Comments on: Planning for Success

By: Alex

Alex — Thu, 13 Mar 2008 19:31:19 +0000

Hi Chaya,
I send you best wishes and my prayers and love for the journey ahead. I am very interested in your experience with Revlimid, as I am considering that for the same reasons. I am in partial remission after PCR, but still have some nodes in the 3cm range. Any information you can post on “tumor flare reactions” and other side effects of Revlimid would be very helpful in making this difficult choice. Thanks so much.

By: chaya

chaya — Wed, 05 Mar 2008 17:55:28 +0000

Aditi:

The 70% response rate for truly chemo naive patients comes from another MDA article in the JCO. Here is the PubMed citation for th article, write if you want help locating the full text of it.

Chaya

Keating MJ, O’Brien S, Albitar M, Lerner S, Plunkett W, Giles F, Andreeff M, Cortes J, Faderl S, Thomas D, Koller C, Wierda W, Detry MA, Lynn A, Kantarjian H.

Department of Leukemia, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Unit 428, Houston, TX 77030, USA. mkeating@mdanderson.org

PURPOSE: Fludarabine and cyclophosphamide (FC), which are active in treatment of chronic lymphocytic leukemia (CLL), are synergistic with the monoclonal antibody rituximab in vitro in lymphoma cell lines. A chemoimmunotherapy program consisting of fludarabine, cyclophosphamide, and rituximab (FCR) was developed with the goal of increasing the complete remission (CR) rate in previously untreated CLL patients to >/= 50%.

PATIENTS AND METHODS: We conducted a single-arm study of FCR as initial therapy in 224 patients with progressive or advanced CLL. Flow cytometry was used to measure residual disease. Results and safety were compared with a previous regimen using FC.

RESULTS: The median age was 58 years; 75 patients (33%) had Rai stage III to IV disease. The CR rate was 70% (95% CI, 63% to 76%), the nodular partial remission rate was 10%, and the partial remission rate was 15%, for an overall response rate of 95% (95% CI, 92% to 98%). Two thirds of patients evaluated with flow cytometry had less than 1% CD5- and CD19-coexpressing cells in bone marrow after therapy. Grade 3 to 4 neutropenia occurred during 52% of courses; major and minor infections were seen in 2.6% and 10% of courses, respectively. One third of the 224 patients had >/= one episode of infection, and 10% had a fever of unknown origin.

CONCLUSION: FCR produced a high CR rate in previously untreated CLL. Most patients had no detectable disease on flow cytometry at the end of therapy. Time to treatment failure analysis showed that 69% of patients were projected to be failure free at 4 years (95% CI, 57% to 81%).
PMID: 15767648

By: Aditi Silverstein

Aditi Silverstein — Wed, 05 Mar 2008 17:37:35 +0000

Chaya – You said that truly therapy-naive patients achieved 70% CR rate. I can’t see in the chart where that information is. Can you help me understand where you get the 70% CR rate from? Thanks! Aditi

By: Chonette Taylor

Chonette Taylor — Wed, 05 Mar 2008 08:38:08 +0000

During my last treatment, the first round of Fluradabine and Rituximab did absolutely nothing to my nodes or even my numbers, we decided to change the strategy and add HDMP to the combo for the second round, nodes and counts went on the right direction fast after that round, and continued for 3 more rounds, then all stopped, so we did not do the 6th round of HDMP though we did 6 of Fluradabine if we include the first one. Treatment finished in September and nodes are on the growing again.

I had had little treatment before that mainly Rituximab and low doses Chlorambucil one treatment, I was actually surprised how little effect fluradabine had had on me having a good FISH test even I am unmutated.

As HDMP is the only thing I seem to respond, we will be doing that for the salvage therapy (HDMP and Campath) locally and then other chemo in London.
I am not looking forwards to the road ahead.
Chonette

By: Chonette Taylor

Chonette Taylor — Wed, 05 Mar 2008 08:24:50 +0000

Thanks chaya for this update, I had a conversation with my consultant yesterday and she said that patients my age that have had Rituximab and Campath (which I will have as part of the 4th line salvage therapy) have more GVHD problems.
Is there any where one can find out how many transplants have been done worldwide on patients with CLL?
The Royal Free Hospital in London has only done 19 CLL transplants, I should be the 20th, of course they have done many in other heamatology conditions, provably all young people as I noticed when I was on the waiting room last week, I was the only person without a transplant, all others had and were all younger people.
Thanks for sharing your path with us
Chonette

By: Beth and Mark

Beth and Mark — Fri, 29 Feb 2008 04:17:06 +0000

This new information/ Rituxan therapy is quite startling, and of course gives me chills since Mark is 5 years into Rituxan maintenance. Still, it is better to know what we may be facing. I look forward to more posts on this important subject. Looks like we may have a very hard time getting a good CR for a transplant too, this puts so many things in a different light. Time to rethink the five year plan. Thanks Chaya for bringing this important information.
Beth

By: Carol Rhoades

Carol Rhoades — Fri, 29 Feb 2008 03:59:25 +0000

My pre-transplant nodes were about 2-3 cm so my midi-allo sibling transplant was iffy for relapse. I’m happy to say after 2 years post SCT my nodes are normal and no sign of SLL/CLL. My regimen was Bu/Flu R with 1 day TBI but previously I had CHOP,F, FRC,R,and high dose steroids. I wish “Harvey” the best for the cord blood SCT–Make sure he doesn’t trip with IV attached-wash hands,get all horizontal surfaces cleaned by housekeeping,get the shower disinfected routinely–small things but very important. I found that patients who rolled their IV poles around and fell was a big problem in the transplant unit. I’ve heard very good things about Minn. Regards, Carol Rhoades

By: Joan McEnery

Joan McEnery — Thu, 28 Feb 2008 23:45:20 +0000

It became apparent some time during 1996 that I had some form of lymphoma by the enlarged nodes on my neck and arm pits. I finally had a biopsy in 2000 that diagnosed me with SLL/CLL which I received Chemo for in 2002. The Chemo was RF with something else on the day of the Retuxin. I finished the six cycles and am still in remission but not CR since I still have some lynph nodes that have appeared. It will be six years in Novemeber 2008 since the Chemo.

My case sounds similar to Harvey’s that is why I am very interested in the journal.

I want to thank you for the imformation that you have been providing and I wish a complete remission for Harvey.

Sincerely,

Joan McEnery

By: chaya

chaya — Thu, 28 Feb 2008 20:44:32 +0000

You can find the official program description at http://www.revassist.com.

Before you can take Revlimid as a patient outside of clinical trials, you and your physician must enroll in the Revassist program. Having gone through it personally, Harvey’s impression is that it is a mechanism set up to avoid any possibility of fetal exposure to Revlimid. Given the historical experience with thalidomide use in pregnant women and the risk of birth defects, you can understand the caution for this thalidomide-related drug.

In reality, complying with the Revassist requirements is very simple. You have to swear you are not now pregnant, and you have no intentions of ever getting pregnant while you are taking Revlimid. If you are a guy, you have to promise you will not get anyone else pregnant during this period.

Celgene also has a Patient Support Coordinator to help with reimbursement issues: http://www.revlimid.com/hcp/hcp-psc.aspx.

They have a patient help program to mitigate the cost of the drug for patients whose insurance does not cover the cost of the drug. You will find contact information at the link provided.

Medicare programs seem to be different in different states, and in any case neither Harvey nor I are experts on this subject. If stem cell transplant and insurance coverage is an issue, we suggest you review the articles we published recently on http://www.clltopics.org on the subject of heavily subsidized (as in almost completely free of charge) transplant protocols at the NCI. Your tax dollars at work. I am amazed more patients don’t know about this terrific “deal”.

By: SAL G

SAL G — Thu, 28 Feb 2008 19:20:59 +0000

CHAYRA,GLAD TO HEAR THAT HARVEY HAS ACHEIVED A CR.I DO HAVE A FEW QUESTIONS.CAN YOU PLEASE DESCRIBE THE REVASSIST PROGRAM AND DO YOU KNOW IF THE MEDICARE PROGRAM COVERS A MINI ALLO TRANSPLANT FOR A CLL
PATIENT.THANKS