Chandrakanth Are, MBBS, MBA, FRCS, FACS
For comments on the phase III DIPLOMA trial, which found outcomes comparable between minimally invasive and open distal pancreatectomy, The ASCO Post interviewed Chandrakanth Are, MBBS, MBA, FRCS, FACS, the Jerald L. & Carolynn J. Varner Professor of Surgical Oncology & Global Health; Associate Dean for Graduate Medical Education; and Vice Chair of the Education Department of Surgery, University of Nebraska Medical Center, Omaha. He first noted the challenge of conducting randomized clinical trials in surgical practice that focus on operative procedures. This becomes even more difficult when it includes patients with pancreatic cancer because of its technical complexity, he added.
“Very few patients are surgical candidates—particularly so for patients with lesions in the body and tail of the pancreas because of the more advanced stage of disease at the time of detection. To enroll more than 250 patients over 3 years into a study of distal pancreatectomy is impressive,” Dr. Are said about the DIPLOMA trial.
The importance of having data from a randomized trial in this disease that focus on the surgical technique cannot be overstated, Dr. Are emphasized. Only a minority of papers published in the surgical literature consist of randomized controlled trials, and those evaluating operative approaches in surgical oncology are especially difficult, especially in pancreatic cancer. “When such randomized trials are submitted, we do our best to publish them as long as the methodology is sound,” he said.
However, the lack of such comparative studies has not impeded the growth of minimally invasive surgery for pancreatectomy. “I’d say 15 to 20 years ago, if you needed to do a distal pancreatectomy, it was mostly by the open approach, and you wondered which patient would be a candidate for minimally invasive surgery. Now, you ask why a patient is not a candidate for minimally invasive surgery,” Dr. Are explained.
Clinical Considerations
Commenting on the current study, Dr. Are noted that the R0 resection rate of 73% is acceptable, but with an open surgical approach, he would have expected higher than the 69% observed in the study.
The intraperitoneal recurrence rate may also be an underestimate in terms of longer-term outcomes, according to Dr. Are, since patients were followed for only 2 weeks to 2 years. “At 5 years, survival after resection is only about 10%,” he pointed out.
The addition of adjuvant chemotherapy may also affect survival. Although these patients did not undergo neoadjuvant chemotherapy, this is a growing practice, even with resectable tumors, and its use could also have changed the long-term outcomes. The exclusion of patients with neoadjuvant chemotherapy across both arms (and different regimens), however, did eliminate a potential confounder for the comparison, he pointed out.
“The results of DIPLOMA confirm that, for the right patient with pancreas cancer in the body and tail, minimally invasive distal pancreatectomy has been demonstrated to be noninferior to the open approach. This important trial will accentuate the growing adoption of minimally invasive approaches for treating patients with pancreas cancer,” Dr. Are concluded.
DISCLOSURE: Dr. Are reported no conflicts of interest.
