Laparoscopy-Assisted Distal Gastrectomy Effective for Clinical-Stage-I Gastric Cancer

By Will Boggs MD

December 06, 2019

NEW YORK (Reuters Health) - Laparoscopy-assisted distal gastrectomy (LADG) performed by experienced surgeons provides outcomes similar to those of open distal gastrectomy (ODG) with nodal dissection for patients with clinical-stage-IA or -IB gastric cancer, according to a noninferiority phase-3 trial.

ODG has long been the standard treatment for early-stage gastric cancer, but LADG has emerged as an alternative and is now considered an option for clinical-stage-I gastric cancer in the 2017 Gastric Cancer Treatment Guidelines in Japan, where the new study was conducted.

Dr. Hitoshi Katai of the National Cancer Center Hospital, in Tokyo, and colleagues previously reported that LADG performed by accredited surgeons is as safe as ODG in terms of adverse event frequency and short-term clinical outcomes.

Now they report long-term survival data from this open-label, multicenter, noninferiority, phase-3 randomized controlled trial of 921 patients treated by 48 surgeons from 33 institutions in Japan (459 assigned to ODG and 462 assigned to LADG).

Surgery was significantly longer in the LADG group than in the ODG group (median, 278 vs. 194 minutes), but blood loss was lower in the LADG group (median, 38 mL vs. 115 mL).

The primary outcome, three-year relapse-free survival, was 95.8% in the ODG group versus 97.4% in the LADG group, which fell within the predefined noninferiority margin, the team reports in The Lancet Gastroenterology and Hepatology, online November 19.

Similarly, overall survival did not differ significantly between the ODG and LADG groups at three years (97.4% and 98.3%, respectively) or at five years (95.2% and 97.0%, respectively).

Late grade-3 or -4 adverse event rates did not differ significantly between the ODG group (4%) and the LADG group (2%), and there were no apparent differences in the frequencies of most specific adverse events (although bowel obstruction was less common in the LADG group).

Relapse-free survival did not differ in subgroup analyses by sex, age, histology, clinical stage, cN, or cT, but patients with a BMI of 25 or higher tended to show poorer survival after LADG than after ODG.

This is the second clinical trial that has shown "the noninferiority of LADG compared with ODG for safe and efficacious treatment of clinical stage IA or IB gastric cancer. Therefore," the authors conclude, "LADG performed by an experienced surgeon should be considered a standard surgical option for the treatment of clinical stage IA or IB gastric cancer."

"Minimally invasive gastrectomy seems to be feasible, safe, and effective for gastric cancer if it is performed by experienced surgeons in specialized centers," write Dr. Felix Berlth and Dr. Peter Philipp Grimminger of University Medical Center of the Johannes Gutenberg University, in Mainz, Germany, in a linked editorial.

"With recent progress in Europe to establish a new and effective perioperative chemotherapy, such as FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel), and with advances in the development of targeted drugs, it is important that surgery allows for the maximum potential of medical therapy for patients with gastric cancer," they note.

"Laparoscopic gastrectomy has the potential to achieve this goal without compromising oncological radicality, so we must work towards providing more specialized centers that are able to perform highly standardized, minimally invasive gastrectomy, and doing further randomized controlled trials in these settings to evaluate long-term outcomes," Drs. Berlth and Grimminger add.

Dr. Kaitlyn J. Kelly of the University of California, San Diego, in La Jolla, who recently reviewed the surgical management of gastric tumors, told Reuters Health by email, "As a gastric cancer surgeon in the U.S., I found it interesting that 921 patients with early-stage disease were able to be enrolled in the study in a period of only 3.5 years. This highlights the tremendous difference in incidence of this disease in Japan versus the United States and also the effectiveness of screening for early detection."

"This is an important and well-designed study that confirms the appropriateness of LADG for this highly selected population of patients," she said. "It is important to emphasize, however, that these patients all had clinically early-stage disease and none were obese. Additionally, the participating surgeons were confirmed to be highly experienced with the procedures. The factors must be kept in mind when interpreting the study results."

"These results can only be expected to be achieved with surgeons and patients similar to those included in the study," Dr. Kelly said.

Dr. Katai did not respond to a request for comments.

SOURCE: https://bit.ly/2R0mF1s and https://bit.ly/2KZ99qL

Lancet Gastroenterol Hepatol 2019.

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