ASH Preview: Progression of Disease in 24 Months for FL

A few posts ago, I looked briefly at an upcoming ASH session called "Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study."


The presentation looked at 1202 patients in the GALLIUM clinical trial, which compared two immunochemoptherapy regimens.  In one, patients had Obinutuzumab + chemo, followed by Obinutuzumab maintenance. In the other, patients had Rituxan + chemo, followed by Rituxan maintenance. As I said in the post last week, the results from this trial helped get the Obinutuzumab regimen approved for untreated Follicular Lymphoma.

Because the study dealt with untreated patients who were getting immunochemotherapy (the chemo was CHOP, CVP, or Bendamustine), it was a convenient place to also look at POD24.

POD24 stands for Progression of Disease at 24 months -- for patients who had received  immunochemotherapy and then had their disease get worse, their Overall Survival was lower than those who did not have Progression of Disease in that time.

I know some of you are in this group, or have had immunochemotherapy and haven't made it to 24 months yet, and the numbers worry you. I'm not going to tell you not to worry. I've been in your shoes -- the diagnosis is still raw, and it might not matter what anyone tells you. The worry is going to be there.

But it might be helpful to look more closely at the numbers.

Of the 1202 patients in the trial, after 24 months, 155 were POD24, and 916 did not progress.  So, first off, if you've had immunochemo and you haven't gotten to 24 months yet, the numbers show that the treatment worked well for a whole bunch of people -- about 87% of them. Of the 155 patients who were POD24, 56 died. Of those 56, only 40 died due to Proogression of Disease; the other 16 died of other causes (remember, Overall Survival measures death by any cause).

So 40 of 1202 patients who received immunochemotherapy died from their disease -- that's about 3%. As for those who were POD24, that's about 26%.

It's easy to focus on words like "lower Overall Survival," and it's easy to get caught up in numbers. But it's also important to remember that those numbers look at trends, not at individual patients. What happened to 40 people in a large trial doesn't say anything about you individually. And if you want to look at numbers, look at this: 40 of 155 POD24 patients died, but 115 of 155 didn't. That's a 74% survival rate. Pretty good odds, really.

To me, you can look at POD24 as being bad or good. Most who are in the situation will think of it as bad, and that's an understandable reaction. While the idea of POD24 is only a few years old, POD24 patients have been around for as long as Follicular Lymphoma -- we just hadn't identified that group yet. So being able to identify POD24 patients is a good thing. Researchers know they exist, and can start finding ways to help them.

There are a few other POD24-related presentations at ASH.

Like the GALLIUM presentation, another one confirms that POD24 is a valid thing: "Validation of POD24 As a Robust Early Clinical Endpoint of Poor Survival in Follicular Lymphoma: Results from the Follicular Lymphoma Analysis of Surrogacy Hypothesis (FLASH) Investigation Using Individual Data from 5,453 Patients on 13 Clinical Trials"

The good thing about this one is, besides confirming that there are POD24 patients, they also found some other factors that could help build a prognostic model. In other words, they might be able to identify trends that could allow oncologists to identify patients as being at higher risk for POD24, and find other ways to treat them.

Another presentation, "The Tumor Microenvironment Is Independently Prognostic of Conventional and Clinicogenetic Risk Models in Follicular Lymphoma," also confirms that POD24 is real, and goes a step farther by identifying some Tumor Microenvironment markers that could help researchers figure out who is at higher risk.

Yet another presentation, "Impact of PET Staging of Follicular Lymphoma on Treatment Outcomes and Prognosis," looked at the effect of CT and PET scans on EFS24 (Event-Free Survival at 24 months, similar to POD24). Researchers found that patients who had PET scans had a higher OS than those who had CT scans, indicating that PET might be useful in predicting EFS24.

All of this research points to the same thing. While there isn't yet a way to predict POD24 patients, or a way to treat them that is guaranteed to work, a bunch of teams of researchers are working on it. In the last couple of years, I've seen many Follicular Lymphoma experts give summaries of where they think research is headed, and almost all of them said that it was important to work on the POD24 issue -- finding ways to identify them, and finding ways to treat them. Clearly, that work is happening.

In the meantime, the best thing we can do is what we've always done -- pay attention to you body, stay informed, and insist on honest and open communication so you can get the best care possible.