No Survival Benefit with Rituxan Maintenance

The Journal of Clinical Oncology published the results of a study a few days ago that looked at long-term benefits of Rituxan Maintenance. The article is called "Long-Term Follow-Up of the RESORT Study (E4402): A Randomized Phase III Comparison of Two Different Rituximab Dosing Strategies for Low–Tumor Burden Follicular Lymphoma." The big news from the study is that there doesn't seem to be a survival benefit from Rituxan Maintenance in low-tumor burden Follicular Lymphoma patients. 

A few things need some explaining here. 

First, Rituxan Maintenance is a type of treatment where patients first receive a treatment that includes Rituxan (also know as Rituximab and Mabthera), a monoclonal antibody. The treatment could be just Rituxan, or it could be Rituxan combined with something else (like R-CHOP or R-Bendamustine). For this particular study, the patients received only Rituxan, once a week for four weeks. The "maintenance" part comes next, after the initial treatment -- patients receive just Rituxan on a regular schedule for a certain time period. For this study, the patents recieved Rituxan every 13 weeks until they need treatment again. (Some Rituxan Maintenance studies have a different dosing schedule, like every 2 months for 2 years, and then no more.)

The idea behind Maintenance is that the regular doses of Rituxan will help "clean up" any leftover cancer cells, or any new cells that develop. It's always been kind of controversial, with some studies showing a benefit and others showing no benefit, and others showing a small benefit but asking if the additional cost and additional weakening of the immune system is worth it (Rituxan reduces cancerous B cells, which are part of the immune system, but also healthy B cells).

For what it's worth, my own treatment, 14 years ago, was 6 weekly rounds of Rituxan. I haven't needed treatment since. I do remember asking my oncologist, as we discussed treatment, if we should consider doing maintenance. Back then, he told me that there was good evidence that maintenance helped people who had received immunochemotherpay (R-CHOP or R-Bendamustine, or back then, R-CVP, which is less common these days), but less evidence that there was a benefit for people who received only Rituxan.

What seemed like the case, 14 years ago, is confirmed by this research, which looked at a long-term follow-up of patients like me, with low tumor burden, receiving only Rituxan.

I'll repeat this, because I think it's important -- this study looked only at low-tumor burden FL patients who received only Rituxan. There's a whole other body of research on patients who had high tumor burden, or who received other treatments (though they are controversial in their own ways -- you can search for what I have written about them over the years). 

For this study, 289 FL patients were divided into two groups, as I mentioned above. The first group received four weeks of Rituxan, and then no other treatment until their disease returned and got bad enough to need treatment. The second group received Rituxan, and then more Rituxan every 13 weeks until it stopped working and they needed a different treatment. 

The Maintenance group did have some benefits to their treatment. After 7 years, 83% of the patients who had received Maintenance had still not needed a second treatment. In the first group, only 63% of patients had been able to avoid treatment.

Also, some patients had their disease return, even though they didn't need a second treatment yet. After 7 years, 71% of the Maintenance group had not had their disease return, while only 37% of the non-Maintenance group remained in remission.  

But it was Overall Survival that showed no difference. After 10 years, 83% of the Maintenance group was still alive, as was 84% of the non-Maintenance group. 

And the OS was what the researchers focused on. And of course, that's important. We all want to live longer. But I think the other numbers are important, too, and I have some thoughts about them.

This seems like a good time to remind you all that I am not an oncologist or a cancer researcher. The best person to talk to about treatment decisions is your own oncologist.

It seems to me that patients who receive only Rituxan are in a situation where they have a less aggressive version of FL. This was certainly the case for me. And while we do have some treatments that have the potential for very long-term remission, or even A Cure, we're not really there yet. So there may be some FL patients whose goal is to stay in remission for as long as possible. They know (or assume) that they will eventually need treatment again, and they want to delay it as long as possible. Maybe a Maintenance strategy is the best way to do that -- a relatively less aggressive treatment at first (compared to something like traditional chemo), followed by less aggressive treatments for a while. Of course, doing this also costs money, and increases the chance for infection, but also holds off more aggressive treatment for a while.

I'm not endorsing Rituxan Maintenance for anyone. I'm not endorsing any particular treatment at all. My point is not only that your oncologist is the best person to talk to about this, but also that your a very specific discussion of your goals should be a part of that conversation. Not everyone is looking for A Cure. Maybe your life style or your overall health make that difficult. But that's the ind of topic that should be a part of your oncologist visits. It is for mine. Even after 16 years, I want to know what the next steps might be, if I ever need them.

We are fortunate to have lots of choices. It's good to know what they are, and which is best for each of us.