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An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer

The antiangiogenic effects of thalidomide have been assessed in clinical trials in patients with various solid and haematological malignancies. Thalidomide blocks the activity of angiogenic agents including bFGF, VEGF and IL-6. We undertook an open-label study using thalidomide 100 mg once daily for...

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Autores principales: Drake, M J, Robson, W, Mehta, P, Schofield, I, Neal, D E, Leung, H Y
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2003
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2377091/
https://www.ncbi.nlm.nih.gov/pubmed/12644816
http://dx.doi.org/10.1038/sj.bjc.6600817
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author Drake, M J
Robson, W
Mehta, P
Schofield, I
Neal, D E
Leung, H Y
author_facet Drake, M J
Robson, W
Mehta, P
Schofield, I
Neal, D E
Leung, H Y
author_sort Drake, M J
collection PubMed
description The antiangiogenic effects of thalidomide have been assessed in clinical trials in patients with various solid and haematological malignancies. Thalidomide blocks the activity of angiogenic agents including bFGF, VEGF and IL-6. We undertook an open-label study using thalidomide 100 mg once daily for up to 6 months in 20 men with androgen-independent prostate cancer. The mean time of study was 109 days (median 107, range 4–184 days). Patients underwent regular measurement of prostate-specific antigen (PSA), urea and electrolytes, serum bFGF and VEGF. Three men (15%) showed a decline in serum PSA of at least 50%, sustained throughout treatment. Of 16 men treated for at least 2 months, six (37.5%) showed a fall in absolute PSA by a median of 48%. Increasing levels of serum bFGF and VEGF were associated with progressive disease; five of six men who demonstrated a fall in PSA also showed a decline in bFGF and VEGF levels, and three of four men with a rising PSA showed an increase in both growth factors. Adverse effects included constipation, morning drowsiness, dizziness and rash, and resulted in withdrawal from the study by three men. Evidence of peripheral sensory neuropathy was found in nine of 13 men before treatment. In the seven men who completed six months on thalidomide, subclinical evidence of peripheral neuropathy was found in four before treatment, but in all seven at repeat testing. The findings indicate that thalidomide may be an option for patients who have failed other forms of therapy, provided close follow-up is maintained for development of peripheral neuropathy.
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spelling pubmed-23770912009-09-10 An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer Drake, M J Robson, W Mehta, P Schofield, I Neal, D E Leung, H Y Br J Cancer Clinical The antiangiogenic effects of thalidomide have been assessed in clinical trials in patients with various solid and haematological malignancies. Thalidomide blocks the activity of angiogenic agents including bFGF, VEGF and IL-6. We undertook an open-label study using thalidomide 100 mg once daily for up to 6 months in 20 men with androgen-independent prostate cancer. The mean time of study was 109 days (median 107, range 4–184 days). Patients underwent regular measurement of prostate-specific antigen (PSA), urea and electrolytes, serum bFGF and VEGF. Three men (15%) showed a decline in serum PSA of at least 50%, sustained throughout treatment. Of 16 men treated for at least 2 months, six (37.5%) showed a fall in absolute PSA by a median of 48%. Increasing levels of serum bFGF and VEGF were associated with progressive disease; five of six men who demonstrated a fall in PSA also showed a decline in bFGF and VEGF levels, and three of four men with a rising PSA showed an increase in both growth factors. Adverse effects included constipation, morning drowsiness, dizziness and rash, and resulted in withdrawal from the study by three men. Evidence of peripheral sensory neuropathy was found in nine of 13 men before treatment. In the seven men who completed six months on thalidomide, subclinical evidence of peripheral neuropathy was found in four before treatment, but in all seven at repeat testing. The findings indicate that thalidomide may be an option for patients who have failed other forms of therapy, provided close follow-up is maintained for development of peripheral neuropathy. Nature Publishing Group 2003-03-24 2003-03-18 /pmc/articles/PMC2377091/ /pubmed/12644816 http://dx.doi.org/10.1038/sj.bjc.6600817 Text en Copyright © 2003 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Clinical
Drake, M J
Robson, W
Mehta, P
Schofield, I
Neal, D E
Leung, H Y
An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title_full An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title_fullStr An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title_full_unstemmed An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title_short An open-label phase II study of low-dose thalidomide in androgen-independent prostate cancer
title_sort open-label phase ii study of low-dose thalidomide in androgen-independent prostate cancer
topic Clinical
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2377091/
https://www.ncbi.nlm.nih.gov/pubmed/12644816
http://dx.doi.org/10.1038/sj.bjc.6600817
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