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Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial

Summary Background Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-rec... Full description

Journal Title: Lancet (London England), 2015, Vol.387 (10021), p.866-873
Main Author: Forbes, John F, Prof
Other Authors: Sestak, Ivana, PhD , Howell, Anthony, Prof , Bonanni, Bernardo, MD , Bundred, Nigel, Prof , Levy, Christelle, MD , von Minckwitz, Gunter, Prof , Eiermann, Wolfgang, MD , Neven, Patrick, Prof , Stierer, Michael, Prof , Holcombe, Chris, MD , Coleman, Robert E, Prof , Jones, Louise, Prof , Ellis, Ian, Prof , Cuzick, Jack, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
Link: https://www.ncbi.nlm.nih.gov/pubmed/26686313
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title: Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial
format: Article
creator:
  • Forbes, John F, Prof
  • Sestak, Ivana, PhD
  • Howell, Anthony, Prof
  • Bonanni, Bernardo, MD
  • Bundred, Nigel, Prof
  • Levy, Christelle, MD
  • von Minckwitz, Gunter, Prof
  • Eiermann, Wolfgang, MD
  • Neven, Patrick, Prof
  • Stierer, Michael, Prof
  • Holcombe, Chris, MD
  • Coleman, Robert E, Prof
  • Jones, Louise, Prof
  • Ellis, Ian, Prof
  • Cuzick, Jack, Prof
subjects:
  • Abridged Index Medicus
  • Administration, Oral
  • anastrozole
  • Antineoplastic Agents, Hormonal - administration & dosage
  • Antineoplastic Agents, Hormonal - therapeutic use
  • Aromatase Inhibitors - administration & dosage
  • Aromatase Inhibitors - adverse effects
  • Aromatase Inhibitors - therapeutic use
  • Articles
  • Breast cancer
  • Breast Neoplasms - prevention & control
  • Breast Neoplasms - surgery
  • Cancer
  • Carcinoma
  • Carcinoma, Ductal, Breast - prevention & control
  • Chemotherapy
  • Clinical trials
  • Colorectal cancer
  • connective tissue diseases
  • Double-Blind Method
  • ductal carcinoma
  • Endocrine therapy
  • Female
  • Hormones
  • Humans
  • Intention to Treat Analysis
  • Internal Medicine
  • Medicine(all)
  • Middle Aged
  • Neoplasm Recurrence, Local - prevention & control
  • Nitriles - administration & dosage
  • Nitriles - adverse effects
  • Nitriles - therapeutic use
  • Older people
  • Oncology, Experimental
  • Postmenopausal women
  • Postmenopause
  • Prevention
  • skin
  • Tamoxifen
  • Tamoxifen - administration & dosage
  • Tamoxifen - adverse effects
  • Tamoxifen - therapeutic use
  • Triazoles - administration & dosage
  • Triazoles - adverse effects
  • Triazoles - therapeutic use
  • Tumors
  • Womens health
ispartof: Lancet (London, England), 2015, Vol.387 (10021), p.866-873
description: Summary Background Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS. Methods In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358. Results Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6–8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64–1·23]). The non-inferiority of anastrozole was established (upper 95% CI
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0140-6736
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
url: Link


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titleAnastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial
sourceAlma/SFX Local Collection
creatorForbes, John F, Prof ; Sestak, Ivana, PhD ; Howell, Anthony, Prof ; Bonanni, Bernardo, MD ; Bundred, Nigel, Prof ; Levy, Christelle, MD ; von Minckwitz, Gunter, Prof ; Eiermann, Wolfgang, MD ; Neven, Patrick, Prof ; Stierer, Michael, Prof ; Holcombe, Chris, MD ; Coleman, Robert E, Prof ; Jones, Louise, Prof ; Ellis, Ian, Prof ; Cuzick, Jack, Prof
creatorcontribForbes, John F, Prof ; Sestak, Ivana, PhD ; Howell, Anthony, Prof ; Bonanni, Bernardo, MD ; Bundred, Nigel, Prof ; Levy, Christelle, MD ; von Minckwitz, Gunter, Prof ; Eiermann, Wolfgang, MD ; Neven, Patrick, Prof ; Stierer, Michael, Prof ; Holcombe, Chris, MD ; Coleman, Robert E, Prof ; Jones, Louise, Prof ; Ellis, Ian, Prof ; Cuzick, Jack, Prof ; IBIS-II investigators
descriptionSummary Background Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS. Methods In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358. Results Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6–8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64–1·23]). The non-inferiority of anastrozole was established (upper 95% CI <1·25), but its superiority to tamoxifen was not (p=0·49). A total of 69 deaths were recorded (33 for anastrozole vs 36 for tamoxifen; HR 0·93 [95% CI 0·58–1·50], p=0·78), and no specific cause was more common in one group than the other. The number of women reporting any adverse event was similar between anastrozole (1323 women, 91%) and tamoxifen (1379 women, 93%); the side-effect profiles of the two drugs differed, with more fractures, musculoskeletal events, hypercholesterolaemia, and strokes with anastrozole and more muscle spasm, gynaecological cancers and symptoms, vasomotor symptoms, and deep vein thromboses with tamoxifen. Conclusions No clear efficacy differences were seen between the two treatments. Anastrozole offers another treatment option for postmenopausal women with hormone-receptor-positive DCIS, which may be be more appropriate for some women with contraindications for tamoxifen. Longer follow-up will be necessary to fully evaluate treatment differences. Funding Cancer Research UK, National Health and Medical Research Council Australia, Breast Cancer Research Fund, AstraZeneca, Sanofi Aventis.
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languageeng
publisherEngland: Elsevier Ltd
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ispartofLancet (London, England), 2015, Vol.387 (10021), p.866-873
rights
0Forbes et al. Open Access article distributed under the terms of CC BY
12016 Forbes et al. Open Access article distributed under the terms of CC BY
2Copyright © 2016 Forbes et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.
3COPYRIGHT 2016 Elsevier B.V.
4Copyright Elsevier Limited Feb 27, 2016
52016 Forbes et al. Open Access article distributed under the terms of CC BY 2016
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0Forbes, John F, Prof
1Sestak, Ivana, PhD
2Howell, Anthony, Prof
3Bonanni, Bernardo, MD
4Bundred, Nigel, Prof
5Levy, Christelle, MD
6von Minckwitz, Gunter, Prof
7Eiermann, Wolfgang, MD
8Neven, Patrick, Prof
9Stierer, Michael, Prof
10Holcombe, Chris, MD
11Coleman, Robert E, Prof
12Jones, Louise, Prof
13Ellis, Ian, Prof
14Cuzick, Jack, Prof
15IBIS-II investigators
title
0Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial
1Lancet (London, England)
addtitleLancet
descriptionSummary Background Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS. Methods In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358. Results Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6–8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64–1·23]). The non-inferiority of anastrozole was established (upper 95% CI <1·25), but its superiority to tamoxifen was not (p=0·49). A total of 69 deaths were recorded (33 for anastrozole vs 36 for tamoxifen; HR 0·93 [95% CI 0·58–1·50], p=0·78), and no specific cause was more common in one group than the other. The number of women reporting any adverse event was similar between anastrozole (1323 women, 91%) and tamoxifen (1379 women, 93%); the side-effect profiles of the two drugs differed, with more fractures, musculoskeletal events, hypercholesterolaemia, and strokes with anastrozole and more muscle spasm, gynaecological cancers and symptoms, vasomotor symptoms, and deep vein thromboses with tamoxifen. Conclusions No clear efficacy differences were seen between the two treatments. Anastrozole offers another treatment option for postmenopausal women with hormone-receptor-positive DCIS, which may be be more appropriate for some women with contraindications for tamoxifen. Longer follow-up will be necessary to fully evaluate treatment differences. Funding Cancer Research UK, National Health and Medical Research Council Australia, Breast Cancer Research Fund, AstraZeneca, Sanofi Aventis.
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0Abridged Index Medicus
1Administration, Oral
2anastrozole
3Antineoplastic Agents, Hormonal - administration & dosage
4Antineoplastic Agents, Hormonal - therapeutic use
5Aromatase Inhibitors - administration & dosage
6Aromatase Inhibitors - adverse effects
7Aromatase Inhibitors - therapeutic use
8Articles
9Breast cancer
10Breast Neoplasms - prevention & control
11Breast Neoplasms - surgery
12Cancer
13Carcinoma
14Carcinoma, Ductal, Breast - prevention & control
15Chemotherapy
16Clinical trials
17Colorectal cancer
18connective tissue diseases
19Double-Blind Method
20ductal carcinoma
21Endocrine therapy
22Female
23Hormones
24Humans
25Intention to Treat Analysis
26Internal Medicine
27Medicine(all)
28Middle Aged
29Neoplasm Recurrence, Local - prevention & control
30Nitriles - administration & dosage
31Nitriles - adverse effects
32Nitriles - therapeutic use
33Older people
34Oncology, Experimental
35Postmenopausal women
36Postmenopause
37Prevention
38skin
39Tamoxifen
40Tamoxifen - administration & dosage
41Tamoxifen - adverse effects
42Tamoxifen - therapeutic use
43Triazoles - administration & dosage
44Triazoles - adverse effects
45Triazoles - therapeutic use
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titleAnastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial
authorForbes, John F, Prof ; Sestak, Ivana, PhD ; Howell, Anthony, Prof ; Bonanni, Bernardo, MD ; Bundred, Nigel, Prof ; Levy, Christelle, MD ; von Minckwitz, Gunter, Prof ; Eiermann, Wolfgang, MD ; Neven, Patrick, Prof ; Stierer, Michael, Prof ; Holcombe, Chris, MD ; Coleman, Robert E, Prof ; Jones, Louise, Prof ; Ellis, Ian, Prof ; Cuzick, Jack, Prof
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28Middle Aged
29Neoplasm Recurrence, Local - prevention & control
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31Nitriles - adverse effects
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33Older people
34Oncology, Experimental
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36Postmenopause
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41Tamoxifen - adverse effects
42Tamoxifen - therapeutic use
43Triazoles - administration & dosage
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11Coleman, Robert E, Prof
12Jones, Louise, Prof
13Ellis, Ian, Prof
14Cuzick, Jack, Prof
aucorpIBIS-II investigators
formatjournal
genrearticle
ristypeJOUR
atitleAnastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): a double-blind, randomised controlled trial
jtitleLancet (London, England)
addtitleLancet
date2015
risdate2015
volume387
issue10021
spage866
epage873
pages866-873
issn0140-6736
eissn1474-547X
codenLANCAO
notesMembers listed in appendix
abstractSummary Background Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS. Methods In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358. Results Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6–8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64–1·23]). The non-inferiority of anastrozole was established (upper 95% CI <1·25), but its superiority to tamoxifen was not (p=0·49). A total of 69 deaths were recorded (33 for anastrozole vs 36 for tamoxifen; HR 0·93 [95% CI 0·58–1·50], p=0·78), and no specific cause was more common in one group than the other. The number of women reporting any adverse event was similar between anastrozole (1323 women, 91%) and tamoxifen (1379 women, 93%); the side-effect profiles of the two drugs differed, with more fractures, musculoskeletal events, hypercholesterolaemia, and strokes with anastrozole and more muscle spasm, gynaecological cancers and symptoms, vasomotor symptoms, and deep vein thromboses with tamoxifen. Conclusions No clear efficacy differences were seen between the two treatments. Anastrozole offers another treatment option for postmenopausal women with hormone-receptor-positive DCIS, which may be be more appropriate for some women with contraindications for tamoxifen. Longer follow-up will be necessary to fully evaluate treatment differences. Funding Cancer Research UK, National Health and Medical Research Council Australia, Breast Cancer Research Fund, AstraZeneca, Sanofi Aventis.
copEngland
pubElsevier Ltd
pmid26686313
doi10.1016/S0140-6736(15)01129-0
oafree_for_read