دورية أكاديمية
Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.
| العنوان: | Anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial. |
|---|---|
| المؤلفون: | Margolese RG; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Jewish General Hospital, McGill University, Montreal, QC, Canada. Electronic address: richard.margolese@mcgill.ca., Cecchini RS; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA., Julian TB; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Surgical Oncology, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA, USA., Ganz PA; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; University of California, Los Angeles, CA, USA., Costantino JP; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA., Vallow LA; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL, USA., Albain KS; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; SWOG, San Antonio, TX, USA; Department of Medicine, Loyola University Chicago Stritch School of Medicine, Chicago, IL, USA., Whitworth PW; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; ALLIANCE/ACOSOG, Chicago, IL, USA; Nashville Breast Center, Nashville, TN, USA., Cianfrocca ME; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; SWOG, San Antonio, TX, USA; ECOG/ACRIN, Philadelphia, PA, USA; Department of Hematology/Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, USA., Brufsky AM; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Hematology/Oncology, Magee Womens Hospital/University of Pittsburgh Department of Hematology/Oncology, Pittsburgh, PA, USA., Gross HM; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Dayton Physicians LLC, Dayton, OH, USA., Soori GS; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Missouri Valley Cancer Consortium, Omaha, NE, USA., Hopkins JO; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; SCOR NCORP, Winston Salem, NC, USA; Department of Hematology/Oncology, Forsyth Regional Cancer Center, Winston Salem, NC, USA., Fehrenbacher L; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Medical Oncology, Kaiser Permanente Northern California Vallejo, CA, USA., Sturtz K; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Medical Oncology Colorado Cancer Research Program, Denver, CO, USA., Wozniak TF; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; CCOP, Christiana Care Health Systems, Newark, DE, USA., Seay TE; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Atlanta Regional Community Clinical Oncology Program, Atlanta, GA, USA., Mamounas EP; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; UF Health Cancer Center at Orlando Health, Orlando, FL, USA., Wolmark N; NRG Oncology/National Surgical Adjuvant Breast and Bowel Project (NSABP), Pittsburgh, PA, USA; Department of Surgical Oncology, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA, USA. |
| المصدر: | Lancet (London, England) [Lancet] 2016 Feb 27; Vol. 387 (10021), pp. 849-56. Date of Electronic Publication: 2015 Dec 11. |
| نوع المنشور: | Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: England NLM ID: 2985213R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1474-547X (Electronic) Linking ISSN: 01406736 NLM ISO Abbreviation: Lancet Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2004- : London : Elsevier Original Publication: London : J. Onwhyn |
| مواضيع طبية MeSH: | Antineoplastic Agents, Hormonal/*therapeutic use , Aromatase Inhibitors/*therapeutic use , Breast Neoplasms/*drug therapy , Carcinoma, Ductal, Breast/*drug therapy , Nitriles/*therapeutic use , Tamoxifen/*therapeutic use , Triazoles/*therapeutic use, Administration, Oral ; Age Factors ; Anastrozole ; Antineoplastic Agents, Hormonal/administration & dosage ; Antineoplastic Agents, Hormonal/adverse effects ; Aromatase Inhibitors/administration & dosage ; Aromatase Inhibitors/adverse effects ; Breast Neoplasms/radiotherapy ; Breast Neoplasms/surgery ; Carcinoma, Ductal, Breast/radiotherapy ; Carcinoma, Ductal, Breast/surgery ; Combined Modality Therapy ; Double-Blind Method ; Embolism/chemically induced ; Female ; Humans ; Mastectomy, Segmental ; Middle Aged ; Nitriles/administration & dosage ; Nitriles/adverse effects ; Postmenopause ; Tamoxifen/administration & dosage ; Tamoxifen/adverse effects ; Thrombosis/chemically induced ; Triazoles/administration & dosage ; Triazoles/adverse effects |
| مستخلص: | Background: Ductal carcinoma in situ is currently managed with excision, radiotherapy, and adjuvant hormone therapy, usually tamoxifen. We postulated that an aromatase inhibitor would be safer and more effective. We therefore undertook this trial to compare anastrozole versus tamoxifen in postmenopausal women with ductal carcinoma in situ undergoing lumpectomy plus radiotherapy. Methods: The double-blind, randomised, phase 3 National Surgical Adjuvant Breast and Bowel Project (NSABP) B-35 trial was done in 333 participating NSABP centres in the USA and Canada. Postmenopausal women with hormone-positive ductal carcinoma in situ treated by lumpectomy with clear resection margins and whole-breast irradiation were enrolled and randomly assigned (1:1) to receive either oral tamoxifen 20 mg per day (with matching placebo in place of anastrozole) or oral anastrozole 1 mg per day (with matching placebo in place of tamoxifen) for 5 years. Randomisation was stratified by age (<60 vs ≥60 years) and patients and investigators were masked to treatment allocation. The primary outcome was breast cancer-free interval, defined as time from randomisation to any breast cancer event (local, regional, or distant recurrence, or contralateral breast cancer, invasive disease, or ductal carcinoma in situ), analysed by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00053898, and is complete. Findings: Between Jan 1, 2003, and June 15, 2006, 3104 eligible patients were enrolled and randomly assigned to the two treatment groups (1552 to tamoxifen and 1552 to anastrozole). As of Feb 28, 2015, follow-up information was available for 3083 patients for overall survival and 3077 for all other disease-free endpoints, with median follow-up of 9·0 years (IQR 8·2-10·0). In total, 212 breast cancer-free interval events occurred: 122 in the tamoxifen group and 90 in the anastrozole group (HR 0·73 [95% CI 0·56-0·96], p=0·0234). A significant time-by-treatment interaction (p=0·0410) became evident later in the study. There was also a significant interaction between treatment and age group (p=0·0379), showing that anastrozole is superior only in women younger than 60 years of age. Adverse events did not differ between the groups, except for thrombosis or embolism--a known side-effect of tamoxifen-for which there were 17 grade 4 or worse events in the tamoxifen group versus four in the anastrozole group. Interpretation: Compared with tamoxifen, anastrozole treatment provided a significant improvement in breast cancer-free interval, mainly in women younger than 60 years of age. This finding means that women will benefit from having a choice of effective agents for ductal carcinoma in situ. Funding: US National Cancer Institute and AstraZeneca Pharmaceuticals LP. (Copyright © 2016 Elsevier Ltd. All rights reserved.) |
| التعليقات: | Comment in: Lancet. 2016 Feb 27;387(10021):819-21. (PMID: 26686312) |
| References: | J Clin Oncol. 2000 Nov 15;18(22):3758-67. (PMID: 11078488) Lancet. 2002 Jun 22;359(9324):2131-9. (PMID: 12090977) N Engl J Med. 1993 Jun 3;328(22):1581-6. (PMID: 8292119) Lancet. 2014 Mar 22;383(9922):1041-8. (PMID: 24333009) Cancer. 1995 Oct 1;76(7):1197-200. (PMID: 8630897) J Clin Oncol. 1998 Feb;16(2):441-52. (PMID: 9469327) J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. (PMID: 9747868) Lancet. 1999 Jun 12;353(9169):1993-2000. (PMID: 10376613) J Natl Cancer Inst. 2011 Mar 16;103(6):478-88. (PMID: 21398619) Semin Diagn Pathol. 1994 Aug;11(3):223-35. (PMID: 7831534) JAMA Oncol. 2015 Oct;1(7):888-96. (PMID: 26291673) |
| معلومات مُعتمدة: | U10 CA180868 United States CA NCI NIH HHS; UG1 CA189867 United States CA NCI NIH HHS; U10CA-189867 United States CA NCI NIH HHS; U10CA-180822 United States CA NCI NIH HHS; U24 CA114732 United States CA NCI NIH HHS; U10CA-180868 United States CA NCI NIH HHS; UG1 CA189805 United States CA NCI NIH HHS; U10CA-196067 United States CA NCI NIH HHS; U24 CA196067 United States CA NCI NIH HHS; U10CA-114732 United States CA NCI NIH HHS; U10 CA180888 United States CA NCI NIH HHS; U10 CA180822 United States CA NCI NIH HHS |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00053898 |
| المشرفين على المادة: | 0 (Antineoplastic Agents, Hormonal) 0 (Aromatase Inhibitors) 0 (Nitriles) 0 (Triazoles) 094ZI81Y45 (Tamoxifen) 2Z07MYW1AZ (Anastrozole) |
| تواريخ الأحداث: | Date Created: 20151222 Date Completed: 20160321 Latest Revision: 20220310 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC4792688 |
| DOI: | 10.1016/S0140-6736(15)01168-X |
| PMID: | 26686957 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1474-547X |
|---|---|
| DOI: | 10.1016/S0140-6736(15)01168-X |