Select Adverse Reactions

Grading of select adverse events seen with ENHERTU

Nausea toxicity grading criteria1,2

Severity Description (NCI-CTCAEa grading) Incidence in
DESTINY-Breast01
with ENHERTU 5.4 mg/kg
(N=184)
Grade 1 and Grade 2
  • Grade 1: Loss of appetite without alteration in eating habits
  • Grade 2: Oral intake decreased without significant weight loss, dehydration or malnutrition
69.6%
Grade 3 and Grade 4
  • Grade 3: Inadequate oral caloric or fluid intake; tube feeding, TPN, or hospitalization indicated
  • Grade 4: Not available
7.6%

aNational Cancer Institute (NCI)—Common Terminology for Adverse Events (CTCAE) version 4.03.

Vomiting toxicity grading criteria1,2

Severity Description (NCI-CTCAEa grading) Incidence in
DESTINY-Breast01
with ENHERTU 5.4 mg/kg
(N=184)
Grade 1 and Grade 2
  • Grade 1: 1-2 episodes (separated by 5 minutes) in 24 hours
  • Grade 2: 3-5 episodes (separated by 5 minutes) in 24 hours
41.3%
Grade 3 and Grade 4
  • Grade 3: ≥6 episodes (separated by 5 minutes) in 24 hours; tube feeding, TPN or hospitalization indicated
  • Grade 4: Life-threatening consequences
3.8%

aNational Cancer Institute (NCI)—Common Terminology for Adverse Events (CTCAE) version 4.03.

Fatigue toxicity grading criteria1,2

Severity Description (NCI-CTCAEa grading) Incidence in
DESTINY-Breast01
with ENHERTU 5.4 mg/kg
(N=184)
Grade 1 and Grade 2
  • Grade 1: Fatigue relieved by rest
  • Grade 2: Fatigue not relieved by rest, limiting instrumental activities of daily living
42.4%
Grade 3 and Grade 4
  • Grade 3: Fatigue not relieved by rest, limiting self-care activities of daily living
  • Grade 4: Not available
5.4%

aNational Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.03.

Alopecia toxicity grading criteria1,2

Severity Description (NCI-CTCAEa grading) Incidence in
DESTINY-Breast01
with ENHERTU 5.4 mg/kg
(N=184)
Grade 1 and Grade 2
  • Grade 1: Hair loss of <50% of normal for that individual that is not obvious from 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
36.4%
  • Grade 2: Hair loss of ≥50% 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
10.9%

aNational Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 4.03.

0.5% Grade 3 alopecia was reported by investigators. Per NCI-CTCAE v.4.03, the highest NCI-CTCAE grade for alopecia was Grade 2.1,2

Review information for these other potential treatment risks:

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TPN, total parenteral nutrition.