Minimally invasive surgery ‘safe, valid’ alternative to open approach for pancreatic cancer
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Key takeaways:
- A noninferiority trial showed similar rates of radical resection with both approaches.
- OS and DFS curves of the two approaches nearly overlapped.
Minimally invasive surgery appeared safe and just as effective as open surgery for patients with resectable pancreatic cancer, according to results of the DIPLOMA trial scheduled for presentation at ASCO Annual Meeting.
“This trial, which is the first trial of its kind, can confirm that minimally invasive distal pancreatectomy is a safe, valid and efficient alternative to the open approach in the treatment of resectable pancreatic cancer in the body and tail of the pancreas,” Mohammad Abu Hilal, MD, PhD, surgical director at Instituto Ospedaliero Fondazione Poliambulanza in Brescia, Italy, said during a press conference. “This is confirmed by a noninferior radical resection rate, lymph node yield and comparable survival.”
Researchers could not confirm the benefit of shorter time to functional recovery with the minimally invasive approach, possibly because of differences in patient management among the 35 centers in 12 countries that participated in the study, Abu Hilal said.
Background and methods
Minimally invasive distal pancreatectomy has been increasing since its adoption about 25 years ago, according to Abu Hilal. The approach uses a series of small incisions to remove tumors from the body or tail of the pancreas and spleen, thus reducing risk for serious complications vs. the open approach.
The safety and efficacy of the minimally invasive vs. open approach has been a topic of debate among surgeons. To address the issue, Abu Hilal and colleagues conducted the randomized phase 3 DIPLOMA noninferiority trial, which enrolled 258 patients with resectable pancreatic cancer. The researchers randomly assigned patients in a 1:1 ratio to laparoscopic or robot-assisted minimally invasive distal pancreatectomy or open distal pancreatectomy. They blinded pathologists and patients to the approach and conducted follow-up from 2 weeks to 12 months.
Radical resection with 1 mm or greater distance between the tumor and margin served as the primary endpoint. The trial had a noninferiority margin of 7%.
Results
With the minimally invasive approach, 73% of patients (n = 83) had a radical resection compared with 69% (n = 76) who underwent open surgery (P for noninferiority = .039). The groups also had a similar median lymph node yield (22 vs. 23), time to functional recovery (5 days for both) and rate of serious adverse events (18% vs. 22%).
The OS and DFS curves of the two approaches nearly overlapped, Abu Hilal noted, with median OS of 40 months with minimally invasive surgery vs. 39 months with open surgery and median DFS of 44 months vs. 45 months.
Implications, next steps
Researchers plan to compare outcomes at 3 years and 5 years and will evaluate the number of lymph nodes removed from the spleen to gauge whether spleen removal is necessary, according to an ASCO press release.
“This randomized surgical trial will help both surgeons and patients feel comfortable that minimally invasive surgery, in expert hands, is not inferior to open surgery,” Jennifer F. Tseng, MD, MPH, an ASCO expert and surgical oncologist and gastrointestinal surgeon at Boston Medical Center, said in the press release. “This may provide benefits like faster recovery time and less infection risk, without increasing cancer risk.”
References:
- Abu Hilal M, et al. Abstract 4163. Scheduled for presentation at: ASCO Annual Meeting; June 2-6, 2023; Chicago.
- ASCO. Minimally invasive surgery is an effective treatment option for early-stage pancreatic cancer (press release). Published May 25, 2023. Accessed May 25, 2023.
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Abu Hilal M, et al. Abstract 4163. Scheduled for presentation at: ASCO Annual Meeting; June 2-6, 2023; Chicago.
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