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Do adjuvant aromatase inhibitors increase the cardiovascular risk in postmenopausal women with early breast cancer
Author(s) -
Cuppone Federica,
Bria Emilio,
Verma Sunil,
Pritchard Kathleen I.,
Gandhi Sonal,
Carlini Paolo,
Milella Michele,
Nisticò Cecilia,
Terzoli Edmondo,
Cognetti Francesco,
Giannarelli Diana
Publication year - 2007
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.23171
Subject(s) - medicine , tamoxifen , breast cancer , relative risk , confidence interval , oncology , clinical endpoint , number needed to harm , randomized controlled trial , cancer , gynecology , number needed to treat
BACKGROUND. Despite the advantages from using aromatase inhibitors (AIs) compared with tamoxifen for early breast cancer, an unexpectedly greater number of grade 3 and 4 cardiovascular events (CVAE) (as defined by National Cancer Institute of Canada‐Common Toxicity Criteria [version 2.0] was demonstrated. METHODS. Phase 3 randomized clinical trials (RCTs) comparing AI with tamoxifen in early breast cancer were considered eligible for this review. The event‐based risk ratios (RRs) with 95% confidence intervals (95% CIs) were derived, and a test of heterogeneity was applied. Finally, absolute differences (ADs) in event rates and the number of patients needed to harm 1 patient (NNH) were determined. RESULTS. Seven eligible RCTs (19,818 patients) reported CVAE results. When considering all RCTs, the AD of the primary endpoint (CVAE) between the 2 arms (0.52%), tamoxifen versus AI, was statistically significant (RR, 1.31; 95% CI, 1.07–1.60; P = .007). This translated into an NNH value of 189 patients; when only third‐generation AIs were considered, the difference (0.57%) remained significant (RR, 1.34; 95% CI, 1.09–1.63; P = .0038). Thromboembolic events were significantly more frequent in the tamoxifen arm, regardless of the strategy adopted (RR, 0.53; 95% CI, 0.42–0.65; P < .0001), without significant heterogeneity ( P = .21). An AD of 1.17% and an NNH value of 85 patients were observed. CONCLUSIONS. According to the results from this meta‐analysis, the risk of grade 3 and 4 CVAEs in patients who were receiving AIs was higher compared with the risk in patients who were receiving tamoxifen, and the difference reached statistical significance. However, the AD was relatively low, and from 160 to 180 patients had to be treated to produce 1 event. Cancer 2008. © 2007 American Cancer Society.