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 ^[1] (lena­lido­mide), thalidomide ^[2] (Thalomid), and Velcade ^[3] (bor­tez­o­mib) are commonly used to treat re­lapsed and refractory myeloma.

A pre­vi­ous study found that Revlimid in com­bi­na­tion with dexamethasone ^[4] (Decadron) is effective in patients over 75 years of age with re­lapsed myeloma (see related Beacon ^[5] 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 ^[6] (abstract).