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A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer

Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy n...

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Autores principales: Stathopoulos, G P, Syrigos, K, Aravantinos, G, Polyzos, A, Papakotoulas, P, Fountzilas, G, Potamianou, A, Ziras, N, Boukovinas, J, Varthalitis, J, Androulakis, N, Kotsakis, A, Samonis, G, Georgoulias, V
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2006
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360678/
https://www.ncbi.nlm.nih.gov/pubmed/16909140
http://dx.doi.org/10.1038/sj.bjc.6603301
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author Stathopoulos, G P
Syrigos, K
Aravantinos, G
Polyzos, A
Papakotoulas, P
Fountzilas, G
Potamianou, A
Ziras, N
Boukovinas, J
Varthalitis, J
Androulakis, N
Kotsakis, A
Samonis, G
Georgoulias, V
author_facet Stathopoulos, G P
Syrigos, K
Aravantinos, G
Polyzos, A
Papakotoulas, P
Fountzilas, G
Potamianou, A
Ziras, N
Boukovinas, J
Varthalitis, J
Androulakis, N
Kotsakis, A
Samonis, G
Georgoulias, V
author_sort Stathopoulos, G P
collection PubMed
description Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m(−2) on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m(−2) on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96–24.04 and 95% CI 2.97–17.03, respectively; P=0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival.
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spelling pubmed-23606782009-09-10 A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer Stathopoulos, G P Syrigos, K Aravantinos, G Polyzos, A Papakotoulas, P Fountzilas, G Potamianou, A Ziras, N Boukovinas, J Varthalitis, J Androulakis, N Kotsakis, A Samonis, G Georgoulias, V Br J Cancer Clinical Study Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m(−2) on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m(−2) on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96–24.04 and 95% CI 2.97–17.03, respectively; P=0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival. Nature Publishing Group 2006-09-04 2006-08-08 /pmc/articles/PMC2360678/ /pubmed/16909140 http://dx.doi.org/10.1038/sj.bjc.6603301 Text en Copyright © 2006 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
Stathopoulos, G P
Syrigos, K
Aravantinos, G
Polyzos, A
Papakotoulas, P
Fountzilas, G
Potamianou, A
Ziras, N
Boukovinas, J
Varthalitis, J
Androulakis, N
Kotsakis, A
Samonis, G
Georgoulias, V
A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title_full A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title_fullStr A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title_full_unstemmed A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title_short A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
title_sort multicenter phase iii trial comparing irinotecan-gemcitabine (ig) with gemcitabine (g) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer
topic Clinical Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2360678/
https://www.ncbi.nlm.nih.gov/pubmed/16909140
http://dx.doi.org/10.1038/sj.bjc.6603301
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