Left Ventricular Dysfunction

Management of left ventricular ejection fraction (LVEF) decrease with ENHERTU1,2

Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. LVEF decrease has been observed with anti-HER2 therapies, including ENHERTU.

  • In the 491 patients with unresectable or metastatic HER2+ breast cancer who received ENHERTU 5.4 mg/kg, 13 cases (2.6%) of asymptomatic LVEF decrease were reported. No decreases of LVEF to <40% were observed
  • Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated
  • Manage through treatment interruption or discontinuation
  • Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment

Dose modifications for decreased LVEF1

Severity Treatment modification
LVEF greater than 45% and
absolute decrease from baseline is
10% to 20%
  • Continue treatment with ENHERTU
LVEF
40%
to
45%
And absolute decrease from baseline is less than
10%
  • Continue treatment with ENHERTU
  • Repeat LVEF assessment within 3 weeks
And absolute decrease from baseline is 10% to 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU
  • If LVEF recovers to within 10% of baseline, resume treatment with ENHERTU at the same dose
LVEF less than 40% or absolute decrease from baseline is greater
than 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF of less than 40% or absolute decrease from baseline of greater than 20% is confirmed, permanently discontinue ENHERTU
Symptomatic congestive heart
failure (CHF)
  • Permanently discontinue ENHERTU
Severity Treatment modification
LVEF greater than 45% and absolute decrease from baseline is 10% to 20%
  • Continue treatment with ENHERTU
LVEF 40% to 45% And absolute decrease from baseline is less than 10%
  • Continue treatment with ENHERTU
  • Repeat LVEF assessment within 3 weeks
And absolute decrease from baseline is 10% to 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU
  • If LVEF recovers to within 10% of baseline, resume treatment with ENHERTU at the same dose
LVEF less than 40% or absolute decrease from baseline is greater than 20%
  • Interrupt ENHERTU
  • Repeat LVEF assessment within 3 weeks
  • If LVEF of less than 40% or absolute decrease from baseline of greater than 20% is confirmed, permanently discontinue ENHERTU
Symptomatic congestive heart failure (CHF)
  • Permanently discontinue ENHERTU

Toxicity grades are in accordance with NCI-CTCAE v.5.0.

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HER2, human epidermal growth factor receptor 2; NCI-CTCAE, National Cancer Institute–Common Terminology Criteria for Adverse Events.