Kurokawa Y, et al. - Experts gauged the survival benefit of bursectomy in patients with resectable gastric cancer. A survival advantage was not provided by bursectomy vs non-bursectomy. For resectable cT3–T4a gastric cancer, D2 dissection with omentectomy alone should a standard surgery.

Methods

• Authors conducted this phase 3, open-label, randomized controlled trial at 57 hospitals in Japan.
• They randomly assigned (1:1) patients aged 20-80 years with cT3(SS)–cT4a(SE) histologically proven gastric adenocarcinoma with an Eastern Cooperative Oncology Group performance status of 0 or 1 and body-mass index less than 30 kg/m²and who did not have distant metastasis or bulky lymph nodes to receive omentectomy alone (non-bursectomy) or bursectomy during surgery.
• They performed the randomization by telephone or website to the Japan Clinical Oncology Group Data Center and used a minimization method with a random component to adjust for institution, cT status (T3 vs T4a), and type of gastrectomy (distal vs total).
• Total or distal gastrectomy with D2 lymphadenectomy was done in both the groups.
• Overall survival, analyzed in the intention-to-treat population, was the primary endpoint.

Results

• Between June 1, 2010 and March 30, 2015, 1,503 patients were enrolled based on preoperative inclusion and exclusion criteria.
• As per data, 1,204 patients met the intraoperative inclusion and exclusion criteria, of which 602 were allocated to the non-bursectomy group and 602 were allocated to the bursectomy group.
• Results were independently reviewed by the JCOG Data and Safety Monitoring Committee at the planned second interim analysis on Sept 17, 2016, and their early publication was recommended on the basis of futility, because overall survival was lower in the bursectomy group vs the non-bursectomy group, and because of significantly higher predictive probability of overall survival in bursectomy than non-bursectomy patients at the final analysis was only 12.7%.
• Five-year overall survival was 76.7% (95% CI 72.0–80.6) in the non-bursectomy group and 76.9% (72.6–80.7) in the bursectomy group (hazard ratio 1.05, 95% CI 0.81–1.37, one-sided p=0.65). Grade 3–4 operative morbidity was seen in 64 (11%) of 601 in the non-bursectomy group and 77 (13%) of 600 patients in the bursectomy group.
• Compared to the non-bursectomy group, pancreatic fistula was significantly more common in the bursectomy group (29 [5%] vs 15 [2%]; p=0.032).
• Either in-hospital or within 1 month of surgery, six deaths occurred: five in the non-bursectomy group and one in the bursectomy group.