The Oncological Efficacy of Complete Mesogastric Excision for Locally Advanced Gastric Cancer: 3-Year Outcomes of a Randomized Clinical Trial

Abstract

IMPORTANCE: Gastrectomy with D2 lymphadenectomy is the standard treatment for curable gastric cancer. Whether implementation of complete mesogastric excision along with D2 lymphadenectomy, named D2 lymphadenectomy plus complete mesogastric excision (D2+CME) improves oncological benefit is uncertain.

OBJECTIVE: To compare conventional D2 lymphadenectomy with D2+CME in patients undergoing gastrectomy for curable gastric cancer.

DESIGN, SETTING, AND PARTICIPANTS: We conducted a randomized, controlled trial (DCGC01). Between September 2014 and June 2018, 486 patients with stage cT2-4N0-3M0 gastric cancer were enrolled. The modified intention-to-treat (mITT) population were defined (169 patients in D2 and 169 patients in D2+CME group who were pathologically diagnosed with gastric adenocarcinoma with pT1N1-3M0 and pT2-4N0-3M0) for the final data analysis.I

NTERVENTIONS: Patients were randomly assigned (1:1) during surgery to receive conventional D2 or D2+CME procedure.M

AIN OUTCOMES AND MEASURES: The primary endpoint was 3-year disease-free survival.

RESULTS: The median follow-up periods of patients in D2 and D2+CME group was 55 months (IQR: 37-60 months) and 51 months (IQR: 40-60 months), respectively. The recurrence occurred with 50 patients in D2 group (29·6%) and 33 patients in D2+CME group (19·5%) (p=0·032). The 3-year disease-free survival rate was 75·5% (95% CI, 68·3-81·3) in the D2 group and 85·0% (95% CI, 78·7-89·6) in the D2+CME group (log-rank p=0·042). The HR for recurrence in D2+CME group versus D2 group was 0·637 (95% CI, 0·411-0·990) by Cox regression (two-sided p= 0·045). Subgroup analyses showed that among patients with pathological stage III, 3-year disease-free survival rate was 57·5% (95% CI, 45·6-67·8) in the D2 group and 75·5% (95% CI, 62·2-84·7) in the D2+CME group (HR for recurrence 0·605, 95% CI 0·347-1·052, log-rank p=0·069).

CONCLUSIONS AND RELEVANCE: Compared to conventional D2 dissection, D2+CME shows favorable long-term outcomes in curable advanced gastric cancer. Gastrectomy with D2+CME could be justified to treat patients with advanced gastric cancer.

Note:
Clinical Trial Registration Details: ClinicalTrials.gov, Identifier: NCT01978444.

Funding Information: This work was supported by the National Natural Science Foundation of China (grants 81372324 and 81874185).

Declaration of Interests: The authors declare no competing interests.

Ethical Approval Statement: The study protocol and any relevant documents (for example, the study protocol, the subject’s informed consent form) has been reviewed by the ethic committee and, the study has been approved by the Tongji Hospital Ethics Committee (TJ-C20130811). All patients are freely informed to participate in this study and can decide to withdraw from this trial at any time. If a patient withdraws, his/her information will not be unveiled in this study. However, research team can still collect outcome data from their health care records. Patients are informed in the consent that their personal data held by this study can be freely withdrawn, otherwise these data will be retained.

Keywords: D2+CME, D2 lymphadenectomy, mesogastric excision, Gastric cancer, Randomized controlled trial