Adding to the Maintenance Controversy

If you've been reading the blog for a long time, you probably know that there's a controversy in Follicular Lymphoma circles about Maintenance.

Maintenance is the idea that there is some benefit to continuing a treatment (usually Rituxan, but sometimes a different treatment) every couple of months for two years (though there are different schedules that are used), after the initial treatment (usually immunochemotherapy) has proven successful.

Every now and then, someone will publish research that shows the Maintenance is absolutely necessary. And then, a few months later, there will be new research that shows that there is no benefit, or that there might even be some harm.

Last November, I wrote about a presentation at ASH that showed there was no benefit to Maintenance, and it adds to treatment costs and could lead to Rituxan not working anymore for a patient.

Last July, I wrote about a study that showed there WAS a small improvement in Overall Survival and Progression-Free Survival in patients who had Maintenance.

A few months before that, I write about an earlier ASH presentation that showed that there was a PFS benefit, but no OS benefit, and once again questioned whether there potential Quality of Life issues make it worth it. A few days after that, I wrote a long piece, answering a reader's comment, about Maintenance and its long-term effects.

And that's only some of what I've written about Maintenance in the last 18 months or so.

My point is, it's definitely a controversial topic, and there hasn't been any research that has answered the question once and for all of whether or not Maintenance is a good idea.

And now we have another bit of research to add to the controversy.

At the International Conference on Malignant Lymphoma a few weeks ago, there was a presentation on the FOLL12 trial from Italy. The presentation was called "RESPONSE ORIENTED MAINTENANCE THERAPY IN ADVANCED FOLLICULAR LYMPHOMA. RESULTS OF THE INTERIM ANALYSIS OF THE FOLL12 TRIAL CONDUCTED BY THE FONDAZIONE ITALIANA LINFOMI."

(The original title was in ALL CAPS, and I decided to keep it that way here. My mom's father was born in Italy, and I lived there for 10 months when I was in school many years ago, and I like to imagine that the authors of the study just talk loudly and passionately about it, so the ALL CAPS just makes sense.

Actually, the lead researcher on the study, Dr. Massimo Federico from the University of Modena, discusses it in a video on Lymphoma Hub. He's very quiet and reasonable about it, not all loud and passionate. But I'm keeping the ALL CAPS anyway.)

The study looked at 800 Follicualr Lymphoma patients. Half were given immunochemotherapy, and then given Maintenance. The other half had immunochemo, but were then given "response-oriented therapy" -- they were given PET scans and then treatment was decided based on what was found. If the PET was clear, then no second treatment. Or they could have gotten maintenance, or some other treatment.

The researchers were expecting to find that response-oriented treatment would be the best choice. However, what they found was that the PET scans did not pick up all of the evidence that the disease was still there. So some patients didn't receive any second treatment or maintenance when they should have. Those patients had a PFS of 69%. But the patients who had Maintenance, whatever the PET scan said, had a PFS of 84%. Just getting maintenance as a matter of course seemed to help. They recommend that Maintenance be a regular part of treatment.

Interestingly, Dr. John Leonard, Lymphoma Rock Star from Weill Cornell, made this the #1 on his "leonard List" for the ICML conference. (He presented his list on Twitter, so I'm not going to link to it.) While he acknowledges the results of the study, he's not ready to accept Maintenance is the answer ("Findings undermine value of 'response adapted' rx in follicular NHL though value of maint R still debatable.")

So what does it all mean?

Well, for me, as someone who follows all of this stuff, it means I'm probably going to have some research to write about in a few months that says the exact opposite.

In all seriousness, I can't see any research coming down any time soon that shows that there is a definite benefit to Maintenance. It does seem to prolong Progression-Free Survival in a lot of patients, and that's a great thing. If a patient's goal is to have treatment and then extend it just a little bit with the idea that there won't be need for treatment for possibly many years, then Maintenance seems like a good idea. For others who are more concerned about other Quality of Life issues (Rituxan does cause some side effects, after all), then maybe no Maintenance is better.

No easy answers, I'm afraid. A conversation with your oncologist is your best course of action.

In the meantime, we can keep hoping for some research that DOES give us easy answers.

And be happy that we have a bunch of choices.