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Title
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Caelyx™ in malignant mesothelioma : a phase II EORTC study
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Author
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Abstract
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| Background: The use of doxorubicin has shown some activity in malignant mesothelioma but prolonged administration is hampered by cardiotoxicity. Caelyx(TM), a new liposomal and pegylated form of doxorubicin has shown a better pharmacokinetic and toxic profile then doxorubicin. In a phase II study, the efficacy and toxicity of Caelyx(TM) was tested in previously untreated patients with malignant pleural mesothelioma. Patients and methods: Thirty-three patients who had measurable or evaluable histologically confirmed malignant pleural mesothelioma were included in the study. Caelyx(TM) (45 mg/m(2)) was given i.v. on outpatient base every four weeks for nine cycles or till progression or unacceptable toxicity occurred. Results: Of the 33 patients, 32 were evaluable for toxicity and 31 for response. Two patients had a partial response (6%, 95% confidence interval: 0.2%-20.2%). The median survival was 13 months. Forty percent of the patients received > 6 cycles. Toxicity was mild with palmar plantar erythrodysesthesia being most pronounced (62% grade 1-2, 6% grade 3) and of limited duration. Ten percent of patients had grade 3 anemia and 3% grade 3 thrombocytopenia. Two patients (6%) had grade 3 or 4 cardiac toxicity, which was not drug related. Conclusion: At the prescribed dose, single agent Caelyx(TM) is well tolerated but its activity in chemotherapy-naive mesothelioma patients does not warrant further investigation as a single agent. |
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Language
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English
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Source (journal)
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Annals of oncology / European Society for Medical Oncology. - Amsterdam
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Publication
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Amsterdam
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2000
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ISSN
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0923-7534
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DOI
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10.1023/A:1008346925273
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Volume/pages
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11
:6
(2000)
, p. 697-700
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ISI
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000088219600015
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Full text (Publisher's DOI)
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Full text (publisher's version - intranet only)
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