'The best level 1 evidence available'

The CONKO-001 trial presents a mix of good news and bad news, said Dr. Wolff of the M.D. Anderson Cancer Center.

In the good news category, the trial was a large multicenter one with “clean” therapy assignments and strict selection criteria; moreover, gemcitabine is a simple regimen with acceptable toxicity.

“I believe this supports gemcitabine as a community standard as adjuvant therapy for resected pancreatic cancer,” he asserted, noting that the findings constitute the best level 1 evidence available. “It [the trial] also supports gemcitabine as the control arm for future adjuvant trials.”

In the bad news category, Dr. Wolff pointed out that the gain in survival was small and the trial does not improve on the selection of patients for surgery. Furthermore, the investigators did not report the total number of patients who underwent upfront surgery-only a subset of this group was subsequently eligible for the trial. He commented that upfront surgery with adjuvant therapy has made little progress over more than 20 years, with nearly the same median survival achieved in the best arms of the GITSG trial in 1985 (21.0 months) and the CONKO-001 trial in 2008 (22.8 months).

“Remember, these results apply only to the eligible, and please note the local failure rates on these trials,” Dr. Wolff said. These range from 34% to 60% across such trials. He concluded that preoperative therapy may be a better approach for selecting patients who will benefit from subsequent surgery.