ADJUVANT SAFETY PROFILE
The APHINITY trial safety profile.
Most common adverse reactions (ARs)
Most common overall ARs (>20%, all grades) in patients receiving PERJETA1
During the targeted treatment-alone phase (following completion of chemotherapy), the only ARs occurring in >10% of patients in the PERJETA treatment group were diarrhea (18%), arthralgia (15%), radiation skin injury (12%), and hot flush (12%).1
Most common >2% severe (Grades 3-4) ARs1
*Denotes an AR that has been reported in association with a fatal outcome.1
Cardiac safety profile1
†A substantial decrease in LVEF is defined as a decrease of 10 or more percentage points, to a value <50%.2
Discontinuation rates due to ARs1
Rates of permanent discontinuation of any study therapy due to ARs were1:
- 13% for patients receiving PERJETA and Herceptin and chemotherapy
- 12% for patients receiving placebo and Herceptin and chemotherapy
Diarrhea rates during chemotherapy and after it was discontinued
All grades diarrhea1
Overall incidence of diarrhea was 71% in the PERJETA-treated group and 45% in the placebo-treated group.
Grade 2 diarrhea3
Incidence of Grade 2 diarrhea when targeted therapy was administered with chemotherapy:
- 26% in the PERJETA-treated group
- 13% in the placebo-treated group
Grades 3-4 diarrhea1,2
Incidence of Grades 3-4 diarrhea1,2
†Includes Grade ≥3 ARs with onset from
first dose of any study treatment through 28 days after last dose of
‡Includes Grade ≥3 ARs with onset during the targeted therapy post-chemotherapy treatment period.2
- PERJETA Prescribing Information. Genentech, Inc. 2020.
- von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377(2):122-131 and supplementary appendix. doi:10.1056/NEJMoa1703643.
- Bines J, de Azambuja E, Zardavas D, et al. Incidence and management of diarrhea with adjuvant pertuzumab and trastuzumab in HER2-positive breast cancer. Poster presented at: San Antonio Breast Cancer Symposium; December 5, 2017; San Antonio, TX.