Watching and Waiting vs Rituxan

The medical journal The Lancet Haematology just published an important, long-term study that compared watching and waiting with Rituxan in advanced, low tumor burden Follicular Lymphoma. I find it especially interesting because it happened right about the time I was diagnosed, and I was just the kind of patient that would have been eligible. It has some important lessons for FL patients even today.

The article is called "Early rituximab monotherapy versus watchful waiting for advanced stage, asymptomatic, low tumour burden follicular lymphoma: long-term results of a randomised, phase 3 trial." Along with the article, the journal also published a commentary titled "Rituximab versus active surveillance in patients with follicular lymphoma." It's worth reading both of them.

The main article describes a phase 3 clinical trial and its long-term results. The trial involved 455 patients with asymptomatic, low tumor burden, advanced stage Follicular Lymphoma. The trial took place between 2004 and 2009. As I said, I would have been eligible for this -- I was asymptomatic, stage 3, diagnosed in 2008. 

Patients in the trial were divided into 3 groups. One of them watched ad waited (what the main article called "watchful waiting" and the commentary calls "active surveillance" -- it's all the same thing, holding off treatment until necessary). A second group was given straight Rituxan (four weekly doses). The third group did Rituxan maintenance -- four weekly doses followed by another dose every 8 weeks for a total of 12 doses.  

The researchers eventually dropped the Rituxan-only group because not many people signed up for it. So in the end, they had 183 in the watching and waiting group, 82 in the Rituxan group, and 190 in the maintenance group.

This was a long-term study, so the researchers checked on the patients after 15 years. They found that after that time, 65% of those in the maintenance group did not need any further treatment. The same was true of 49% of those in the Rituxan group, and 34% of those who watched and waited. 

The reserachers also measure Time To Next Treatment (TTNT). For the maintenance group, the median had not yet been reached (meaning more than half of the patients in that group still had not needed a second treatment). It was 14.8 years for the Rituxan group, and 5.6 years for the watching and waiting group.

The researchers point out that the long TTNT for both of the Rituxan groups shows that giving some kind of Rituxan right away is good way to potentially avoid traditional chemotherapy, which at least for the patients in the study, would have been the likely next treatment. And, as they say, since the median age for FL diagnosis is about 65 years old, it is likely that a significant number of patients could take Rituxan early on and avoid chemo altogether, since they could go many years before a second treatment was needed. 

But the commentary points out something interesting, too. About one third of patients who watched and waited never needed treatment at all. This suggests that a whole lot of patients, even if they only had Rituxan, were being over-treated. In other words, a lot of those Rituxan group patients didn't even need the Rituxan. For the writer of the commentary, this shows that watching and waiting is still a valid option for many patients.

So for me, as someone who has been following the watching and waiting debate for many years, this ends up being just another in a long line of studies that really doesn't give us definitive answer.

One more bit of data from the study. The Overall Survival at 15 years was 73% for the Maintenance group, 66% for the Rituxan group, and 68% for the watching and waiting group. The number is slightly higher for the watchers than the Rituxan group, but in statistical terms, there is no significant difference between the three groups.

This is a good time to remind everyone that I am not a medical doctor, or even a cancer biologist -- I'm just a Cancer Nerd, a patient who reads a lot. If you have questions about your own treatment, the best person to ask is your oncologist, not some guy on the internet.

That said, I think all of this is just a reminder that when we do make a decision to treat, we are hopefully doing it with as much information as possible, and that our choice will never have as much information as we'd like, and we do the best we can. And if we choose watching and waiting, or we chose Rituxan, or something else, we can't make a bad choice. Statistically, any choice will likely not have a negative effect on our Overall Survival. If you read a study like this and start to doubt your choices -- don't. You made the right choice for yourself. 

I often get emails from readers asking me about how I made the choices I made, so I'll sum that up here again. I was diagnosed in January 2008 with stage 3, grade 1 and 2 Follicular Lymphoma. I was asymptomatic, other than swollen nodes in my groin. A PET scan showed a few other areas of lymphoma activity (chest, underarms), but none with swollen nodes that could be felt. After a month, my disease was not getting worse, so, with my oncologist's advice, I chose to watch and wait. It seemed ridiculous to me at the time, but I did it, and I have no regrets. Two years later, in January 2010, I started six weekly rounds of Rituxan. A few weeks before, I noticed swelling in my left leg. At first I thought it was from eating too many Christmas cookies, but then I saw that my right leg was much smaller. The nodes in my groin had grown and were blocking something that was causing the swelling. I don't regret the decision to take Rituxan, especially because they were so few options for me back then other than traditional chemotherapy.

I hope everyone is feeling good about where they are right now, mentally and physically. As I write this, the sun just came out after three days of rain. I'm going to go outside and small some beautiful spring flowers. I hope you'll all do something good for yourselves, too.