Abstract | BACKGROUND: METHODS: The authors conducted a review of the available data comparing the PK and pharmacodynamic effects of PEG Intron and IFN-alpha-2b. Safety and efficacy data from Phase I/II studies of PEG Intron in patients with chronic myelogenous leukemia (CML) and solid tumors were also reviewed. RESULTS: Data from patients with chronic hepatitis C infection suggest that exposure to IFN at a PEG Intron dose of 0.25 microg/kg per week is similar to that observed after administration of IFN-alpha-2b at a dose of 3 million International Units, three times per week. PEG Intron at doses up to 6 microg/kg per week was well tolerated and demonstrated clinical activity in patients with CML and solid tumors, including metastatic melanoma and renal cell carcinoma. CONCLUSIONS: Dose intensification can be achieved safely in patients with CML and solid tumors using PEG Intron, which could improve efficacy. These results provide useful dosing guidelines to clinicians investigating the antitumor activity of PEG Intron in patients with malignancies. More data are needed to determine the optimal dose in various oncologic indications. However, these results provide a sound rationale for further investigation of PEG Intron.
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Authors | Ronald M Bukowski, Craig Tendler, David Cutler, Esther Rose, Mark M Laughlin, Paul Statkevich |
Journal | Cancer
(Cancer)
Vol. 95
Issue 2
Pg. 389-96
(Jul 15 2002)
ISSN: 0008-543X [Print] United States |
PMID | 12124839
(Publication Type: Journal Article, Review)
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Copyright | Copyright 2002 American Cancer Society.DOI 10.1002/cncr.10663 |
Chemical References |
- Antineoplastic Agents
- Interferon alpha-2
- Interferon-alpha
- Recombinant Proteins
- Polyethylene Glycols
- peginterferon alfa-2b
- peginterferon alfa-2a
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Topics |
- Antineoplastic Agents
(administration & dosage, pharmacokinetics, pharmacology)
- Dose-Response Relationship, Drug
- Drug Administration Schedule
- Humans
- Interferon alpha-2
- Interferon-alpha
(administration & dosage, pharmacokinetics, pharmacology)
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
(drug therapy)
- Polyethylene Glycols
- Recombinant Proteins
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