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Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial

Few data are available regarding the influence of adjuvant capecitabine on long-term survival of patients with early breast cancer. METHODS: The Finland Capecitabine Trial (FinXX) is a randomized, open-label, multicenter trial that evaluates integration of capecitabine to an adjuvant chemotherapy re...

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Autores principales: Joensuu, Heikki, Kellokumpu-Lehtinen, Pirkko-Liisa, Huovinen, Riikka, Jukkola, Arja, Tanner, Minna, Ahlgren, Johan, Auvinen, Päivi, Lahdenperä, Outi, Villman, Kenneth, Nyandoto, Paul, Nilsson, Greger, Poikonen-Saksela, Paula, Kataja, Vesa, Bono, Petri, Junnila, Jouni, Lindman, Henrik
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8966968/
https://www.ncbi.nlm.nih.gov/pubmed/35020465
http://dx.doi.org/10.1200/JCO.21.02054
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author Joensuu, Heikki
Kellokumpu-Lehtinen, Pirkko-Liisa
Huovinen, Riikka
Jukkola, Arja
Tanner, Minna
Ahlgren, Johan
Auvinen, Päivi
Lahdenperä, Outi
Villman, Kenneth
Nyandoto, Paul
Nilsson, Greger
Poikonen-Saksela, Paula
Kataja, Vesa
Bono, Petri
Junnila, Jouni
Lindman, Henrik
author_facet Joensuu, Heikki
Kellokumpu-Lehtinen, Pirkko-Liisa
Huovinen, Riikka
Jukkola, Arja
Tanner, Minna
Ahlgren, Johan
Auvinen, Päivi
Lahdenperä, Outi
Villman, Kenneth
Nyandoto, Paul
Nilsson, Greger
Poikonen-Saksela, Paula
Kataja, Vesa
Bono, Petri
Junnila, Jouni
Lindman, Henrik
author_sort Joensuu, Heikki
collection PubMed
description Few data are available regarding the influence of adjuvant capecitabine on long-term survival of patients with early breast cancer. METHODS: The Finland Capecitabine Trial (FinXX) is a randomized, open-label, multicenter trial that evaluates integration of capecitabine to an adjuvant chemotherapy regimen containing a taxane and an anthracycline for the treatment of early breast cancer. Between January 27, 2004, and May 29, 2007, 1,500 patients with axillary node-positive or high-risk node-negative early breast cancer were accrued. The patients were randomly allocated to either TX-CEX, consisting of three cycles of docetaxel (T) plus capecitabine (X) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX, 753 patients), or to T-CEF, consisting of three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF, 747 patients). We performed a protocol-scheduled analysis of overall survival on the basis of approximately 15-year follow-up of the patients. RESULTS: The data collection was locked on December 31, 2020. By this date, the median follow-up time of the patients alive was 15.3 years (interquartile range, 14.5-16.1 years) in the TX-CEX group and 15.4 years (interquartile range, 14.8-16.0 years) in the T-CEF group. Patients assigned to TX-CEX survived longer than those assigned to T-CEF (hazard ratio 0.81; 95% CI, 0.66 to 0.99; P = .037). The 15-year survival rate was 77.6% in the TX-CEX group and 73.3% in the T-CEF group. In exploratory subgroup analyses, patients with estrogen receptor–negative cancer and those with triple-negative cancer treated with TX-CEX tended to live longer than those treated with T-CEF. CONCLUSION: Addition of capecitabine to a chemotherapy regimen that contained docetaxel, epirubicin, and cyclophosphamide prolonged the survival of patients with early breast cancer.
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spelling pubmed-89669682023-04-01 Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial Joensuu, Heikki Kellokumpu-Lehtinen, Pirkko-Liisa Huovinen, Riikka Jukkola, Arja Tanner, Minna Ahlgren, Johan Auvinen, Päivi Lahdenperä, Outi Villman, Kenneth Nyandoto, Paul Nilsson, Greger Poikonen-Saksela, Paula Kataja, Vesa Bono, Petri Junnila, Jouni Lindman, Henrik J Clin Oncol ORIGINAL REPORTS Few data are available regarding the influence of adjuvant capecitabine on long-term survival of patients with early breast cancer. METHODS: The Finland Capecitabine Trial (FinXX) is a randomized, open-label, multicenter trial that evaluates integration of capecitabine to an adjuvant chemotherapy regimen containing a taxane and an anthracycline for the treatment of early breast cancer. Between January 27, 2004, and May 29, 2007, 1,500 patients with axillary node-positive or high-risk node-negative early breast cancer were accrued. The patients were randomly allocated to either TX-CEX, consisting of three cycles of docetaxel (T) plus capecitabine (X) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX, 753 patients), or to T-CEF, consisting of three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF, 747 patients). We performed a protocol-scheduled analysis of overall survival on the basis of approximately 15-year follow-up of the patients. RESULTS: The data collection was locked on December 31, 2020. By this date, the median follow-up time of the patients alive was 15.3 years (interquartile range, 14.5-16.1 years) in the TX-CEX group and 15.4 years (interquartile range, 14.8-16.0 years) in the T-CEF group. Patients assigned to TX-CEX survived longer than those assigned to T-CEF (hazard ratio 0.81; 95% CI, 0.66 to 0.99; P = .037). The 15-year survival rate was 77.6% in the TX-CEX group and 73.3% in the T-CEF group. In exploratory subgroup analyses, patients with estrogen receptor–negative cancer and those with triple-negative cancer treated with TX-CEX tended to live longer than those treated with T-CEF. CONCLUSION: Addition of capecitabine to a chemotherapy regimen that contained docetaxel, epirubicin, and cyclophosphamide prolonged the survival of patients with early breast cancer. Wolters Kluwer Health 2022-04-01 2022-01-12 /pmc/articles/PMC8966968/ /pubmed/35020465 http://dx.doi.org/10.1200/JCO.21.02054 Text en © 2022 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle ORIGINAL REPORTS
Joensuu, Heikki
Kellokumpu-Lehtinen, Pirkko-Liisa
Huovinen, Riikka
Jukkola, Arja
Tanner, Minna
Ahlgren, Johan
Auvinen, Päivi
Lahdenperä, Outi
Villman, Kenneth
Nyandoto, Paul
Nilsson, Greger
Poikonen-Saksela, Paula
Kataja, Vesa
Bono, Petri
Junnila, Jouni
Lindman, Henrik
Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title_full Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title_fullStr Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title_full_unstemmed Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title_short Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial
title_sort adjuvant capecitabine for early breast cancer: 15-year overall survival results from a randomized trial
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8966968/
https://www.ncbi.nlm.nih.gov/pubmed/35020465
http://dx.doi.org/10.1200/JCO.21.02054
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