Adding Thalidomide to Myeloma Therapy of Little Benefit

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Adding Thalidomide to Myeloma Therapy of Little Benefit

Reuters Health Information 2006. © 2006 Reuters Ltd.

NEW YORK (Reuters Health) Mar 08 - Adding

thalidomide to high-dose therapy for multiple

myeloma makes complete responses more likely and

increases event-free survival, but does not

improve overall survival and has considerable toxicity, new research shows.

Melphalan-based high-dose therapy has been shown

to improve the survival of multiple myeloma.

However, it was unclear if adding thalidomide, an

agent with activity against advanced and

refractory disease, to this therapy could further improve outcomes.

To investigate, Dr. Bart Barlogie, from the

University of Arkansas for Medical Sciences in

Little Rock, and colleagues assessed the outcomes

of 668 patients who were randomized to receive

two cycles of melphalan-based therapy, supported

by hematopoietic-cell transplantation, with or without thalidomide.

The researchers' findings appear in The New

England Journal of Medicine for March 9th.

After a median follow-up period of 42 months, the

complete response rate in the thalidomide group

was 62%, significantly higher than the 43% rate

noted in the control group (p < 0.001), the

authors state. Similarly, the 5-year event-free

survival rate in the thalidomide group was also higher, 56% vs. 44% (p = 0.01).

Now for the bad news.

Due in part to a lower response rate to salvage

therapy, the addition of thalidomide did not

improve overall survival; both groups had a

5-year overall survival rate of about 65%. The

median survival period after relapse in the

thalidomide group was 1.1 years compared with a

period of 2.7 years in the control group (p = 0.001).

Deep vein thrombosis occurred in 34% of

thalidomide-treated patients compared with 18% of

controls (p < 0.001). Treatment with

low-molecular-weight heparin did not eliminate

the elevated risk. Other adverse events seen more

often in the thalidomide group included

peripheral neuropathy, syncope, bowel obstruction, tremor and neutropenia.

" These results indicate that contrary to a widely

held belief, a complete response is not a valid

surrogate for overall survival in clinical

trials, " Dr. Michele Cavo and Dr. Michele

Baccarani, from the University of Bologna in

Italy, comment in a related editorial.

" The higher rate of failure to respond to salvage

therapy in the thalidomide group needs to be

investigated further, " they suggest, " especially

with respect to the salvage potential of new

drugs in patients who had received thalidomide as initial treatment. "

N Engl J Med 2006;354:1021-1030,1076-1078.