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Study Confirms Survival Benefit Of Revlimid-Dexamethasone Combo In Elderly Relapsed / Refractory Myeloma Patients

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Published: Aug 10, 2012 12:09 pm

Results from a recent retrospective study con­firm that treat­ment with a com­bi­na­tion of Revlimid and dexa­meth­a­sone slows disease pro­gres­sion and im­proves survival in elderly patients with re­lapsed or refractory myeloma.

However, findings from the study also indicate that certain side effects, such as anemia and blood clots, occurred more frequently in elderly patients.

Novel agents such as Revlimid (lena­lido­mide), thalidomide (Thalomid), and Velcade (bor­tez­o­mib) are commonly used to treat re­lapsed and refractory myeloma.

A pre­vi­ous study found that Revlimid in com­bi­na­tion with dexamethasone (Decadron) is effective in patients over 75 years of age with re­lapsed myeloma (see related Beacon news).

FDA approval of the Revlimid-dexamethasone com­bi­na­tion was based on two ran­dom­ized Phase 3 studies that dem­onstrated its efficacy in people with re­lapsed or refractory myeloma.  Patients were enrolled in those studies from 2003 to 2005.

In the current study, researchers retrospectively analyzed pooled data from these two trials to assess if treat­ment out­come was asso­ci­ated with age.

Among the 704 patients in­cluded in the studies, 55 per­cent were below 65 years of age, 33 per­cent were between 65 and 74 years, and 12 per­cent were 75 years or older.

Results from the analysis showed that treat­ment with Revlimid and dexa­meth­a­sone was effective in all age groups, including patients over 65 years of age.

In all age groups, a greater per­cent of patients responded to Revlimid-dexamethasone treat­ment as compared to treat­ment with dexa­meth­a­sone alone.

Specifically, among patients below 65 years of age, 61 per­cent responded to Revlimid-dexamethasone as compared to 22 per­cent who responded to dexa­meth­a­sone alone.  Among patients 65 to 74 years of age, 54 per­cent responded to Revlimid-dexamethasone versus 21 per­cent who responded to dexa­meth­a­sone.  Finally, among patients 75 years or older, 70 per­cent responded to Revlimid-dexamethasone versus 21 per­cent who responded to dexa­meth­a­sone.

Revlimid-dexamethasone also provided a pro­gres­sion-free survival advantage for each of the age groups, as compared to dexa­meth­a­sone alone.

For the youngest group, median pro­gres­sion-free survival was 11.1 months for Revlimid-dexamethasone versus 4.6 months for dexa­meth­a­sone alone.  For patients between 65 and 74 years, pro­gres­sion-free survival was 9.4 months versus 4.6 months, re­spec­tive­ly.  For the oldest group of patients, pro­gres­sion-free survival was 14.1 months versus 3.8 months, re­spec­tive­ly.

Median over­all survival was also higher for each of the age groups treated with Revlimid-dexamethasone as compared to dexa­meth­a­sone alone, but the survival differences between the two treat­ment regi­mens were not statistically sig­nif­i­cant.

Specifically, among patients below 65 years of age, the median over­all survival time was 43.9 months for those treated with Revlimid-dexamethasone as compared to 36.2 months for those treated with dexa­meth­a­sone alone.  Among patients 65 to 74 years of age, over­all survival was 33.3 months for the Revlimid-dexamethasone group versus 23.3 months for the dexa­meth­a­sone-only group.  Finally, among patients 75 years or older, over­all survival was 34.3 months for Revlimid-dexamethasone-treated patients versus 19.5 months for those treated only with dexa­meth­a­sone.

The results also showed that the occurrence of some, but not all, side effects of Revlimid-dexamethasone treat­ment increased with age.

Anemia (low red blood cell counts), deep-vein thrombosis (blood clots in deep veins), periph­eral neu­rop­athy (pain, tingling, or loss of sensation in the extremities), and gastro-intestinal disorders occurred more frequently in older patients.

Older patients were also more likely to require dose reductions and to need them earlier in their course of treat­ment than younger patients.  The first reduction was required after a median of 4.3 months of treat­ment in patients below 65 years of age, but 2.6 months in patients who were 65 or older.

For more in­­for­ma­tion, please see the study in the International Journal of Hematology (abstract).

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10 Comments »

  • suzierose said:

    Is it correct that the patients were on this 'maintenance' therapy for 2 yrs i.e. 2003-2005 (period of retrospective analysis.

    What was the incidence of SPM over that period in this population?

    Or was the only parameter analyzed from the pooled data, age related outcome?

  • Beacon Staff said:

    Suzierose, patients were treated until their disease progressed or they were unable to tolerate treatment.

    This particular analysis only looked at age-related outcomes.

    The rate of second cancers in these two studies were reported previously, though:
    http://www.myelomabeacon.com/news/2012/05/07/fda-issues-extensive-update-about-revlimid-lenalidomide-and-second-cancers/

    "The analyses also show that relapsed and refractory myeloma patients treated with Revlimid and dexa­methasone (Decadron) are more likely to develop a second cancer than patients treated with dexamethasone alone.

    "Specifically, data from the two clinical trials that supported the FDA’s approval of Revlimid show that 3.98 percent of relapsed and refractory myeloma patients developed a second cancer during each year of treatment with Revlimid and dexamethasone, compared to 1.38 percent of patients treated with dexa­metha­sone and placebo. A key contributor to the different rates of second cancer was a noticeably higher rate of non-melanoma skin cancer among the patients treated with Revlimid."

  • Christina said:

    So,let me see if I understand this.... Patients treated with rev/ dex maintenance remained progression free for 43.9 months. This would be the group I'm in under 65.
    So my question is, you stay on the rev/ dex till it stops working? And Is the dose 25 mg rev? And what dose of dex.
    I'm asking because I just reached CR on rev/ dex after 4 months, and the question is do I keep on it or go off? My hem/onc says I can really go either way?......
    So I'm trying to get as much info as I can.....
    Thanks so much, Christina

  • DontbedefinedbyMM said:

    Christina

    The 43.9 month number for the under 65 group(treated with Rev and dex) pertains to median overall SURVIVAL. Progression-free survival for this group of Rev-dex patients is shorter, lasting for a median of 11.1 months. Of course, I would like to know what the progession-free survival time is for subgroups of patients, such as those with low-risk disease.

    Also: keep in mind that these studies apply ONLY to patients who have relapsed after previous treatment or have become refactory to treatment. If you have not been treated before, these numbers do not apply. Your message is not clear on your treatment status.

    Indeed,if you are a NEWLY diagnosed patient being treated with Rev plus dex, the median progression-free survival after treatment is about 28 months and with the addition of Biaxin - apparently 4 years. See, for example, the following abstract, which includes a free link to the entire article. http://onlinelibrary.wiley.com/doi/10.1002/ajh.21777/abstract

    P.S. I am three months into the Rev plus dex (plus clarithromycin) treatment and, assuming I achieve a CR, do not plan on using any drugs during maintenance. But this decision will likely depend on your initial presentation, overall health, risk-factors etc.

  • Christina said:

    No, I am not newly diagnosed. Was diagnosed in 2005, sct in 2006, lasted in CR till 2010.
    Did rev / dec for 8 months, CR for 4 of those. Then, no drugs for 11 months, and then relapsed eith very small m protein, .3
    I decided to stare rev/ dex again, and again CR in four months. I assume
    I'm low risk, although no one has ever said that to me.
    So , now I face, go off like I did last time or stay on maintenance. That's why when I saw this study I was in interested in the 43 months progression free statistic.
    Thanks for your interpretation. I'm not sure which way to go, my hem/ onc leans toward going off, so as to not build resistance to the 4
    Rev/dex, but since this is my second time round , not sure?
    Hope you get CR soon, I think that 4 month things start to turn around.
    Best wishes,
    Christina

  • DontbedefinedbyMM said:

    Thanks for the clarification. I think you are taking the right approach -- going for maintenance - given the absence of statistically significant evidence in this study that maintenance with these drugs improves overall survival - indeed it could be reducing it for all we know -- why build up resistance?

    Dex exacts a huge toll on the body in the long-run and despites it profound and excellent action, revlimid also, in some sense, resets the immune system, appears to increase the risk of secondary malignancies, and confers resisance while potentially selected for new, more aggressive clones.

    Like you, I would like to keep my options open down the road, not just with revlimid, but also with pomalidomide, velcade, carfilzomib, etc.

    Best wishes

  • DontbedefinedbyMM said:

    Whoops -- I meant going for DRUG-FREE maintenance as the right approach...

  • Christina said:

    Thanks so much for those thoughts. I am really on the fence about this , so your input really helps .
    Best wishes for. CR soon.
    Christina

  • Barry Paul said:

    I am taking revlimid and dex. The skin on my arms is very susceptable to brusing under the skin. I don't bleed but get a large blood bruise that sometimes looks black. After a week or two it usually slowly disappears. In mean time I look like I was mugged. Also day I take Dex my hands cramp. Not bad sometimes and very painful other times. Any suggestions or similarities to this.

  • judyriseman said:

    my husband has been taken off revlimid-concerns about it causing other cancers-he also has melanoma-should i/we be frightened. he has been in remission with myeloma since taking revlimid &dexamethasone.