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Thread: News about Rituxan from this weekend's Lymphoma and Myeloma 2011 Conference

  1. #1
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    News about Rituxan from this weekend's Lymphoma and Myeloma 2011 Conference

    Liz from the Hope-for Lymphoma facebook board attended the Q & A session at this weekend's Lymphoma and Myeloma 2011 Conference. The topic of the session was about Rituxan maintenance and also the use of Rituxan in early, asymptomatic, low tumor-burden, previously untreated FL patients (such as myself). The following is Liz's email to me. I don't think she will mind that I share it:

    "David, the consensus from the researchers I admire most, Myron Czuczman, David Maloney, Jonathan Friedberg, John Leonard, Richard Furman, Anas Younes and more is that the old saw about waiting for treatment and how early treatment doesn't impact overall survival is really applicable to chemo only. Certain chemo regimens and their toxicities may increase risk of future MDS, even secondary cancers and perhaps even play a role in transformation (the purine or other nucleoside analogs such as cytarabine and fludarabine are suspect).Myron Czuczman in particular, who was more conservative last December, was more convinced that we should ditch the palliative care approach and that for patients with low tumor burden, no B-symptoms and normal or near normal LDH, that Rituxan monotherapy is the way to go and go early.

    They've got 4 years of data now for the Ardneshna study and it's looking better all the time. The 4 year update of data on Ardneshna's study is showing great results and that fears of infections or resistance were perhaps overrated. The mood yesterday shifted so dramatically after the forced debate. Once Czuczman, who had the job of arguing against early Rituxan treatment, was done in his role as devil's advocate, he was free to express his real opinion and eventually became quite enthusiastic in extolling the virtues of early Rituxan treatment of asymptomatic FL. And he had been relatively cautious about this last December.

    John Leonard was very pro on the use of Rituxan early on even in asymptomatic patients. He stressed how many patients, especially those with low tumor bruden (and whose disease isn't high grade and rapidly progressing) never need another treatment or perhaps only need another round of Rituxan many years later. He stressed that Watch and Wait meets no criteria for a treatment and can't cure or control FL. John Leonard and Morton Coleman stated (emphatically) yesterday, there are a significant number of patients who if treated early with 4 cycles of Rituxan never need another treatment or perhaps only need another round of Rituxan many years down the line.

    Rituxan x 4 was the path for patients in situations such as yours. Morton Coleman proffered that from the Weil Cornel clinical observations, 4 cycles of Rituxan may be sufficient for treatment of many asymptomatic, lower tumor burden patients who are now on Watch and Wait. Coleman was a little hesitant for the full 2 years. And there is some suggestion in one data set that men might be more susceptible to very lowered white counts when undergoing long, heavy Rituxan dosing schedules. John Leonard was so for the R x 4 for patients like you and stressed over an over that it is possibly curative for some patients and relieves anxiety. Long term anxiety, worry and stress are not good for anyone.

    The speaker who was supposed to be arguing against it and was cautious about it last year, Czuczman, bailed on his argument for watch and wait as soon as he was done and they progressed to the panel discussion. Even he was for it."

    Looks to me like the game is changing.

    David
    David
    Age 43
    March 1, 2011 - Grade 1 Follicular Lymphoma from node removed from neck.
    2/22 PET/CT scan revealed one additional node in groin - also removed.
    Officially Grade 1 / Stage 3 due to second node.
    No Other Evidence of Disease.
    7/8 PET/CT shows two new small nodes - opposite sides, neck and groin.
    1/06/12 Completed Rituxan x 4 Monotherapy. 2/29/12 NED! Completed 4 additional maintenance doses of Rituxan. 12/12 NED! 6/14 NED!

  2. #2
    Administrator Top User Kermica's Avatar
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    David, thanks for bringing this forward, this is very encouraging information for all of us with indolent NHLs. I will be seeing my onc mid month next and will definitely be reviewing this post with him. I don't think I am quite as effusive in my expectations as your friend but it is still very, very encouraging.

    Good health,

    kermica
    When the world says, "Give up," Hope whispers, "Try it one more time."
    ~Author Unknown

    Age 63
    Follicular lymphoma diagnosed August 08, Stage 1
    2 cycles (20 treatments each) localized radiation to tumor sites. Remission confirmed July 09
    Restaged to Stage 3 May 2010
    Recurrence confirmed May 2010 - Watch and Wait commenced - multiple scans with minimal progression.
    Cutaneous Squamous Cell Carcinoma diagnosed September 2012. Mohs surgical excision 09/2012. Successful, clean edges all around.
    Significant progression detected in PET scan - December 2012
    Biopsy to check for transformation 1/18/2013 - negative for that but full of lymphoma, of course.
    July 2013 - Rescan due to progression shows one tumor (among many) very suspect for transformation, another biopsy 8/12/13.
    August 2013 - No evidence of transformation, 6 courses of B+R commence 8/29 due to "extensive, systemic disease".
    February 2014 - Diagnostic PET scan states: Negative PET scan. Previous noted hypermetabolic cervical, axillary, iliac and inguinal lymphadenopathy has resolved. Doctor confirms full remission.
    June 2014 - started 2 year maintenance Rituxin, 1 infusion every 3 months. Doctor confirms lump under right arm are "suspicious" for recurrent disease, deferring scans for now.

    Remember the Rules!

  3. #3
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    Thanks buddy. Yeah, I am very encouraged by this update. I have already forwarded it to both of my oncologists here, particularly since several of the physicians mentioned above were the ones who were not advocates of early Rituxan in the article my first doctor gave me initially.

    I'm going to move forward with the Rituxan x 4 only. I'll keep you and everyone else updated.

    Here is more from Liz and her report:

    "David Maloney of Fred Hutchinson says that the data on no overall survival advantage has been misinterpreted and their analysis shows that 1) it does seem to impact OS in a positive way and 2) that we need more than 3-4 years to measure that. David Maloney in particular thinks they are seeing an increase in overall survival, especially in certain subsets of patients and they anticipate seeing further increases in OS as time goes by. What was interesting is that incidence of resistance is lower than feared and incidence of infection was not as high. HOWEVER, some data indicated that men may be more susceptible to lowered white counts than women.


    Morton Coleman proffered that from the Weil Cornel clinical observations, 4 cycles of Rituxan may be sufficient for treatment of many asymptomatic, lower tumor burden patients who are now on Watch and Wait. He also observed that among patients receiving maintenance he is seeing a slight increase in cases of chronic sinusitis requiring gamma globulin therapies because they are unresponsive to antibiotics. David Maloney pointed out that there is a high incidence of FL patients who have always had troubles with IgG and other IG levels. He suggested that we should probably be testing for that to see if that is really the problem and it is exacerbated by Rituxan maintenance.

    The 4 year update of data on Ardneshna's study is showing great results and that fears of infections or resistance were perhaps overrated."

    And finally, regarding Rituxan Maintenance:

    "Does Rituxan Maintenance improve Overall Survival?

    Old school -- without any real data -- says we haven't seen that yet. But now that we are getting more mature data just this year, researchers such as David Maloney from Seattle's legendary Fred Hutchinson Cancer Research Center, say YES, it certainly seems that we are beginning to see a positive trend in Overall Survival, not just Progression or Event Free Survival.

    Several top researchers yesterday at the conference were convinced we are seeing an improvement in OS from Rituxan maintenance and we need to wait longer to see more of it. They also pointed to difficulties in interpreting limited data focusing on heavily pretreated patients. Additionally, data will be presented in two months showing that longer maintenance periods of up to 5 years appear safe for most FL survivors, with lower incidence of developing Rituxan resistance than previously anticipated. Not to mention several new antibodies in the pipeline, attacking not only CD20, but CD10 and CD19, too.

    I mention David Maloney at the Hutch. There were several studies and Maloney had a meta analysis and subset analysis, too. Additionally, we heard from one of the investigators on one of the studies in the Q & A and he gave perspective in favor of Rituxan's impact on OS and the need for more time to make that clear. Data was also coming from the continued follow up on Ardneshna's study, the 36 month update for which was presented at ASH last year. The four year data is in now and the trend continues to be positive in terms of what looks like signs of an increase in OS. The trend at 4-5 years is obviously not very strong so when they look at all patients, many of whom may be elderly and/or may have other conditions impacting survival, it is a little muddy. Even though it is early on , several researchers yesterday were of the opinion that when you look more closely and remove confounding factors, you do see an increase in OS that they think time will prove out."
    David
    Age 43
    March 1, 2011 - Grade 1 Follicular Lymphoma from node removed from neck.
    2/22 PET/CT scan revealed one additional node in groin - also removed.
    Officially Grade 1 / Stage 3 due to second node.
    No Other Evidence of Disease.
    7/8 PET/CT shows two new small nodes - opposite sides, neck and groin.
    1/06/12 Completed Rituxan x 4 Monotherapy. 2/29/12 NED! Completed 4 additional maintenance doses of Rituxan. 12/12 NED! 6/14 NED!

  4. #4
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    David

    Very interesting, but I am concerned about the "One Size Fits All" approach the industry is taking toward Rituxun. The researchers in WM generally agree but not for everybody. A big factor is quality of life
    Aprox 10% of indolents react badly to R and it seems to make sense to treat nhl and if there is a relapse, then simply treat the nhl again.

    My 84 yo Mom was dx with CLL about three weeks before I was DX. She did 4 R treatments and is now in CR. Now of course I am a familial nhl'r, which new research suggests should be treated differently than
    sporadic nhl, including less reliance on R, with drugs such as Bortzimib, Velcade Bendamustine and others

    Mark
    Chicago 54 years old
    LPL/Waldenstroms indolent nhl, dix Friday the 13th 5/13/11
    R-CVP, 5/23/11 6 cycles, 12/20/11 PR, w&w for now

  5. #5
    Administrator Top User Kermica's Avatar
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    David Maloney pointed out that there is a high incidence of FL patients who have always had troubles with IgG and other IG levels. He suggested that we should probably be testing for that to see if that is really the problem and it is exacerbated by Rituxan maintenance.
    Hmmm...I am one of those FL patients who has the GM1 antibody as a direct result of having FL Multi-focal neuropathy ongoing, not severe but always there. Are they saying that Rituxan may be problematic for people like me (about 1% of FL patients develop this antibody)?

    To Mark's point it is never one size fits all and rarely simple, is it?

    Good health,

    kermica
    When the world says, "Give up," Hope whispers, "Try it one more time."
    ~Author Unknown

    Age 63
    Follicular lymphoma diagnosed August 08, Stage 1
    2 cycles (20 treatments each) localized radiation to tumor sites. Remission confirmed July 09
    Restaged to Stage 3 May 2010
    Recurrence confirmed May 2010 - Watch and Wait commenced - multiple scans with minimal progression.
    Cutaneous Squamous Cell Carcinoma diagnosed September 2012. Mohs surgical excision 09/2012. Successful, clean edges all around.
    Significant progression detected in PET scan - December 2012
    Biopsy to check for transformation 1/18/2013 - negative for that but full of lymphoma, of course.
    July 2013 - Rescan due to progression shows one tumor (among many) very suspect for transformation, another biopsy 8/12/13.
    August 2013 - No evidence of transformation, 6 courses of B+R commence 8/29 due to "extensive, systemic disease".
    February 2014 - Diagnostic PET scan states: Negative PET scan. Previous noted hypermetabolic cervical, axillary, iliac and inguinal lymphadenopathy has resolved. Doctor confirms full remission.
    June 2014 - started 2 year maintenance Rituxin, 1 infusion every 3 months. Doctor confirms lump under right arm are "suspicious" for recurrent disease, deferring scans for now.

    Remember the Rules!

  6. #6
    Senior User
    Join Date
    Feb 2011
    Posts
    492
    You can apparently have your CSF checked for the virus that causes PML, which sounds like a very good idea to me. Here is a comment also from the discussion about this:

    "An expert from Mayo reporting (informally) 57 cases of PML in lymphoma patients, which is rapidly fatal. Maloney argued that there is also a background incidence of PML (in the pre-rituxan era) so it’s not possible to define the role of Rituxan in PML. One response to this was that the incidence of PML prior to Rituxan would be impossible to verify and compare. (I will try to find a published Mayo report … but based on this conversation at the conference the risk of PML seems to be higher than I previously thought … and therefore a more legitimate concern – particularly absent any evidence of a survival benefit for maintenance in follicular lymphoma."

    I'm fairly confident the chance of PML would be much lower with just Rituxan x 4 and not 2-year maintenance. I need some clarification on this however.

    david
    David
    Age 43
    March 1, 2011 - Grade 1 Follicular Lymphoma from node removed from neck.
    2/22 PET/CT scan revealed one additional node in groin - also removed.
    Officially Grade 1 / Stage 3 due to second node.
    No Other Evidence of Disease.
    7/8 PET/CT shows two new small nodes - opposite sides, neck and groin.
    1/06/12 Completed Rituxan x 4 Monotherapy. 2/29/12 NED! Completed 4 additional maintenance doses of Rituxan. 12/12 NED! 6/14 NED!

 
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