Survival benefit of bursectomy in patients with resectable gastric cancer: Interim analysis results of a randomized controlled trial

Junya Fujita, Yukinori Kurokawa, Tomoyuki Sugimoto, Isao Miyashiro, Shohei Iijima, Yutaka Kimura, Shuji Takiguchi, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro Doki

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Abstract

Background Bursectomy is regarded as a standard surgical procedure during gastrectomy for serosa-positive gastric cancer in Japan. There is little evidence, however, that bursectomy has clinical benefit. We conducted a randomized controlled trial to demonstrate non-inferiority of treatment with the omission of bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-T3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy and D2 lymphadenectomy with or without bursectomy. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival, operative morbidity, and levels of amylase in drainage fluid on postoperative day 1. Two interim analyses were performed, in September 2008 and August 2010. Results Overall morbidity (14.3%) and mortality (0.95%) rates were the same in the two groups. The median levels of amylase in drainage fluid on postoperative day 1 were similar in the two groups (P = 0.543). In the second interim analysis, the 3-year OS rates were 85.6% in the bursectomy group and 79.6% in the non-bursectomy group. The hazard ratio for death without bursectomy was 1.44 (95% confidence interval [CI] 0.79-2.61; P = 0.443 for non-inferiority). Among 48 serosa-positive (pT3-T4) patients, the 3-year OS was 69.8% for the bursectomy group and 50.2% for the non-bursectomy group, conferring a hazard ratio for death of 2.16 (95% CI 0.89-5.22; P = 0.791 for non-inferiority). More patients in the nonbursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7%). Conclusions The interim analyses suggest that bursectomy may improve survival and should not be abandoned as a futile procedure until more definitive data can be obtained.

Original languageEnglish
Pages (from-to)42-48
Number of pages7
JournalGastric Cancer
Volume15
Issue number1
DOIs
Publication statusPublished - Jan 1 2012

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Stomach Neoplasms
Randomized Controlled Trials
Serous Membrane
Survival
Gastrectomy
Amylases
Drainage
Confidence Intervals
Morbidity
Recurrence
Lymph Node Excision
Stomach
Japan
Adenocarcinoma
Survival Rate
Mortality
Therapeutics

All Science Journal Classification (ASJC) codes

  • Oncology
  • Gastroenterology
  • Cancer Research

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Survival benefit of bursectomy in patients with resectable gastric cancer : Interim analysis results of a randomized controlled trial. / Fujita, Junya; Kurokawa, Yukinori; Sugimoto, Tomoyuki; Miyashiro, Isao; Iijima, Shohei; Kimura, Yutaka; Takiguchi, Shuji; Fujiwara, Yoshiyuki; Mori, Masaki; Doki, Yuichiro.

In: Gastric Cancer, Vol. 15, No. 1, 01.01.2012, p. 42-48.

Research output: Contribution to journalArticle

Fujita, J, Kurokawa, Y, Sugimoto, T, Miyashiro, I, Iijima, S, Kimura, Y, Takiguchi, S, Fujiwara, Y, Mori, M & Doki, Y 2012, 'Survival benefit of bursectomy in patients with resectable gastric cancer: Interim analysis results of a randomized controlled trial', Gastric Cancer, vol. 15, no. 1, pp. 42-48. https://doi.org/10.1007/s10120-011-0058-9
Fujita, Junya ; Kurokawa, Yukinori ; Sugimoto, Tomoyuki ; Miyashiro, Isao ; Iijima, Shohei ; Kimura, Yutaka ; Takiguchi, Shuji ; Fujiwara, Yoshiyuki ; Mori, Masaki ; Doki, Yuichiro. / Survival benefit of bursectomy in patients with resectable gastric cancer : Interim analysis results of a randomized controlled trial. In: Gastric Cancer. 2012 ; Vol. 15, No. 1. pp. 42-48.
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abstract = "Background Bursectomy is regarded as a standard surgical procedure during gastrectomy for serosa-positive gastric cancer in Japan. There is little evidence, however, that bursectomy has clinical benefit. We conducted a randomized controlled trial to demonstrate non-inferiority of treatment with the omission of bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-T3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy and D2 lymphadenectomy with or without bursectomy. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival, operative morbidity, and levels of amylase in drainage fluid on postoperative day 1. Two interim analyses were performed, in September 2008 and August 2010. Results Overall morbidity (14.3{\%}) and mortality (0.95{\%}) rates were the same in the two groups. The median levels of amylase in drainage fluid on postoperative day 1 were similar in the two groups (P = 0.543). In the second interim analysis, the 3-year OS rates were 85.6{\%} in the bursectomy group and 79.6{\%} in the non-bursectomy group. The hazard ratio for death without bursectomy was 1.44 (95{\%} confidence interval [CI] 0.79-2.61; P = 0.443 for non-inferiority). Among 48 serosa-positive (pT3-T4) patients, the 3-year OS was 69.8{\%} for the bursectomy group and 50.2{\%} for the non-bursectomy group, conferring a hazard ratio for death of 2.16 (95{\%} CI 0.89-5.22; P = 0.791 for non-inferiority). More patients in the nonbursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7{\%}). Conclusions The interim analyses suggest that bursectomy may improve survival and should not be abandoned as a futile procedure until more definitive data can be obtained.",
author = "Junya Fujita and Yukinori Kurokawa and Tomoyuki Sugimoto and Isao Miyashiro and Shohei Iijima and Yutaka Kimura and Shuji Takiguchi and Yoshiyuki Fujiwara and Masaki Mori and Yuichiro Doki",
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T1 - Survival benefit of bursectomy in patients with resectable gastric cancer

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AU - Fujita, Junya

AU - Kurokawa, Yukinori

AU - Sugimoto, Tomoyuki

AU - Miyashiro, Isao

AU - Iijima, Shohei

AU - Kimura, Yutaka

AU - Takiguchi, Shuji

AU - Fujiwara, Yoshiyuki

AU - Mori, Masaki

AU - Doki, Yuichiro

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N2 - Background Bursectomy is regarded as a standard surgical procedure during gastrectomy for serosa-positive gastric cancer in Japan. There is little evidence, however, that bursectomy has clinical benefit. We conducted a randomized controlled trial to demonstrate non-inferiority of treatment with the omission of bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-T3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy and D2 lymphadenectomy with or without bursectomy. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival, operative morbidity, and levels of amylase in drainage fluid on postoperative day 1. Two interim analyses were performed, in September 2008 and August 2010. Results Overall morbidity (14.3%) and mortality (0.95%) rates were the same in the two groups. The median levels of amylase in drainage fluid on postoperative day 1 were similar in the two groups (P = 0.543). In the second interim analysis, the 3-year OS rates were 85.6% in the bursectomy group and 79.6% in the non-bursectomy group. The hazard ratio for death without bursectomy was 1.44 (95% confidence interval [CI] 0.79-2.61; P = 0.443 for non-inferiority). Among 48 serosa-positive (pT3-T4) patients, the 3-year OS was 69.8% for the bursectomy group and 50.2% for the non-bursectomy group, conferring a hazard ratio for death of 2.16 (95% CI 0.89-5.22; P = 0.791 for non-inferiority). More patients in the nonbursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7%). Conclusions The interim analyses suggest that bursectomy may improve survival and should not be abandoned as a futile procedure until more definitive data can be obtained.

AB - Background Bursectomy is regarded as a standard surgical procedure during gastrectomy for serosa-positive gastric cancer in Japan. There is little evidence, however, that bursectomy has clinical benefit. We conducted a randomized controlled trial to demonstrate non-inferiority of treatment with the omission of bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-T3 gastric adenocarcinoma were intraoperatively randomized to radical gastrectomy and D2 lymphadenectomy with or without bursectomy. The primary endpoint was overall survival (OS). Secondary endpoints were recurrence-free survival, operative morbidity, and levels of amylase in drainage fluid on postoperative day 1. Two interim analyses were performed, in September 2008 and August 2010. Results Overall morbidity (14.3%) and mortality (0.95%) rates were the same in the two groups. The median levels of amylase in drainage fluid on postoperative day 1 were similar in the two groups (P = 0.543). In the second interim analysis, the 3-year OS rates were 85.6% in the bursectomy group and 79.6% in the non-bursectomy group. The hazard ratio for death without bursectomy was 1.44 (95% confidence interval [CI] 0.79-2.61; P = 0.443 for non-inferiority). Among 48 serosa-positive (pT3-T4) patients, the 3-year OS was 69.8% for the bursectomy group and 50.2% for the non-bursectomy group, conferring a hazard ratio for death of 2.16 (95% CI 0.89-5.22; P = 0.791 for non-inferiority). More patients in the nonbursectomy group had peritoneal recurrences than in the bursectomy group (13.2 vs. 8.7%). Conclusions The interim analyses suggest that bursectomy may improve survival and should not be abandoned as a futile procedure until more definitive data can be obtained.

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