DOI: 10.1097/01.COT.0000287365.59647.0d

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Issn Print: 0276-2234

Publication Date: 2005/03/10


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Myeloma: ‘Thal-Dex’ Superior to Dexamethasone Alone

Robert H. Carlson

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Excerpt

SAN DIEGO—A regimen of thalidomide plus dexamethasone (Thal-Dex) as first-line therapy in patients with newly diagnosed multiple myeloma produced response rates superior to those of dexamethasone alone in a Phase III trial presented here at the American Society of Hematology Annual Meeting.
The researchers warned, however, that the use of the combination must be weighed for each patient because toxicities in the combination were higher than with dexamethasone alone.
But they also said that both regimens have low progression rates as pre-transplant therapy, and both would negate the need for intravenous vincristine-doxorubicin-dexamethasone (VAD) therapy.
The study, coordinated by the Eastern Cooperative Oncology Group (ECOG), included newly diagnosed, untreated patients with symptomatic multiple myeloma. Patients were randomized to receive one-month cycles of oral thalidomide at 200 mg/day plus dexamethasone at 40 mg (103 patients), or dexamethasone at 40 mg alone (104).
“Our goal was to develop safe induction regimens for patients like this, so they could then proceed to more aggressive strategies,” said first author S. Vincent Rajkumar, MD, Associate Professor of Medicine in the Division of Hematology at the Mayo Clinic.
Dr. Rajkumar was the recipient at this meeting of Celgene Corporation's Young Investigator Award for significant research contributions in clinical hematology by a clinician under the age of 45.
The primary study endpoint was best response at four months on an intent-to-treat basis, and the patients' median age was 65.
Among 198 evaluable patients, 63% of those receiving the combination therapy had a response, compared with 41% of those receiving dexamethasone alone.
Response was defined as a decrease in serum and urine monoclonal protein by 50%, verified on two consecutive determinations separated by at least two weeks.
The rapid median time to response—1.1 months—was the same for both groups of patients. Confirmed disease progression occurred within the first four months of therapy in three combination-arm patients and in two dexamethasone-alone patients.
Grade 3 or higher non-hematologic toxicities within approximately four months of initiation of therapy occurred in 68% of the combination-arm patients vs 43% in the dexamethasone-alone arm.
Grade 3 or higher cardiac ischemia occurred in three Thal-Dex patients at four months vs two in the single-agent arm.
“This combination demonstrates a superior response,” Dr. Rajkumar said, “but it should be considered on an individual basis due to the higher toxicity level.
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