Long-term survival outcomes are similar with laparoscopic distal gastrectomy (LDG) and open distal gastrectomy (ODG) in patients with locally advanced gastric cancer, according to research published in JAMA Surgery.1

The phase 3 CLASS-01 trial (ClinicalTrials.gov Identifier: NCT01609309) was designed to compare LDG and ODG in patients with clinical stage T2, T3, or T4a gastric cancer without bulky nodes or distant metastases.

Prior results from this study revealed comparable disease-free survival rates with LDG and ODG at 3 years.2 For the current analysis, researchers assessed overall survival (OS) at 5 years.


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The analysis included 1039 patients, 519 who underwent LDG and 520 who underwent ODG. Most patients in each arm were men (73.2% and 66.5%, respectively) and had a performance status of 0 (72.3% and 75.2%, respectively).

The mean age at baseline was 56.5 years in the LDG arm and 55.8 years in the ODG arm. Less than half of patients in each arm received chemotherapy (37% and 41.7%, respectively), and the mean tumor size was 4.0 cm in both arms.

The 5-year OS rate was 72.6% in the LDG arm and 76.3% in the ODG arm (hazard ratio [HR], 1.17; 95% CI, 0.93-1.48; P =.19).

The 5-year OS rates by tumor stage — in the LDG and ODG arms, respectively — were:

  • 90.0% vs 88.5% for stage I (P =.70)
  • 79.1% vs 84.5% for stage II (P =.14)
  • 58.6% vs 59.5% for stage III (P =.95).

When the researchers controlled for all competing risk events, they found no significant differences between the arms for gastric cancer-related death (HR, 1.14; 95% CI, 0.87-1.49; P =.34) or death from other causes (HR, 1.23; 95% CI, 0.74-2.05; P = .42).

“[W]e found 5-year overall survival not to differ significantly between patients who underwent LDG with D2 lymphadenectomy vs ODG performed by experienced surgeons at high-volume, specialized centers, regardless of tumor stage,” the researchers wrote. “This finding provides further evidence for the safety and efficacy of LDG for treatment of gastric cancer.”

References

  1. Huang C, Liu H, Hu Y, et al. Laparoscopic vs open distal gastrectomy for locally advanced gastric cancer: Five-year outcomes from the CLASS-01 randomized clinical trial. JAMA Surg. Published online October 20, 2021. doi:10.1001/jamasurg.2021.5104
  2. Yu J, Huang C, Sun Y, et al. Effect of laparoscopic vs open distal gastrectomy on 3-year disease-free survival in patients with locally advanced gastric cancer: The CLASS-01 randomized clinical trial. JAMA. 2019;321(20):1983-1992.  doi:10.1001/jama.2019.5359