Safety aspect of lenalidomide

Posts related to the sub-type 5q deletion

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sophie
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Safety aspect of lenalidomide

Postby sophie » 17 Apr 2012 17:29

As posted before - lenalidomide is being re-assessed by the EMA (European Medicines Agency) to make sure it does not cause other secondary primary cancers.

It has been used in the US for a long time already and we know of many patients in Europe and the UK for whom it works extremely well - and who have become transfusion independant with the help of the drug.

I will now post 3 further articles on the subject:

MDS Beacon article:
A retrospective analysis of clinical trials involving the use of Revlimid in lower-risk myelodysplastic syndromes patients shows that that the rate of cancer for Revlimid-treated MDS patients is similar to the rate of cancer in the general public.

The findings were presented at the 2011 American Society of Hematology (ASH) meeting held in December.
The results need to be considered carefully, however, because the analysis compares the rate of second cancers among Revlimid-treated MDS patients in clinical trials with the rate of cancer in the general public.
A more relevant comparison would be to look only at patients within the same controlled clinical trials, and compare cancer rates for patients treated with Revlimid with rates for patients not treated with Revlimid.
Similar to the current MDS study, an analysis involving multiple myeloma patients showed that cancer rates among patients treated with Revlimid were much the same as those in the general public (see related Myeloma Beacon news).
However, other studies showed that myeloma patients treated for long periods with Revlimid in controlled clinical trials were at significantly higher risk of developing a second cancer compared to myeloma patients in the same trials who were not treated with Revlimid (see additional Myeloma Beacon news).
Revlimid (lenalidomide) is approved by the U.S. Food and Drug Administration (FDA) for the treatment of lower-risk myelodysplastic syndromes (MDS) patients who have the deletion 5q chromosomal abnormality and are dependent on red blood cell transfusions.
In April 2011, the FDA began investigating the possibility that Revlimid may cause additional, or secondary, cancers (see related Beacon news). The investigation was started based on the results from clinical trials in patients with the blood cancer multiple myeloma.
The trial results suggested that Revlimid may increase the risk of developing new types of cancers in patients taking the drug for extended periods of time. However, despite its investigation, the FDA advised patients currently taking Revlimid to continue treatment.
In the current study, European and American researchers retrospectively analyzed five clinical trials involving lower-risk MDS patients to determine if Revlimid use was associated with an increased risk of additional cancers in MDS patients.
The analysis included data from 557 lower-risk MDS patients who had received Revlimid treatment. The median patient age was 71 years; 72 percent of patients were 65 years or older.
Of the 557 patients included in the analysis, 16 percent had previously had cancer including skin, brain, breast, and lung cancer.
The researchers found that 5 percent of patients developed at least one secondary cancer after a median of 13.5 months of therapy; of these patients, 18 percent had a prior history of cancer.
The researchers also determined that 2.6 percent of patients developed a secondary cancer each year.
They then compared this rate of cancer development to the rate of new cancer cases in the general public, which are reported to the Surveillance, Epidemiology, and End Results cancer registry, to determine if Revlimid-treated MDS patients were more likely to develop secondary cancers.
The cancer registry shows that 2.1 percent of people who are at least 65 years old develop cancer every year.
For more information, please see abstract 1704 at the ASH 2011 meeting website.
This article comes from MDS Beacon - where you can find other reliable information on MDS:
http://www.mdsbeacon.com/news/2012/02/0 ... -ash-2011/
Sophie - Patient Liaison
For any queries:
Call 0207 733 7558
Email mds-uk@mds-foundation.org

Please do not send me PM messages on this forum - I do not check it often.
This forum is purely for patient to patient communications. Thanks for your help.
sophie
Posts: 249
Joined: 20 Nov 2008 14:05
Contact:

Re: Safety aspect of lenalidomide

Postby sophie » 17 Apr 2012 18:06

SPMs in Lenalidomide treated Low or Int-1 risk MDS patients

To analyse whether or not lenalidomide might be causing Secondary Primary Cancers – a retrospective study was conducted amongst 557 patients.

Here are the results in figures:

Patients analysed n=557:
Median age 71 (range 27-95 yrs)
MDS-001 to -004 & -007
88(16%) had prior history of malignancies

Patients were followed-up over a median time of 13.5 months.

In that time the following SPM (Secondary Primary Cancers) occurred:

n=17 had Invasive SPM:
B cell malignancies(n=2)
Solid tumours (n=15)

n=12 had Non Melanoma skin cancer

Incidence rate is 2.6/100 patient years
(SEER data 2.1/100 patient years for >65 years)

Please read these figures in conjunction with the MDS Beacon article posted in message above.
A power point slide of this information is available of our website

Data courtesy of
Giagounidis et al,Abstract 1704,Saturday,Dec 10 ,ASH,2011
Sophie - Patient Liaison
For any queries:
Call 0207 733 7558
Email mds-uk@mds-foundation.org

Please do not send me PM messages on this forum - I do not check it often.
This forum is purely for patient to patient communications. Thanks for your help.

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