When AML Blast Cells Appear...
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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.
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Survival Data Demonstrate:
THE SIGNIFICANT ADVANTAGE IN AML
Two randomized studies demonstrate a significantly greater survival duration for patients treated with IDAMYCIN®/Ara-C.
Unlike the previous two studies, this study included four maintenance treatments. The data above suggest that intensive maintenance with IDAMYCIN® could have an adverse effect on survival; it is possible that the difference in survival would have been greater had these patients not received maintenance. Incidence of deaths in CR during maintenance phase was considerably higher on the IDAMYCIN® arm than on the duanorubicin arm.
SURVIVAL DATA IN MAJOR RISK CATEGORIES SHOW:
| Table 1. - Survival According to Age and Initial White Blood Cell (WBC) Counts**
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COMPLETE REMISSION DATA SHOW:
THE SIGNIFICANT ADVANTAGE IN AML
Significantly Higher Complete Remission
All three U.S. randomized trials showed higher complete remission rates on the IDAMYCIN® arm. The difference was statistically significant in two of the trials.
More CRs Were Achieved With IDAMYCIN® After Only One Course
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Table 2.- Complete Remission Rates
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CRs in Major Risk Categories Show:
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Table 3. - Survival According to Age and Initial White Blood Cell (WBC) Counts*
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*WBC counts were not obtained at baseline for all patients. Both arms were closed in combination with Ara-C. Value determined by upper quartile of patient values.
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FEWER PATIENTS WITH RESISTANT DISEASE:
THE FIRST SIGNIFICANT ADVANTAGE IN AML
Resistant disease due to peristent blasts was the reason for failure in some patients, within each study. There were significantly fewer cases of resistant disease following therapy with IDAMYCIN® in all three studies.
Table 4. - Patients With Resistant Disease During Induction |
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PATIENTS WITH PERSISTENT BLASTS |
STUDY |
IDA |
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DNR |
MSKCC |
12.3%
(8/65) |
P< 0.5 |
30.8%
(20/65) |
U.S. MULTCENTER TRIAL |
5.9%
(6/101) |
P< 0.5 |
19.5%
(22/113) |
SEG |
9.9%
(11/111) |
P< 0.5 |
19.3%
(23/119) |
SUPERIOR THERAPEUTIC PROFILE DURING INDUCTION:
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Table 5. - Major Adverse Experiences During Induction** (N=570***)
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IDA |
DNR |
Bleeding |
64% |
62% |
Infection |
92% |
95% |
Diarrhea |
62% |
60% |
Mucositis |
58% |
55% |
Alopecia |
70% |
70% |
Nausea/Vomiting |
85% |
85% |
*Of the 570 randomized 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. ***Rare but serious adverse reactions may occur with antileukemic therapy. Please refer to full prescribing information.
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Myelosuppression/Aplasia
The median duration of myelosuppression (defined by WBC < 1000/µL) based on WBC amd platelets following induction indicates comparable duration of aplasia between IDAMYCIN/Ara-C and duanorubicin/Ara-C.
FOREIGN STUDIES (NON-IND)
The Italian cooperative study by GIMEMA group was the first randomized clinical trial in the world comparing IDAMYCIN®/Ara-C to daunorubicin/Ara-C. This study involved only patients >= 55 years of age.
GIMMEMA:
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Table 6.- Complete Remission Rates
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Table 7. - Patients With Peristant Disease During Induction
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Patients with Persisent Blasts
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IDA
13.7%
(17/124)
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P< 0.05
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>DNR
31.2%
(39/125)
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Patients on the Idamycin arm had significantly fewer cases of resistant disease than those receiving duanorubicin.
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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 some of these institutions.
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