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Pivot X, et al. "6 months versus 12 months of adjuvant trastuzumab in early breast cancer: final analysis of a multicentre,open-label, phase 3 randomised trial". The Lancet. 2019. :1979-1987.
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Clinical Question

In patients with Early Breast Cancer with HER2 overexpression, is 6-months adjuvant Trastuzumab non-inferior to the standard 12-months treatment ?

Bottom Line

Major Points

Several small and large randomized trials in diabetics had previously suggested a sizable benefit of tight glycemic control in reducing cardiovascular risk. The ACCORD trial was the largest study of its kind and demonstrated that not only does euglycemia (ie, HbA1c <6%) not reduce cardiovascular risk, it also is associated with a trend towards increased mortality.

Guidelines

Design

Population

Inclusion Criteria

Exclusion Criteria

Baseline Characteristics

Interventions

Outcomes

Comparisons are intensive therapy vs. standard therapy.

Primary Outcomes

Annual rate of nonfatal MI or nonfatal stroke or cardiovascular death
2.11% vs. 2.29% (HR 0.90; 95% CI 0.78-1.04; P=0.16)

Secondary Outcomes

Annual rate of death from any cause
1.41% vs. 1.14% (HR 1.22; 95% CI 1.01-1.46; P=0.04)
Annual rate of cardiovascular death
0.79% vs. 0.56% (HR 1.35; 95% CI 1.04-1.76; P=0.02)

Subgroup Analysis

Adverse Events

Criticisms

Funding

Further Reading