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Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane

BACKGROUND: Anaesthesia may impact long-term cancer survival. In the Cancer and Anaesthesia study, we hypothesised that the hypnotic drug propofol will have an advantage of at least five percentage points in five-year survival over the inhalational anaesthetic sevoflurane for breast cancer surgery....

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Autores principales: Enlund, Mats, Berglund, Anders, Enlund, Anna, Lundberg, Johan, Wärnberg, Fredrik, Wang, Dong-Xin, Ekman, Andreas, Ahlstrand, Rebecca, Flisberg, Per, Hedlund, Lars, Östlund, Ingrid, Bergkvist, Leif
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276257/
https://www.ncbi.nlm.nih.gov/pubmed/37333664
http://dx.doi.org/10.1016/j.eclinm.2023.102037
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author Enlund, Mats
Berglund, Anders
Enlund, Anna
Lundberg, Johan
Wärnberg, Fredrik
Wang, Dong-Xin
Ekman, Andreas
Ahlstrand, Rebecca
Flisberg, Per
Hedlund, Lars
Östlund, Ingrid
Bergkvist, Leif
author_facet Enlund, Mats
Berglund, Anders
Enlund, Anna
Lundberg, Johan
Wärnberg, Fredrik
Wang, Dong-Xin
Ekman, Andreas
Ahlstrand, Rebecca
Flisberg, Per
Hedlund, Lars
Östlund, Ingrid
Bergkvist, Leif
author_sort Enlund, Mats
collection PubMed
description BACKGROUND: Anaesthesia may impact long-term cancer survival. In the Cancer and Anaesthesia study, we hypothesised that the hypnotic drug propofol will have an advantage of at least five percentage points in five-year survival over the inhalational anaesthetic sevoflurane for breast cancer surgery. METHODS: From 2118 eligible breast cancer patients scheduled for primary curable, invasive breast cancer surgery, 1764 were recruited after ethical approval and individual informed consent to this open label, single-blind, randomised trial at four county- and three university hospitals in Sweden and one Chinese university hospital. Of surveyed patients, 354 were excluded, mainly due to refusal to participate. Patients were randomised by computer at the monitoring organisation to general anaesthesia maintenance with either intravenous propofol or inhaled sevoflurane in a 1:1 ratio in permuted blocks. Data related to anaesthesia, surgery, oncology, and demographics were registered. The primary endpoint was five-year overall survival. Data are presented as Kaplan-Meier survival curves and Hazard Ratios based on Cox univariable regression analyses by both intention-to-treat and per-protocol. EudraCT, 2013-002380-25 and ClinicalTrials.gov, NCT01975064. FINDINGS: Of 1764 patients, included from December 3, 2013, to September 29, 2017, 1670 remained for analysis. The numbers who survived at least five years were 773/841 (91.9% (95% CI 90.1–93.8)) in the propofol group and 764/829 (92.2% (90.3–94.0)) in the sevoflurane group, (HR 1.03 (0.73–1.44); P = 0.875); the corresponding results in the per-protocol-analysis were: 733/798 (91.9% (90.0–93.8)) and 653/710 (92.0% (90.0–94.0)) (HR = 1.01 (0.71–1.44); P = 0.955). Survival after a median follow-up of 76.7 months did not indicate any difference between the groups (HR 0.97, 0.72–1.29; P = 0.829, log rank test). INTERPRETATION: No difference in overall survival was found between general anaesthesia with propofol or sevoflurane for breast cancer surgery. FUNDING: 10.13039/501100004359Swedish Research Council; 10.13039/100019032Uppsala-Örebro Regional Research Council; Västmanland Regional Research Fund; Västmanland Cancer Foundation; Stig and Ragna Gohrton Foundation; Birgit and Henry Knutsson Foundation.
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spelling pubmed-102762572023-06-18 Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane Enlund, Mats Berglund, Anders Enlund, Anna Lundberg, Johan Wärnberg, Fredrik Wang, Dong-Xin Ekman, Andreas Ahlstrand, Rebecca Flisberg, Per Hedlund, Lars Östlund, Ingrid Bergkvist, Leif eClinicalMedicine Articles BACKGROUND: Anaesthesia may impact long-term cancer survival. In the Cancer and Anaesthesia study, we hypothesised that the hypnotic drug propofol will have an advantage of at least five percentage points in five-year survival over the inhalational anaesthetic sevoflurane for breast cancer surgery. METHODS: From 2118 eligible breast cancer patients scheduled for primary curable, invasive breast cancer surgery, 1764 were recruited after ethical approval and individual informed consent to this open label, single-blind, randomised trial at four county- and three university hospitals in Sweden and one Chinese university hospital. Of surveyed patients, 354 were excluded, mainly due to refusal to participate. Patients were randomised by computer at the monitoring organisation to general anaesthesia maintenance with either intravenous propofol or inhaled sevoflurane in a 1:1 ratio in permuted blocks. Data related to anaesthesia, surgery, oncology, and demographics were registered. The primary endpoint was five-year overall survival. Data are presented as Kaplan-Meier survival curves and Hazard Ratios based on Cox univariable regression analyses by both intention-to-treat and per-protocol. EudraCT, 2013-002380-25 and ClinicalTrials.gov, NCT01975064. FINDINGS: Of 1764 patients, included from December 3, 2013, to September 29, 2017, 1670 remained for analysis. The numbers who survived at least five years were 773/841 (91.9% (95% CI 90.1–93.8)) in the propofol group and 764/829 (92.2% (90.3–94.0)) in the sevoflurane group, (HR 1.03 (0.73–1.44); P = 0.875); the corresponding results in the per-protocol-analysis were: 733/798 (91.9% (90.0–93.8)) and 653/710 (92.0% (90.0–94.0)) (HR = 1.01 (0.71–1.44); P = 0.955). Survival after a median follow-up of 76.7 months did not indicate any difference between the groups (HR 0.97, 0.72–1.29; P = 0.829, log rank test). INTERPRETATION: No difference in overall survival was found between general anaesthesia with propofol or sevoflurane for breast cancer surgery. FUNDING: 10.13039/501100004359Swedish Research Council; 10.13039/100019032Uppsala-Örebro Regional Research Council; Västmanland Regional Research Fund; Västmanland Cancer Foundation; Stig and Ragna Gohrton Foundation; Birgit and Henry Knutsson Foundation. Elsevier 2023-06-09 /pmc/articles/PMC10276257/ /pubmed/37333664 http://dx.doi.org/10.1016/j.eclinm.2023.102037 Text en © 2023 The Author(s) https://creativecommons.org/licenses/by/4.0/This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Articles
Enlund, Mats
Berglund, Anders
Enlund, Anna
Lundberg, Johan
Wärnberg, Fredrik
Wang, Dong-Xin
Ekman, Andreas
Ahlstrand, Rebecca
Flisberg, Per
Hedlund, Lars
Östlund, Ingrid
Bergkvist, Leif
Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title_full Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title_fullStr Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title_full_unstemmed Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title_short Impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the CAN-study, comparing propofol and sevoflurane
title_sort impact of general anaesthesia on breast cancer survival: a 5-year follow up of a pragmatic, randomised, controlled trial, the can-study, comparing propofol and sevoflurane
topic Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10276257/
https://www.ncbi.nlm.nih.gov/pubmed/37333664
http://dx.doi.org/10.1016/j.eclinm.2023.102037
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