Long-term survival results of laparoscopy-assisted distal gastrectomy with suprapancreatic nodal dissection for clinical stage I gastric cancer: A multicenter phase II trial (JCOG 0703).

Authors

null

Mikihito Nakamori

Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan

Mikihito Nakamori , Hitoshi Katai , Junki Mizusawa , Kenichi Nakamura , Naoki Hiki , Takaki Yoshikawa , Kazuyuki Kojima , Haruhiko Imamoto , Motoki Ninomiya , Seigo Kitano , Mitsuru Sasako

Organizations

Second Department of Surgery, Wakayama Medical University, School of Medicine, Wakayama, Japan, Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan, JCOG Data Center, National Cancer Center, Tokyo, Japan, Japan Clinical Oncology Group Operations Office, National Cancer Center, Tokyo, Japan, Department of Surgery, Cancer Institute Hospital, Tokyo, Japan, Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan, Tokyo Medical and Dental University, Tokyo, Japan, Kinki University Faculty of Medicine, Osakasayama, Japan, Hiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan, Oita University, Oita, Japan, Division of Upper Gastrointestinal Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan

Research Funding

Other Foundation

Background: Laparoscopic gastrectomy has been a common tool for gastric cancer patients in eastern Asian countries. A large-scale prospective study with a sample size sufficient to investigate the benefit of laparoscopy-assisted distal gastrectomy (LADG) has never been reported. We conducted a multi-center phase II trial (JCOG0703) to evaluate the safety of LADG with nodal dissection for clinical stage I gastric cancer patients. A short-term outcome including postoperative complications of LADG as a result of this study was already reported and a following multi-center phase III trials (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of overall survival (OS) was already started. Long-term outcomes as the secondary endpoints of this study are reported here after 5-year follow up period. Methods: The subjects of this study comprised patients with clinical stage I gastric cancer that were able to undergo a distal gastrectomy. LADG with D1 plus suprapancreatic lymph node dissection was performed by credentialed gastric surgeons who experienced >=30 LADG and >=30 open gasterctomy. The primary endpoint was the proportion of patients who developed either anastomotic leakage or a pancreatic fistula. The secondary endpoints included surgical morbidity, short-term clinical outcome, OS, and relapse free survival (RFS). Results: Between November 2007 and September 2008, 176 eligible patients were enrolled. 140/23/9/4 patients had pStage IA/IB/II/IIIA disease respectively. No patients had recurrence. 3 patients died without recurrence. 5-year OS was 98.2% (95%CI, 94.7% to 99.4%). 5-year RFS was 98.2% (95%CI, 94.4% to 99.4%). Conclusions: The long-term outcome of LADG for Stage I gastric cancer patients seem comparable to those of open procedures. However, this result should be confirmed by a randomized control trial. We have just finished an accrual of 921 patients for a multi-center phase III trial (JCOG0912) to confirm the non-inferiority of LADG compared with open gastrectomy in terms of OS. Clinical trial information: UMIN000000874.

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Abstract Details

Meeting

2015 Gastrointestinal Cancers Symposium

Session Type

Poster Session

Session Title

General Poster Session A: Cancers of the Esophagus and Stomach

Track

Cancers of the Esophagus and Stomach

Sub Track

Multidisciplinary Treatment

Clinical Trial Registration Number

UMIN000000874

Citation

J Clin Oncol 33, 2015 (suppl 3; abstr 113)

DOI

10.1200/jco.2015.33.3_suppl.113

Abstract #

113

Poster Bd #

C11

Abstract Disclosures