There's a Universal Need in the Treatment of AML...
|
|
|
Fluorescent micrographs (x400) of human acute leukemia cells demonstrating intracellular acculumlation of IDAMYCIN®. (left) cells are shown following a brief period of drug exposure. (right) cells are shown following a longer duration of IDAMYCIN® exposure.
|
|
Survival Data Demonstrate:
SIGNIFICANTLY MORE SURVIVAL TIME
IDAMYCIN® provides a survival advantage over daunorubicin.
Three controlled, randomized U.S. trials compared the efficacy and safety of IRD/Ara-C to DNR/Ara-C in 574 newly diagnosed acute myeloid leukemia (AML) patients. Two studies demonstrate a statistically significant greater survival duration for patients treated wtih IDA/Ara-C
Survival Data:
MSKCC*: Significantly longer survival with IDAMYCIN®**
IDA (n=65) DNR (n=65) MEDIAN SURVIAL: IDA/Ara-C 16.7 MO DNR/Ara-C 14.3 MO P<0.05
PROBABILITY OF SURVIVAL AT 18 MO
U.S. MULTICENTER TRIAL*: Significantly longer survival with IDAMYCIN®
IDA (n=101) DNR (n=113) MEDIAN SURVIAL: IDA/Ara-C 12.9 MO DNR/Ara-C 9.2 MO P<0.05
PROBABILITY OF SURVIVAL AT 18 MO
SEG*: Survival with IDAMYCIN®
IDA (n=111) DNR (n=119) MEDIAN SURVIAL: IDA/Ara-C 10.8 MO DNR/Ara-C 9.1 MO P<0.38
PROBABILITY OF SURVIVAL AT 18 MO
*Among all randomized patients. MSKCC: Memorial Sloan-Kettering Cancer Center. U.S. Multcenter
Trial, consisting of 32 participating institutions. SEG: Southeast Cancer Study Group, consisting of 16 participating
institutions.
COMPLETE REMISSION RATES PROVIDE:
SIGNIFICANTLY MORE SURVIVAL TIME
Significantly higher complete remission rates in two of three U.S. Studies
IDAMYCIN® induces more CRs after the first induction course; duration of CRs are consistently longer.
**CR: normocellular or slightly hypocellular bone marrow, <= 5% blasts, WBC > 3,000µL, granulocyte count > 2,000µL, platelets > 100,000/µL. One study (MSKCC) required at least 4 weeks to be so classified. **Both arms wer closed in combinationwith Ara-C. ***All randomized patients entered were evaluated.
Study Data Demonstrate:
SUPERIOR THERAPEUTIC PROFILE DURING INDUCTION
IDAMYCIN® provides improved efficacy with an acceptable safety profile compared to duanorubicin during injection.* The type and incidence of various side effects seen with IDA/Ara-C are comparable to those observed with DNR/Ara-C.
|
Major Adverse Experiences During Induction** (N=570***)
|
|
IDA |
DNR |
Bleeding |
64% |
62% |
Infection |
92% |
95% |
Diarrhea |
62% |
60% |
Mucositis |
58% |
55% |
Alopecia |
70% |
70% |
Nausea/Vomiting |
85% |
85% |
Comparable Changes in LEVF*** |
Cumulative
Dose (mg/m≤) |
IDA |
0-74 |
75-150 |
> 150 |
DNR |
0-299 |
300-600 |
> 600 |
% of patients with
Severe Decrease in LVEF |
IDA |
0% (0/78) |
1.3% (1/79) |
0% (0/5) |
DNR |
3.5% (/3/85) |
1.2% (1/83) |
0% (0/1) |
In the foreign (non-IND) GIMEMA** study, involving patients >= 55 years of age, a 40% CR rate was achieved with IDA/Ara-C and a 39% CR rate with DNR/Ara-C. As in the U.S. trials, more patients achieved CRs after one course of IDAMYCIN© (74% v 51% P<0.05). Probability of survival at 18 months was 15% for IDA/Ara-C and 18% for DNR/Ara-C. The results of this study emphasize the importance of supportive care during induction. There was a higher incidence of induction deaths, which may have adversely affected the outcome of this trial. It can be speculated that these results were due to the lack of appropriate supportive care of these institutions.
*As with all anthracyclines, attention to supportive care is critical in terms of the outcome. Consolidation therapy may show extended aplasia and increased mucositis. **Rare but serious adverse reactions may occur with antileukemic therapy. Please refer to full prescribing information. ***Of the 574 entered/evaluable patients in the three U.S. studies, four were not treated for various reasons and therefore were not evaluated for toxicities. ****Differences in median severity are not statistically significant. Left ventricular ejection fraction, severe defined as < 0.03. GIMMA: Gruppo Italiano Malattie Ematologiche Maligne dell Adulto.
|
|
