At Moonshot forum, expert in early-onset colorectal cancer calls for greater trial funding
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Cathy Eng, MD, FACP, FASCO, joined a panel of experts at the White House Cancer Moonshot Colorectal Cancer Forum in highlighting the need for greater patient participation in and funding for cancer clinical trials.
Eng, the David H. Johnson professor of surgical and medical oncology at Vanderbilt University, described the panel discussion last month as very productive. Other participants included the widow of actor Chadwick Boseman, who died of colorectal cancer in 2020 at age 43 years.
“Hearing his story was incredibly moving for everyone in the room,” Eng told Healio. “When we share these personal stories, it motivates the group, and the reality is that there is grave concern regarding early-onset colorectal cancer.”
Eng spoke with Healio about the panel discussion and recounted her points about clinical trial participation and funding.
Healio: You spoke about precision oncology and how it has led to an even greater need for increased clinical trial participation. Why is this important?
Eng: I was asked where I believe the field is going in terms of colorectal cancer research. People can clearly see that we are identifying more and more molecular alterations that impact patient care, due to the potential to develop drugs to target those alterations. However, the drawback is that as we continue to parse out the entire field of colorectal cancer in regard to patient care, we are left with a very small molecular subset.
For instance, with BRAF mutations, about 9% of patients have the V600E mutation. We just got FDA approval for tucatinib (Tukysa, Seagen), which is an oral tyrosine kinase inhibitor against HER2-positive colon cancer. This affects roughly 4% of the patient population. So, we have to prescreen so many individuals to identify those four out of every 100 patients we will see. We also have to continue to educate people about how to start testing for these new molecular markers. A lot of people don’t think about HER2 in colorectal cancer. These are things that constantly evolve.
Another example is KRAS G12C. We know it’s very common in lung cancer, but in colon cancer it is a very small patient population. We have a drug that targets G12C, and now we have it in combination with EGFR therapy that’s being explored in ongoing phase 1 through phase 3 clinical trials. However, that is less than 5% of our patient population for colorectal cancer, and only 10% to 20% of patients actually participate in clinical trials.
We need patients to participate in clinical trials because if you’re identifying all these molecular subsets, but patients aren’t participating, it will take forever to get these trials completed. That is obviously an area of concern. Patients don’t always trust what clinical trials entail — they view them as tedious due to work and other factors.
We also need to get the pharmaceutical companies and NCI to allow patients who are in the standard-of-care arms of large phase 2 or phase 3 trials to receive their standard-of-care treatment under their local physician’s care, and have that local physician serve as our community team member. This allows the patient to get great care while reducing stress, travel costs and time away from work for the patient.
Healio: What did you say about the need for better funding for clinical trials?
Eng: I am very supportive of NCI-sponsored studies. I am the co-chair of NCI’s Gastrointestinal Steering Committee, and my co-chair, Karyn Goodman, MD, and I review all the phase 2 and phase 3 proposals. These involve larger studies — they’re usually over 100 patients — and the four NCI cooperative groups. These are often the clinical trials that pharmaceutical companies are not interested in sponsoring, because they may involve comparing two presumed standards of care head-to-head.
The issue is that NCI reimbursement per patient has barely changed since I was a fellow, which was more than 20 years ago. So, these institutions are severely undercompensated for the per-patient cost. The institutions also have to pay for staff to maintain all the information on these trials. Insurance companies only pay for basic bloodwork and CT scans. This impacts the progress of NCI-sponsored studies, because an institution is then less likely to open a trial because they aren’t getting adequate compensation. So, for every NCI trial you open, you have to open up one or two more pharmaceutical-sponsored studies to compensate. As a result, institutions either don’t open these trials or they only enroll a small number of patients. This further delays the ability to complete clinical trials within a reasonable timeframe.
Healio: Did you meet President Joe Biden?
Eng: We did not meet the president, but we met many of his staff members. We also met several very impactful people who are able to contribute to this mission, which is to try to get the message out there about improving colorectal cancer awareness and treatment. Colorectal cancer is still the second-leading cause of cancer death for men and women combined. Despite our best efforts, that number has remained unchanged. We are improving the survival of our patient population by small increments, but there is still a lot more we can do.
For more information:
Cathy Eng, MD, FACP, FASCO, can be reached at Division of Hematology and Oncology, Vanderbilt University, 777 Preston Research Building, 2220 Pierce Ave., Nashville, TN 37232; email: cathy.eng@vumc.org; Twitter @CathyEngMD.
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