Sunday, June 07, 2009

Two thumbs down on Rituxan + fresh frozen plasma

I came. I saw. I wasted my time.

That’s my verdict on Rituxan + fresh frozen plasma. Make that two thumbs down — mine and that of a patient who posted to the ACOR CLL List that his experience with it was “arduous and ineffective.” Better words to describe it I cannot find.

Our two anecdotal cases fly in the face of the results reported by Klepfish et al. in their paper Adding fresh frozen plasma to rituximab for the treatment of patients with refractory advanced CLL, about which I wrote here. The positive results reported on the five patients in the study might as well have come from an alternate universe as far as my experience goes.

R-FFP did nothing for my red counts or platelets. It was completely ineffective on even the smallest of lymph n
odes. Indeed, once Rituxan was added it seemed to lead to a mild case of tumor flare, which eventually subsided with the nodes back at baseline. My lymphocyte count did drop, perhaps at a slightly faster clip than it did the last time I used single agent Rituxan. But the difference was not especially significant and, as my oncologist pointed out, the CLL cells could just as well have been seeking refuge back in the lymph nodes. As time has gone on, my disease has become more node-centric, to coin a phrase.

I underwent two rounds before we abandoned ship, pivoting to another treatment. I am now on monthly high-dose pulses of steroids accompanied by Rituxan, and we’ll probably add some cyclophosphamide. This is essentially a steroid-heavy version of the RCD protocol that got me through my hemolytic crisis in the fall of 2007 and gained me a pretty good remission for the following year.

It's also as close as I'm willing to get to R-CHOP, which is known for its effectiveness on bulky nodes. R-CHOP is probably as much fun as it sounds, and stands for Rituxan + cyclophosphamide;
Hydroxydaunorubicin (aka adriamycin or doxorubicin); Oncovin (vincristine); and prednisone. I can't see doing vincristine again, and have no desire to subject my heart muscle to adriamycin (aka "the red death") if I can avoid it.

I'd rather go the FCR route than the HO route; perhaps, with final approval of Arzerra (HuMax-CD20) by the FDA expected soon, I'll be doing FCH when the time comes. In the meantime, steroids have a proven track record of reducing nodes. Eventually I’ll have another CT scan to see how we’re doing on the abdominal nodes, and we’ll consider following up with something more powerful to deepen and consolidate the remission. We might use Campath if we can get my abdominal node mass down to less than 5
cm. It’s a work in progress.

At least it’s working. The R-FFP involved a great deal of effort for no gain. The FFP was infused at the hospital, which was followed by a short trip to the oncologist’s office for the Rituxan. The hospital took forever to get the job done, forcing me to abandon plans to get two units of FFP and 375 mg/m2 of Rituxan in one day. In the first round there were delays because the hospital took three hours to type and match my blood. I did one unit that day, followed by half the Rituxan. The next day I did the second unit and finished the Rituxan. In the second round it took from 7 a.m. to 3 p.m. for the hospital to get two units in me
(note the happy expression on my face in the photo above); by then it was too late to do the Rituxan, which was infused the following morning.

Marilyn and I learned a few things about FFP. One is that premeds generally are not given prior to its administration. Two is that a type and match is good for 21 days.
Three is that you can add a second filter to the IV setup if you want to be as thorough as possible in catching any errant white blood cells. We insisted on the addition of a leukopoor filter (the circular jobby in the photo) so all the FFP was double-filtered. Four is that nobody seems to know how long the complement gained from the FFP lasts in your body -- could be hours, could be days. Marilyn spoke to the director of the blood bank and he said nobody knew, that no study had ever been done.

Hopefully these details will be of no use to you as you will sensibly avoid undergoing this protocol. I might add here that my CLL is not as advanced as those in the study, nor can it be called refractory. Although I have had a lot of Rituxan in my time (two of the patients in the study were refractory to the drug), I should have been a fairly easy patient, as it were. Of course, one thing we know in CLL is that some people respond better to a particular treatment than others, and this may just not have been my cup of tea, or bag of plasma.

One of the bags was especially murky and yellow, causing the nurse to comment that the donor must have had a fatty steak dinner before they gave plasma. Perhaps the donor should also have had some jalapenos, which might have given the protocol more kick.