Highlights
- •We studied palbociclib plus endocrine therapy (ET) for older HR+/HER2– advanced breast cancer (ABC) patients.
- •Palbociclib improved progression-free survival in older patients irrespective of prior treatment status.
- •Patient-reported quality of life was maintained.
- •Palbociclib plus ET has a favourable safety profile in older patients.
- •Palbociclib plus ET is an effective treatment option for older ABC patients.
Abstract
Aim
Because incidence of breast cancer and comorbidities increase with age, it is important
to determine treatment benefit in elderly patients. We evaluated outcomes with palbociclib
plus endocrine therapy in patients aged ≥65 years.
Methods
Data were pooled from three randomised studies (NCT00721409, NCT01740427 and NCT01942135)
of women with HR+/HER2− advanced breast cancer (ABC). In PALOMA-1 (open-label) and
PALOMA-2 (double-blind, placebo-controlled), treatment-naïve patients received palbociclib
plus letrozole or letrozole alone. In PALOMA-3 (double-blind, placebo-controlled),
patients with endocrine-resistant disease received palbociclib plus fulvestrant or
fulvestrant alone.
Results
Among 528 patients treated with palbociclib plus letrozole and 347 treated with palbociclib
plus fulvestrant, 218 (41.3%) and 86 (24.8%), respectively, were aged ≥65 years. Versus
endocrine therapy alone, median progression-free survival was significantly improved
in patients aged 65–74 years (hazard ratio [HR], 0.66; 95% confidence interval [CI],
0.45–0.97; P = 0.016) and ≥75 years (HR, 0.31; 95% CI, 0.16–0.61; P<0.001) receiving palbociclib plus letrozole and in patients aged 65–74 years (HR,
0.27; 95% CI, 0.16–0.48; P<0.001) receiving palbociclib plus fulvestrant; few patients aged ≥75 years received
palbociclib plus fulvestrant (HR, 0.59; 95% CI, 0.19–1.8; P = 0.18). Patient-reported functioning and quality of life was maintained. No clinically
relevant differences in palbociclib exposure were observed between age groups. Although
myelosuppression was more common among patients aged ≥75 years, incidence of grade
≥III myelosuppression was similar across age groups, and febrile neutropenia was uncommon
(≤2.4%); no new safety concerns were identified in older patients.
Conclusions
Palbociclib plus endocrine therapy is an effective, well-tolerated treatment for older
patients with ABC.
Keywords
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Article info
Publication history
Published online: July 25, 2018
Accepted:
May 3,
2018
Received:
March 16,
2018
Identification
Copyright
© 2018 Published by Elsevier Ltd.
