WCIO Leaders Take the Helm of E1208 -- a historic opportunity

NCI cooperative group trials of IO therapies are few and far between, with a dismal track record; so much so that IR’s have the reputation in the NCI community of being ”unable to do trials”. Unfortunately we still lack a clinical trials group for IO, so to access the resources needed for national multicenter trials requires either industry funding -- a rare thing on this scale from the device world -- or the national cooperative groups. 

There are some breaths of fresh air from our industry colleagues. Merit Medical, BTG and Sirtex are all running multicenter embolotherapy trials for HCC and/or liver metastases. 

ECOG 1208, a phase 3 randomized double-blind trial of chemoembolization of HCC with sorafenib or placebo, was activated in October 2009. The primary endpoint is progression-free survival, with a planned accrual of 200 patients in each arm. Jeff Geschwind and I served as the IR co-chairs for the protocol design, but the trial has been run largely by medical oncologists. Among the 123 sites approved to accrue to the study, only one has a recognized IR as the site PI. Accrual has been a dismal 167 patients over the past 4 years, less than half of the planned rate. Only three centers in the country have enrolled 10 or more patients. Accrual has remained so poor that the ECOG DSMB and the medical oncologists on the steering committee recommended consideration of closing the trial. 

In a recent turn of events, the med onc PI for E1208 left, and the leadership of the ECOG GI committee turned over to Peter O’Dwyer, a Penn medical oncologist and IO enthusiast. Dr. O’Dwyer saw the futility in med oncs running an IO trial, and asked us to take it over. In essence, he has thrown down the gauntlet: can IO’s run a successful cooperative group trial of image-guided therapy?  This is an historic opportunity--- for the first time, interventionalists are running an NCI cooperative group trial. Jeff Geschwind will take over as the PI, with Riad Salem and myself as the co-chairs.

As an IO community, we need to rise to this challenge. We do not want to be left holding the blame for the failure of the study. As I discussed in a prior post, trials of IO therapies are difficult to accrue (see “IO Clinical Research; the Good, the Bad, the Ugly”, Jan 13, 2013). Having treatment arms involving different specialists, instead of the patient being managed by a single doctor, is a major negative accrual factor for any trial. IO’s doing chemoembolization should be able to prescribe and manage sorafenib; but if you are not comfortable, then team up with a medical oncologist or hepatologist from your HCC team who is.  Coordinator support from the cooperative groups is skimpy; your cancer center should supply a coordinator funded by your group. It is an intergroup trial, so SWOG, CALGB, NCCTG, NSABP, and RTOG sites are all able to participate. Make sure the trial is active at your site, and that your HCC tumor board funnels eligible patients to the trial. See http://ecog.dfci.harvard.edu/general/E1208info.html for physician and patient information about the trial.

Jeff, Riad and I will be reaching out to centers likely to be able to put patients on the study. We need the concerted effort of the IO community to prove to our med onc, surg onc, and rad onc colleagues that we can do trials too, and cement our credibility as the fourth pillar of cancer care. 

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