Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases

Nicholas C. Turner, R. S. Finn, M. Martin, S. A. Im, A. DeMichele, J. Ettl, V. Diéras, S. Moulder, O. Lipatov, M. Colleoni, M. Cristofanilli, D. R. Lu, A. Mori, C. Giorgetti, S. Iyer, C. Huang Bartlett, K. A. Gelmon

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Abstract

Background: This report assesses the efficacy and safety of palbociclib plus endocrine therapy (ET) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) with or without visceral metastases. Patients and methods: Pre- and postmenopausal women with disease progression following prior ET (PALOMA-3; N = 521) and postmenopausal women untreated for ABC (PALOMA-2; N = 666) were randomized 2: 1 to ET (fulvestrant or letrozole, respectively) plus palbociclib or placebo. Progression-free survival (PFS), safety, and patient-reported quality of life (QoL) were evaluated by prior treatment and visceral involvement. Results: Visceral metastases incidence was higher in patients with prior resistance to ET (58.3%, PALOMA-3) than in patients naive to ET in the ABC setting (48.6%, PALOMA-2). In patients with prior resistance to ET and visceral metastases,median PFS (mPFS) was 9.2months with palbociclib plus fulvestrant versus 3.4months with placebo plus fulvestrant [hazard ratio (HR), 0.47; 95% confidence interval (CI), 0.35-0.61], and objective response rate (ORR) was 28.0% versus 6.7%, respectively. In patients with nonvisceral metastases, mPFS was 16.6 versus 7.3months, HR 0.53; 95% CI 0.36-0.77. In patients with visceral disease and naive to ET in the advanced disease setting, mPFS was 19.3months with palbociclib plus letrozole versus 12.9months with placebo plus letrozole (HR 0.63; 95% CI 0.47-0.85); ORR was 55.1% versus 40.0%; in patients with nonvisceral disease, mPFS was not reached with palbociclib plus letrozole versus 16.8months with placebo plus letrozole (HR 0.50; 95% CI 0.36-0.70). In patients with prior resistance to ET with visceral metastases, palbociclib plus fulvestrant significantly delayed deterioration of QoL versus placebo plus fulvestrant, whereas patient-reported QoL was maintained with palbociclib plus letrozole in patients naive to endocrine-based therapy for ABC. Conclusions: Palbociclib plus ET prolonged mPFS in patients with visceral metastases, increased ORRs, and in patients previously treated for ABC, delayed QoL deterioration, presenting a standard treatment option among patients with visceral metastases amenable to endocrine-based therapy.

Original languageEnglish
Article numbermdx821
Pages (from-to)669-680
Number of pages12
JournalAnnals of Oncology
Volume29
Issue number3
DOIs
Publication statusPublished - Mar 1 2018

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letrozole
Breast Neoplasms
Neoplasm Metastasis
Placebos
Therapeutics
Quality of Life
Confidence Intervals
palbociclib
Disease-Free Survival
Patient Safety
Disease Progression
fulvestrant
Hormones

Keywords

  • Advanced breast cancer
  • Metastatic breast cancer
  • Palbociclib
  • Visceral disease
  • Visceral metastases

ASJC Scopus subject areas

  • Hematology
  • Oncology

Cite this

Turner, N. C., Finn, R. S., Martin, M., Im, S. A., DeMichele, A., Ettl, J., ... Gelmon, K. A. (2018). Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. Annals of Oncology, 29(3), 669-680. [mdx821]. https://doi.org/10.1093/annonc/mdx797

Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. / Turner, Nicholas C.; Finn, R. S.; Martin, M.; Im, S. A.; DeMichele, A.; Ettl, J.; Diéras, V.; Moulder, S.; Lipatov, O.; Colleoni, M.; Cristofanilli, M.; Lu, D. R.; Mori, A.; Giorgetti, C.; Iyer, S.; Huang Bartlett, C.; Gelmon, K. A.

In: Annals of Oncology, Vol. 29, No. 3, mdx821, 01.03.2018, p. 669-680.

Research output: Contribution to journalArticle

Turner, NC, Finn, RS, Martin, M, Im, SA, DeMichele, A, Ettl, J, Diéras, V, Moulder, S, Lipatov, O, Colleoni, M, Cristofanilli, M, Lu, DR, Mori, A, Giorgetti, C, Iyer, S, Huang Bartlett, C & Gelmon, KA 2018, 'Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases', Annals of Oncology, vol. 29, no. 3, mdx821, pp. 669-680. https://doi.org/10.1093/annonc/mdx797
Turner, Nicholas C. ; Finn, R. S. ; Martin, M. ; Im, S. A. ; DeMichele, A. ; Ettl, J. ; Diéras, V. ; Moulder, S. ; Lipatov, O. ; Colleoni, M. ; Cristofanilli, M. ; Lu, D. R. ; Mori, A. ; Giorgetti, C. ; Iyer, S. ; Huang Bartlett, C. ; Gelmon, K. A. / Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. In: Annals of Oncology. 2018 ; Vol. 29, No. 3. pp. 669-680.
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abstract = "Background: This report assesses the efficacy and safety of palbociclib plus endocrine therapy (ET) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) with or without visceral metastases. Patients and methods: Pre- and postmenopausal women with disease progression following prior ET (PALOMA-3; N = 521) and postmenopausal women untreated for ABC (PALOMA-2; N = 666) were randomized 2: 1 to ET (fulvestrant or letrozole, respectively) plus palbociclib or placebo. Progression-free survival (PFS), safety, and patient-reported quality of life (QoL) were evaluated by prior treatment and visceral involvement. Results: Visceral metastases incidence was higher in patients with prior resistance to ET (58.3{\%}, PALOMA-3) than in patients naive to ET in the ABC setting (48.6{\%}, PALOMA-2). In patients with prior resistance to ET and visceral metastases,median PFS (mPFS) was 9.2months with palbociclib plus fulvestrant versus 3.4months with placebo plus fulvestrant [hazard ratio (HR), 0.47; 95{\%} confidence interval (CI), 0.35-0.61], and objective response rate (ORR) was 28.0{\%} versus 6.7{\%}, respectively. In patients with nonvisceral metastases, mPFS was 16.6 versus 7.3months, HR 0.53; 95{\%} CI 0.36-0.77. In patients with visceral disease and naive to ET in the advanced disease setting, mPFS was 19.3months with palbociclib plus letrozole versus 12.9months with placebo plus letrozole (HR 0.63; 95{\%} CI 0.47-0.85); ORR was 55.1{\%} versus 40.0{\%}; in patients with nonvisceral disease, mPFS was not reached with palbociclib plus letrozole versus 16.8months with placebo plus letrozole (HR 0.50; 95{\%} CI 0.36-0.70). In patients with prior resistance to ET with visceral metastases, palbociclib plus fulvestrant significantly delayed deterioration of QoL versus placebo plus fulvestrant, whereas patient-reported QoL was maintained with palbociclib plus letrozole in patients naive to endocrine-based therapy for ABC. Conclusions: Palbociclib plus ET prolonged mPFS in patients with visceral metastases, increased ORRs, and in patients previously treated for ABC, delayed QoL deterioration, presenting a standard treatment option among patients with visceral metastases amenable to endocrine-based therapy.",
keywords = "Advanced breast cancer, Metastatic breast cancer, Palbociclib, Visceral disease, Visceral metastases",
author = "Turner, {Nicholas C.} and Finn, {R. S.} and M. Martin and Im, {S. A.} and A. DeMichele and J. Ettl and V. Di{\'e}ras and S. Moulder and O. Lipatov and M. Colleoni and M. Cristofanilli and Lu, {D. R.} and A. Mori and C. Giorgetti and S. Iyer and {Huang Bartlett}, C. and Gelmon, {K. A.}",
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TY - JOUR

T1 - Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases

AU - Turner, Nicholas C.

AU - Finn, R. S.

AU - Martin, M.

AU - Im, S. A.

AU - DeMichele, A.

AU - Ettl, J.

AU - Diéras, V.

AU - Moulder, S.

AU - Lipatov, O.

AU - Colleoni, M.

AU - Cristofanilli, M.

AU - Lu, D. R.

AU - Mori, A.

AU - Giorgetti, C.

AU - Iyer, S.

AU - Huang Bartlett, C.

AU - Gelmon, K. A.

PY - 2018/3/1

Y1 - 2018/3/1

N2 - Background: This report assesses the efficacy and safety of palbociclib plus endocrine therapy (ET) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) with or without visceral metastases. Patients and methods: Pre- and postmenopausal women with disease progression following prior ET (PALOMA-3; N = 521) and postmenopausal women untreated for ABC (PALOMA-2; N = 666) were randomized 2: 1 to ET (fulvestrant or letrozole, respectively) plus palbociclib or placebo. Progression-free survival (PFS), safety, and patient-reported quality of life (QoL) were evaluated by prior treatment and visceral involvement. Results: Visceral metastases incidence was higher in patients with prior resistance to ET (58.3%, PALOMA-3) than in patients naive to ET in the ABC setting (48.6%, PALOMA-2). In patients with prior resistance to ET and visceral metastases,median PFS (mPFS) was 9.2months with palbociclib plus fulvestrant versus 3.4months with placebo plus fulvestrant [hazard ratio (HR), 0.47; 95% confidence interval (CI), 0.35-0.61], and objective response rate (ORR) was 28.0% versus 6.7%, respectively. In patients with nonvisceral metastases, mPFS was 16.6 versus 7.3months, HR 0.53; 95% CI 0.36-0.77. In patients with visceral disease and naive to ET in the advanced disease setting, mPFS was 19.3months with palbociclib plus letrozole versus 12.9months with placebo plus letrozole (HR 0.63; 95% CI 0.47-0.85); ORR was 55.1% versus 40.0%; in patients with nonvisceral disease, mPFS was not reached with palbociclib plus letrozole versus 16.8months with placebo plus letrozole (HR 0.50; 95% CI 0.36-0.70). In patients with prior resistance to ET with visceral metastases, palbociclib plus fulvestrant significantly delayed deterioration of QoL versus placebo plus fulvestrant, whereas patient-reported QoL was maintained with palbociclib plus letrozole in patients naive to endocrine-based therapy for ABC. Conclusions: Palbociclib plus ET prolonged mPFS in patients with visceral metastases, increased ORRs, and in patients previously treated for ABC, delayed QoL deterioration, presenting a standard treatment option among patients with visceral metastases amenable to endocrine-based therapy.

AB - Background: This report assesses the efficacy and safety of palbociclib plus endocrine therapy (ET) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) with or without visceral metastases. Patients and methods: Pre- and postmenopausal women with disease progression following prior ET (PALOMA-3; N = 521) and postmenopausal women untreated for ABC (PALOMA-2; N = 666) were randomized 2: 1 to ET (fulvestrant or letrozole, respectively) plus palbociclib or placebo. Progression-free survival (PFS), safety, and patient-reported quality of life (QoL) were evaluated by prior treatment and visceral involvement. Results: Visceral metastases incidence was higher in patients with prior resistance to ET (58.3%, PALOMA-3) than in patients naive to ET in the ABC setting (48.6%, PALOMA-2). In patients with prior resistance to ET and visceral metastases,median PFS (mPFS) was 9.2months with palbociclib plus fulvestrant versus 3.4months with placebo plus fulvestrant [hazard ratio (HR), 0.47; 95% confidence interval (CI), 0.35-0.61], and objective response rate (ORR) was 28.0% versus 6.7%, respectively. In patients with nonvisceral metastases, mPFS was 16.6 versus 7.3months, HR 0.53; 95% CI 0.36-0.77. In patients with visceral disease and naive to ET in the advanced disease setting, mPFS was 19.3months with palbociclib plus letrozole versus 12.9months with placebo plus letrozole (HR 0.63; 95% CI 0.47-0.85); ORR was 55.1% versus 40.0%; in patients with nonvisceral disease, mPFS was not reached with palbociclib plus letrozole versus 16.8months with placebo plus letrozole (HR 0.50; 95% CI 0.36-0.70). In patients with prior resistance to ET with visceral metastases, palbociclib plus fulvestrant significantly delayed deterioration of QoL versus placebo plus fulvestrant, whereas patient-reported QoL was maintained with palbociclib plus letrozole in patients naive to endocrine-based therapy for ABC. Conclusions: Palbociclib plus ET prolonged mPFS in patients with visceral metastases, increased ORRs, and in patients previously treated for ABC, delayed QoL deterioration, presenting a standard treatment option among patients with visceral metastases amenable to endocrine-based therapy.

KW - Advanced breast cancer

KW - Metastatic breast cancer

KW - Palbociclib

KW - Visceral disease

KW - Visceral metastases

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