Patient-reported outcomes with anastrozole versus tamoxifen for postmenopausal patients with ductal carcinoma in situ treated with lumpectomy plus radiotherapy (NSABP B-35): a randomised, double-blind, phase 3 clinical trial.

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Abstract

The NSABP B-35 trial compared 5 years of treatment with anastrozole versus tamoxifen for reducing subsequent occurrence of breast cancer in postmenopausal patients with ductal carcinoma in situ. This report assesses the effect of these drugs on quality of life and symptoms.

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Most cited references 18

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Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study

Gilberto Fisher, J. P. Costantino, D. L. Wickerham … (1998)

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Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial.

Victor G Vogel, Joseph P Costantino, D Wickerham … (2006)

Tamoxifen is approved for the reduction of breast cancer risk, and raloxifene has demonstrated a reduced risk of breast cancer in trials of older women with osteoporosis. To compare the relative effects and safety of raloxifene and tamoxifen on the risk of developing invasive breast cancer and other disease outcomes. The National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial, a prospective, double-blind, randomized clinical trial conducted beginning July 1, 1999, in nearly 200 clinical centers throughout North America, with final analysis initiated after at least 327 incident invasive breast cancers were diagnosed. Patients were 19,747 postmenopausal women of mean age 58.5 years with increased 5-year breast cancer risk (mean risk, 4.03% [SD, 2.17%]). Data reported are based on a cutoff date of December 31, 2005. Oral tamoxifen (20 mg/d) or raloxifene (60 mg/d) over 5 years. Incidence of invasive breast cancer, uterine cancer, noninvasive breast cancer, bone fractures, thromboembolic events. There were 163 cases of invasive breast cancer in women assigned to tamoxifen and 168 in those assigned to raloxifene (incidence, 4.30 per 1000 vs 4.41 per 1000; risk ratio [RR], 1.02; 95% confidence interval [CI], 0.82-1.28). There were fewer cases of noninvasive breast cancer in the tamoxifen group (57 cases) than in the raloxifene group (80 cases) (incidence, 1.51 vs 2.11 per 1000; RR, 1.40; 95% CI, 0.98-2.00). There were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene (RR, 0.62; 95% CI, 0.35-1.08). No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke. Thromboembolic events occurred less often in the raloxifene group (RR, 0.70; 95% CI, 0.54-0.91). The number of osteoporotic fractures in the groups was similar. There were fewer cataracts (RR, 0.79; 95% CI, 0.68-0.92) and cataract surgeries (RR, 0.82; 95% CI, 0.68-0.99) in the women taking raloxifene. There was no difference in the total number of deaths (101 vs 96 for tamoxifen vs raloxifene) or in causes of death. Raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of thromboembolic events and cataracts but a nonstatistically significant higher risk of noninvasive breast cancer. The risk of other cancers, fractures, ischemic heart disease, and stroke is similar for both drugs. clinicaltrials.gov Identifier: NCT00003906.

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Breast Cancer Mortality After a Diagnosis of Ductal Carcinoma In Situ.

Steven A. Narod, Javaid Iqbal, Vasily Giannakeas … (2015)

Women with ductal carcinoma in situ (DCIS), or stage 0 breast cancer, often experience a second primary breast cancer (DCIS or invasive), and some ultimately die of breast cancer.

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Author and article information

Journal

Journal ID (iso-abbrev): Lancet

Title: Lancet (London, England)

Publisher: Elsevier BV

ISSN (Electronic): 1474-547X

ISSN (Print): 0140-6736

Publication date (Electronic): Feb 27 2016

Volume: 387

Issue: 10021

Affiliations

[1 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; University of California, Los Angeles, CA, USA. Electronic address: pganz@mednet.ucla.edu.

[2 ] NRG Oncology, Pittsburgh, PA, USA; Department of Biostatistics, University of Pittsburgh, Pittsburgh, PA, USA.

[3 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Department of Surgical Oncology, Allegheny Cancer Center at Allegheny General Hospital, Pittsburgh, PA, USA.

[4 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; The Jewish General Hospital, McGill University, Montréal, QC, Canada.

[5 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Department of Radiation Oncology, Mayo Clinic, Jacksonville, FL, USA.

[6 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Southwest Oncology Group, San Antonio, TX, USA; Department of Medicine, Loyola University Chicago Stritch School of Medicine, Chicago, IL, USA.

[7 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Alliance for Clinical Trials in Oncology/American College of Surgeons Oncology Group, Chicago, IL, USA; Nashville Breast Center, Nashville, TN, USA.

[8 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Southwest Oncology Group, San Antonio, TX, USA; Eastern Cooperative Oncology Group/American College of Radiology Imaging Network, Philadelphia, PA, USA; Department of Hematology/Oncology, Banner MD Anderson Cancer Center, Gilbert, AZ, USA.

[9 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Department of Hematology/Oncology, Magee Womens Hospital/University of Pittsburgh, Pittsburgh, PA, USA.

[10 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Dayton Physicians, Dayton, OH, USA.

[11 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Missouri Valley Cancer Consortium, Omaha, NE, USA.

[12 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Southeast Clinical Oncology Research Consortium National Cancer Institute Community Oncology Research Program, Winston Salem, NC, USA; Department of Hematology/Oncology, Forsyth Regional Cancer Center, Winston Salem, NC, USA.

[13 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Department of Medical Oncology, Kaiser Permanente, Northern California Vallejo, CA, USA.

[14 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Department of Medical Oncology Colorado Cancer Research Program, Denver, CO, USA.

[15 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Community Clinical Oncology Program, Christiana Care Health Systems, Wilmington, DE, USA.

[16 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; Atlanta Regional Community Clinical Oncology Program, Atlanta, GA, USA.

[17 ] NRG Oncology/National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA, USA; UF Health Cancer Center at Orlando Health, Orlando, FL, USA.

Article

Publisher Item ID: S0140-6736(15)01169-1 Mid ID: NIHMS746761

DOI: 10.1016/S0140-6736(15)01169-1

PMC ID: 4792658

PubMed ID: 26686960

SO-VID: fed0413e-62e4-4e78-86bc-5dd4031a8bf6

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