As reported in JAMA Surgery by Huang et al, the Chinese phase III CLASS-01 trial has shown no difference in 5-year overall survival in patients with locally advanced gastric cancer who underwent laparoscopic vs open distal gastrectomy. The previously reported primary analysis of the trial showed no difference in 3-year disease-free survival between the two approaches.
In the multicenter open-label trial, 1,056 patients with clinical stage T2, T3, or T4a disease without bulky nodes or distant metastases were randomly assigned to receive laparoscopic distal gastrectomy (n = 528) or open distal gastrectomy (n = 528) with D2 lymphadenectomy. Final follow-up was in December 2019.
Key Findings
Median follow-up was 71 months (interquartile range = 43–77 months). The overall survival analysis population consisted of 1,039 patients, including 519 in the laparoscopic group and 520 in the open-surgery group.
[L]aparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer.— Huang et al
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At 5 years, overall survival was 72.6% (95% confidence interval [CI] = 69%–77%) in the laparoscopic group vs 76.3% (95% CI = 73%-80%) in the open-surgery group (hazard ratio [HR] = 1.17, 95% CI = 0.93–1.48, P = .19). No significant differences were observed according to disease stage, with 5-year rates of 90% vs 88.5% for stage I (P = .70), 79.1% vs 84.5% for stage II (P = .14), and 58.6% vs 59.5% for stage III tumors (P = .95).
In analysis adjusting for competing risks, hazard ratios for laparoscopic vs open surgery were 1.14 (95% CI = 0.87–1.49, P = .34) for gastric cancer deaths and 1.23 (95% CI = 0.74–2.05, P = .42) for deaths from other causes.
In analysis adjusting for age, sex, body mass index, Eastern Cooperative Oncology Group performance status, comorbidity, tumor size, histologic features, TNM stage, and chemotherapy, the hazard ratio for open surgery vs laparoscopy was 1.14 (95% CI = 0.89–1.46, P = .25).
Restricted mean survival time was 51.5 months (95% CI = 50.2–52.8 months) in the laparoscopic group vs 52.5 months (95% CI = 51.3–53.8 months) in the open-surgery group, yielding a restricted mean survival time ratio of 0.98 (95% CI = 0.94–1.01, P =.27), indicating a nonsignificant 2% shorter median survival time in the laparoscopic group.
The investigators concluded, “This study found that laparoscopic distal gastrectomy with D2 lymphadenectomy performed by experienced surgeons in high-volume specialized institutions resulted in similar 5-year overall survival compared with open distal gastrectomy among patients with locally advanced gastric cancer.”
Guoxin Li, MD, PhD, of the Guangdong Provincial Key Laboratory of Precision and Minimally Invasive Medicine for GI Cancers, Nanfang Hospital, Southern Medical University, Guangzhou, is the corresponding author for the JAMA Surgery article.
Disclosure: The study was funded by Guangdong Provincial Key Laboratory of Precision Medicine for Gastrointestinal Cancer, Guangdong Provincial Major Talents Project, National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit jamanetwork.com.
