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Listen to medical experts discuss the efficacy and safety of ENHERTU from DESTINY-Breast 01, including their experience treating these patients with ENHERTU.

Incidence of Select Adverse Reactions in DESTINY-Breast01 in Patients Treated With ENHERTU (5.4 mg/kg; N=184)1,2

Nausea2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 41.3 28.3 7.6 0
  • Incidence decreased by cycle
    • Cycle 1 = 65.2% of patients
    • Cycle 2 = 28% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • Prophylaxis and treatment
    • 70.1% of patients received an antiemetic and/or antinauseant as prophylaxis or for treatment of nausea
    • Available data did not allow for differentiation between prophylaxis use and treatment of nausea
  • The median duration of the first event of nausea was 8.0 days (range: 1-323)
  • 34.8% of patients had 1 event of nausea, 13.6% had 2 events, and 28.8% had >2 events
  • No patients discontinued treatment due to nausea. Dose interruption was required in 1.6% of patients and 2.7% required dose reduction

Vomiting2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 27.2 14.1 3.8 0
  • Incidence decreased by cycle
    • Cycle 1 = 27.2% of patients
    • Cycle 2 = 14.8% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • Prophylaxis and treatment
    • 70.1% of patients received an antiemetic and/or antinauseant as prophylaxis or for treatment of vomiting
    • Available data did not allow for differentiation between prophylaxis use and treatment of vomiting
  • The median duration of the first event of vomiting was 3.0 days (range: 1-215)
  • 23.4% of patients had 1 event of vomiting, 7.1% had 2 events, and 14.7% had >2 events
  • No patients discontinued treatment due to vomiting. Dose interruption was required in 1.1% of patients and 1.6% required dose reduction

Fatigue2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 22.3 20.1 5.4 0
  • Incidence decreased by cycle
    • Cycle 1 = 29.3% of patients
    • Cycle 2 = 11.5% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • The median duration of the first event of fatigue was 15.0 days (range: 1-207)
  • 32.1% of patients had 1 event of fatigue, 7.6% had 2 events, and 8.2% had >2 events
  • No patients discontinued treatment due to fatigue. Dose interruption was required in 1.6% of patients and 3.3% required dose reduction

Alopecia2

  Grade
1a
Grade
2b,c
Incidence (%) 36.4 10.9
  • Incidence decreased by cycle
    • Cycle 1 = 14.7% of patients
    • Cycle 2 = 13.2% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • No patients discontinued treatment due to alopecia. No patients required dose interruption or dose reduction

Constipation2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 26.6 7.1 0.5 0
  • Incidence decreased by cycle
    • Cycle 1 = 15.8% of patients
    • Cycle 2 = 8.2% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • Prophylaxis and treatment
    • 39.7% of patients received medication for constipation
    • Available data did not allow for differentiation between prophylaxis use and treatment of constipation
  • The median duration of the first event of constipation was 15.0 days (range: 1-180)
  • 25.5% of patients had 1 event of constipation, 5.4% had 2 events, and 3.3% had >2 events
  • No patients discontinued treatment due to constipation. No patients required dose interruption or dose reduction

Diarrhea2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 16.8 8.2 1.6 0
  • Incidence decreased by cycle
    • Cycle 1 = 10.9% of patients
    • Cycle 2 = 7.1% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • Prophylaxis and treatment
    • 19.6% of patients received medication for the treatment of diarrhea
    • Available data did not allow for differentiation between prophylaxis use and treatment of diarrhea
  • The median duration of the first event of diarrhea was 4.0 days (range: 1-99)
  • 17.4% of patients had 1 event of diarrhea, 7.1% had 2 events, and 2.2% had >2 events
  • No patients discontinued treatment due to diarrhea. Dose interruption was required in 1.1% of patients and 0.5% required dose reduction

Decreased appetite2

  Grade 1 Grade 2 Grade 3 Grade 4
Incidence (%) 20.1 7.1 1.6 0
  • Incidence decreased by cycle
    • Cycle 1 = 17.4% of patients
    • Cycle 2 = 4.9% of patients
    • Rates decreased in subsequent cycles
    • No conclusions may be drawn on whether the decreased rates are due to increased tolerance, prophylaxis use, patient discontinuations, dose modifications, etc.
  • Prophylaxis and treatment
    • 1.6% of patients received appetite stimulants
    • Available data did not allow for differentiation between prophylaxis use and treatment of decreased appetite
  • The median duration of the first event of decreased appetite was 16.0 days (range: 2-288)
  • 20.7% of patients had 1 event of decreased appetite, 4.3% had 2 events, and 3.8% had >2 events
  • No patients discontinued treatment due to decreased appetite. Dose interruption was required in 0% of patients and 1.1% required dose reduction

aGrade1: Hair loss of <50% of normal for that individual that is not obvious form a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage.3

bGrade 2: Hair loss of ≥50% of normal that is readily apparent to others; a wig or hair piece is necessary if the patient desires to completely camouflage the hair loss; associated with psychosocial impact.3

cPer NCI-CTCAE v.4.03, the highest NCI-CTCAE grade for alopecia was Grade 2. 0.5% Grade 3 alopecia (1 patient) was reported by investigators.2

Review information for these other potential treatment risks:

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NCI-CTCAE, National Cancer Institute—Common Terminology Criteria for Adverse Events.