Friday, June 16, 2006

ThaDD

The addition of pegylated liposomal doxorubicin to the combination of thalidomide and dexamethasone appears to improve outcomes in patients with advanced multiple myeloma.

Laura Corvatta, MD, co-investigator and physician, hematology clinic, United Hospitals of the Polytechnic University of Ancona, Ancona, Italy, presented the results of a retrospective, case-matched study on June 16 at the 2006 Congress of the European Hematology Association.

The overall response rate (including minimal response) for ThaDD was significantly greater than for Thal-Dex (87% vs 64%; P < .01). In particular, there were significantly better qualities of response for ThaDD over Thal-Dex, respectively, for partial response or better (76.6% vs 59.6%, P = .077); very good partial response or better (36.2% vs 14.9%, P = .018), and complete plus near complete response (29.8% vs 10.6%, P = .021).

Median progression-free survival was significantly longer for ThaDD, at 22 months versus 11.5 months (36% vs 13%; P = .0008), as was the median event-free survival of 21 months versus 11.5 months (28% vs 13%; P = .0077). Overall survival was not reached in the ThaDD group, showing a trend in favor of this treatment (not reached vs 23.5 months; 52% vs 26% at 3 years; P = .0511).

The toxicity profiles for the ThaDD and Thal-Dex combinations showed significantly greater grade 3/4 neutropenia (25% vs 0%, respectively; P < .0001) and grade 3/4 infections (23% vs 0%; P < .0001). The researchers also observed a trend towards lower grades of peripheral neuropathy with the ThaDD regimen (grade 1, 19% vs 6.5%; grade 2, 6.5% vs 21%; grade 3, 2% vs 0%; P = .0510).

However, Dr. Corvatta noted that the addition of ciprofloxacin prophylaxis to the ThaDD regimen reduced infections to <10%.

"The main message is that ThaDD in combination with chemotherapy is superior to thalidomide alone or in combination with dexamethasone," she said, and noted that the increased infections seen with ThaDD were manageable and largely preventable with adequate prophylaxis.

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