Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404)

a phase 3, randomised controlled trial

Seigo Kitano, Masafumi Inomata, Junki Mizusawa, Hiroshi Katayama, Masahiko Watanabe, Seiichiro Yamamoto, Masaaki Ito, Shuji Saito, Shoichi Fujii, Fumio Konishi, Yoshihisa Saida, Hirotoshi Hasegawa, Tomonori Akagi, Kenichi Sugihara, Takashi Yamaguchi, Tadahiko Masaki, Yosuke Fukunaga, Kohei Murata, Masazumi Okajima, Yoshihiro Moriya & 1 others Yasuhiro Shimada

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Background Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. Methods We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20–75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0–2, and metastasis stage M0; and tumour size of 8 cm or smaller were included. Only accredited surgeons did surgery as an operator or instructor. Patients were randomly assigned (1:1) preoperatively to undergo D3 resection either by an open route or a laparoscopic route, via phone call or fax to the Japan Clinical Oncology Group (JCOG) Data Center. Randomisation used a minimisation method with a biased-coin assignment according to tumour location (caecum, ascending vs sigmoid, rectosigmoid) and institution. The primary endpoint was overall survival and was analysed by intention to treat. The non-inferiority margin for the hazard ratio (HR) was set at 1·366. This study is registered with UMIN Clinical Trials Registry, number C000000105, and ClinicalTrials.gov, number NCT00147134. Findings Between Oct 1, 2004, and March 27, 2009, 1057 patients were randomly assigned to either open surgery (n=528) or laparoscopic surgery (n=529). 5-year overall survival was 90·4% (95% CI 87·5–92·6) for open surgery and 91·8% (89·1–93·8) for laparoscopic surgery. Laparoscopic D3 surgery was not non-inferior to open surgery for overall survival (HR 1·06, 90% CI 0·79–1·41; pnon-inferiority=0·073). 65 (13%) patients in the open surgery group and 53 (10%) patients in the laparoscopic surgery group had grade 2–4 adverse events. Grade 2–4 adverse events included diarrhoea (15 [3%] in the open surgery group vs 14 [3%] in the laparoscopic surgery group), paralytic ileus (six [1%] vs nine [2%]), and small intestine bowel obstruction (16 [3%] vs 11 [2%]). Two treatment-related deaths occurred in the open surgery group: one patient died 7 days after surgery (probably due to myocardial infarction), and one patient died from febrile neutropenia, pneumonia, diarrhoea, and gastrointestinal haemorrhage during postoperative chemotherapy. Interpretation Laparoscopic D3 surgery was not non-inferior to open D3 surgery in terms of overall survival for patients with stage II or III colon cancer. However, because overall survival in both groups was similar and better than expected, laparoscopic D3 surgery could be an acceptable treatment option for patients with stage II or III colon cancer. Funding National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, and Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan.

Original languageEnglish
Pages (from-to)261-268
Number of pages8
JournalThe Lancet Gastroenterology and Hepatology
Volume2
Issue number4
DOIs
Publication statusPublished - 2017 Apr 1

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Laparoscopy
Colonic Neoplasms
Dissection
Randomized Controlled Trials
Survival
Neoplasms
Japan
Sigmoid Colon
diaziquone
Research
Diarrhea
Telefacsimile
Intestinal Pseudo-Obstruction
Febrile Neutropenia
Numismatics
Gastrointestinal Hemorrhage
Medical Oncology
Organized Financing
Health
Random Allocation

ASJC Scopus subject areas

  • Gastroenterology
  • Hepatology

Cite this

Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404) : a phase 3, randomised controlled trial. / Kitano, Seigo; Inomata, Masafumi; Mizusawa, Junki; Katayama, Hiroshi; Watanabe, Masahiko; Yamamoto, Seiichiro; Ito, Masaaki; Saito, Shuji; Fujii, Shoichi; Konishi, Fumio; Saida, Yoshihisa; Hasegawa, Hirotoshi; Akagi, Tomonori; Sugihara, Kenichi; Yamaguchi, Takashi; Masaki, Tadahiko; Fukunaga, Yosuke; Murata, Kohei; Okajima, Masazumi; Moriya, Yoshihiro; Shimada, Yasuhiro.

In: The Lancet Gastroenterology and Hepatology, Vol. 2, No. 4, 01.04.2017, p. 261-268.

Research output: Contribution to journalArticle

Kitano, S, Inomata, M, Mizusawa, J, Katayama, H, Watanabe, M, Yamamoto, S, Ito, M, Saito, S, Fujii, S, Konishi, F, Saida, Y, Hasegawa, H, Akagi, T, Sugihara, K, Yamaguchi, T, Masaki, T, Fukunaga, Y, Murata, K, Okajima, M, Moriya, Y & Shimada, Y 2017, 'Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial', The Lancet Gastroenterology and Hepatology, vol. 2, no. 4, pp. 261-268. https://doi.org/10.1016/S2468-1253(16)30207-2
Kitano, Seigo ; Inomata, Masafumi ; Mizusawa, Junki ; Katayama, Hiroshi ; Watanabe, Masahiko ; Yamamoto, Seiichiro ; Ito, Masaaki ; Saito, Shuji ; Fujii, Shoichi ; Konishi, Fumio ; Saida, Yoshihisa ; Hasegawa, Hirotoshi ; Akagi, Tomonori ; Sugihara, Kenichi ; Yamaguchi, Takashi ; Masaki, Tadahiko ; Fukunaga, Yosuke ; Murata, Kohei ; Okajima, Masazumi ; Moriya, Yoshihiro ; Shimada, Yasuhiro. / Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404) : a phase 3, randomised controlled trial. In: The Lancet Gastroenterology and Hepatology. 2017 ; Vol. 2, No. 4. pp. 261-268.
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T1 - Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404)

T2 - a phase 3, randomised controlled trial

AU - Kitano, Seigo

AU - Inomata, Masafumi

AU - Mizusawa, Junki

AU - Katayama, Hiroshi

AU - Watanabe, Masahiko

AU - Yamamoto, Seiichiro

AU - Ito, Masaaki

AU - Saito, Shuji

AU - Fujii, Shoichi

AU - Konishi, Fumio

AU - Saida, Yoshihisa

AU - Hasegawa, Hirotoshi

AU - Akagi, Tomonori

AU - Sugihara, Kenichi

AU - Yamaguchi, Takashi

AU - Masaki, Tadahiko

AU - Fukunaga, Yosuke

AU - Murata, Kohei

AU - Okajima, Masazumi

AU - Moriya, Yoshihiro

AU - Shimada, Yasuhiro

PY - 2017/4/1

Y1 - 2017/4/1

N2 - Background Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. Methods We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20–75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0–2, and metastasis stage M0; and tumour size of 8 cm or smaller were included. Only accredited surgeons did surgery as an operator or instructor. Patients were randomly assigned (1:1) preoperatively to undergo D3 resection either by an open route or a laparoscopic route, via phone call or fax to the Japan Clinical Oncology Group (JCOG) Data Center. Randomisation used a minimisation method with a biased-coin assignment according to tumour location (caecum, ascending vs sigmoid, rectosigmoid) and institution. The primary endpoint was overall survival and was analysed by intention to treat. The non-inferiority margin for the hazard ratio (HR) was set at 1·366. This study is registered with UMIN Clinical Trials Registry, number C000000105, and ClinicalTrials.gov, number NCT00147134. Findings Between Oct 1, 2004, and March 27, 2009, 1057 patients were randomly assigned to either open surgery (n=528) or laparoscopic surgery (n=529). 5-year overall survival was 90·4% (95% CI 87·5–92·6) for open surgery and 91·8% (89·1–93·8) for laparoscopic surgery. Laparoscopic D3 surgery was not non-inferior to open surgery for overall survival (HR 1·06, 90% CI 0·79–1·41; pnon-inferiority=0·073). 65 (13%) patients in the open surgery group and 53 (10%) patients in the laparoscopic surgery group had grade 2–4 adverse events. Grade 2–4 adverse events included diarrhoea (15 [3%] in the open surgery group vs 14 [3%] in the laparoscopic surgery group), paralytic ileus (six [1%] vs nine [2%]), and small intestine bowel obstruction (16 [3%] vs 11 [2%]). Two treatment-related deaths occurred in the open surgery group: one patient died 7 days after surgery (probably due to myocardial infarction), and one patient died from febrile neutropenia, pneumonia, diarrhoea, and gastrointestinal haemorrhage during postoperative chemotherapy. Interpretation Laparoscopic D3 surgery was not non-inferior to open D3 surgery in terms of overall survival for patients with stage II or III colon cancer. However, because overall survival in both groups was similar and better than expected, laparoscopic D3 surgery could be an acceptable treatment option for patients with stage II or III colon cancer. Funding National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, and Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan.

AB - Background Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. Methods We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20–75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0–2, and metastasis stage M0; and tumour size of 8 cm or smaller were included. Only accredited surgeons did surgery as an operator or instructor. Patients were randomly assigned (1:1) preoperatively to undergo D3 resection either by an open route or a laparoscopic route, via phone call or fax to the Japan Clinical Oncology Group (JCOG) Data Center. Randomisation used a minimisation method with a biased-coin assignment according to tumour location (caecum, ascending vs sigmoid, rectosigmoid) and institution. The primary endpoint was overall survival and was analysed by intention to treat. The non-inferiority margin for the hazard ratio (HR) was set at 1·366. This study is registered with UMIN Clinical Trials Registry, number C000000105, and ClinicalTrials.gov, number NCT00147134. Findings Between Oct 1, 2004, and March 27, 2009, 1057 patients were randomly assigned to either open surgery (n=528) or laparoscopic surgery (n=529). 5-year overall survival was 90·4% (95% CI 87·5–92·6) for open surgery and 91·8% (89·1–93·8) for laparoscopic surgery. Laparoscopic D3 surgery was not non-inferior to open surgery for overall survival (HR 1·06, 90% CI 0·79–1·41; pnon-inferiority=0·073). 65 (13%) patients in the open surgery group and 53 (10%) patients in the laparoscopic surgery group had grade 2–4 adverse events. Grade 2–4 adverse events included diarrhoea (15 [3%] in the open surgery group vs 14 [3%] in the laparoscopic surgery group), paralytic ileus (six [1%] vs nine [2%]), and small intestine bowel obstruction (16 [3%] vs 11 [2%]). Two treatment-related deaths occurred in the open surgery group: one patient died 7 days after surgery (probably due to myocardial infarction), and one patient died from febrile neutropenia, pneumonia, diarrhoea, and gastrointestinal haemorrhage during postoperative chemotherapy. Interpretation Laparoscopic D3 surgery was not non-inferior to open D3 surgery in terms of overall survival for patients with stage II or III colon cancer. However, because overall survival in both groups was similar and better than expected, laparoscopic D3 surgery could be an acceptable treatment option for patients with stage II or III colon cancer. Funding National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, and Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan.

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