As session moderator, Fredrick Hagemeister, MD, Professor of Medicine, University of Texas MD Anderson Cancer Center, Houston, commented during the discussion of Dr. Connors’ study. He first emphasized the need to establish the safety of new drugs in clinical trials before incorporating them off-label in the clinic.

“When our new biologic agents become available, it’s necessary to do carefully designed trials of combinations. We would never have known about the pulmonary toxicity with bleomycin and brentuximab vedotin without this particular trial,” he said.

He also questioned whether, in light of the positive data for the combination of AVD and brentuximab vedotin, patients will elect to enroll in ECHELON-1 and accept treatment with ABVD alone.

Dr. Connors responded: “The question is, is there equipoise, and I think there is. But these are preliminary results in a small number of patients selected for enrollment in a phase II trial. They should never be taken as evidence that this regimen should be incorporated into standard practice yet.”

“The state of the art continues to rely on ABVD as the best balance of effectiveness and toxicity for advanced-stage Hodgkin lymphoma. Only through trials such as ECHELON-1 can we take a step forward,” he said.

Dr. Hagemeister told The ASCO Post that he hopes the trial will fully accrue. “We do need this confirmatory trial, though personally, I think there may be evidence that for high-risk patients who don’t want to go onto this trial, one could give them the option of receiving brentuximab vedotin plus AVD, and that has to be carefully considered. It’s a personal opinion, not everyone’s.”

Commenting on Dr. Forero-Torres’ study, Dr. Hagemeister said, “We now have an idea of what brentuximab vedotin does in untreated patients. It doesn’t look like it holds up to what many had hoped. You can give the drug and get away with it, but the median progression-free survival is short.” ■

Disclosure: Dr. Hagemeister reported no potential conflicts of interest.