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Cosmegen

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Cosmegen

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Generally, the actinomycins exert an inhibitory effect on gram-positive and gram-negative bacteria and on some fungi. However, the toxic properties of the actinomycins (including dactinomycin) in relation to antibacterial activity are such as to preclude their use as antibiotics in the treatment of infectious diseases.

Because the actinomycins are cytotoxic, they have an antineoplastic effect which has been demonstrated in experimental animals with various types of tumor implants. This cytotoxic action is the basis for their use in the treatment of certain types of cancer. Dactinomycin is believed to produce its cytotoxic effects by binding DNA and inhibiting RNA synthesis.

Pharmacokinetics and Metabolism

Results of a study in patients with malignant melanoma indicate that dactinomycin (3H actinomycin D) is minimally metabolized, is concentrated in nucleated cells, and does not penetrate the blood-brain barrier. Approximately 30% of the dose was recovered in urine and feces in one week. The terminal plasma half-life for radioactivity was approximately 36 hours.

CLINICAL STUDIES

A wide variety of single agent and combination chemotherapy regimens with COSMEGEN have been studied. Because chemotherapeutic regimens are constantly changing, the decision to employ COSMEGEN should be directly supervised by physicians familiar with current oncologic practices and new advances in therapy.

Wilms' Tumor

The neoplasm responding most frequently to COSMEGEN is Wilms' tumor. Data from the National Wilms' Tumor Studies (NWTS-1, NWTS-2, NWTS-3 and NWTS-4) support the use of COSMEGEN in Wilms' tumor. The NWTS-3 evaluated results in 1,439 patients randomized to various regimens incorporating COSMEGEN (see table below).1

* Registered trademark of MERCK & CO., Inc. COPYRIGHT © MERCK & CO., Inc., 1983, 2000 All rights reserved

The Third National Wilms 'Tumor Study

Stage

Regimen

4-Year Relapse Free Survival (%)

4-Year Overall Survival (%)

I (favourable histology)

L

EE

89.0

91.8

95.6

97.4

II (favorable historlogy)

DD

DD2

K

K2

87.9

86.9

87.4

90.1

93.6

89.6

91.1

94.9

III (favorable histology)

DD1

DD2

K1

K2

82.0

85.9

71.4

76.8

90.9

86.7

85.2

85.1

Brand Name: Cosmegen
Generic Name: Dactinomycin

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