Referring Patients with Colorectal Cancer to Clinical Trials

Transcript:John L. Marshall, MD: What, I think, a lot of us struggle with, is we’re comfortable with chemotherapy and the patient’s comfortable with chemotherapy; they get to this place. We have this twinkle in the eye that maybe it will respond, but we’re leaving OS on the table. Of course, all of us also have the other incentive that we’re driven by, and that is clinical trial accrual. Many of our clinical trials don’t require this line of therapy, and we have other things to do. Start us off as a world’s expert in clinical research. Where are we looking for clinical trials in patients in colon cancer?

Cathy Eng, MD: What do you mean where?

John L. Marshall, MD: Which patient is the most appropriate, or ready, for a clinical trial?

Cathy Eng, MD: I would say probably almost any patient with a good PS of 0 to 1 and good laboratory values.

John L. Marshall, MD: Even in the refractory setting?

Cathy Eng, MD: Regardless of refractory setting, yes. And, the willingness to participate in a trial, make the effort to come on a regular basis, and be adherent. We need patients to participate in clinical trials; that’s how we make the impact on advancing the field.

John L. Marshall, MD: Why don’t we have a frontline clinical trial right now?

Daniel G. Haller, MD: I was going to ask about that. What about window trials? They do it in pediatrics. In a patient with asymptomatic metastatic disease, what about using a window trial, moving a biologic from the twenty-third—line of therapy up to first-line therapy?

John L. Marshall, MD: Perfect place. I invite you to our poster of what we call the Alexandria trial of TAS-102 and bevacizumab in the maintenance setting. It’s something to do in that window, not that exciting, but it’s a switch in a way. We’ve been really struggling with frontlines. Second-line is really hard to accrue to, in my opinion, because they keep coming from different angles. So, this space has been the most successful space.

Daniel G. Haller, MD: Also, “lines of therapy” is an antiquated term. When you use maintenance therapy, what is it? Did you stop because of toxicity, or did you stop because of progression, or you just stopped? Those are very different patients.

John L. Marshall, MD: Let’s say I’ve got this patient who has good PS. For now, they’re doing that repeat biopsy and maybe doing another profile, and seeing if they fit into MATCH or TAPUR. Is this a patient that you want to be doing that in?

Cathy Eng, MD: Yes.

John L. Marshall, MD: That’s the thought. With these trials, we’ll have an outlet for those patients going forward. A year goes by, a new ASCO. What’s important and new that every community oncologist needs to know in colorectal cancer?

Tanios Bekaii-Saab, MD: I think the biggest story at ASCO is the left-sided versus right-sided tumor and its potential implication of prognosis, and possibly selection of agents coupled with chemotherapy. Pay close attention to the side of the tumor.

John L. Marshall, MD: Cathy, what are the hot new drugs and other new approaches that we need to be looking at?

Cathy Eng, MD: There’s obviously a lot of interesting early developments, but nothing that’s really a home run right now. The greatest interest is probably the sidedness.

John L. Marshall, MD: Tara, thoughts, closing?

Tara E. Seery, MD: The sidedness is huge, but also, encouraging patients to enroll in a trial. That’s the ‘be all and end all’ when we have them.

John L. Marshall, MD: It’s always good. Dan, you’ve been at this a long time. Where are we in colon cancer? Are you pleased with where we’ve gotten?

Daniel G. Haller, MD: Now, it’s confusing. Being confused is good, but I think the most exciting next step is probably going to be the checkpoint inhibitors. We didn’t talk much about it, but checkpoint inhibitors work when you have a lot of mutations—melanoma, non-small cell lung cancer, bladder cancer, most recently, and MSI-high GI tumors. The work from Hopkins from Clare Jung Eun Lee is amazing, showing third-line pancreas Lynch patients with response rates in the double digits. I think there’s no chance that those drugs are not going to be approved in some subset of colon cancer. If it’s only 5% because MSI-high primary tumors don’t relapse as often, good, bad—we don’t have very many metastatic MSI-high patients. But, it’s as high as ALK for crizotinib. It’s as high as a lot of other mutations, so I’m pretty excited about that.

John L. Marshall, MD: I want to thank all of you for joining me. This really is an exciting and confusing time, so we want to take good care of our patients. Our patients are living longer, and I hope this session has been useful to you out there as we’ve moved forward in advancing the ball in the treatment of metastatic colon cancer. On behalf of OncLive and all of these really smart people up here, I’m John Marshall. Thank you for joining us.

Transcript Edited for Clarity