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  4. Masayuki Shinoda MD
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  5. Soji Ozawa MD, FACS
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  6. Hideaki Shimizu MD
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  7. Tsutomu Nakamura MD
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  8. Hiroshi Yabusaki MD
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  9. Norio Aoyama MD
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  10. Akira Kurita MD
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  11. Kenichiro Ikeda MD
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  12. Tatsuo Kanda MD
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  13. Toshimasa Tsujinaka MD
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  14. Kenichi Nakamura MD
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  15. Haruhiko Fukuda MD
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Corresponding author

Correspondence to Nobutoshi Ando MD, FACS.

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Ando, N., Kato, H., Igaki, H. et al. A Randomized Trial Comparing Postoperative Adjuvant Chemotherapy with Cisplatin and 5-Fluorouracil Versus Preoperative Chemotherapy for Localized Advanced Squamous Cell Carcinoma of the Thoracic Esophagus (JCOG9907). Ann Surg Oncol 19, 68–74 (2012). https://doi.org/10.1245/s10434-011-2049-9

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  • DOI: https://doi.org/10.1245/s10434-011-2049-9

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