It's chemo time

Treatment starts Tuesday. I have decided to go with bendamustine and rituximab (aka Treanda and Rituxan), the first round of which will be given in the hospital so I can be monitored for tumor lysis.

As readers of this blog know, I have been looking for a kinase inhibitor trial for some time. A series of events out of my control has kept me out of trials, and my clinical condition now demands something bigger and stronger.

I was invited into the CAL-101 plus ofatumumab trial at UCLA last August, only to be told that there was a mistake by the company that organizes the trials and that the slot didn't actually exist. Had this worked out, it would have been ideal, since I was still at Stage 2 with ample hemoglobin and platelets. It would probably have been a seamless transition from the lenalidomide (Revlimid) I was on, and it probably would have forestalled the situation I now find myself in. At last count, hemoglobin was 7.9, platelets were 96, and the lymph nodes are bigger than ever. My spleen is 6 cm below the costal margin and the liver is, in the words of my oncologist, Dr. Droll, "pronounced."

In March, I was invited into the ABT-199 trial at the University of Arizona Cancer Center. I went there for the testing that is required before entering the trial, only to find out that there was now a problem between the drug company, Abbott, and UA. Since then I have been able to piece together some of the story; it appears that a failure to do something right at UA lead to the suspension of recruitment there. Which left me with nothing other than the promise that I would have first crack when a slot opened in the AVL-292 trial, in which UA was also participating.

The slot for AVL-292 finally opened, and I was faced with a difficult fact: Hemoglobin of 9.0 is required for admission, and while mine had been a steady 9.2 for months, it dropped to 8.5 and now 7.9. So I wasn't going to get in the trial regardless.

The cart before the horse

This all dragged on much longer than anticipated, and as it did my hemoglobin began to head south. It became apparent to me that between my failing marrow and disease bulk, using a kinase inhibitor would be like trying to stop a house from burning down with a garden hose. Even if it addressed the nodes to some extent, it was almost assuredly not going to address the marrow, or do so with much depth and rapidity, and that is probably the worst problem I have at the moment.

I went in for a bone marrow biopsy on Thursday; I haven't heard the official results, but the person who did the BMB -- and all she does is BMBs, day in and day out -- said my marrow was "packed." I'm not surprised.

(For BMB fans, of which there are none, it is worth noting that they put me under for the procedure with propofol, as well as using lidocaine on my hip. This is the way to go as far as I'm concerned. I woke up a few minutes early and felt her digging the needle around in my hip bone; it was much more pleasant being knocked out.)

Ultimately, it makes a lot more sense to deliver as big a blow as I can to the disease now, and then follow up with a trial, probably a kinase inhibitor, as maintenance afterward. I might also consider using lenalidomide as maintenance; perhaps at a low dose I could tolerate it, and with less disease burden it might not be as overreactive in terms of tumor flare as it proved to be last November.

The choice

Basically, there are two choices for Big Chemo these days: FCR or BR. In my case, given the low hemoglobin and the fact that I had autoimmune hemolytic anemia from 2007 to 2010, FCR is just too risky. While the CR can moderate fludarabine's ability to trigger AIHA, it is still a risk, and one that someone with a hemoglobin of 7.9 should not take.

Bendamustine is newish, at least in practice in the U.S., and is supposed to be less myelosuppressive than FCR. Reading anecdotal case histories, one finds that most patients get through it with good results. There are exceptions, usually when neutrophils crash, triggering bad reactions, which is why using Neulasta during treatment makes some sense.

The most reputable paper on BR comes from the German CLL Study Group, which examined the treatment in a tough group of relapsed and refractory patients. The abstract is available here. For those who don't know, bendamustine was developed in East Germany. After reunification, it attracted the interest of researchers and drug companies. An alkalyting agent like cyclophosphamide, it also seems to have properties similar to purine analogues like fludarabine.

The full paper from the German group is worth reading. Bendamustine can work on those who are fludarabine-refractory, with 45.5% responding. It can also work on those who have had  rituximab, and I have had plenty in years past. Of seven patients who had previously received rituximab, five responded with a partial remission.

A disturbing fact involves Richter's Transformation. Four of 78 patients were diagnosed with Richter's Transformation after the end of treatment. The authors imply this was unrelated to treatment, but I'm not so sure. Richter's can be set up by profound immunosuppression resulting from treatment; just because it doesn't show up until later doesn't mean treatment had nothing to do with it.

The bottom line is that all therapy comes with risks; kinase inhibitors are not risk-free, as Chaya Venkat makes clear in a recent report at CLL Topics Updates.

What I can expect

Based on the German data and my clinical situation, I am hoping for a partial remission that significantly reduces the nodes and clears out the marrow to a great extent. I am not anticipating a CR, despite the optimistic words of Dr. Daruka Mahadevan at UA, who said BR would "clean me out."

This is why maintenance should be initiated soon after I complete BR in December. I need to keep the disease in check through some means; if there has been a lesson for me in my experience since November, it is "don't let up."

I will report on BR in some detail as I experience it; little has been written, even anecdotally, about patient experiences with the drug, and it is here to stay as a major player in CLL.

I'll be doing the first round in the hospital so I can be monitored 24/7 for tumor lysis. In someone with my disease bulk, so many CLL cells could die so quickly that my kidneys might be at risk. Both Dr. Mahadevan and Dr. Droll thought this was a good idea, and I can't argue. As much as I don't like the hospital, I like my kidneys. I also expect that Dr. Droll will go with a lower-than-usual dose of bendamustine in the beginning, another way to guard against potential problems.

And so the next chapter begins in my CLL Diary. I am looking forward to the treatment, which I hope will restore some of the quality of life that I have lost. I had seven years of relatively easy CLL; when things head south, one is reminded of how difficult (and, yes, how potentially deadly) this disease can be.

Thank you, Mr. Roberts

Word is out now that Chief Justice John Roberts switched his vote before Thursday's U.S. Supreme Court ruling on the Affordable Care Act.

And for that, I say thank you, Mr. Chief Justice. I could, perhaps, owe him my life.

I have been counting the months until 2014, when I should be able to purchase decent insurance through one of  the newly-established exchanges among states. The new law requires that they take me despite my preexisting condition -- chronic lymphocytic leukemia -- and that premiums be capped to that I can actually afford, like most middle-income people, to pay. If coverage is anything like it is in the current and temporary PCP -- the Pre-existing Condition Program that the ACA set up for adults who have been without insurance for six months -- it should allow me a much wider network, including out-of-state expert centers. And, unlike my existing insurance, it would probably provide for a stem cell transplant, should that day ever come.

This will allow me to get away from Merciless Healthcare Group, which was set up in Arizona as a state-backed plan for small businesses. Over the years what was once a limited HMO that took care of its members has become a penny-pinching HMO with ever-higher deductibles and co-insurance and an ever-shrinking network.

For example, the emergency room where I was diagnosed with CLL in 2003 is about a half-mile from my home. It is no longer contracted with my insurer, which no longer has a relationship with Northern Arizona Healthcare, the largest provider in the region. Today, to go to a contracted hospital I have to drive an hour and a half to Prescott, and that goes for getting CT scans or outpatient infusions as well. If you live in my county, you can't even buy into my insurance any more. I am what they called "grandfathered" in. (And, of course, no other insurer will touch me because of my CLL, at least until the ACA takes full effect in 2014.)

I suppose I should consider myself lucky to have insurance at all. Reading online forums, I have seen more than one CLLer describe attempts to deal with the disease without insurance. Chlorambucil may be affordable but it is hardly the standard of care these days. Neither is drinking a lot of green tea.

The whole question of the Affordable Care Act can be an emotional one for both sides. I plead guilty here. For me it may make a huge difference in quality of care, which could mean life and death. On principle, I also think a country that constantly touts itself as the greatest in the world should be able to provide real access to health care for everyone. American "exceptionalism" should not include an exceptional inability to create a workable medical system.

There was an anti-ACA sign held by one of the protesters outside the Supreme Court building while everyone waited for Thursday's decision. It read something to the effect of: "Obamacare: Thank you for paying for my poor life decisions."

CLL is not a product of poor life decisions, and neither are most cancers and chronic diseases. Sometimes shit happens. Let these people walk a mile in the shoes of the uninsured, or underinsured. Let them learn what financial and emotional strain truly are. Now that the election approaches, some Republicans talk of "repeal and replace," but in all the years they held power, at least post-Nixon, they never made an effort to address such matters as preexisting conditions. Given their continued lurch toward the hardline right, one expects they never will.

Please join me in voting Democratic this Fall, from the state level to the federal, to insure that the law is implemented as it should be. The ACA may be flawed in some ways, and it may need tweaking as it goes along, but is is a giant step for our country, and for many of our fellow CLLers, as well as other cancer patients.