American Society of Clinical Oncology: Oral Drug Combination for Multiple Myeloma
Speaker: Vincent Rajkumar, MD, Hematologist, Mayo Clinic, Rochester, Minnesota.
Patients with newly diagnosed multiple myeloma responded better to treatment with the oral drug combination of thalidomide (Thalomid®, Celgene) plus dexamethasone (Decadron generic, Merck) (thal/dex) than to dexamethasone therapy alone.
In a phase III clinical trial, coordinated by the Eastern Cooperative Oncology Group (ECOG), 207 patients were randomly assigned to take oral thalidomide 200 mg/day with oral dexamethasone 40 mg/day on the first to fourth days, the ninth to 12th days, and the 17th to 20th days or to take dexa-methasone alone on the same schedule. Therapy was repeated monthly for four cycles.
Response to treatment was defined as a 50% or greater decrease in serum and urine monoclonal M-proteins, known indicators of tumor burden. In patients whose serum levels of M-protein were not measurable, a 90% or higher decrease in the urine M-protein was required.
The best response within four cycles of treatment was 58 of 98 patients receiving thal/dex, or 59%, versus 40 of 98 patients on dexamethasone alone, or 41%. These results suggest that this oral regimen can help bring multiple myeloma under good control and can prepare these patients for undergoing stem cell transplantation, a standard treatment used to stop the disease and prolong life.
The side-effect profile with thal/dex, however, was considerably greater than that seen with dexamethasone drug alone; 44% of patients in the thal/dex arm of the study had serious ADEs, compared with 19% receiving dexamethasone alone. The fact that deep vein thrombosis occurred in 16% of patients receiving thal/dex, but in only 3% of patients treated with dexa-methasone alone, points to the need for anticoagulants to be given initially to prevent these blood clots.
On the basis of the promising results of thal/dex and dexa-methasone in this study, it appears that this oral regimen might provide an effective alternative for complex IV chemotherapy such as vincristine/adriamycin/dexamethasone (VAD) as first-line treatment for multiple myeloma. Physicians might consider dexamethasone generic alone for low-risk patients and thal/dex for patients with more aggressive disease necessitating immediate tumor reduction.
Darbepoetin alfa for Anemia of Cancer
Speaker: Venna Charu, MD, Community Oncologist, Pacific Cancer Medical Center, Anaheim, California.
Results from a multicenter study indicated that darbepoetin alfa (Aranesp®, Amgen) was effective in treating anemia of cancer in patients who were not receiving concurrent chemotherapy.
More than a quarter of a million cancer patients experience anemia of cancer annually. Investigators conducted a multi-center, randomized, comparative, open-label, 25-week study to estimate the difference in the number of hospitalization days over 12 weeks in patients with anemia of cancer treated with darbepoetin alfa and in patients not receiving treatment. The study also aimed to compare the efficacy and safety of darbepoetin alfa versus no treatment.
Patients were randomly selected to receive darbepoetin alfa 3 mcg/kg every two weeks for 21 weeks, with a dose increase permitted or a control observation for 12 weeks. This step was followed by optional treatment with darbepoetin alfa 3 mcg/kg every two weeks for nine weeks, with a dose increase permitted.
Although the planned sample size was 1,000 patients, a total of 285 patients were enrolled, in a 4:1 ratio; 226 were assigned to the darbepoetin alfa group and 59 were assigned to the control group. At this point, study enrollment was terminated. prescription drugs online canada
Patients were permitted to receive transfusions at the treating physician’s discretion. A Subjects Outcomes Questionnaire was administered at the baseline evaluation and every four weeks through the end of the study. All patients returned for a follow-up visit four weeks after receiving the last dose of the study drug.
Hospitalization results were comparable for treated and control patients. The number of patients hospitalized was similar, and the length of hospital stay was equivalent. However, these results were not conclusive because the target sample size of 1,000 patients (800 patients taking darbepoetin and 200 control patients) was not reached.
The incidence of red blood cell transfusions was significantly lower for the darbepoetin alfa patients than for the controls during the fifth to 12th weeks, with transfusions being required in 8% of patients taking darbepoetin alfa and in 22% of the patients in the control group.
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Patients taking darbepoetin alfa experienced a significant reduction in fatigue and mean change in hemoglobin over time that was significantly greater than in the controls. Patients in the control group who elected to receive darbepoetin alfa after 13 weeks of observation experience a substantial increase in mean change in hemoglobin during weeks 13 to 21.
