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01-01-2012 | Thoracic Oncology

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)

Authors: Nobutoshi Ando, MD, FACS, Hoichi Kato, MD, Hiroyasu Igaki, MD, Masayuki Shinoda, MD, Soji Ozawa, MD, FACS, Hideaki Shimizu, MD, Tsutomu Nakamura, MD, Hiroshi Yabusaki, MD, Norio Aoyama, MD, Akira Kurita, MD, Kenichiro Ikeda, MD, Tatsuo Kanda, MD, Toshimasa Tsujinaka, MD, Kenichi Nakamura, MD, Haruhiko Fukuda, MD

Published in: Annals of Surgical Oncology | Issue 1/2012

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.

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.PubMedCrossRef

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

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.PubMedCrossRef

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.PubMedCrossRef

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.CrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.

10.

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

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

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.PubMedCrossRef

Title: 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)
Authors: Nobutoshi Ando, MD, FACS
Hoichi Kato, MD
Hiroyasu Igaki, MD
Masayuki Shinoda, MD
Soji Ozawa, MD, FACS
Hideaki Shimizu, MD
Tsutomu Nakamura, MD
Hiroshi Yabusaki, MD
Norio Aoyama, MD
Akira Kurita, MD
Kenichiro Ikeda, MD
Tatsuo Kanda, MD
Toshimasa Tsujinaka, MD
Kenichi Nakamura, MD
Haruhiko Fukuda, MD
Publication date: 01-01-2012
Publisher: Springer-Verlag
Published in: Annals of Surgical Oncology / Issue 1/2012
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-011-2049-9

Keynote webinar | Spotlight on medication adherence

Springer Medicine

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)

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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