R-Squared Is Still Great

The Journal of Clinical Oncology has an update on the RELEVANCE trial. The very short summary is:  R-Squared is still great for Follicular Lymphoma.

Just as a reminder -- R-Squared is the name given to the combination of Rituxan and Lenalidomide (also known as Revlimid). The combination has already been approved by the FDA for FL patients who had already received another treatment. In short, the trials that led to the approval found that R-Squared was as effective as Rituxan + chemotherapy + Rituxan Maintenance. It was also considered more or less as safe as the chemo routine -- there were different side effects with R-Squared than with chemo, but not necessarily more dangerous side effects.

The approval was a big deal -- it showed that a non-chemotherapy treatment could be as effective as a chemotherapy. To me, that was a big deal in a sort of emotional sense, too. Many patients fear the word "chemotherapy" because they have probably seen its negative effects on family and friends. So to be able to tell a patient "this is NOT chemo" might make the emotional and psychological burden of cancer treatment just a tiny bit easier, at least for some people.

The article is called "Six-Year Results From RELEVANCE: Lenalidomide Plus Rituximab (R²) Versus Rituximab-Chemotherapy Followed by Rituximab Maintenance in Untreated Advanced Follicular Lymphoma," and it is an update on the trial that compared R-Squared to Chemotherapy in patients who had not yet been treated.

As the title suggests, this article reports on a six year follow-up of the 1030 patients in the trial (a pretty big number of patients). One important element of a treatment is durability -- sometimes a new treatment will take care of the cancer immediately, but then the cancer can come back in a matter of months. A six-year follow-up is a pretty good indicator of durability.

The results of the study showed that R-Squared remained just as effective after 6 years as it had been up to that point. The Progression-Free Survival (showing that the disease didn't get worse after 6 years) was 60% for R-Squared and 59% for R-chemo. Overall Survival was 89% for both groups. The transformation rate (the slow-growing FL turned into a fast-growing cancer) per year was 0.68% for R-Sqaured and 0.45% for R-chemo, and secondary primary malignancies (patients developed a new, different cancer) was 11% for R-Squared and 13% for R-chemo. There are some other statistical comparisons as well, but they all say the same thing -- R-Squared is as effective as R-chemo, and as safe.

The conclusion is pretty straightforward: R-Squared is a safe, effective alternative to chemotherapy for FL patients who have not yet been treated. 

This article is an update of a presentation made at ASH last December. Because it has been published, it is now considered peer-reviewed. That means the data has been checked by other experts. 

It's great news for us -- or for those of you who have not yet received treatment, anyway. R-Squared is not yet approved by the FDA as a first treatment for FL (it has only been approved for patients who have already had two other treatments). It will be interesting to see if this update leads to an FDA application for approval (though they don't seem to be in a big hurry). If so, that's one more option for FL patients.  

And that's good news.