“Don’t drug company researchers have an obligation to continue fine-tuning our treatment so that the drugs they develop don’t kill us before the cancer does?”
Allow me to be blunt: Like many other drugs, novel therapy agents were never intended to be used for extended periods of time.
Clinical trials for Thalomid, Revlimid and Velcade didn’t anticipate this. And don’t get me started about using dex indefinitely. It can’t be good for you to use any corticosteroid for years at a time!
Ten years ago when these drugs were being developed, I don’t think researchers anticipated that they might be used indefinitely, for years at a time. The plan was to use them to knock a patient’s multiple myeloma back, then stop. If and when the myeloma became active again, hopefully that drug would work again, too.
So Phase 1 safety profiles using high doses of any of these drugs were never run longer than a year or two. The toll taken on our bodies while staying on one or more of these drugs indefinitely are still largely unknown.
I’m a perfect example of this. I eat very well, exercise regularly, don’t smoke and don’t have any significant co-morbidities. My blood pressure is perfect. My weight is good. Yet I can’t seem to keep my white counts up high enough to use Revlimid continually. Eventually it wears my body down.
Even before I underwent my auto stem cell transplant last year, Revlimid assaulted my neutrophil (ANC) counts. The good news was Revlimid worked for me. The bad news? After three years, I wasn’t even able to take 5 mg for the standard 21 days on, with 7 days off.
Following my transplant, I’m finding that Revlimid is even harder on me. Once again, the good news is it seems to be working–like my transplant hit a re-set button. But my body doesn’t seem to be able to withstand an ongoing Revlimid maintenance regimen.
I have been neutropenic (when a patient’s ANC count falls below 1.0) several times each of the past two months. And my platelet counts have been knocked-back too, hovering around 100.
I’m getting Velcade sub-q once a week, 4 weeks on and 4 weeks off. That doesn’t seem to be an issue–at least so far. And my doctors both agreed to drop the dex, so that’s not the problem. It’s Revlimid. After a short year, even 10 mg Revlimid is too much for my body to take.
Once upon a time, my white counts could recover after a week off. But no more. Next week my dose has been reduced to 5 mg.
The thing that troubles me most is few in the research/medical field seem concerned about this. Our dear and very persistent friend, researcher Gary Blau, rails against the medical establishment’s resistance to begin using individualized dosing. Without knowing what an optimum dose of Revlimid is for me, how can my doctors even know how much Revlimid I should take–and how often?
I’m afraid that in their haste to develop the next, best novel therapy agent, pharmaceutical companies have little interest in fine-tuning treatment protocols. That’s left up to our physicians–and they’re just guessing!
If myeloma patients are expected to live with our cancer for decades or longer, doesn’t common sense teach us that it’s counter-productive to have our bodies destroyed by the drugs that are designed to save us?
My wife endured a hellish six month long chemotherapy pounding eleven years ago after she was diagnosed with ovarian cancer. It was tough. But at least we had hope that her treatment might cure her, and that she would not be forced to undergo her treatment indefinitely.
Don’t drug company researchers have an obligation to continue fine-tuning our treatment so that the drugs they develop don’t kill us before the cancer does?
But I’m stubborn. In spite of it all, I’m going to try to feel good and keep smiling today! Why don’t you join me? Pat
September 14th, 2012 at 1:14 pm
Pat,
I’m 12 months post sct. I’ve had mm for only 18 months. Revlimid works for me, the only therapy I’m using right now, but my WBC is never normal and my platelets consistently hover between 80 and 105. Thankfully, my ANC usually, but not always, is in the acceptable, non-neutropenic range. However, 21 days of Revlimid at 10mg kept me neutropenic. 14 days kept me neutropenic. So now, my dr. has me on 10mg 7 days on, 7 days off. I’m still in remission and still holding strong.
Similarly, I haven’t tolerated Zometa well. The first full dose over 30 minutes left me with an ice pack on my jaw for a week. I am now working my way up to a full dose over an hour of infusion.
I think I have been fortunate to have responsive doctors. Or maybe they just got tired of hearing me complain
Your new frequent commenter,
Susan
September 14th, 2012 at 1:20 pm
Killing the cancer and saving the patient has always been the cancer treatment dilema and will, I suspect, continue to be THE challenge over the next several years with MM and other cancers as well. Add to that challenge the clonal heterogeneity across the MM population as well as within every MM patient and the customization of patient treatment only becomes more elusive. Still, with some of the drugs in the pipeline, in various phases of course, there are some reasons to not only be hopeful, but even a little bit excited I belive!
One of your better commentaries, Pat. Well done.
Steve Cochran
September 14th, 2012 at 2:08 pm
I definitely like this Pat K. better than the one that was making the impassioned defense of “total therapy” last week!!!
I could not agree more with this column. Did you notice this Forum post last week? What an interesting view from a caregiver whose husband was diagnosed in 1998. They do not seem to be very impressed with the progress (???) that has been made in myeloma therapy in the last 14 years.
“Congratulations Arnie, on being home and on the road to recovery!
My husband, Ron, had an allo transplant from his brother in 1998, (Toronto, Canada) followed by 14 fantastic, disease free years! Very upsettingly, the myeloma returned this April, and they do not want to try an allo transplant again. The doctors feel there is more benefit to CyborD ( forever? Are you kidding me?) as the treatment paradigms have changed from transplant (potential cure) to maintenance (forever on chemo). Very disappointing. I understand they are reluctant to do higher risk procedures when there are other treatment options, but the allo transplant was truly a fantastic solution at the time. He had a little bit of GVHD that was easily controlled by a short course of prednisone( easy to say now of course. At the time there was no way to predict how the GVHD would unfold). There were entire years that we didn’t even talk about cancer.”
An entire year without thinking about the cancer. Many patients these days are reminded daily when they take their Revlimid. They have certainly made little progress in the QOL area.
September 14th, 2012 at 2:11 pm
Hello and nice to read your blog. This is sure a very good thing to talk about. I agree with your point and would be great to have an answer.
My husband is 9 years into the MM world and (tomorrow) will have his 4th year post transplant. He has been on many therapies as you state..jumping from one to another with no relief from all these meds. (1 1/2 year break after SCT)
I do have to say that if this new drug Kyprolis had not been pushed through by the FDA and my husband a perfect candidate..last week he may have been burried.
So good things to think about all around. Today I am celebrating his life as we are about to recieve his 3rd dose and pray it works.
I will also continue to HOPE for the research warriors to move forward as you said…to treat it all as a cure. I know we all want the same thing.
Many blessings to you, glenda
September 14th, 2012 at 2:14 pm
Pat: I hear your frustration. Unfortunately you are correct. Look at the latest wonder drug (that I know you love)carfilsomib. 75% of the patients experience toxicities even in the short term. The drug has never even been in long term phase III clinical trials. The MM community is demanding the FDA get “drugs into people” whether they are safe are not. Onyx is not even thinking of long term treatment other than the cash flow that will result if patients take the drug for long periods of time. (I would love to see these numbers). I won’t rail against the medical establish this time BUT I will be persistent in bringing the importance personalized dosing message to the patient community. Quality of life has got to be considered in any treatment decision.
Thanks for pointing all this out.
September 14th, 2012 at 2:18 pm
Glad you are doing so well, Susan! 7 days on and 7 days off is a great idea! Whatever works, right?
September 14th, 2012 at 2:22 pm
“Impassioned defense, Mark?” HA! Just think TT may be emerging as a possible option for younger patients with the need to try and chase a cure. The survival numbers are pretty good. Just like an allo early-on may be the best option for other similar patients. 14 years is pretty impressive! My good friend in Minneapolis had similar luck. But graft/host was a constant battle. Guess the bottom line is its better to be young and strong!
September 14th, 2012 at 2:24 pm
Aren’t we fortunate that reader’s like Mark and Gary take the time to share their insightful comments? As always, thanks guys!
September 14th, 2012 at 2:27 pm
And thanks, Steve! I share your optimistic enthusiasm! Helps make our bumpy road a bit easier to take each day!
September 16th, 2012 at 8:49 am
Hi, Pat–I’m the other Susan who likes to read and comment on your blogs. =)
I couldn’t agree more! Even though my counts seem to be somewhat normal, even after having taken Revlimid now for 4 years, I have no idea what the drug is doing to me long term as far as secondary cancers or even if it will start to lower my counts as time goes on. Those of us with this “treatable” cancer are stuck with taking chemicals indefinitely and the doctors ARE guessing. My own oncologist will tell you that; they just keep sticking with a “good” thing because I’m doing well. Office visits and blood work will go so far; I’m thinking of asking for a whole body scan to look for solid tumors pretty soon. On the flip side, I’m afraid of stopping the drug for fear I will relapse and maybe it will come back worse and then I’m really in a fix.
We are really stuck between a rock and a hard place!
September 16th, 2012 at 4:42 pm
Great hearing from you, Susan! Couldn’t have said it better myself!
September 29th, 2012 at 11:26 pm
Pat, I am not sure that there is a better place to share this, so, if you have Multiple Myeloma and suffer back pain, you may want to visit you favorite LMT. Mine found a plethora of knots and other issues that she worked out. Besides reducing the pain that I perceived to be bone pain issues, I reduced pain meds, and feel better, I have taken 8 to 12 strokes off my golf score and say to myself each morning, why didn’t I do this sooner.
IgA with High Risk, bone biopsy with 42% cancer cells in Jan 2011, AST in Oct. 2011, and still “negative” as of 2 weeks ago. Thank you Dr. Kellogg, Dr. Mikhael, and Mayo Clinic, and my LMT.
Jim
September 30th, 2012 at 12:16 am
LMT? I get the “massage therapist” part. What does the “L” stand for? Licensed? And great suggestion, Jim!