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A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis
BACKGROUND: Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed o...
Autores principales: | , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer-Verlag
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397225/ https://www.ncbi.nlm.nih.gov/pubmed/22526159 http://dx.doi.org/10.1007/s00432-012-1221-3 |
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author | Mahner, Sven Oskay-Özcelik, Gülten Heidrich-Lorsbach, Elke Fuxius, Stefan Sommer, Harald Klare, Peter Belau, Antje Ruhmland, Birgit Heuser, Thomas Kölbl, Heinz Markmann, Susanne Sehouli, Jalid |
author_facet | Mahner, Sven Oskay-Özcelik, Gülten Heidrich-Lorsbach, Elke Fuxius, Stefan Sommer, Harald Klare, Peter Belau, Antje Ruhmland, Birgit Heuser, Thomas Kölbl, Heinz Markmann, Susanne Sehouli, Jalid |
author_sort | Mahner, Sven |
collection | PubMed |
description | BACKGROUND: Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens. METHODS: Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1–28 of a 56-day cycle) for a maximum of 12 cycles (i.v.) or 12 months (p.o.). Indecisive patients were randomized. Toxicity was evaluated according to the NCI-CTC version 2.0. RESULTS: Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70–82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1–12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %). CONCLUSION: Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued. |
format | Online Article Text |
id | pubmed-3397225 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Springer-Verlag |
record_format | MEDLINE/PubMed |
spelling | pubmed-33972252012-07-23 A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis Mahner, Sven Oskay-Özcelik, Gülten Heidrich-Lorsbach, Elke Fuxius, Stefan Sommer, Harald Klare, Peter Belau, Antje Ruhmland, Birgit Heuser, Thomas Kölbl, Heinz Markmann, Susanne Sehouli, Jalid J Cancer Res Clin Oncol Original Paper BACKGROUND: Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens. METHODS: Patients had a free choice of treosulfan i.v. (7,000 mg/m(2) day 1 of a 28-day cycle) or p.o. (600 mg/m(2) day 1–28 of a 56-day cycle) for a maximum of 12 cycles (i.v.) or 12 months (p.o.). Indecisive patients were randomized. Toxicity was evaluated according to the NCI-CTC version 2.0. RESULTS: Twenty-five of 51 recruited patients completed therapy at the time of the planned interim analysis (median age, 75 years; range, 70–82). Median ECOG was 1, and median number of prior chemotherapy regimens was 2. A median number of 4 cycles (range, 1–12) were administered per patient. Anemia was the most common hematological toxicity (88 % of patients). Most frequent non-hematological toxicities were nausea (76 %), constipation (68 %), and fatigue (64 %). CONCLUSION: Treatment was generally well tolerated despite the fact that most patients suffered from multiple comorbidities and were heavily pretreated. There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, the next step of study recruitment was continued. Springer-Verlag 2012-04-15 2012 /pmc/articles/PMC3397225/ /pubmed/22526159 http://dx.doi.org/10.1007/s00432-012-1221-3 Text en © The Author(s) 2012 https://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited. |
spellingShingle | Original Paper Mahner, Sven Oskay-Özcelik, Gülten Heidrich-Lorsbach, Elke Fuxius, Stefan Sommer, Harald Klare, Peter Belau, Antje Ruhmland, Birgit Heuser, Thomas Kölbl, Heinz Markmann, Susanne Sehouli, Jalid A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title | A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title_full | A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title_fullStr | A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title_full_unstemmed | A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title_short | A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
title_sort | prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis |
topic | Original Paper |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3397225/ https://www.ncbi.nlm.nih.gov/pubmed/22526159 http://dx.doi.org/10.1007/s00432-012-1221-3 |
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