Qualifying Statements
➤ Tumor markers or circulating tumor cells should NOT be used as the sole
criteria for determining disease progression.
➤ Providers should recognize and acknowledge special issues faced by
premenopausal women with MBC, including loss of fertility.
➤ Treatment should take into account the biology of the tumor and the
menopausal status of the patient, with careful attention paid to ovarian
production of estrogen.
➤ There is more toxicity associated with the combination of exemestane
and everolimus compared with other single-agent endocrine options.
➤ There is more toxicity associated with the combination of palbociclib and
endocrine therapy compared with other single-agent endocrine options.
➤ Palbociclib should be administered once per day for 21 days every
28 days.
• The primary toxicity is neutropenia. Blood counts should be monitored every
14 days for the first two 28-day cycles, then at the start of each subsequent cycle,
with neutropenia managed by dose delays and reductions.
• Although no data exist at present, any AI could be substituted depending on
individual tolerance.
• On the basis of the data from PALOMA-3, palbociclib can also be combined
with fulvestrant in the second-line setting or greater, including after one line of
chemotherapy.
➤ Chemotherapy in combination with HER2-targeted therapy is indicated in
de novo and visceral dominant disease, because this treatment offers a
survival benefit compared with chemotherapy alone.
➤ There is no routine clinical role for genomic or expression profiling in the
selection of treatment for HR+ MBC.
