Benjamin Herzberg, Thoracic Oncologist at Herbert Irving Comprehensive Cancer Center, shared a post on X:
“Since Balazs Halmos highlighted it, a good opportunity to share recent work in JNCI about which patients are eligible for KRAS G12C inhibitor clinical trials, led by Margaux Wooster and Michael May.
There’s been a lot of work to broaden trial access, but we found that between 60-70% of patients are still ineligible, including for first-line studies. To our surprise, there is little variation in the eligibility criteria for randomized Phase 3 versus Ph1 studies.
While we demand evidence for much of what we do in medicine, there’s almost no evidence for which eligibility criteria actually make a difference to study outcomes or accrual.
Do we really need absolute lymphocyte counts in the eligibility criteria for KRAS G12C inhibitors?
To address this, we report outcomes in our cohort after varying eligibility criteria. Brain mets and renal dysfunction, common exclusions, had no affect on survival while greatly increasing potential accrual. But performance status remained a predictor of smaller potential HRs.
Our hope is that this can begin to build data for smarter trial designs, especially for molecularly-targeted therapies. And stop requiring “supermen” (Balazs Halmos) for trial eligibility. Patients deserve good trial options as they are KRASKickers, Jill Feldman, LUNGevity Foundation.
This work was a narrow but big lift by the great first authors (and above) and great collaborators Christine Garcia and Kathryn C. Arbour.”
Jill Feldman, Lung cancer Patient and Advocate, Co-Founder of EGFR Resisters, shared a post on X:
“This “While we demand evidence for much of what we do in medicine, there’s almost no evidence for which eligibility criteria actually make a difference to study outcomes or accrual.” Well said, Benjamin Herzberg.
Clean data should never come at the cost of people having access to trials. There’s little to no data to support whether most of these criteria meaningfully impact outcomes or safety, YET the DO meaningfully impact lives. Eligibility criteria may be a ‘checked box’ in developing a trial. But, for a person with few options, it’s the difference between access/a chance/hope and being left behind.”
Title: The impact of eligibility criteria on KRASG12C inhibitor trials in patients with NSCLC
Authors: Margaux Wooster, Michael May, Prashasti Agrawal, Jonathan Lee, Benjamin May, Xin Ma, Stephanie Bogdan, Catherine A. Shu, Brian S. Henick, Anjali Saqi, Mahesh Mansukhani, Gregory Riely, Dawn L. Hershman, Christine Garcia, Kathryn C. Arbour, Benjamin O. Herzberg
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