Thursday, November 30, 2017

ASH Preview: Rituxan Maintenance

Another ASH preview: This one is for "Long Term Follow-up of the PRIMA Study: Half of Patients Receiving Rituximab Maintenance Remain Progression Free at 10 Years."

The PRIMA Study has been looking at the long-term effects of Rituxan Maintenance on Follicular Lymphoma for a while now, and this presentation will look at how patients have been doing after 10 years.

Rituxan Maintenance has been fairly controversial in the Follicular Lymphoma community. It's one of those topics where enthusiasm kind of flip-flops with every new study. One study will find a benefit to it, and then another will show that the benefit wasn't as great as it seemed, or that there were new drawbacks. But neither side has shown enough evidence to make everyone agree on a definite Yes or No to Maintenance.

The PRIMA study looked at FL patients who were given Rituxan + chemo (mostly CHOP, but some CVP or Fludarabine) as an initial treatment, between 2004 and 2007. This was followed by half of the patients (505 of them) being given Rituxan Maintenance (every 8 weeks for 2 years), and the rest (513) getting no Maintenance. There have been follow-up studies of the patients at 3 years and 6 years, and now at 10 years.

The results certainly back up a benefit for R-Maintenance. Those who received it had a median Progression Free Survival of over 10 years. For those who didn't get it, the median PFS was just over 4 years. At the 10 year follow-up mark, 51% of the Maintenance patients had not had their disease progress, while only 35% of the non-Maintenance patients had no progression. The median time to a new treatment was just over 6 years for the non-Maintenance group (that is, it took that long for half of them to need treatment), while the Maintenance group hadn't yet reached the median.

One of the arguments against R-Maintenance is that it means patients are being treated for a long time when they haven't necessarily shown a need to be treated. They might have a clean scan, but continue to get Rituxan anyway. Some argue that this could result in over-treatment, with unnecessary side effects and potential long-term problems. 

The argument that the researchers make here for the value of R-Maintenance is that, because Follicular Lymphoma patients are living longer, it's worth the risk of giving Rituxan for two extra years. If it means patients will then not need treatment for another 8 years (at least), it frees them from the side effects (including developing secondary cancers) that might come if they had to go through another round of chemotherapy or other treatment. It's a compelling argument.

On the other hand, despite the longer PFS, there is no Overall Survival benefit to Maintenance. Both groups had a median OS of about 80% at 10 years. There is a group of people in the FL community that says, while extended PFS is nice, Maintenance doesn't make anybody live longer, and that's really the ultimate goal. So maybe the extra cost, time, and potential side effects of the Maintenance aren't worth it.

I'm still on the fence about it, for what it's worth. I do think that OS is ultimately what we are all aiming for. But as someone who has managed, with just Rituxan, to go almost 8 years without further treatment, I can say that it's pretty nice to not have to stress out about going to the treatment room. There's certainly a Quality of Life argument to be made here. Patients who can go for years without further treatment? That's a worthy goal, too.

The ASH conference is always followed up with commentary from experts, and I'll be very interested to see what the experts have to say about this. Will some of those anti-Maintenance folks come around and change their minds? Will they point out something in the data that we can't see right now by just looking at the abstract? I have a feeling this is going to be one those presentations that gets lots of attention.

ASH is coming up very soon -- it starts next week. We won't have to wait for long to hear from real experts (and not just Cancer Nerds).



6 comments:

Anonymous said...

Hi Bob,

That's amazing news! I opted for the 2 year maintenance and am now 4 years PF. I have to say that I disagree with those that believe the only goal is OS. Those extra years with no disease progression to me means better quality of life. It means trips with the family, working, feeling good and putting this disease on the back burner for as long as I can. I may not live longer, but I'll live better!
I respect those who opt out of maintenance, but this study sure gives a convincing argument. Thanks for providing all this research to us :)

Anonymous said...

Thank you for this info. I think I read somewhere that if you get R maintenance you may need infusions of immunoglobulin ?
I always appreciate the information you share.
Donna

Mylegacy said...

What follows is/are a/several convoluted question(s). I do not know enough to say what follows as a statement of fact. IF I've missed the boat - PLEASE give me the smack down I'll deserve!

I understand that most of us who die with our "incurable" guest will do so from "infection." Most likely pneumonia or other respiratory illnesses. We will not succumb to FL, as such, but to the failure of our - by the time we're near dying - badly damaged white B cells being unable to guide the T cells to the pneumonia in great enough numbers, and in a short enough time frame, for our immune system to save us. Is what I have just written there correct(ish)?

IF SO: Then that is why I'm opposed to R maintenance. R is an indiscriminate killer of white B cells (is it not?). Cancer, or no cancer, R kills them. The ONLY reason it is safe(ish) is because it DOES NOT kill white B STEM cells. These "Baby B cell factories" continue to produce new B cells in our bone marrow.

However - over time IF you use R maintenance - who are reducing B cells and you end up with mostly new(ish) immature B cells. Our immune systems suffer - those of us who will die, will do so from the infections our mostly "baby/immature" B cells can not destroy. Our adult, mature, effective B cells have been decimated over time.

I've only had one 6 month R/B dance so far but just now (6 months after my final 2 day adventure) I'm in the 19th day of a cold. I'm 71, had a few colds in my time, but NEVER have I had one last this long. I'm beginning to think I understand what my future might look like. To make this journey even more interesting - I've already had pneumonia once about 15 years ago.

Intuitively, why wouldn't B maintenance (just killing Cancer cells) make more sense than reducing generations of adult B cells and diminish our bodies immune system being able to find and identify the bad guys for or T cells to kill?

Lymphomaniac said...

Donna,
My understanding is that some maintenance patients will need Immunoglobulin as well. Not sure what the percentage is, but I think it's fairly common.
Bob

Anonymous said...

I did the R maintenance but dind"t get the Immunoglobulin
I have seen four or five hematologist in Brazil and all of them told me to keep taking rituximb for more two years (mantenance).
It seems to be a medical protocol here in Brazil.
Best wishes for all!
Rodrigo

Anonymous said...

Retuxan does not attack and kill all B cells indiscriminately, only CD20 positive B cells. It is a targeted therapy.