The Experts below are selected from a list of 276 Experts worldwide ranked by ideXlab platform
Yuichiro Doki - One of the best experts on this subject based on the ideXlab platform.
-
Final results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2021Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206 Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-Bursectomy arm, 602 in Bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-Bursectomy arm and 74.9% (71.2 to 78.2) in Bursectomy arm. Hazard ratio (HR) for Bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-Bursectomy arm and 66.8% (62.9 to 70.5) in Bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-Bursectomy arm, 73 (12.1%) in Bursectomy arm], and Bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-Bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but Bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, Bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.
-
Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial
The lancet. Gastroenterology & hepatology, 2018Co-Authors: Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Masanori Terashima, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Norimasa FukushimaAbstract:Summary Background The role of Bursectomy, in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected, has long been controversial for preventing peritoneal metastasis. We investigated the survival benefit of Bursectomy in patients with resectable gastric cancer. Methods This phase 3, open-label, randomised controlled trial was done at 57 hospitals in Japan. Patients aged 20–80 years who had cT3(SS)–cT4a(SE) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m 2 and who did not have distant metastasis or bulky lymph nodes were randomly assigned (1:1) during surgery to receive omentectomy alone (non-Bursectomy) or Bursectomy. Randomisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a random component to adjust for institution, cT status (T3 vs T4a), and type of gastrectomy (distal vs total). Both groups had total or distal gastrectomy with D2 lymphadenectomy. The primary endpoint was overall survival, analysed in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000003688. Findings Between June 1, 2010, and March 30, 2015, 1503 patients were enrolled based on preoperative inclusion and exclusion criteria. Intraoperative inclusion and exclusion criteria were met in 1204 patients, of which 602 were allocated to the non-Bursectomy group and 602 were allocated to the Bursectomy group. At the planned second interim analysis on Sept 17, 2016, the JCOG Data and Safety Monitoring Committee independently reviewed the results and recommended their early publication on the basis of futility because overall survival was lower in the Bursectomy group than the non-Bursectomy group, and because the predictive probability of overall survival being significantly higher in Bursectomy than non-Bursectomy patients at the final analysis was only 12·7%. 5-year overall survival was 76·7% (95% CI 72·0–80·6) in the non-Bursectomy group and 76·9% (72·6–80·7) in the Bursectomy group (hazard ratio 1·05, 95% CI 0·81–1·37, one-sided p=0·65). 64 (11%) of 601 in the non-Bursectomy group and 77 (13%) of 600 patients in the Bursectomy group had grade 3–4 operative morbidity. Pancreatic fistula was significantly more common in the Bursectomy group than in the non-Bursectomy group (29 [5%] vs 15 [2%]; p=0·032). Six deaths occurred either in hospital or within 1 month of surgery: five in the non-Bursectomy group and one in the Bursectomy group. Interpretation Bursectomy did not provide a survival advantage over non-Bursectomy. D2 dissection with omentectomy alone should be done as a standard surgery for resectable cT3–T4a gastric cancer. Funding Japan Agency for Medical Research and Development, the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Centre Research and Development Fund.
-
final results of a phase iii trial to evaluate Bursectomy for patients with subserosal serosal gastric cancer jcog1001
Journal of Clinical Oncology, 2017Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the ...
-
Primary results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2017Co-Authors: Masanori Terashima, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Yoshiaki IwasakiAbstract:5Background: The role of Bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of Bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-Bursectomy 602, Bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was ...
-
Long-term outcomes after prophylactic Bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial
Surgery, 2015Co-Authors: Motohiro Hirao, Yukinori Kurokawa, Yutaka Kimura, Shuji Takiguchi, Junya Fujita, Hiroshi Imamura, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro DokiAbstract:Background Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of Bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without Bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. Results After the median follow-up of 80 months, 5-year OS was 77.5% for the Bursectomy group and 71.3% for the nonBursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonBursectomy group was 1.40 (95% CI, 0.87–2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the Bursectomy and nonBursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that Bursectomy was an independent prognostic factor of good OS ( P = .033). Subgroup analysis showed a trend toward improved survival after Bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. Conclusion The final analysis could not demonstrate the noninferiority of the omission of Bursectomy. Bursectomy should not be abandoned as a futile procedure.
Yukinori Kurokawa - One of the best experts on this subject based on the ideXlab platform.
-
Final results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2021Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206 Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-Bursectomy arm, 602 in Bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-Bursectomy arm and 74.9% (71.2 to 78.2) in Bursectomy arm. Hazard ratio (HR) for Bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-Bursectomy arm and 66.8% (62.9 to 70.5) in Bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-Bursectomy arm, 73 (12.1%) in Bursectomy arm], and Bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-Bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but Bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, Bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.
-
Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial
The lancet. Gastroenterology & hepatology, 2018Co-Authors: Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Masanori Terashima, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Norimasa FukushimaAbstract:Summary Background The role of Bursectomy, in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected, has long been controversial for preventing peritoneal metastasis. We investigated the survival benefit of Bursectomy in patients with resectable gastric cancer. Methods This phase 3, open-label, randomised controlled trial was done at 57 hospitals in Japan. Patients aged 20–80 years who had cT3(SS)–cT4a(SE) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m 2 and who did not have distant metastasis or bulky lymph nodes were randomly assigned (1:1) during surgery to receive omentectomy alone (non-Bursectomy) or Bursectomy. Randomisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a random component to adjust for institution, cT status (T3 vs T4a), and type of gastrectomy (distal vs total). Both groups had total or distal gastrectomy with D2 lymphadenectomy. The primary endpoint was overall survival, analysed in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000003688. Findings Between June 1, 2010, and March 30, 2015, 1503 patients were enrolled based on preoperative inclusion and exclusion criteria. Intraoperative inclusion and exclusion criteria were met in 1204 patients, of which 602 were allocated to the non-Bursectomy group and 602 were allocated to the Bursectomy group. At the planned second interim analysis on Sept 17, 2016, the JCOG Data and Safety Monitoring Committee independently reviewed the results and recommended their early publication on the basis of futility because overall survival was lower in the Bursectomy group than the non-Bursectomy group, and because the predictive probability of overall survival being significantly higher in Bursectomy than non-Bursectomy patients at the final analysis was only 12·7%. 5-year overall survival was 76·7% (95% CI 72·0–80·6) in the non-Bursectomy group and 76·9% (72·6–80·7) in the Bursectomy group (hazard ratio 1·05, 95% CI 0·81–1·37, one-sided p=0·65). 64 (11%) of 601 in the non-Bursectomy group and 77 (13%) of 600 patients in the Bursectomy group had grade 3–4 operative morbidity. Pancreatic fistula was significantly more common in the Bursectomy group than in the non-Bursectomy group (29 [5%] vs 15 [2%]; p=0·032). Six deaths occurred either in hospital or within 1 month of surgery: five in the non-Bursectomy group and one in the Bursectomy group. Interpretation Bursectomy did not provide a survival advantage over non-Bursectomy. D2 dissection with omentectomy alone should be done as a standard surgery for resectable cT3–T4a gastric cancer. Funding Japan Agency for Medical Research and Development, the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Centre Research and Development Fund.
-
final results of a phase iii trial to evaluate Bursectomy for patients with subserosal serosal gastric cancer jcog1001
Journal of Clinical Oncology, 2017Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the ...
-
Primary results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2017Co-Authors: Masanori Terashima, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Yoshiaki IwasakiAbstract:5Background: The role of Bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of Bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-Bursectomy 602, Bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was ...
-
Long-term outcomes after prophylactic Bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial
Surgery, 2015Co-Authors: Motohiro Hirao, Yukinori Kurokawa, Yutaka Kimura, Shuji Takiguchi, Junya Fujita, Hiroshi Imamura, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro DokiAbstract:Background Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of Bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without Bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. Results After the median follow-up of 80 months, 5-year OS was 77.5% for the Bursectomy group and 71.3% for the nonBursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonBursectomy group was 1.40 (95% CI, 0.87–2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the Bursectomy and nonBursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that Bursectomy was an independent prognostic factor of good OS ( P = .033). Subgroup analysis showed a trend toward improved survival after Bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. Conclusion The final analysis could not demonstrate the noninferiority of the omission of Bursectomy. Bursectomy should not be abandoned as a futile procedure.
Shuji Takiguchi - One of the best experts on this subject based on the ideXlab platform.
-
Final results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2021Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206 Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-Bursectomy arm, 602 in Bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-Bursectomy arm and 74.9% (71.2 to 78.2) in Bursectomy arm. Hazard ratio (HR) for Bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-Bursectomy arm and 66.8% (62.9 to 70.5) in Bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-Bursectomy arm, 73 (12.1%) in Bursectomy arm], and Bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-Bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but Bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, Bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.
-
Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial
The lancet. Gastroenterology & hepatology, 2018Co-Authors: Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Masanori Terashima, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Norimasa FukushimaAbstract:Summary Background The role of Bursectomy, in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected, has long been controversial for preventing peritoneal metastasis. We investigated the survival benefit of Bursectomy in patients with resectable gastric cancer. Methods This phase 3, open-label, randomised controlled trial was done at 57 hospitals in Japan. Patients aged 20–80 years who had cT3(SS)–cT4a(SE) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m 2 and who did not have distant metastasis or bulky lymph nodes were randomly assigned (1:1) during surgery to receive omentectomy alone (non-Bursectomy) or Bursectomy. Randomisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a random component to adjust for institution, cT status (T3 vs T4a), and type of gastrectomy (distal vs total). Both groups had total or distal gastrectomy with D2 lymphadenectomy. The primary endpoint was overall survival, analysed in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000003688. Findings Between June 1, 2010, and March 30, 2015, 1503 patients were enrolled based on preoperative inclusion and exclusion criteria. Intraoperative inclusion and exclusion criteria were met in 1204 patients, of which 602 were allocated to the non-Bursectomy group and 602 were allocated to the Bursectomy group. At the planned second interim analysis on Sept 17, 2016, the JCOG Data and Safety Monitoring Committee independently reviewed the results and recommended their early publication on the basis of futility because overall survival was lower in the Bursectomy group than the non-Bursectomy group, and because the predictive probability of overall survival being significantly higher in Bursectomy than non-Bursectomy patients at the final analysis was only 12·7%. 5-year overall survival was 76·7% (95% CI 72·0–80·6) in the non-Bursectomy group and 76·9% (72·6–80·7) in the Bursectomy group (hazard ratio 1·05, 95% CI 0·81–1·37, one-sided p=0·65). 64 (11%) of 601 in the non-Bursectomy group and 77 (13%) of 600 patients in the Bursectomy group had grade 3–4 operative morbidity. Pancreatic fistula was significantly more common in the Bursectomy group than in the non-Bursectomy group (29 [5%] vs 15 [2%]; p=0·032). Six deaths occurred either in hospital or within 1 month of surgery: five in the non-Bursectomy group and one in the Bursectomy group. Interpretation Bursectomy did not provide a survival advantage over non-Bursectomy. D2 dissection with omentectomy alone should be done as a standard surgery for resectable cT3–T4a gastric cancer. Funding Japan Agency for Medical Research and Development, the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Centre Research and Development Fund.
-
final results of a phase iii trial to evaluate Bursectomy for patients with subserosal serosal gastric cancer jcog1001
Journal of Clinical Oncology, 2017Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the ...
-
Primary results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2017Co-Authors: Masanori Terashima, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Yoshiaki IwasakiAbstract:5Background: The role of Bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of Bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-Bursectomy 602, Bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was ...
-
Long-term outcomes after prophylactic Bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial
Surgery, 2015Co-Authors: Motohiro Hirao, Yukinori Kurokawa, Yutaka Kimura, Shuji Takiguchi, Junya Fujita, Hiroshi Imamura, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro DokiAbstract:Background Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of Bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without Bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. Results After the median follow-up of 80 months, 5-year OS was 77.5% for the Bursectomy group and 71.3% for the nonBursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonBursectomy group was 1.40 (95% CI, 0.87–2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the Bursectomy and nonBursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that Bursectomy was an independent prognostic factor of good OS ( P = .033). Subgroup analysis showed a trend toward improved survival after Bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. Conclusion The final analysis could not demonstrate the noninferiority of the omission of Bursectomy. Bursectomy should not be abandoned as a futile procedure.
Yutaka Kimura - One of the best experts on this subject based on the ideXlab platform.
-
Final results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2021Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206 Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-Bursectomy arm, 602 in Bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-Bursectomy arm and 74.9% (71.2 to 78.2) in Bursectomy arm. Hazard ratio (HR) for Bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-Bursectomy arm and 66.8% (62.9 to 70.5) in Bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-Bursectomy arm, 73 (12.1%) in Bursectomy arm], and Bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-Bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but Bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, Bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.
-
Bursectomy versus omentectomy alone for resectable gastric cancer (JCOG1001): a phase 3, open-label, randomised controlled trial
The lancet. Gastroenterology & hepatology, 2018Co-Authors: Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Masanori Terashima, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Norimasa FukushimaAbstract:Summary Background The role of Bursectomy, in which the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon are dissected, has long been controversial for preventing peritoneal metastasis. We investigated the survival benefit of Bursectomy in patients with resectable gastric cancer. Methods This phase 3, open-label, randomised controlled trial was done at 57 hospitals in Japan. Patients aged 20–80 years who had cT3(SS)–cT4a(SE) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m 2 and who did not have distant metastasis or bulky lymph nodes were randomly assigned (1:1) during surgery to receive omentectomy alone (non-Bursectomy) or Bursectomy. Randomisation was done by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimisation method with a random component to adjust for institution, cT status (T3 vs T4a), and type of gastrectomy (distal vs total). Both groups had total or distal gastrectomy with D2 lymphadenectomy. The primary endpoint was overall survival, analysed in the intention-to-treat population. The study is registered with UMIN-CTR, number UMIN000003688. Findings Between June 1, 2010, and March 30, 2015, 1503 patients were enrolled based on preoperative inclusion and exclusion criteria. Intraoperative inclusion and exclusion criteria were met in 1204 patients, of which 602 were allocated to the non-Bursectomy group and 602 were allocated to the Bursectomy group. At the planned second interim analysis on Sept 17, 2016, the JCOG Data and Safety Monitoring Committee independently reviewed the results and recommended their early publication on the basis of futility because overall survival was lower in the Bursectomy group than the non-Bursectomy group, and because the predictive probability of overall survival being significantly higher in Bursectomy than non-Bursectomy patients at the final analysis was only 12·7%. 5-year overall survival was 76·7% (95% CI 72·0–80·6) in the non-Bursectomy group and 76·9% (72·6–80·7) in the Bursectomy group (hazard ratio 1·05, 95% CI 0·81–1·37, one-sided p=0·65). 64 (11%) of 601 in the non-Bursectomy group and 77 (13%) of 600 patients in the Bursectomy group had grade 3–4 operative morbidity. Pancreatic fistula was significantly more common in the Bursectomy group than in the non-Bursectomy group (29 [5%] vs 15 [2%]; p=0·032). Six deaths occurred either in hospital or within 1 month of surgery: five in the non-Bursectomy group and one in the Bursectomy group. Interpretation Bursectomy did not provide a survival advantage over non-Bursectomy. D2 dissection with omentectomy alone should be done as a standard surgery for resectable cT3–T4a gastric cancer. Funding Japan Agency for Medical Research and Development, the Ministry of Health, Labour and Welfare of Japan, and the National Cancer Centre Research and Development Fund.
-
final results of a phase iii trial to evaluate Bursectomy for patients with subserosal serosal gastric cancer jcog1001
Journal of Clinical Oncology, 2017Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the ...
-
Primary results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2017Co-Authors: Masanori Terashima, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Hitoshi Katai, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Yoshiaki IwasakiAbstract:5Background: The role of Bursectomy dissecting the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon for preventing peritoneal metastasis had long been controversial. We conducted a phase III trial evaluating the role of Bursectomy in patients with subserosal (SS) / serosal (SE) gastric cancer. Patient accrual had been completed on Mar. 2015. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach; cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival. A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: Between Jun 2010 and Mar 2015, 1,204 patients were accrued from 57 institutions (non-Bursectomy 602, Bursectomy 602). Patients’ background and operative procedures were well balanced between the arms. After completion of patient enrollment, the second interim analysis was ...
-
Long-term outcomes after prophylactic Bursectomy in patients with resectable gastric cancer: Final analysis of a multicenter randomized controlled trial
Surgery, 2015Co-Authors: Motohiro Hirao, Yukinori Kurokawa, Yutaka Kimura, Shuji Takiguchi, Junya Fujita, Hiroshi Imamura, Yoshiyuki Fujiwara, Masaki Mori, Yuichiro DokiAbstract:Background Bursectomy, a traditional operative procedure to remove the peritoneal lining covering the pancreas and the anterior plane of the transverse mesocolon, has been performed for serosa-positive gastric cancer in Japan and Eastern Asia. We conducted a multicenter, randomized, controlled trial to demonstrate the noninferiority of the omission of Bursectomy. Methods Between July 2002 and January 2007, 210 patients with cT2-3 gastric adenocarcinoma were randomized intraoperatively to D2 gastrectomy with or without Bursectomy. The primary endpoint was overall survival (OS). We provide the results of the final analysis of the complete 5-year follow-up data. Results After the median follow-up of 80 months, 5-year OS was 77.5% for the Bursectomy group and 71.3% for the nonBursectomy group (2-sided P = .16 for superiority; 1-sided P = .99 for noninferiority). The hazard ratio for death in the nonBursectomy group was 1.40 (95% CI, 0.87–2.25). The 5-year recurrence-free survivals were 73.7% and 66.6% in the Bursectomy and nonBursectomy groups, respectively (2-sided P = .33 for superiority; 1-sided P = .99 for noninferiority). Cox multivariate analysis revealed that Bursectomy was an independent prognostic factor of good OS ( P = .033). Subgroup analysis showed a trend toward improved survival after Bursectomy for tumors in the middle or lower third of the stomach and for pathologically serosa-positive tumors. Conclusion The final analysis could not demonstrate the noninferiority of the omission of Bursectomy. Bursectomy should not be abandoned as a futile procedure.
Kenichi Nakamura - One of the best experts on this subject based on the ideXlab platform.
-
Final results of a phase III trial to evaluate Bursectomy for patients with subserosal/serosal gastric cancer (JCOG1001).
Journal of Clinical Oncology, 2021Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206 Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the expected events observed. We report the final 5-year follow-up data. Methods: Eligibility criteria included histologically proven adenocarcinoma of the stomach, cT3(SS) or cT4a(SE). Patients were intraoperatively randomized to non-Bursectomy arm or Bursectomy arm. Primary endpoint was overall survival (OS), and secondary endpoint was relapse-free survival (RFS). A total of 1,200 patients were required to detect a hazard ratio of 0.77 with a one-sided alpha of 5% and 80% power. Results: A total of 1204 eligible patients with cT3 / cT4a gastric cancer were randomized (602 in non-Bursectomy arm, 602 in Bursectomy arm, respectively). Patients’ background and operative procedures were well balanced between the arms. The 5y-OS were 76.5% (95% CI, 72.8 to 79.7) in non-Bursectomy arm and 74.9% (71.2 to 78.2) in Bursectomy arm. Hazard ratio (HR) for Bursectomy was 1.03 (0.83-1.27, one-sided p = 0.598). The 5y-RFS were 70.7% (66.9 to 74.2) in non-Bursectomy arm and 66.8% (62.9 to 70.5) in Bursectomy arm [HR: 1.131 (0.93-1.38)]. HR for death was almost similar in all sub-categories (0.73-1.29) except cN2 (13th edition of Japanese Classification of Gastric Carcinoma); HR classified by cN was 1.06 (95% CI: 0.75-1.49) for cN0 (n = 521), 1.25 (0.92-1.71) for cN1 (n = 525), and 0.59 (0.32-1.06) for cN2 (n = 158) (p = 0.048 for interaction). The most frequent site of recurrence was the peritoneum [74 (12.3%) in non-Bursectomy arm, 73 (12.1%) in Bursectomy arm], and Bursectomy arm showed a trend of increasing liver metastasis (n = 45, 7.5%) as compared with non-Bursectomy arm (n = 33, 5.5%). Six independent poor prognostic factors were identified by multivariable analysis for OS: age ≥ 66 (vs. ≤ 65) (HR, 1.30; 95% CI, 1.04-1.62), macroscopic type 3/5 (vs. type 0/1/2) (1.43; 1.15-1.79), total gastrectomy (vs. distal gastrectomy) (1.44; 1.03-2.02), pT3 (vs. pT1-2) (1.77; 1.17-2.676), pT4 (vs. pT1-2) (3.00; 1.99-4.53), pN1 (vs. pN0) (2.34; 1.52-3.59), pN2-3b (vs. pN0)(4.02; 2.82-5.74) and adjuvant chemotherapy (vs. without chemotherapy) (0.53; 0.42-0.67), but Bursectomy was not significant (1.10 0.89-1.36). Conclusions: In the final analysis as well as in the interim analysis, Bursectomy was not recommended as a standard treatment for cT3 or cT4 gastric cancer. Clinical trial information: UMIN000003688.
-
final results of a phase iii trial to evaluate Bursectomy for patients with subserosal serosal gastric cancer jcog1001
Journal of Clinical Oncology, 2017Co-Authors: Hitoshi Katai, Yukinori Kurokawa, Yuichiro Doki, Junki Mizusawa, Takaki Yoshikawa, Yutaka Kimura, Shuji Takiguchi, Yasunori Nishida, Takeshi Sano, Kenichi NakamuraAbstract:206Background: We previously reported that the superiority of Bursectomy was not demonstrated for subserosal(SS)/serosal(SE) gastric cancer by the second interim analysis performed with 54% of the ...
