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Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer
The purpose of this study was to determine the maximum-tolerated dose of gemcitabine plus mitoxantrone in women with metastatic breast cancer (MBC) and to evaluate activity and toxicity of this combination in a phase II trial. Sixty-three patients with MBC, previously treated with chemotherapy inclu...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2003
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2377160/ https://www.ncbi.nlm.nih.gov/pubmed/12592360 http://dx.doi.org/10.1038/sj.bjc.6600780 |
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author | Lorusso, V Crucitta, E Silvestris, N Catino, A Caporusso, L Mazzei, A Guida, M Latorre, A Sambiasi, D D'Amico, C Schittulli, F Calabrese, P De Lena, M |
author_facet | Lorusso, V Crucitta, E Silvestris, N Catino, A Caporusso, L Mazzei, A Guida, M Latorre, A Sambiasi, D D'Amico, C Schittulli, F Calabrese, P De Lena, M |
author_sort | Lorusso, V |
collection | PubMed |
description | The purpose of this study was to determine the maximum-tolerated dose of gemcitabine plus mitoxantrone in women with metastatic breast cancer (MBC) and to evaluate activity and toxicity of this combination in a phase II trial. Sixty-three patients with MBC, previously treated with chemotherapy including anthracycline and/or taxanes, were treated with mitoxantrone 10 or 12 mg m(−2) intravenously on day 1 plus gemcitabine in escalating doses from 600 to 1200 mg m(−2) intravenously on days 1 and 8, every 3 weeks. In phase I, on 23 patients entered on study, dose-limiting toxicity occurred at the dosage of 1200 mg m(−2) gemcitabine and 10 mg m(−2) mitoxantrone, with three out of five patients developing grade 4 neutropenia. In phase II, with gemcitabine administered at 1000 mg m(−2) and mitoxantrone at 10 mg m(−2), 12 (30%) out of 40 assessable patients responded, even if no complete response was obtained. Moreover, stable disease was observed in eight (20%) patients. The median time to treatment failure was 22 weeks (range, 2–33), and median survival was 42 weeks (range, 2–92). Grade 3 and 4 neutropenia were observed in 12 (30%) and one (2.5%) cases respectively; grade 3 thrombocytopenia was observed in two patients (5%), grade 2 mucositis in two patients (5%), grade 3 anaemia in two patients (5%), grade 3 alopecia in one patient (2.5%) and asymptomatic cardiotoxicity in three patients (8%), respectively. In conclusion, the doses of 10 mg m(−2) (day 1) for mitoxantrone and 1000 mg m(−2) for gemcitabine (days 1–8) every 3 weeks resulted active and safe in MBC. Further investigations in less heavily pretreated patients are warranted. |
format | Text |
id | pubmed-2377160 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2003 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-23771602009-09-10 Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer Lorusso, V Crucitta, E Silvestris, N Catino, A Caporusso, L Mazzei, A Guida, M Latorre, A Sambiasi, D D'Amico, C Schittulli, F Calabrese, P De Lena, M Br J Cancer Clinical The purpose of this study was to determine the maximum-tolerated dose of gemcitabine plus mitoxantrone in women with metastatic breast cancer (MBC) and to evaluate activity and toxicity of this combination in a phase II trial. Sixty-three patients with MBC, previously treated with chemotherapy including anthracycline and/or taxanes, were treated with mitoxantrone 10 or 12 mg m(−2) intravenously on day 1 plus gemcitabine in escalating doses from 600 to 1200 mg m(−2) intravenously on days 1 and 8, every 3 weeks. In phase I, on 23 patients entered on study, dose-limiting toxicity occurred at the dosage of 1200 mg m(−2) gemcitabine and 10 mg m(−2) mitoxantrone, with three out of five patients developing grade 4 neutropenia. In phase II, with gemcitabine administered at 1000 mg m(−2) and mitoxantrone at 10 mg m(−2), 12 (30%) out of 40 assessable patients responded, even if no complete response was obtained. Moreover, stable disease was observed in eight (20%) patients. The median time to treatment failure was 22 weeks (range, 2–33), and median survival was 42 weeks (range, 2–92). Grade 3 and 4 neutropenia were observed in 12 (30%) and one (2.5%) cases respectively; grade 3 thrombocytopenia was observed in two patients (5%), grade 2 mucositis in two patients (5%), grade 3 anaemia in two patients (5%), grade 3 alopecia in one patient (2.5%) and asymptomatic cardiotoxicity in three patients (8%), respectively. In conclusion, the doses of 10 mg m(−2) (day 1) for mitoxantrone and 1000 mg m(−2) for gemcitabine (days 1–8) every 3 weeks resulted active and safe in MBC. Further investigations in less heavily pretreated patients are warranted. Nature Publishing Group 2003-02-24 2003-02-18 /pmc/articles/PMC2377160/ /pubmed/12592360 http://dx.doi.org/10.1038/sj.bjc.6600780 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 Lorusso, V Crucitta, E Silvestris, N Catino, A Caporusso, L Mazzei, A Guida, M Latorre, A Sambiasi, D D'Amico, C Schittulli, F Calabrese, P De Lena, M Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title | Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title_full | Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title_fullStr | Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title_full_unstemmed | Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title_short | Phase I/II study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
title_sort | phase i/ii study of gemcitabine plus mitoxantrone as salvage chemotherapy in metastatic breast cancer |
topic | Clinical |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2377160/ https://www.ncbi.nlm.nih.gov/pubmed/12592360 http://dx.doi.org/10.1038/sj.bjc.6600780 |
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