Thursday, December 29, 2016

CR30: A New Way to Measure Effectiveness

While I've been looking at stuff from the ASH conference earlier this month, there's been even more research on Follicular Lymphoma that has been posted online. This one came out just yesterday in the Journal of Clinical Oncology: "Thirty-Month Complete Response as a Surrogate End Point in First-Line Follicular Lymphoma Therapy: An Individual Patient-Level Analysis of Multiple Randomized Trials."

If you follow clinical trials for Follicular Lymphoma, then you know that a couple of things are true: first, the best measure of a trial's success is Progression Free Survival (PFS). This is a measurement of how long the lymphoma takes to come back (if there was a Complete Response) or get worse (if there was a Partial Response). Overall Survival (measuring how long people live) would be great, but with an indolent lymphoma like FL, that's not a great measure of success. So we use PFS.

The second thing that is true is that PFS can go on for a long time. If a median PFS is necessary (that is, half of the patients in a trial have achieved a PFS), then the process can go on for a long time -- 6 or 8 years for some treatments.

That's great news for individual patients -- it means lots of us will have a long time before we need another treatment (I'm getting close to 7 years since my last Rituxan).

But it's not as good for us as as a group. A regulatory body (like the FDA in the U.S. or the EMA in Europe) might want to see a final PFS number before approving a treatment. That's a long time to wait.

The researchers in this study looked at a number of clinical trials conducted since 1990, involving over 3800 patients, and found that 30 months was a good substitute for median PFS. In other words, if the patients in a trial had a median PFS of 30 months, it was likely that the PFS would actually go on for some time.

Interestingly, they also tried to measure this with a 24 month time period, and found that it was not as accurate as the 30 month time.

It is important to note that this does NOT mean that an individual patient who has reached 30 months without needing treatment is not going to need treatment for a while after that. The number is not meant to predict individual patients' success with a treatment.

So what is it good for? Well, if agencies like the FDA and EMA accept it, it could mean that clinical trials could be shorter, and new treatments could become available to patients a little sooner. (One problem, though, is that looking at only the PFS rate means long-term side effects are not being measured, though I'm not sure how much that's taken into consideration anyway. Short-term side effects definitely are, but not necessarily long-term.)

So we can call this one "helpful down the road" -- we won't see the effects directly when we sit in the chair in a treatment room, but what they give us might be available to us because of it.

I'll look for something more exciting to report on next time.....

Sunday, December 25, 2016

Merry Christmas

Over the last couple of days, I was thinking about what I wanted to write today. And as I planned it out in my head, I noticed that it sounded familiar.

I checked what I wrote last year on Christmas, and it turned out, the message I was planning was pretty much what I wrote last year.

It was a wish for peace.

Today is Christmas, celebrated by much of the world (including me). And a traditional Christmas sentiment is "Peace on Earth." I'm going to wish for it again this year.

Last year, my wish was that all of us with cancer would have a little bit of peace for the day, and maybe pass that peace on to others we meet. Inner peace.

This year, I think I want peace beyond that. Outer peace.

It seems like we're living in a very divided world. People don't listen to the people who don't agree with them. Disagreement boils over into outright hatred. Last year was tough on a lot of people (whether or not they have cancer). Some days, I feel like the next year isn't going to be much better.

So my wish again is for peace.

Be patient. Be kind. Listen. Try to really understand one another. We all hurt in some way. Respect that in one another. Know that we all want the same things -- a healthy body, a job that gives us some dignity, to love and be loved. We might think differently about the way to get those things. But we all want them.

I don't know if I can connect this to cancer. Hatred is a cancer that spreads too easily? The outer turmoil of the world reflects our inner turmoil? We should listen to others the way we carefully watch and wait? I don't know. All of this goes beyond cancer.

So Peace to you all. Inner and Outer. Enjoy the day (whether you are celebrating Christmas, Chanukah, or just another day being alive), and stay healthy.

-- Bob

Image result for peace on earth

Sunday, December 18, 2016

ASH Review from Medscape

I plan to write about a few more interesting sessions from ASH that dealt with Follicular Lymphoma, but today I thought I'd let some experts do the talking.

Medscape asked two Hematology experts (Dr. Ann LaCasce and DR. Kerry Savage) to review the ASH meeting and talk about the things that they thought were significant. As the headline for the article indicates, sessions dealing with CAR-T were big news (we're going to keep seeing CAR-T news for a while, I think, as a treatment for Lymphoma and for a bunch of other cancers -- and it's only going to get more effective as time goes on and researchers learn more about how it works). But there were also a lot of "negative trials," where the outcome wasn't as good as researchers had hoped.

Of course, the big news for Follicular Lymphoma was the success of Obinutuzumab as an addition to chemotherapy (O-CHOP instead of R-CHOP, for example). Interestingly, Dr. Savage is not willing to call the study a game-changer, because there is still no data for Overall Survival, and Obinutuzumab might cost more and have more side effects that Rituxan. Time will tell how much of a change this study brings about for clinical oncologists (the folks we see at our regular appointments).

The link above will take you to a video of their conversation. They discuss lots of things from ASH, not just FL news. (And sometimes Medscape articles are hard to get to through a link, so if you can't access the article, I'm including a transcript below, which Medscape was kind enough to provide with the original article.)


Ann S. LaCasce, MD, MSc: Welcome to Medscape Oncology Insights. I am Ann LaCasce, associate professor of medicine at Harvard Medical School and senior physician at Dana-Farber Cancer Institute. Joining me today is Kerry Savage, associate professor at the University of British Columbia and a medical oncologist and clinical scientist at the BC Cancer Agency. We are at the American Society of Hematology (ASH) 2016 Annual Meeting in San Diego, where there have been a number of important lymphoma studies that we would like to highlight for you.
Kerry, what do you think is the most interesting abstract being presented at the meeting this year?
Kerry Savage, MD: It's tough. There were a few interesting phase 3 studies that came out, but for me, and I think for a lot of lymphoma specialists, we were waiting for the CALGB study comparing dose-adjusted EPOCH-R with R-CHOP.[1] This included newly diagnosed diffuse large B-cell lymphoma. Disappointingly, but probably not surprisingly, this was a negative study with equivalent event-free survival and more toxicity with the dose-adjusted EPOCH-R. We are eagerly awaiting the subgroup analyses to see if there are subsets that may benefit.
Dr LaCasce: Do you think the subset analyses will yield anything? For instance, in primary mediastinal lymphoma, where there seemed to be a signal that suggested that EPOCH is more effective.
Dr Savage: I'm hoping, but I'm not sure the numbers will be there since it's only about 6% of the whole population. But I certainly want to see those data. The one I am most interested in is the GCB cell-of-origin subtype from the previous phase 2 studies. It seems like that was the subtype that would benefit, given the proliferative drive as opposed to the antiapoptotic effect and NF-B pathways of activated B. I am hoping that we see some of that data, but it might come out at a future date.
Dr LaCasce: In terms of double-hit or double-protein expressors, maybe we will get some information on that.
Dr Savage: Again, I think the double-hit might be too infrequent, at 5%. For the dual expressor, I am not holding my breath for that because most are activated B, and that is not the group that I think will see the benefit. For me, that is the talk I want to hear the most, even though it is a negative study. It is a really important study.
Dr LaCasce: What about the GOYA study[2] with obinutuzumab?
Dr Savage: The GOYA study was on newly diagnosed diffuse large B-cell lymphoma, but this time comparing R-CHOP with obinutuzumab (GA101). Again, it was a negative study. There seemed to be no benefit from the addition of obinutuzumab. There is, in the abstract, a suggestion that perhaps there might be a benefit in the GCB subtype, so we will be looking to see that. It's disappointing that we haven't seen the benefits of these additional agents in diffuse large B-cell lymphoma.
Dr LaCasce: In terms of the toxicity of that antibody, do you think the signal was impressive or not that important?
Dr Savage: I think it's important. We see a lot of infusion-related reactions with obinutuzumab as well as additional infection and neutropenia.
Dr LaCasce: In terms of obinutuzumab and follicular lymphoma, the plenary, we had a big study looking at obinutuzumab versus rituximab in upfront follicular lymphoma.[3] Do you think this will change practice?
Dr Savage: It's an interesting study. As a reminder, it was a study comparing any chemotherapy backbone—it could have been CVP, CHOP, or bendamustine with rituximab—with the same chemotherapy backbone and obinutuzumab. That was actually a positive study, which is why it's in the plenary session for progression-free survival. If you look at the curves, the absolute benefit is still quite small. It is only about 4%-5%. And again, we have the additional toxicity that we already talked about, such as infusion-related neutropenia and infection. And, of course, there is cost on top of that. Given that this is a chronic disease, we still don't know about overall survival. I am not sure how that's going to follow in terms of being practice-changing.
Dr LaCasce: In terms of maintenance, do you think it impacts how you assess the results of the study?
Dr Savage: Potentially, although both arms got maintenance.
Dr LaCasce: There was a hint of more secondary malignancies. Do you think that's real? It was a large randomized study.
Dr Savage: It's interesting. I am wondering if that will come out when we hear the discussion. There are double the number of secondary malignancies, but they are still low overall (6% versus 3%-4%), and it is early to be seeing that. I think we need more details. I would like to know if those are all solid tumors or if there could be some transformation events. That is something we will have to watch for and probably see some more mature follow-up.
Dr LaCasce: Mechanistically, it does not make sense. Something that everyone is looking forward to is seeing some more data on CAR T cells. What do you think about the late-breaking abstract on diffuse large B-cell lymphoma[4] and the other abstract looking at transformed follicular and mediastinal lymphoma?[5]
Dr Savage: It's exciting. These are patients who do not have any other options, and we have seen excellent efficacy in T-cell acute lymphoblastic leukemia (TALL). Now we are seeing this therapy spill into the lymphoma world. I'm very interested in the late-breaking abstract looking at a fairly large dataset of relapsed/refractory diffuse large B-cell lymphoma with CAR T-cell therapy.[4] The CR rate is almost 50%. The duration of follow-up is still short. I think they are only looking at 1 and 3 months. So, the big question is: How durable are these responses? Considering how heavily pretreated this population is, these are very encouraging results. Similar findings were in the transformed and primary mediastinal population as well. Again, a difficult-to-treat population.
Dr LaCasce: Maybe a hint that they may respond a little bit better. What about the toxicity?
Dr Savage: Always the flip side. The cytokine release syndrome is worrisome. This can only be given in specialized centers that are attached to ICUs. Also, the signal of neurotoxicity still raises concerns. Can we strike that balance of efficacy and toxicity? We will have to see more data on that.
Dr LaCasce: Yes, it will be interesting to see how that's scaled up and taken to a much broader group of patients. What about mantle cell lymphoma? The maintenance rituximab after autotransplant[6]—those data were compelling. Do you think that will change practice?
Dr Savage: I think it could. Some people are probably already using rituximab in the maintenance setting. This was a well-designed phase 3 study showing a benefit in progression-free survival with the addition of maintenance rituximab.[6] It was quite a significant difference in the progression-free survival—about 20%. Rituximab was given every 2 months for 3 years. It's a little bit different from other settings. Whether you need it for that long, I don't know, but it could potentially be practice-changing. It was a well-conducted study.
Dr LaCasce: It looked like the toxicity was not that different between the two arms. What about Hodgkin's lymphoma? We are going to see some data in the first relapse setting combining brentuximab and nivolumab.[7] What do you think about those data?
Dr Savage: It's interesting. The data we have seen so far with the checkpoint inhibitors have all been in patients post-transplant, or there have not been a lot pre-transplant. The design of this trial was to function as a salvage regimen as a lead-in to transplants: brentuximab vedotin and nivolumab, a phase 1/2 study, and four cycles. The response rate is very high at 92%, with a CR rate of about 60%. It is higher than what you would expect with nivolumab and a little bit better than what you would expect with brentuximab. There is certainly some rationale to combining them, and there is synergy. Brentuximab is immunogenic. Of course, we need to see longer-term follow-up and the progression-free survival, but I think we are going to be seeing more studies like this in that setting in Hodgkin's lymphoma.
Dr LaCasce: As we are seeing more patients getting brentuximab earlier, and maybe with the results of the randomized study, how are we going to move this forward?
Dr Savage: It's difficult. Depending on how ECHELON-1, the phase 3 upfront study, reads out, the rules are all going to change. Is the efficacy going to be as good? We have some data to support that brentuximab in the re-treatment setting works. I think the limitation will be peripheral neuropathy and the toxicity associated with it. We will need more data to know whether the landscape is going to change if brentuximab becomes incorporated into frontline therapy.
Dr LaCasce: Do you think there will still be a role for autologous transplants if we have these combination studies that have high complete remission rates?
Dr Savage: I have to admit that I'm still on that. I would not want to deny a transplant. We have such good data that transplants are curable. The stakes are high in this young population. Would you be willing to do a trial that does not do transplant? You'd really have to think carefully about how to design that trial and the patient population.
Dr LaCasce: It seems like there aren't really any interventions that have changed overall survival, so maybe it would be open to study.
Last, in cutaneous T-cell lymphoma, there was a randomized study comparing brentuximab with investigator choice.[8] How do you interpret that study?
Dr Savage: That was an interesting study. Patients had to have had one prior therapy, and then they were randomized to either brentuximab or investigator's choice of methotrexate or bexarotene. There was a striking difference in outcome. They had an interesting primary endpoint. It was ORR4, which means overall response rate sustained for 4 months. It was significantly better in the brentuximab arm, at about 56%. Looking at the conventional response rate, it was hitting around 60%. There was a striking difference in median progression-free survival of almost 1.5 years versus about 3-4 months. This is definitely practice-changing. This is a difficult-to-treat population. It is difficult to assess response, but they did their best to use this global score to assess response. The data are quite compelling that we are going to see brentuximab used in this setting.
Dr LaCasce: Thank you, Kerry, for joining me for a very interesting discussion, and thank you for joining us both for this edition of Medscape Oncology Insights. This is Ann LaCasce with Kerry Savage, reporting from ASH 2016.

Wednesday, December 14, 2016

ASH: More on Zevalin

OK, back to ASH abstracts.

There is a lot of great stuff from ASH this year. I think I've covered the ones that have made big news, but there is still a lot that, to me, is worth looking at.

I already write about a new possible RadioImmunoTherapy (RIT) treatment that was discussed at ASH, and how that was good because RIT is shown to be very effective but is very underused in the U.S. We may lose Zevalin forever.

And yet, at ASH, there were two presentations that had very positive things to to say about Zevalin.

The first is called "90Yttrium-Ibritumomab Tiuxetan as First Line Treatment for Follicular Non-Hodgkin Lymphoma. 5 Year Results from an International Multicenter Phase II Clinical Trial." In the U.S., Zevalin is approved for use on patients who have already had treatment, and whose condition has gotten worse enough that they need treatment again. This study reports on a clinical trial (of European patients, from what I can tell) who had Zevalin as a first treatment. The trial involved 59 patients with Follicular Lymphoma of different stages. 

After 6 months, 56% of the patients had achieved a Complete Response, and 31% had achieved a Partial Response (for a 87% Overall Response Rate). Pretty good. After 1 year, 26 of the 39 patients who had a Complete Response had not had their disease return. Of those 26, 57% had still not seen their disease return after 5 years (a 40% Progression Free Survival). Overall Survival for the whole group after 5 years was 80%. Most side effects were well-tolerated.

The researchers conclude that Zevalin is effective, safe, and useful as a first-line treatment.

In another study ("Short Course of Bendamustine and Rituximab Followed By 90Y-Ibritumomab Tiuxetan in Patients with Chemotherapy-Naive Follicular Lymphoma (FOL-BRITe): Final Report of Response Rates and Progression Free Survival"), Zevalin was given to patients after they had 4 rounds of Bendamustine + Rituxan. Early research on Zevalin as a consolidation treatment (that is, used right after a first treatment as a way of cleaning up any leftover cancer) lokked at Zevalin after R-CHOP. Since B-R is seen as even better than R-CHOP, it makes sense to see if following B-R up with Zevalin is even better than it would be following R-CHOP.

The study involved 39 patients. After receiving the Bendamustibe, 22 of them had a CR, and 16 had a PR, so the Overall Response rate was 97%.  Of those 16 with a PR, 10 had a Complete Response after they received Zevalin.

After a median follow up of 30 months, 71% did not have their disease return. Side effects were well-tolerated.

So, both studies continue to show that Zevalin works well, lasts for a while for a lot of patients, is safe, and should remain an option for Follicular Lymphoma patients.

Now there are some other people who need to be convinced of that.......

Saturday, December 10, 2016

A Reminder about Being Positive

We're taking a short break from ASH proposals today.

I saw this blog post ("Can I Please be Allowed to Have Bad Days After Cancer?") on my Facebook wall yesterday, and I thought it was a good time to bring up the idea of positivity. I like to come off as very upbeat and hopeful when I write on Lympho Bob, and I think people who know me will agree that I'm like that offline, too. I tend to look on the bright side.

But I have my rough days, and frustrating days, and downright sad days sometimes. When you're as upbeat as I am, people tend to notice when you're even a little bit down. I had one of those sad, heavy days about a week ago. It wasn't something cancer-related, but it did weigh on me very heavily.

The blog post that I linked to is from a survivor of Acute Myeloid Leukemia, and while she seems to have made her way through it, she still finds herself feeling very sad some days, and then guilty for feeling sad; she's a survivor, after all -- what is there to be sad about?

I think we all get that way as cancer survivors (and we're all survivors, even if we're still in treatment, or watching and waiting, or just feeling horrible -- we were diagnosed, and we're still here, so we're survivors).

For those of us with Follicular Lymphoma, the feelings might be a little different. We're told we have an incurable disease, so even if we are cancer-free, we can never quite be sure about it. Even though it's been almost 7 years since my last treatment, I still worry. After my Rituxan, I was told I had a Partial Response, so there was a little cancer left. Same with my last scan a couple of years ago -- not completely clean. I don't have those same feelings of guilt as the woman who wrote the blog post, but I still feel that sadness sometimes. And for some of us, that does come with a similar kind of guilt. We're survivors, too, aren't we? Unlike some cancer patients, we have a shot at a long Overall Survival. How many of us have been told we have "the good kind" of blood cancer? How many of us have been told, "If you have to get cancer, this is the one to get"?

So why should we feel sad about having cancer?

My point is this -- it's OK to feel sad. It's OK to have a bad day.

There's an idea in the cancer community called "The Tyranny of Positive Thinking." (It comes from a book by Dr. Jimmie Holland called The Human Side of Cancer, and I first saw it posted in my online support group.)

The idea stems from the that, as cancer patients, we should always be positive, and that any negative feelings might actually make our cancer worse. People tell us this all the time -- "Hang in there! Stay positive! It's the only way you'll get better!" I think it's one of those things that people say when they don't know what else to say, and it's a message that cancer patients are constantly getting from others. Now, a positive attitude can be an excellent thing. But it can be a burden, too. Because if we're having a down day, and we're being told to stay positive, and we just don't feel like it, we now have the burden of feeling guilty, too. Double the negative emotion with none of the good results. (And on top of that, there is no scientific evidence that feeling negative thoughts hurts you.)

As I said, I like to stay positive in the blog, and I do my best to focus on things that are hopeful. I hope I'm not contributing to anyone feeling guilty about being down.

But if I do, here's the big message here:

It's OK to feel sad sometimes.

You've been diagnosed with what everyone keeps telling you is an incurable cancer. You might have kids, or a spouse, or family and friends that rely on you. You might have big plans that have been shoved aside. Why wouldn't you feel sad some days?

So if you're having a bad day, you have my permission to not smile. Have your bad day. Call in sick to work. Go back to bed and watch sad movies all day and eat ice cream for lunch. Let your dog up on the couch with you. Tell someone to bring you something that's bad for you. Put your head under the blanket and stay there. Scream into your pillow. Be short and nasty to anyone who talks to you.

Have a bad day. You deserve it.

And if tomorrow is bad, stay in bed then, too.

But here's the thing -- if you feel this way three days in a row, get some help. Talk to someone. Put down the ice cream and call your doctor and see if there's a professional who can assist you.

Depression is a real thing for cancer patients, especially newly diagnosed ones. A sad day or two is OK. But a sad life is one that needs some help.

Thanks for listening. I hope your days are happy.

(I can't help myself....)

(Back to more of that positive stuff from ASH.)

Wednesday, December 7, 2016

ASH: Another Possible Rituxan Replacement

The ASH Conference is now actually over (it ended Monday), but I still have lots of Follicular Lymphoma news to go through. We're starting to see lots of folks bragging about their presentations, which is great. There was a lot of stuff worth bragging about this year.

It seems like one of the really big winners of this conference was Obinutuzumab, which I wrote about a few weeks ago. It is a potential replacement for Rituxan -- it operates in much the same way, but may be even more effective because of the way it was created. (Of course, the really really big winners are those of us with Follicular Lymphoma....)

Rituxan has been a huge part of why Follicular Lymphoma survival rates have been increasing in the last 20 years or so, and there have been a bunch of attempts to find a monoclonal antibody that can improve on Rituxan. So far, no one has been able to find one. Until now. I don't think Obinutuzumab will replace Rituxan completely (oncologists' habits are hard to break), but it might chip away at its dominance.

Combine that with another presentation from ASH, and we might very well see a lot less Rituxan soon.

Rituxan's patents have expired (in 2013 in Europe and a few months ago in the U.S.). That means generic or biosimilar versions can be sold. Biosimilars are basically copies of the already-used treatment (in this case, Rituxan). If they are developed properly, they will be as effective as the original, with the same kinds of side effects. They will also likely be cheaper, since pharmaceutical companies use a lot of their profits to help recoup their costs for research and marketing of their products. A generic or biosimilar has a head start -- people already know it works as well as Rituxan.

Of course, that assumes that it does work.

The ASH presentation called "A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 Versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma" set out to show that a biosimilar can indeed work as well as Rituxan.

The researchers tested a biosimilar called GP2013. The study looked at 629 patients in 26 counties. Half were given the chemotherapy CVP + GP2013, and then 2 years of maintenance with GP2013. The other group was given CVP + Rituxan, plus 2 years of Rituxan maintenance.

The Overall Response Rate for the GP2013 group was 87.1%. For the Rituxan group, it was 87.5%. That's a very small difference -- enough to say that the biosimilar is indeed similar to the original. The researchers also tried to measure median Progression-Free Survival and Overall Survival, but the median had not been reached after 3 years (that is, less than half of the group had progressed or died, so they couldn't measure it).

Both groups also had similar side effects.

There are actually quite a few Rituxan biosimilars being developed. I'm still not willing to say they will replace Rituxan completely, but it's good to know there are some out there. Cost is a factor for everyone, if something can give the same results for a lower price, we all benefit.

The only thing left for GP2013 to do is come up with a better name. They definitely need something snappier -- ideally, with an X or a Z in it. Or more than one. My suggestion? "Rituxisimilex." (If you're reading, dear researchers, you're welcome to use that name. No charge. Just keep doing what you're doing.)

Thursday, December 1, 2016

ASH: A New RadioImmunoTherapy Treatment?

In the U.S., we're dealing with a sad decline in the use of RadioImmunoTherapy (RIT). Bexxar is no longer available to patients, and Zevalin is being made difficult to use because of unreasonable government regulations.

But that doesn't mean RIT is dead yet (we need to keep fighting for it in the U.S., people).

More importantly, there's another RIT treatment in early clinical trials in Europe, and results are bing reported at ASH.

The treatment is called Betalutin, and the ASH report is called "177lu-Satetraxetan-Lilotomab in the Treatment of Patients with Indolent Non-Hodgkin B-Cell Lymphoma (NHL), Phase 1/2 Safety and Efficacy Data from Four Different Pre-Dosing Regimens."

Like other RIT treatments, this one involves attaching a small amount of radiation to  monoclonal antibody that targets a protein on lymphoma cells. Zevalin, for example targets the protein CD20. The new RIT treatment, Betalutin, targets a different protein, CD37.

Many of the same researchers from the ASH study reported in Blood journal a couple of years ago that Betlutin seemed safe, with manageable side effects. I assume the ASH results are from the same trial, or a related one, given the overlap in researchers, but I don't know that for sure. Whatever the case, the ASH presentation gives a more detailed look at the results.

They describe this as a phase 1/phase 2 trial, so it's fairly small -- 36 patients enrolled, 23 able to evaluated, and 20 of those 24 had Follicular Lymphoma. Patients were divided into 4 groups. Because it's an early trial, part of the goal is to see which is the most effective way of giving the treatment, each of those 4 groups was given the Betalutin in a slightly different way. All of them were given a dose of Rituxan first, and then they were given some combination of Rituxan and/or Lilotomab (an anti-CD37 monoclonal antibody), and then Betalutin.

Patients were given a PET/CT scan at 3 months and 6 months after they finished treatment, and then after 5 years. There were some side effects, but no deaths and so secondary cancers as a result of the treatment.

The results were pretty good. The Overall Response rate was 57% (7 Complete Responses and 6 Partial Responses). 5 patients has stable disease, which left 5 whose disease got worse.

The researchers' conclusion: "Betalutin has the potential to be a novel, safe and effective therapy for B-cell malignancies with durable responses. Betalutin, a single dose, ready-to-use formulation, has a predictable and manageable safety profile which is improved by pre-dosing. Most AEs were haematological, all transient and reversible."

RIT works. That's all there is to say. I hope Betalutin proves to be effective in future, larger trials, and it helps you folks in Europe. As for us in the U.S., I hope this type of treatment doesn't go away. We have lots of arrows in our quiver, and I'd hate to see us lose even one -- especially one that has done so much good for so many people.