A ‘safe and effective’ minimally invasive alternative to invasive approaches for pancreatic cancer



Source/disclosure information

sauce:

Abu Hilal M et al. Abstract 4163. To be announced at: ASCO Annual Meeting. June 2-6, 2023. Chicago.


Disclosure: Ethikon and Medtronic funded this study. Abu Hilal reported research funding from Ethikon and Medtronic. See abstract for relevant financial disclosures for all other researchers.


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Important points:

  • A non-inferiority trial showed similar curative resection rates with both approaches.
  • The OS and DFS curves of the two approaches were nearly overlapping.

Minimally invasive surgery appears to be safe and as effective as open surgery for patients with resectable pancreatic cancer, according to results from the DIPLOMA trial, which will be presented at the ASCO Annual Meeting.

“This study, the first of its kind, demonstrates that minimally invasive distal pancreatic resection is a safe, effective and effective alternative to the open approach for the treatment of resectable pancreatic cancer of the body and tail of the pancreas. We can confirm that it is an efficient alternative.” Mohammad Abu Hilal, MD, The head of surgery at the Instituto Ospedagliero Fondazione Polyambranza in Brescia, Italy, said at a press conference. “This is confirmed by non-inferior radical resection rates, lymph node yields and comparable survival rates.”



Curative resection rate infographic
Data were obtained from Abu Hilal M et al. Abstract 4163. To be announced at: ASCO Annual Meeting. June 2-6, 2023. Chicago.

Abu Hilal said the researchers were unable to confirm the time-to-recovery benefits of minimally invasive approaches, possibly due to differences in patient management among the 35 centers in the 12 countries that participated in the study. Stated.

Background and method

Abu Hilal said minimally invasive pancreatectomy has been on the rise since it was introduced about 25 years ago. This approach uses a series of small incisions to remove the tumor from the body or tail of the pancreas and spleen, thus reducing the risk of serious complications compared to the open approach.

The safety and efficacy of minimally invasive and open approaches are controversial among surgeons. To address this issue, Abu Hilal and colleagues conducted a randomized phase 3 DIPLOMA non-inferiority trial that enrolled 258 patients with resectable pancreatic cancer. Investigators randomly assigned patients in a 1:1 ratio to undergo laparoscopic or robotic-assisted minimally invasive distal pancreatic resection or open distal pancreatic resection. They blinded pathologists and patients to this approach and performed follow-up from 2 weeks to 12 months.

The primary endpoint was radical resection with a distance between tumor and margin of 1 mm or greater. The non-inferiority margin for this trial was 7%.

result

With minimally invasive approaches, 73% (n = 83) of patients underwent radical resection compared to 69% (n = 76) of patients who underwent open surgery (P. for non-inferiority = .039). The median incidence of lymph nodes in each group (22 vs. 23), time to functional recovery (both 5 days) and the incidence of serious adverse events (18% vs. 22%) were also similar.

Abu Hilal noted that the OS and DFS curves for the two approaches were nearly overlapping, with median OS of 40 months for minimally invasive surgery and 39 months for open surgery, and median DFS of 44 vs. 45 months. .

Impact and next steps

According to an ASCO press release, the researchers will compare outcomes after three and five years and will assess the number of lymph nodes removed from the spleen to determine whether a splenectomy is necessary. It says.

“This randomized surgical trial will help reassure both surgeons and patients that minimally invasive surgery in the hands of experts is not inferior to open surgery.” Dr. Jennifer F. Tseng, MPH, An ASCO expert, a surgical oncologist and gastroenterologist at Boston Medical Center, said in a press release. “This may provide benefits such as faster recovery time and reduced risk of infection, without increasing cancer risk.”

References:

  • Abu Hilal M et al. Abstract 4163. To be announced 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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