Wednesday, March 11, 2015

Kit Draw

That's what they call it.  For the first time in 92 cycles of Pomalyst, we three did not drive the 200-mile round trip from home to Mayo Clinic and back.  Instead we agreed with Mayo that the blood draw could be done at a local clinic.  Mayo, however, still wanted to use their own lab for the critical measurements of IgG, M-spike, and maybe some others.  This is how it worked:
  • A couple of weeks ago Mayo sent me a cube-shaped box (kit), perhaps 10 inches on all sides, containing five vials, instructions, a FedEx overnight return label, and a freezable gel block about the size of a pound of hamburger.  Instructions said to do the draw on March 9.  
  • Just to check, I stopped in at the clinic a week or so ago, showed them the box, and asked about the kit draw.  "Oh yeah, we do that all the time," was the response.  
  • I froze the gel.  
  • On March 9, Monday afternoon (fasting!), I put the gel back in the box and took the whole box to the local clinic.  The two people at the lab desk were unfamiliar with the process but they read the instructions and were game to do it, if I would stick around for an hour or two and carry the completed kit to the FedEx office a half mile away.  It might take that long because the instructions required them to centrifuge a couple of the samples.
  • While I waited, though, we encountered a more seasoned technician who had indeed done this before, and who informed us all that the clinic has a regular, scheduled FedEx pickup every afternoon.  So I left it all in their good hands.  
  • By Tuesday afternoon the results were available for my viewing in my Mayo Clinic account, looking very much like my usual results.
In particular IgG was down slightly, from 1270 to 1210 mg/dL, and M-spike from 1.2 to 1.1 g/dL.  Down is better than up, but I'm thinking that both of those changes are probably within the margin of error for their tests, so the differences are not significant.  Stable = boring = wonderful.  Life is good.  I feel like going out for a run.

Tuesday, February 24, 2015

FDA Approves Farydak (Panobinostat)

This is a victory for myeloma patients, and perhaps for all patients facing a life-threatening disease.

Farydak (panobinostat) is a new oral drug approved specifically for use with bortezomib (Velcade) and dexamethasone to treat patients who have previously undergone at least two prior regimens, including Velcade and an immunomodulatory agent (thalidomide, Revlimid, or Pomalyst).

It comes with this boxed warning:


In other words it can be very unpleasant and can put your life at risk.  Further, in addition to the symptoms listed in the box, it can cause a reduction in platelets, neutrophils, or red cells, and can cause other serious problems.

So why is this a victory for patients?  Because Farydak can extend the lives of patients taking Velcade by months, perhaps years, that's why.

Nevertheless, last November the FDA Oncologic Drugs Advisory Committee (ODAC) voted 5 to 2 against approval of Farydak, judging that the potential benefits did not outweigh the risks.  This is a panel of "experts" (not a patient among them) deciding by themselves what risks WE patients should be permitted to take, and attempting to block us from all access to this drug.  In a recent speech I said "for people in my shoes, the side effect of NOT having the drug is worse – we call it death"!  

All of the new FDA-approved drugs have a daunting list of possible side effects, but we take them anyway because we don't like the alternative.  And as a result the median survival for myeloma patients has doubled during the 12 years since my diagnosis.  In my own case the advertised side effects of my little magic pill have been mostly absent - I've run 58 marathons now in my seven years on Pomalyst.

I congratulate the FDA on their understanding of this issue and their willingness to let us, with our pretty damn smart doctors, make the life-determining decisions ourselves.  This seems new, and I hope it is a harbinger of things to come.

Farydak is new too.  It works on an entirely new principle - it's called a histone deacetylase (HDAC) inhibitor - with the potential to be combined with any of the drugs that work on other principles. There is much to be learned about Farydak.  I hope I never need it, but I'm glad to have it in my quiver.

For more about access to emerging treatment technologies, please visit Closing the Gap Now .

Saturday, February 14, 2015

Pomalyst Study Ends

But I'm still on Pomalyst, 2 mg daily with no days off, thanks to insurance.

Somewhat to our surprise, Mayo Clinic abruptly cancelled my participation in the study at the visit which ended my 89th 28-day cycle.  As far as I know the drug manufacturer, Celgene, was prepared to continue the study, but Mayo explained that they needed the resources elsewhere.

I headed home from that last visit with no meds and wondering how or when I would get them, and also wondering if or when I would have any appointment.  Happily, answers to those questions came in a few days (after some phone calls) and treatment is back on track.  My copay is quite manageable, and of course I'm aware that there are organizations that will help with the copay if I seek help.

I've now had my first "regular" appointment at Mayo, where we established a new schedule:  I will continue to get myeloma markers checked every month, but will actually drive the 200-mile round trip to Mayo only every second or third month, otherwise mailing in the blood samples and getting the results online.  The next Mayo visit will be in April and we will do either an x-ray bone survey or a PET scan at that time, to be determined after this upcoming marathon.

This time Mayo chose to do my CBC in the morning, together with all of the other blood tests, and found that the neutrophil count was barely above the lower limit of 1.0 k/uL.  We decided to go back to our earlier practice of taking the CBC the afternoon before the visit, because the afternoon neutrophil count is usually double the morning reading.  The neutrophils are there in the morning too of course - they apparently just don't like to get up early.  There may be a better medical explanation for that.

Results from the last study cycle and this first regular cycle indicate that the myeloma is still stable, with an IgG of 1270 mg/dL and M-Spike of 1200 mg/dL (1.2 g/dL).  Both of these values are within the range of values seen recently.  The myeloma will probably take over someday, but not yet.

At a gluten-free restaurant called Nourish in Gilbert, AZ.
That dressing is lime-based, perfect for the salmon and the salad.

Tuesday, December 9, 2014

Beta Blockers May Improve Myeloma Survival

ASH Monday, December 8, 2014

Yi Lisa Hwa, DNP, Mayo Clinic in Rochester, MN, noticed that one of her patients MM numbers improved when she prescribed the beta blocker propanolol. So she took a look back in time. In a retrospective study of Mayo patients seen between 1993 and 2010, 136 patients who had taken beta blockers were compared with 136 who were statistically matched but did not take beta blockers. Median followup was seven years.

Results: The five-year overall survival (OS) for myeloma patients taking beta blockers was about 62%, contrasted with OS of 47% for those not taking beta blockers.

This is quite a big difference, and it's real. In a discussion with the author, she did point out that beta blockers are now being used in treatment of other cancers. I doubt we have heard the last of this one in myeloma. How does it work? How much is enough or too much? Is it really the beta blocker, or is it the underlying condition or lifestyle that prompted the doctor to prescribe the beta blocker? There is work to be done.

Caution: Beta blockers are contraindicated for some people, and anyone contemplating the addition of beta blockers to their regimen should discuss it with the prescribing doctor. I myself probably should not take them, because my resting heart rate is too low. Darn.

Link to abstract.

Excellent Results with Pomalyst and Velcade

ASH Monday December 8, 2014

Dr M Q Lacy, of the Mayo Clinic in Rochester, MN, presented the results of a small phase I/II study of Pomalyst with Velcade and dexamethasone (PVD) for 42 patients who had prior Revlimid but for whom Revlimid was no longer working. Many had other prior regimens as well; two thirds had a prior stem cell transplant, and more than half had prior Velcade. The results are startling.

Overall response in these relapsed and refractory patients was 81%, including 82% of the high-risk patients. A complete response (CR) was seen in 19%, including a stringent CR in two patients. At 9 months, 72% were progression free, and the median progression-free period was a year and a half.

Quoting from the abstract: "PVD is a highly attractive option in patients with relapsed and refractory MM." Here is the abstract.

Monday, December 8, 2014

Breaking MM News From ASH

Revlimid Does Not Increase the Risk of Second Primary Cancers for Newly-Diagnosed Patients

I know patients who say that their doctor would not recommend Revlimid for them because the doctor believed that Revlimid posed a risk of second primary malignancy (SPM), meaning some other cancer in addition to MM. Some early studies seemed to indicate that, and some doctors have taken it to heart without paying much attention to contrary data, choosing to avoid Revlimid even when it may be the most promising option.

Now an organization called "Connect MM," consisting of doctors from medical centers all over the country and even including our own Dr Brian Durie, has presented a paper based on a data base called the Multiple Myeloma Disease Registry, compiled by the National Cancer Institute. The data base provided actual clinical data from 1493 newly-diagnosed multiple myeloma (NDMM) patients, who were enrolled at 243 different US sites and observed for an average of about 2 1/2 years.

Bottom line: NDMM patients taking Revlimid have no more risk of SPM than patients taking other regimens. Here is the paper. The only significant risk factor the doctors found was "prior invasive malignancy," meaning that you are more likely to get a new cancer if you have had one before.  No surprise there.

I've written about this before, arguing that the early data was misinterpreted and that Revlimid did not pose an elevated risk for SPM. This pretty much clinches it, at least for newly-diagnosed patients and it has some meaning for all of us.

ASH Saturday, December 6, 2014

The High Cost of Innovation

ASH is the American Society of Hematology (Hematology.org), and its annual meeting is the ASH Conference, or just ASH. This year ASH is in San Francisco, and we three are among the 20,000 attendees.

A few hundred people attended a session titled "The Rising Cost of Medical Care: Understanding the Problem and Exploring Solutions"  The underlying assumption is that the cost of health care is rising at an unsustainable rate, which may be true, and that a major contributor is the high cost of the new, innovative, (and often highly-effective) cancer drugs, which is debatable. First a panel of experts spoke on the issues, followed by questions from the floor.

Dr Hagop Kantarjian, from M D Anderson in Houston, was the first panelist and by far the most negative, roundly condemning the pharmaceutical companies and anyone who doesn't likewise condemn them. If it is possible to make a good case against the high prices, his talk did not do that, because it included provably incorrect information, outdated and superseded data, and assumptions that don't stand up. To his credit, he did conclude by saying that nothing would happen without intervention by the patients, which I believe is true but probably not in the way that he imagines. I learned something about M D Anderson.

In contrast Mr Alex W Bastian, of GFK Market Access, had a much more factual and reasonable presentation. Among other facts he showed data demonstrating that the cost of cancer care has remained at about 5% of total health costs in recent years. I wish I could recall more of what he said.

I asked, from a microphone on the floor, if I could tell a little of my story, as a patient, instead of just asking a question, and was given permission. I can't recall exactly what I said, and have no record of it (though there may be a video of the session somewhere), but here is what I think I said, or I now wish I had said:

          I was diagnosed with myeloma more than 11 years ago, and, with my family, have since traveled the country and run 85 marathons, living a vital and enjoyable life. I could do that because, for most of that time, I have been on an innovative new myeloma treatment called Pomalyst, just a pill that I take every night.

Where did Pomalyst come from? Someone discovered that thalidomide was a useful treatment for myeloma, and the profits from Thalidomide funded the research, development, and testing of Revlimid. Then the profits from Revlimid similarly funded the development of Pomalyst. That is how our system works. As long as a pharmaceutical company can see the possibility of a good return on their investment, it will be willing to innovate and take the risk of bringing a new drug to market. If we somehow remove that incentive, innovation will go elsewhere. Common sense.

An Australian doctor suggested to me that the government should be in charge of the entire process, so that it could be more fair. I doubt that it would result in more or better new drugs, and I suspect that everyone would oppose it, including the insurers, the pharmaceutical companies, and the patients.

I'm sure of two things: First, the system that we have is working. It isn't perfect, but it works for me and many thousands of others who are alive and thriving today because of the new treatments. Second, the sky is not falling. Or if costs of health care are rising unsustainably, the high cost of cancer drugs is no more to blame than any other aspect of health care.

I have had a wonderful life in the past 11 years. My wife and daughter appreciate it, as do my two sons, my brother and sister, and lots of nephews and nieces. Not only did I enjoy the birth of two grandsons in that time, but they got to know their grandpa. And isn't that why we're all here?

I think I did say most of that, and I'm impressed that they let me say it all. It will be the highlight of ASH for me.

Sunday, December 7, 2014

All Is Well

In recent weeks I have been approached by some people (well, at least two) who are concerned that I have not posted on this blog since August, wondering if something is wrong. Nope - everything is fine.

We've just been very busy, and the visits to Mayo Clinic have been "steady as she goes." Stable. I have actually written, on the running blog, about the marathons that we have run in Portland, Ottawa, and Vancouver since August.

Life at home has been exceedingly busy, however, as we are in the midst of moving five miles, from our lake home in Lake Elmo to a smaller and less-demanding townhome in Stillwater, MN. Moving is a bigger job than any of us really imagined. It's not over, either, but at the moment I am taking a little time off to attend the ASH conference in San Francisco.

I do have another meeting with my Dr L on Thursday, and I may post about that, especially if there is news. Since this is a case of "no news is good news," I rather hope there is no news. Meantime, I may post about what is happening at ASH.

Saturday, August 2, 2014

Better Still

Today I felt much more like myself, even went for a stroll and mowed a little bit of the lawn.  Temps are normal and the pulse oximeter regularly shows numbers in the high 90's.

The pneumonia is on the run, and I won't post any more about it here unless there is a dramatic reversal.

Friday, August 1, 2014

Recovering at Home

They let me out of the hospital this noon, and I like being with my loved ones.  I feel a little better than yesterday, but the regimen is about the same at home as it has been in the hospital. Levaquin 750 mg once daily, probiotics to mediate the effect of the Levaquin on the stomach, lots of sleep.

I'm pretty sure that the pneumonia is viral, not bacterial, because it has responded so slowly to three different antibiotics.  Nevertheless I'm taking the Levaquin, despite its risk to the Achilles tendon, in case it really is a virulent bacterium.

Right now my temp is generally around normal, which is a definite improvement, and I have some appetite.  However, blood oxygen isn't much better than it was when I called 911. I have my own pulse oximeter now, which normally would have me at 98 or 99%, but now typically shows low 90's, which means that my lungs are not yet working very well.

Time will tell.  More tomorrow, probably.


Thursday, July 31, 2014

Feeling a Little Better

Still in the hospital.  My temperature seems to have stabilized near normal, I'm coughing a little less, and blood oxygen (without supplemental oxygen) is up in the 94% range.  However, pulse rate and respiration rate are unchanged and much higher than normal, so the jury is still out.

For the medically inclined:  I was started on a Z-Pak (azithromycin) Monday, then in the hospital they added a cephalosporin IV antibiotic Tuesday.  By today (Thursday) we didn't see much progress, so the hospital doctor finally talked me into oral Levaquin, dropping both of the others. That dose was this noon , so it's had only about nine hours to take effect, and obviously I don't know which antibiotic regimen might be working, if indeed anything really is working.

I'm nervous about Levaquin, because it's one of the drugs that can cause the Achilles tendon to rupture.  If that happens my running will be dramatically curtailed (zero).  However I finally agreed to Levaquin because I didn't see progress on the other meds, and I can live without running but I can't run without living.

As always, I'll know more in the morning.  I'm still alive and there is a little more light at the end of the tunnel.


Wednesday, July 30, 2014

Pneumonia Again

July 30, 2014

CRAP! Pneumonia certainly puts a crimp in marathon training. I have a marathon coming up in early september, with a good plan for ramping up carefully to a 20-mile long run three weeks ahead. That's what you do. Setting aside the obvious life-threatening aspect of pneumonia, however, at the very least it puts a big crimp in the training plan.

I've had pneumonia five times in my life now; three times it was viral, once bacterial (last February), and now as-yet undetermined. In February the high-power IV antibiotics took effect within a day, and got me out of the hospital in two days. This time I've been in and out for two days already, and there is little evidence of improvement. I still have a little fever, low pulse oxygen level, a high pulse rate, and a high respiration rate. If it's viral instead of bacterial, prevous experience suggests that the resolution will take weeks instead of days. Grrrr.

Maybe I should just stop whining and be glad I'm still alive. Eventually I will be running again, but that's not the top priority.

I'll know more in the morning. Perhaps the pneumonia will take a sudden turn for the better, or the doctors will try something different.