Saturday, May 6, 2017

Maintenance Rituxan Improves Overall Survival in FL?

New research published in the European Journal of Cancer suggests that Rituxan Maintenance after chemotherapy might improve Overall Survival in Follicular Lymphoma patients.

The idea of Rituxan Maintenance has been controversial since it was approved. The idea is that, after getting some kind of treatment (usually chemotherapy of some sort), the patient is given Rituxan at regular intervals for a period of time -- usually 2 years. The additional Rituxan is supposed to clean up any remaining FL cells and keep the disease away for longer than the initial treatment.

Previous studies of Rituxan Maintenance have shown mixed results -- there seems general agreement that Maintenance improved Progression Free Survival, and some suggest that it improves Overall Survival, though others say the opposite, and it does not improve OS. Maintenance also has its problems -- because it suppresses the immune system, it can raise the risk of infections. And because it is given for a long time, it increases the chances of Rituxan Resistance -- basically, Rituxan just stops doing its job if it is used too much.

So there is some debate about whether or not Maintenance Rituxan is worth doing. As with most Follicular Lymphoma treatments, Overall Survival is an important factor -- if it's not going to keep us alive any longer than other treatments, do the positives outweigh the negatives?

So that's where this new study comes in.

The authors of the study did a IPD meta-analysis -- an Individual Participant Data study. Basically, that means that they didn't look at any new patients. Instead, they went back to the researchers from 7 previous studies of Rituxan Maintenance in FL, and asked to look at their original data. This allowed the researchers of the new study to have a much wider group of patients to look at.

The 7 combined groups involved studies that looked at the same thing -- some patients were given Maintenance after their first treatment, and some were not. The new study looked at 2315 patients -- 1145 received Maintenance, and 1170 did not. Most of them received either chemotherapy (CHOP, CVP, or Fludarabine) or Chemoimmunotherapy (R-CHOP, R-CVP, or R-Fludarabine). Overall, patients who received Maintenance had a better Overall Survival -- 12 years, instead the 11.5 years for patients who did not receive Maintenance.

But the breakdown of different categories makes things less clear. Patients who had Maintenance after one initial treatment of chemo or R+chemo (not just straight chemo) had an Overall Survival about the same as patients who didn't receive Maintenance. But patients who received Maintenance after a second round of R + chemo had a 30% higher OS than those who didn't receive Maintenance.

Complicating things further is that the meta-analysis confirmed that Maintenance raises the risk for infections. And the researchers also point out that the analysis doesn't include any studies that looked at Bendamustine + Rituxan as a pre-Maintenance treatment (important since Bendamustine has become a pretty popular form of chemo for FL patients).

Despite all of that, the authors of the article recommend that all Follicular Lymphoma patients receive Rituxan Maintenance.

The site Cancer Therapy Advisor ran a good summary and commentary about the study (and was very helpful to me in understanding some of the EJC article). It ends with some comments from an oncology researcher, who questions whether the study justifies that all FL patients should get maintenance.

I would tend to agree. (Not that I'm an oncologist or researcher or scientist.) As a patient, I don't think the analysis would have been enough for me to justify Maintenance in my situation (Rituxan but no chemo). That's easy to say, looking back 7 years later, though even back then, I had accepted my oncologist's idea that we should do the minimum necessary, and keep the long road ahead in mind.

Of course, the point of all of this is to not listen to me when you need to make these kinds of decisions, but to listen to your doctor, and know enough to have an informed conversation about it.

Unfortunately, we still have no easy answers when it comes to decisions about Follicular Lymphoma.

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