Recommendation Grading
Type Benefit/harm Evidence Quality
Strength of
Recommendation
EB Evidence-
based
B Benefits
outweigh harms
H High Strong
CB
Consensus-
based
H Harms outweigh
benefits
I Intermediate Moderate
M Moderate
IC Informal
consensus
B/H Relative balance
of benefits and
harms
L Low Weak
Ins Insufficient
Adjuvant Neratinib
➤ Clinicians may use extended adjuvant therapy with neratinib in patients with
early-stage, HER2-positive breast cancer. (Moderate Recommendation; EB-B-H)
Note: Neratinib causes substantial diarrhea, and diarrhea prophylaxis must be used.
Qualifying Statements: The Expert Panel preferentially favors use of neratinib in hormone
receptor-positive and node-positive patients. At 5.2-year follow-up, no OS benefit has been
observed. Patients who began neratinib within one year of trastuzumab completion appeared
to derive the greatest benefit. There are no data on the added benefit of neratinib in patients
who also received pertuzumab in the neoadjuvant or adjuvant setting.
NOTE: Recommendations identified by an asterisk (
*
) are taken verbatim from
the Cancer Care Ontario [CCO] guideline. Otherwise, recommendations have
been substantively adapted or reworded for clarity by the American Society of
Clinical Oncolog y [ASCO] Panel.
