Cargando…
A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis
To test the feasibility and efficacy of epirubicin and ifosfamide added to first-line chemotherapy with cisplatin and paclitaxel in a phase II randomised clinical trial. Patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with c...
Autores principales: | , , , , , , , |
---|---|
Formato: | Texto |
Lenguaje: | English |
Publicado: |
Nature Publishing Group
2008
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2259172/ https://www.ncbi.nlm.nih.gov/pubmed/18253120 http://dx.doi.org/10.1038/sj.bjc.6604231 |
_version_ | 1782151357874044928 |
---|---|
author | Fruscio, R Colombo, N Lissoni, A A Garbi, A Fossati, R Ieda', N Torri, V Mangioni, C |
author_facet | Fruscio, R Colombo, N Lissoni, A A Garbi, A Fossati, R Ieda', N Torri, V Mangioni, C |
author_sort | Fruscio, R |
collection | PubMed |
description | To test the feasibility and efficacy of epirubicin and ifosfamide added to first-line chemotherapy with cisplatin and paclitaxel in a phase II randomised clinical trial. Patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with cisplatin/paclitaxel/epirubicin (CEP) or cisplatin/paclitaxel/ifosfamide (CIP) for six cycles every 21 days. Two hundred and eight patients were randomised between the two treatment arms and the median number of cycles per patient was six. Toxicity was predominantly haematological with both regimens; however, anaemia, leucopaenia, neutropaenic fever and use of granulocyte colony-stimulating factors and transfusion were significantly more frequent in the CIP treatment arm. Response rates were 85% (95% confidence interval (CI) 77–93%) in the CIP arm and 90% (95% CI 84–96%) in the CEP arm; complete response rates were 48 and 52%. After a median follow-up of 82 months, median overall survival (OS) was 51 and 65 months; 5-year survival rates were respectively 43 and 50%. In this clinical trial, both regimens showed good efficacy, but toxicity was heavier with the CIP regimen. Considering that more than 50% of patients were suboptimally debulked after the first surgery, OS seems to be longer than is commonly reported. This unexpected finding might be a consequence of the close surgical surveillance and aggressive chemotherapeutic approach. |
format | Text |
id | pubmed-2259172 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2008 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-22591722009-09-10 A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis Fruscio, R Colombo, N Lissoni, A A Garbi, A Fossati, R Ieda', N Torri, V Mangioni, C Br J Cancer Clinical Study To test the feasibility and efficacy of epirubicin and ifosfamide added to first-line chemotherapy with cisplatin and paclitaxel in a phase II randomised clinical trial. Patients with histologically proven epithelial ovarian cancer were randomly assigned to receive first-line polychemotherapy with cisplatin/paclitaxel/epirubicin (CEP) or cisplatin/paclitaxel/ifosfamide (CIP) for six cycles every 21 days. Two hundred and eight patients were randomised between the two treatment arms and the median number of cycles per patient was six. Toxicity was predominantly haematological with both regimens; however, anaemia, leucopaenia, neutropaenic fever and use of granulocyte colony-stimulating factors and transfusion were significantly more frequent in the CIP treatment arm. Response rates were 85% (95% confidence interval (CI) 77–93%) in the CIP arm and 90% (95% CI 84–96%) in the CEP arm; complete response rates were 48 and 52%. After a median follow-up of 82 months, median overall survival (OS) was 51 and 65 months; 5-year survival rates were respectively 43 and 50%. In this clinical trial, both regimens showed good efficacy, but toxicity was heavier with the CIP regimen. Considering that more than 50% of patients were suboptimally debulked after the first surgery, OS seems to be longer than is commonly reported. This unexpected finding might be a consequence of the close surgical surveillance and aggressive chemotherapeutic approach. Nature Publishing Group 2008-02-26 2008-02-05 /pmc/articles/PMC2259172/ /pubmed/18253120 http://dx.doi.org/10.1038/sj.bjc.6604231 Text en Copyright © 2008 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 Fruscio, R Colombo, N Lissoni, A A Garbi, A Fossati, R Ieda', N Torri, V Mangioni, C A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title | A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title_full | A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title_fullStr | A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title_full_unstemmed | A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title_short | A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
title_sort | phase ii randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2259172/ https://www.ncbi.nlm.nih.gov/pubmed/18253120 http://dx.doi.org/10.1038/sj.bjc.6604231 |
work_keys_str_mv | AT fruscior aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT colombon aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT lissoniaa aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT garbia aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT fossatir aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT iedan aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT torriv aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT mangionic aphaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT fruscior phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT colombon phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT lissoniaa phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT garbia phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT fossatir phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT iedan phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT torriv phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis AT mangionic phaseiirandomisedclinicaltrialcomparingcisplatinpaclitaxelandifosfamidewithcisplatinpaclitaxelandepirubicininnewlydiagnosedadvancedepithelialovariancancerlongtermsurvivalanalysis |