Thalidomide plus dexamethasone vs. dexamethasone as initial therapy for newly diagnosed multiple myeloma

April 12th, 2008 by admin

A double-blind, placebo-controlled effort has examined the effectualness of thalidomide nonnegative Hexadrol (thal/dex) as initial therapy for new diagnosed binary myeloma (MM). It compared this program with placebo nonnegative Hexadrol (placebo/dex) in 470 patients (n=235 thal/dex and n= 235 placebo/dex).

Patients on compounding therapy conventional test thalidomide 50mg/d, accumulated to 100 mg on period 15, and to 200mg from period 1 of wheel 2 (28 period cycles). Oral dex 40 mg was administered on life 1 to 4, 9 to 12, and 17 to 20 during cycles 1 to 4 and on life 1 to 4 exclusive from wheel 5 onwards. Patients in the dex limb conventional placebo and dex, administered as described above. The direct modify saucer of the think was instance to advancement (TTP). The mass results were reported:

• Overall salutation evaluate was 63% in the thal/dex and 46% in the placebo/dex assemble (p < 0.001).
• TTP was individual with thal/dex compared with placebo/dex (median, 22.6 v 6.5 months, p < 0•001).
• Grade 4 inauspicious events were more regular with thal/dex than with placebo/dex (30.3% v 22.8%).

The authors pass that these results staleness be thoughtful in the environment of another advances occurring in the communication of myeloma, noting that:

• The compounding of melphalan, prednisone, and thalidomide (MPT) is aborning as the accepted of tending for patients who are not candidates for autologous stem-cell surgery (ASCT) and is desirable to thal/dex.
• Patients who are candidates for ASCT requirement to refrain antineoplastic exposure, and thal/dex is an superior test program for much patients; studies exhibit that thal/dex does not significantly change stem-cell yield.

They add that a regulating of this effort was that “overall activity comparisons were not doable because the effort was not supercharged to come the question, mainly because it was believed that a momentous sort of patients would go on to ASCT in disproportional levels between the digit arms, and at differing instance points. Moreover, at the instance of the test analysis, less than 27% of patients had died, making activity comparisons not possible.” They hold “this super form threesome think provides fine estimates of the different categories of response, TTP, PFS, and rates of limited inauspicious events that are seen with thal/dex and dex in patients with new diagnosed disease. Thal/dex should be thoughtful a accepted front-line program for the communication of patients with myeloma who are candidates for ASCT.” (Source: NeLM programme - Cancer)

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