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Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 trial.
J Clin Oncol. 2007 Dec 20; 25(36):5715-22.JC

Abstract

PURPOSE

Previous analyses of adjuvant studies of aromatase inhibitors versus tamoxifen, including the Breast International Group (BIG) 1-98 study, have suggested a small numerical excess of cardiac adverse events (AEs) on aromatase inhibitors, a reduction in the incidence of hypercholesterolemia on tamoxifen, and significantly higher incidence of thromboembolic AEs on tamoxifen. The purpose of the present study is to provide detailed updated information on these AEs in BIG 1-98.

PATIENTS AND METHODS

Eight thousand twenty-eight postmenopausal women with receptor-positive early breast cancer were randomly assigned (double-blind) between March 1998 and May 2003 to receive 5 years of adjuvant endocrine therapy with letrozole, tamoxifen, or a sequence of these agents. Seven thousand nine hundred sixty-three patients who actually received therapy are included in this safety analysis, which focuses on cardiovascular events. AE recording ceased 30 days after therapy completion (or after switch on the sequential arms).

RESULTS

Baseline comorbidities were balanced. At a median follow-up time of 30.1 months, we observed similar overall incidence of cardiac AEs (letrozole, 4.8%; tamoxifen, 4.7%), more grade 3 to 5 cardiac AEs on letrozole (letrozole, 2.4%; tamoxifen, 1.4%; P = .001)--an excess only partially attributable to prior hypercholesterolemia--and more overall (tamoxifen, 3.9%; letrozole, 1.7%; P < .001) and grade 3 to 5 thromboembolic AEs on tamoxifen (tamoxifen, 2.3%; letrozole, 0.9%; P < .001). There was no significant difference between tamoxifen and letrozole in incidence of hypertension or cerebrovascular events.

CONCLUSION

The present safety analysis, limited to cardiovascular AEs in BIG 1-98, documents a low overall incidence of cardiovascular AEs, which differed between treatment arms.

Authors+Show Affiliations

Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark. henning.mouridsen@rh.hosp.dkNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17998546

Citation

Mouridsen, Henning, et al. "Cardiovascular Adverse Events During Adjuvant Endocrine Therapy for Early Breast Cancer Using Letrozole or Tamoxifen: Safety Analysis of BIG 1-98 Trial." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 25, no. 36, 2007, pp. 5715-22.
Mouridsen H, Keshaviah A, Coates AS, et al. Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 trial. J Clin Oncol. 2007;25(36):5715-22.
Mouridsen, H., Keshaviah, A., Coates, A. S., Rabaglio, M., Castiglione-Gertsch, M., Sun, Z., Thürlimann, B., Mauriac, L., Forbes, J. F., Paridaens, R., Gelber, R. D., Colleoni, M., Smith, I., Price, K. N., & Goldhirsch, A. (2007). Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 trial. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 25(36), 5715-22.
Mouridsen H, et al. Cardiovascular Adverse Events During Adjuvant Endocrine Therapy for Early Breast Cancer Using Letrozole or Tamoxifen: Safety Analysis of BIG 1-98 Trial. J Clin Oncol. 2007 Dec 20;25(36):5715-22. PubMed PMID: 17998546.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Cardiovascular adverse events during adjuvant endocrine therapy for early breast cancer using letrozole or tamoxifen: safety analysis of BIG 1-98 trial. AU - Mouridsen,Henning, AU - Keshaviah,Aparna, AU - Coates,Alan S, AU - Rabaglio,Manuela, AU - Castiglione-Gertsch,Monica, AU - Sun,Zhuoxin, AU - Thürlimann,Beat, AU - Mauriac,Louis, AU - Forbes,John F, AU - Paridaens,Robert, AU - Gelber,Richard D, AU - Colleoni,Marco, AU - Smith,Ian, AU - Price,Karen N, AU - Goldhirsch,Aron, Y1 - 2007/11/12/ PY - 2007/11/14/pubmed PY - 2008/1/1/medline PY - 2007/11/14/entrez SP - 5715 EP - 22 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 25 IS - 36 N2 - PURPOSE: Previous analyses of adjuvant studies of aromatase inhibitors versus tamoxifen, including the Breast International Group (BIG) 1-98 study, have suggested a small numerical excess of cardiac adverse events (AEs) on aromatase inhibitors, a reduction in the incidence of hypercholesterolemia on tamoxifen, and significantly higher incidence of thromboembolic AEs on tamoxifen. The purpose of the present study is to provide detailed updated information on these AEs in BIG 1-98. PATIENTS AND METHODS: Eight thousand twenty-eight postmenopausal women with receptor-positive early breast cancer were randomly assigned (double-blind) between March 1998 and May 2003 to receive 5 years of adjuvant endocrine therapy with letrozole, tamoxifen, or a sequence of these agents. Seven thousand nine hundred sixty-three patients who actually received therapy are included in this safety analysis, which focuses on cardiovascular events. AE recording ceased 30 days after therapy completion (or after switch on the sequential arms). RESULTS: Baseline comorbidities were balanced. At a median follow-up time of 30.1 months, we observed similar overall incidence of cardiac AEs (letrozole, 4.8%; tamoxifen, 4.7%), more grade 3 to 5 cardiac AEs on letrozole (letrozole, 2.4%; tamoxifen, 1.4%; P = .001)--an excess only partially attributable to prior hypercholesterolemia--and more overall (tamoxifen, 3.9%; letrozole, 1.7%; P < .001) and grade 3 to 5 thromboembolic AEs on tamoxifen (tamoxifen, 2.3%; letrozole, 0.9%; P < .001). There was no significant difference between tamoxifen and letrozole in incidence of hypertension or cerebrovascular events. CONCLUSION: The present safety analysis, limited to cardiovascular AEs in BIG 1-98, documents a low overall incidence of cardiovascular AEs, which differed between treatment arms. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/17998546/Cardiovascular_adverse_events_during_adjuvant_endocrine_therapy_for_early_breast_cancer_using_letrozole_or_tamoxifen:_safety_analysis_of_BIG_1_98_trial_ L2 - https://ascopubs.org/doi/10.1200/JCO.2007.12.1665?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -