Long-term Survival Outcomes of Laparoscopic Gastrectomy for Advanced Gastric Cancer: Five-year Results of a Phase II Prospective Clinical Trial

Sang-Hoon Ahn, So Hyun Kang, Yoontaek Lee, Sa-Hong Min, Young Suk Park, Do Joong Park, Hyung-Ho Kim, Sang-Hoon Ahn, So Hyun Kang, Yoontaek Lee, Sa-Hong Min, Young Suk Park, Do Joong Park, Hyung-Ho Kim

Abstract

Purpose: Despite an increased acceptance of laparoscopic gastrectomy (LG) in early gastric cancer (EGC), there is insufficient evidence for its oncological safety in advanced gastric cancer (AGC). This is a prospective phase II clinical trial to evaluate the feasibility of LG with D2 lymph node dissection (LND) in AGC.

Materials and methods: The primary endpoint was set as 3-year disease-free survival (DFS). The eligibility criteria were as follows: 20-80 years of age, cT2N0-cT4aN3, American Society of Anesthesiologists score of 3 or less, and no other malignancy. Patients were enrolled in this single-arm study between November 2008 and May 2012. Exclusion criteria included cT4b or M1, or having final pathologic results as EGC. All patients underwent D2 lymphadenectomy. Three-year DFS rates were estimated by the Kaplan-Meier method.

Results: A total of 157 patients were enrolled. The overall local complication rate was 10.2%. Conversion to open surgery occurred in 11 patients (7.0%). The mean follow-up period was 55.0±20.4 months (1-81 months). The cumulative 3-year DFS rates were 76.3% for all stages, and 100%, 89.3%, 100%, 88.0%, 71.4%, and 35.3% for stage IB, IIA, IIB, IIIA, IIIB, and IIIC, respectively. Recurrence was observed in 37 patients (23.6%), including hematogenous (n=6), peritoneal (n=13), locoregional (n=1), distant node (n=8), and mixed recurrence (n=9).

Conclusions: In addition to being technically feasible for treatment of AGC in terms of morbidity, LG with D2 LND for locally advanced gastric cancer showed acceptable 3-year DFS outcomes.

Trial registration: ClinicalTrials.gov Identifier: NCT01441336.

Keywords: Surgery; Treatment.

Conflict of interest statement

Conflict of Interest: No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1. CONSORT diagram.
Fig. 1. CONSORT diagram.
AGC = advanced gastric cancer; EGC = early gastric cancer; DFS = disease-free survival; OS = overall survival.
Fig. 2. Long-term outcomes of laparoscopic gastrectomy…
Fig. 2. Long-term outcomes of laparoscopic gastrectomy for advanced gastric cancer. (A) The total 3-year DFS (left) and individual survival curves grouped by TNM stage (right). (B) The total 5-year OS (left) and individual survival curves grouped by TNM stage (right).
DFS = disease-free survival; OS = overall survival.
Fig. 3. Venn diagram of recurrence pattern.
Fig. 3. Venn diagram of recurrence pattern.

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