When experienced surgeons are involved, laparoscopic distal gastrectomy is a safe alternative to open surgery in patients with early-stage gastric cancer, results of a randomized trial suggest.
Five-year overall survival exceeded 93% for both laparoscopic and open surgery groups in the multicenter trial, which included 1,416 patients with stage I gastric cancer treated by 15 surgeons who each had performed at least 100 gastrectomies.
Cancer-specific survival and recurrence were not significantly different between groups, while an intent-to-treat analysis confirmed the noninferiority of laparoscopic gastrectomy versus the open procedure, said investigators, led by Hyung-Ho Kim MD, PhD, of the Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) group.
“Our trial supports the use of laparoscopic distal gastrectomy as a standard treatment option for clinical stage I distal gastric cancer when it can be performed by surgeons with sufficient experience,” Dr. Kim and his coauthors wrote in JAMA Oncology.
Some had doubted the oncologic safety of the laparoscopic approach because of the potential for inadequate lymphadenectomy leading to an increased risk of locoregional recurrence, said Dr. Kim and his coauthors in the KLASS group, “which includes 15 surgeons from 13 institutes.” However, among patients in this phase 3 randomized trial, known as KLASS-01, the mean number of retrieved lymph nodes was similar for the laparoscopic and open surgery groups, and there was no surgical margin involvement in any patient, investigators reported.
“We thus anticipated comparable long-term oncologic outcomes for overall and cancer-specific survival because these early outcomes indicated the oncologic safety of the laparoscopic procedure,” they said. Moreover, they said, earlier publications on the KLASS-01 study demonstrated that the laparoscopic approach was associated with less blood loss, fewer wound complications, and shorter hospital stays, compared with open distal gastrectomy.
In the current study, Dr. Kim and his coauthors reported that, with a median follow-up of about 100 months, the 5-year overall survival rate was 94.2% for the laparoscopic group and 93.3% for the open group (P = .64), while Similarly, the 5-year cancer-specific survival rates were 97.1% and 97.2% for the laparoscopic and open approach, respectively (P = .91), while recurrence was not significantly different at 5.6% and 4.8% (P = .49).
The investigators cited several limitations. One is that the investigators looked only at patients with stage I cancer “suitable for distal subtotal gastrectomy. Applying laparoscopic surgery for more advanced cancers and different operations, such as total gastrectomy, needs to be verified through other clinical trials,” they said.
Nevertheless, they wrote, “These long-term oncologic outcomes of [laparoscopy-assisted distal gastrectomy] support the adoption of this procedure as a standard treatment for clinical stage I gastric cancer.”
Dr. Kim and his coauthors reported no conflicts of interest related to the study, which was supported by a grant from the Ministry of Health & Welfare, Republic of Korea.
SOURCE: Kim HH et al. JAMA Oncol. 2019 Feb 7. doi: 10.1001/jamaoncol.2018.6727.