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A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens
The objective of this study was to determine the objective response rate in patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer to treatment with trabectedin (Yondelis®) administered as a 3-h infusion weekly for 3 weeks of a 4-week cycle. We carried out a multicentre Pha...
Autores principales: | , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2007
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360276/ https://www.ncbi.nlm.nih.gov/pubmed/18000504 http://dx.doi.org/10.1038/sj.bjc.6604088 |
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author | Krasner, C N McMeekin, D S Chan, S Braly, P S Renshaw, F G Kaye, S Provencher, D M Campos, S Gore, M E |
author_facet | Krasner, C N McMeekin, D S Chan, S Braly, P S Renshaw, F G Kaye, S Provencher, D M Campos, S Gore, M E |
author_sort | Krasner, C N |
collection | PubMed |
description | The objective of this study was to determine the objective response rate in patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer to treatment with trabectedin (Yondelis®) administered as a 3-h infusion weekly for 3 weeks of a 4-week cycle. We carried out a multicentre Phase II trial of trabectedin in patients with advanced recurrent ovarian cancer. Trabectedin (0.58 mg m(−2)) was administered via a central line, after premedication with dexamethasone, to 147 patients as a 3-h infusion weekly for 3 weeks followed by 1-week rest. Major eligibility criteria included measurable relapsed advanced ovarian cancer and not more than two prior platinum-containing regimens. Patients were stratified according to the treatment-free interval (TFI) between having either platinum-sensitive (⩾6 months TFI) or platinum-resistant disease (<6 months TFI)/platinum-refractory disease (progression during first line therapy). In the platinum-sensitive cohort, 62 evaluable patients with measurable disease had an overall response rate (ORR) of 29.0% (95% CI: 18.2–41.9%) and median progression-free survival (PFS) was 5.1 months (95% CI: 2.8–6.2). Four patients with measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) criteria had no follow-up scans at the end of treatment. In the platinum-resistant/refractory cohort, 79 patients were evaluable with an ORR of 6.3% (95% CI: 2.1–14.2%). Median PFS was 2.0 months (95% CI: 1.7–3.5 months). Two patients with measurable disease per RECIST criteria had no follow-up scans at the end of treatment. The most frequent (⩾2% of patients) drug-related treatment-emergent grade 3/4 adverse events were reversible liver alanine transferase elevation (10%), neutropaenia (8%), nausea, vomiting, and fatigue (5% each). Trabectedin is an active treatment, with documented responses in patients with platinum sensitive advanced relapsed ovarian cancer, and has a manageable toxicity profile. |
format | Text |
id | pubmed-2360276 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2007 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-23602762009-09-10 A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens Krasner, C N McMeekin, D S Chan, S Braly, P S Renshaw, F G Kaye, S Provencher, D M Campos, S Gore, M E Br J Cancer Clinical Study The objective of this study was to determine the objective response rate in patients with platinum-sensitive and platinum-resistant recurrent ovarian cancer to treatment with trabectedin (Yondelis®) administered as a 3-h infusion weekly for 3 weeks of a 4-week cycle. We carried out a multicentre Phase II trial of trabectedin in patients with advanced recurrent ovarian cancer. Trabectedin (0.58 mg m(−2)) was administered via a central line, after premedication with dexamethasone, to 147 patients as a 3-h infusion weekly for 3 weeks followed by 1-week rest. Major eligibility criteria included measurable relapsed advanced ovarian cancer and not more than two prior platinum-containing regimens. Patients were stratified according to the treatment-free interval (TFI) between having either platinum-sensitive (⩾6 months TFI) or platinum-resistant disease (<6 months TFI)/platinum-refractory disease (progression during first line therapy). In the platinum-sensitive cohort, 62 evaluable patients with measurable disease had an overall response rate (ORR) of 29.0% (95% CI: 18.2–41.9%) and median progression-free survival (PFS) was 5.1 months (95% CI: 2.8–6.2). Four patients with measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) criteria had no follow-up scans at the end of treatment. In the platinum-resistant/refractory cohort, 79 patients were evaluable with an ORR of 6.3% (95% CI: 2.1–14.2%). Median PFS was 2.0 months (95% CI: 1.7–3.5 months). Two patients with measurable disease per RECIST criteria had no follow-up scans at the end of treatment. The most frequent (⩾2% of patients) drug-related treatment-emergent grade 3/4 adverse events were reversible liver alanine transferase elevation (10%), neutropaenia (8%), nausea, vomiting, and fatigue (5% each). Trabectedin is an active treatment, with documented responses in patients with platinum sensitive advanced relapsed ovarian cancer, and has a manageable toxicity profile. Nature Publishing Group 2007-12-17 2007-11-13 /pmc/articles/PMC2360276/ /pubmed/18000504 http://dx.doi.org/10.1038/sj.bjc.6604088 Text en Copyright © 2007 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 Study Krasner, C N McMeekin, D S Chan, S Braly, P S Renshaw, F G Kaye, S Provencher, D M Campos, S Gore, M E A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title | A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title_full | A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title_fullStr | A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title_full_unstemmed | A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title_short | A Phase II study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
title_sort | phase ii study of trabectedin single agent in patients with recurrent ovarian cancer previously treated with platinum-based regimens |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360276/ https://www.ncbi.nlm.nih.gov/pubmed/18000504 http://dx.doi.org/10.1038/sj.bjc.6604088 |
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