|
1
|
Siegel RL, Miller KD and Jemal A: Cancer
statistics, 2020. CA Cancer J Clin. 70:7–30. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
2
|
Edwards BK, Noone AM, Mariotto AB, Simard
EP, Boscoe FP, Henley SJ, Jemal A, Cho H, Anderson RN, Kohler BA,
et al: Annual report to the nation on the status of cancer,
1975–2010, featuring prevalence of comorbidity and impact on
survival among persons with lung, colorectal, breast, or prostate
cancer. Cancer. 120:1290–1314. 2014. View Article : Google Scholar : PubMed/NCBI
|
|
3
|
Topaloğlu US and Özaslan E: Comorbidity
and polypharmacy in patients with breast cancer. Breast Cancer.
27:477–482. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
4
|
Gao JJ, Cheng J, Bloomquist E, Sanchez J,
Wedam SB, Singh H, Amiri-Kordestani L, Ibrahim A, Sridhara R,
Goldberg KB, et al: CDK4/6 inhibitor treatment for patients with
hormone receptor-positive, HER2-negative, advanced or metastatic
breast cancer: A US food and drug administration pooled analysis.
Lancet Oncol. 21:250–260. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
5
|
Hortobagyi GN, Stemmer SM, Burris HA, Yap
YS, Sonke GS, Hart L, Campone M, Petrakova K, Winer EP, Janni W, et
al: LBA17 overall survival (OS) results from the phase III
MONALEESA-2 (ML-2) trial of postmenopausal patients (pts) with
hormone receptor positive/human epidermal growth factor receptor 2
negative (HR+/HER2-) advanced breast cancer (ABC) treated with
endocrine therapy (ET) ± ribociclib (RIB). Ann Oncol. 32
(Suppl_5):S1283–S1346. 2021. View Article : Google Scholar
|
|
6
|
Slamon DJ, Neven P, Chia S, Fasching PA,
De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín
M, et al: Phase III randomized study of ribociclib and fulvestrant
in hormone receptor-positive, human epidermal growth factor
receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin
Oncol. 36:2465–2472. 2018. View Article : Google Scholar : PubMed/NCBI
|
|
7
|
Slamon DJ, Neven P, Chia S, Fasching PA,
De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martín
M, et al: Overall survival with ribociclib plus fulvestrant in
advanced breast cancer. N Engl J Med. 382:514–524. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
8
|
Tripathy D, Im SA, Colleoni M, Franke F,
Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, et al:
Ribociclib plus endocrine therapy for premenopausal women with
hormone-receptor-positive, advanced breast cancer (MONALEESA-7): A
randomised phase 3 trial. Lancet Oncol. 19:904–915. 2018.
View Article : Google Scholar : PubMed/NCBI
|
|
9
|
Sledge GW Jr, Toi M, Neven P, Soh J, Inoue
K, Pivo X, Burdaeva O, Okera M, Masud N, Kaufman PA, et al: MONARCH
2: Abemaciclib in combination with fulvestrant in women With
HR+/HER2- advanced breast cancer who had progressed while receiving
endocrine therapy. J Clin Oncol. 35:2875–2884. 2017. View Article : Google Scholar : PubMed/NCBI
|
|
10
|
Goetz MP, Toi M, Campone M, Sohn J,
Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, et
al: MONARCH 3: Abemaciclib as initial therapy for advanced breast
cancer. J Clin Oncol. 35:3638–3646. 2017. View Article : Google Scholar : PubMed/NCBI
|
|
11
|
Johnston S, Martin M, Di Leo A, Im SA,
Awada A, Forrester T, Frenzel M, Hardebeck MC, Cox J, Barriga S, et
al: MONARCH 3 final PFS: A randomized study of abemaciclib as
initial therapy for advanced breast cancer. NPJ Breast Cancer.
17:52019. View Article : Google Scholar : PubMed/NCBI
|
|
12
|
Finn RS, Martin M, Rugo HS, Jones S, Im
SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, et al:
Palbociclib and Letrozole in advanced breast cancer. N Engl J Med.
375:1925–1936. 2016. View Article : Google Scholar : PubMed/NCBI
|
|
13
|
Turner NC, Slamon DJ, Ro J, Bondarenko I,
Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, et al:
Overall survival with palbociclib and fulvestrant in advanced
breast cancer. N Engl J Med. 379:1926–1936. 2018. View Article : Google Scholar : PubMed/NCBI
|
|
14
|
Finn RS, Rugo HS, Dieras VC, Harbeck N, Im
SA, Gelmon KA, Walshe JM, Martin M, Gregor MCM, Bananis E, et al:
Overall survival (OS) with first-line palbociclib plus letrozole
(PAL+LET) versus placebo plus letrozole (PBO+LET) in women with
estrogen receptor–positive/human epidermal growth factor receptor
2–negative advanced breast cancer (ER+/HER2- ABC): Analyses from
PALOMA-2. J Clin Oncol. 40 (17_suppl):LBA1003. 2022. View Article : Google Scholar
|
|
15
|
Rugo HS, Brufsky A, Liu X, Li B, McRoy L,
Chen C, Layman RM, Cristofanilli M, Torres MA, Curigliano G, et al:
Real-world study of overall survival with palbociclib plus
aromatase inhibitor in HR+/HER2- metastatic breast cancer. NPJ
Breast Cancer. 8:1142022. View Article : Google Scholar : PubMed/NCBI
|
|
16
|
Goetz M, Toi J, Huober J, Sohn J, Tredan
O, Park IH, Campone M, Chen SC, Sanchez LM, Paluch-Shimon S, et al:
MONARCH 3: Interim overall survival (OS) results of abemaciclib
plus a nonsteroidal aromatase inhibitor (NSAI) in patients (pts)
with HR+, HER2- advanced breast cancer (ABC). M.P. Ann Oncol. 33
(Suppl_7):S808–S869. 2022. View Article : Google Scholar
|
|
17
|
Munzone E, Pagan E, Bagnardi V, Montagna
E, Cancello G, Dellapasqua S, Iorfida M, Mazza M and Colleoni M:
Systematic review and meta-analysis of post-progression outcomes in
ER+/HER2- metastatic breast cancer after CDK4/6 inhibitors within
randomized clinical trials. ESMO Open. 6:1003322021. View Article : Google Scholar : PubMed/NCBI
|
|
18
|
Onesti CE and Jerusalem G: CDK4/6
inhibitors in breast cancer: Differences in toxicity profiles and
impact on agent choice. A systematic review and meta-analysis.
Expert Rev Anticancer Ther. 21:283–298. 2021. View Article : Google Scholar : PubMed/NCBI
|
|
19
|
National Comprehensive Cancer Network
(NCCN), . Breast Cancer. Clinical Practice Guidelines in
Oncology-version 1. NCCN. 2023.
|
|
20
|
Goetz M: LBA15 - MONARCH 3: Interim
overall survival (OS) results of abemaciclib plus a nonsteroidal
aromatase inhibitor (NSAI) in patients (pts) with HR+, HER2-
advanced breast cancer (ABC). Ann Oncol. 33 (Suppl 7):S808–S869.
2022. View Article : Google Scholar
|
|
21
|
Roncato R, Angelini J, Pani A, Cecchin E,
Sartore-Bianchi A, Siena S, De Mattia E, Scaglione F and Toffoli G:
CDK4/6 Inhibitors in breast cancer treatment: Potential
interactions with drug, gene, and pathophysiological conditions.
Int J Mol Sci. 21:63502020. View Article : Google Scholar : PubMed/NCBI
|
|
22
|
Danese MD, O'Malley C, Lindquist K,
Gleeson M and Griffiths RI: An observational study of the
prevalence and incidence of comorbid conditions in older women with
breast cancer. Ann Oncol. 23:1756–1765. 2012. View Article : Google Scholar : PubMed/NCBI
|
|
23
|
Omarini C, Piacentini F, Sperduti I,
Barbolini M, Isca C, Toss A, Cortesi L, Barbieri E, Dominici M and
Moscetti L: Combined endocrine approaches vs. endocrine therapy
alone as first line treatment in elderly patients with hormone
receptor-positive, HER2 negative, advanced breast cancer: To
prescribe for the patient or the physician? A meta-analysis of
phase II and III randomized clinical trials. BMC Cancer.
20:4182020. View Article : Google Scholar : PubMed/NCBI
|
|
24
|
Fry DW, Harvey PJ, Keller PR, Elliott WL,
Meade M, Trachet E, Albassam M, Zheng X, Leopold WR, Pryer NK and
Toogood PL: Specific inhibition of cyclin-dependent kinase 4/6 by
PD 0332991 and associated antitumor activity in human tumor
xenografts. Mol Cancer Ther. 3:1427–1438. 2004. View Article : Google Scholar : PubMed/NCBI
|
|
25
|
Marra A and Curigliano G: Are all
cyclin-dependent kinases 4/6 inhibitors created equal? NPJ Breast
Cancer. 5:272019. View Article : Google Scholar : PubMed/NCBI
|
|
26
|
Hamilton E, Cortes J, Ozyilkan O, Chen SC,
Petrakova K, Manikhas A, Jerusalem G, Hegg R, Huober J, Chapman SC,
et al: NextMONARCH: Abemaciclib monotherapy or combined with
tamoxifen for metastatic breast cancer. Clin Breast Cancer.
21:181–190.e2. 2021. View Article : Google Scholar : PubMed/NCBI
|
|
27
|
Nguyen LV, Searle K and Jerzak KJ: Central
nervous system-specific efficacy of CDK4/6 inhibitors in randomized
controlled trials for metastatic breast cancer. Oncotarget.
10:6317–6322. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
28
|
Anders CK, Le Rhun E, Bachelot TD, Yardley
DA, Awada A, Conte PF, Kabos P, Bear M, Yang Z, Chen Y and Tolaney
SM: A phase II study of abemaciclib in patients (pts) with brain
metastases (BM) secondary to HR+, HER2 metastatic breast cancer
(MBC). J Clin Oncol. 37:10172019. View Article : Google Scholar
|
|
29
|
Tolaney SM, Sahebjam S, Le Rhun E,
Bachelot T, Kabos P, Awada A, Yardley D, Chan A, Conte P, Diéras V,
et al: A phase II study of abemaciclib in patients with brain
metastases secondary to hormone receptor-positive breast cancer.
Clin Cancer Res. 26:5310–5319. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
30
|
Fogli S, Del Re M, Curigliano G, van
Schaik RH, Lancellotti P and Danesi R: Drug-drug interactions in
breast cancer patients treated with CDK4/6 inhibitors. Cancer Treat
Rev. 74:21–28. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
31
|
KISQALI®(ribociclib). Highlights of
Prescribing Information. 2020, . Available online. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209092s004lbl.pdf(accessed
on 14 August 2020).
|
|
32
|
Committee for Medicinal Products for Human
Use (CHMP). KISQALI®(ribociclib) EPAR Assessment Report Variation.
Available online, . https://www.ema.europa.eu/en/documents/variationreport/kisqali-h-c-4213-ii0004-epar-assessment-report-variation_en.pdf(accessed
on 31 August 2020).
|
|
33
|
Ji Y, Yartsev V, Quinlan M, Serra P, Wang
Y, Chakraborty A and Miller M: Justifying ribociclib dose in
patients with advanced breast cancer with renal impairment based on
PK, safety, and efficacy data: An innovative approach integrating
data from a dedicated renal impairment study and oncology clinical
trials. Clin Pharmacokinet. 62:493–504. 2023. View Article : Google Scholar : PubMed/NCBI
|
|
34
|
Committee for Medicinal Products for Human
Use (CHMP). VERZENIOTM (abemaciclib) EPAR Assessment Report, .
Available online:. https://www.ema.europa.eu/en/documents/assessment-report/verzenios-eparpublic-assessment-report_en.pdf(accessed
on 31 August 2020).
|
|
35
|
Howie LJ, Singh H, Bloomquist E, Wedam S,
Amiri-Kordestani L, Tang S, Sridhara R, Sanchez J, Prowell TM,
Kluetz PG, et al: Outcomes of older women with hormone
receptor-positive, human epidermal growth factor receptor-negative
metastatic breast cancer treated with a CDK4/6 inhibitor and an
aromatase inhibitor: An FDA pooled analysis. J Clin Oncol.
37:3475–3483. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
36
|
Kassem L, Shohdy KS, Lasheen S,
Abdel-Rahman O and Bachelot T: Hematological adverse effects in
breast cancer patients treated with cyclin-dependent kinase 4 and 6
inhibitors: a systematic review and meta-analysis. Breast Cancer.
25:17–27. 2018. View Article : Google Scholar : PubMed/NCBI
|
|
37
|
Matsunuma R: Significance of renal
function monitoring during treatment with abemaciclib. J Clin Exp
Nephrol Vol. 5:812020.
|
|
38
|
Flaherty KT, Lorusso PM, Demichele A,
Abramson VG, Courtney R, Randolph SS, Shaik MN, Wilner KD, O'Dwyer
PJ, Schwartz GK, et al: Phase I, dose-escalation trial of the oral
cyclin-dependent kinase 4/6 inhibitor PD 0332991, administered
using a 21-day schedule in patients with advanced cancer. Clin
Cancer Res. 18:568–576. 2012. View Article : Google Scholar : PubMed/NCBI
|
|
39
|
Zhu Z and Zhu Q: Differences in metabolic
transport and resistance mechanisms of Abemaciclib, Palbociclib,
and Ribociclib. Front. Pharmacol. 14:12129862023.PubMed/NCBI
|
|
40
|
Battisti NML, De Glas N, Sedrak MS, Loh
KP, Liposits G, Soto-Perez-de-Celis E, Krok-Schoen JL, Menjak IB
and Ring A: Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors
in older patients with ER-positive HER2-negative breast cancer:
Young international society of geriatric oncology review paper.
Ther Adv Med Oncol. 10:17588359188096102018. View Article : Google Scholar : PubMed/NCBI
|
|
41
|
Patnaik JL, Byers T, Diguiseppi C, Denberg
TD and Dabelea D: The influence of comorbidities on overall
survival among older women diagnosed with breast cancer. J Natl
Cancer Inst. 103:1101–1111. 2011. View Article : Google Scholar : PubMed/NCBI
|
|
42
|
Fu MR, Axelrod D, Guth AA, Cleland CM,
Ryan CE, Weaver KR, Qiu JM, Kleinman R, Scagliola J, Palamar JJ and
Melkus GD: Comorbidities and quality of life among breast cancer
survivors: A prospective study. J Pers Med. 5:229–242. 2015.
View Article : Google Scholar : PubMed/NCBI
|
|
43
|
Ewertz M and Jensen AB: Late effects of
breast cancer treatment and potentials for rehabilitation. Acta
Oncol. 50:187–193. 2011. View Article : Google Scholar : PubMed/NCBI
|
|
44
|
Common Toxicity Criteria and Version 2.0.
Publish Date: April 30, 1999. Cancer Therapy EvaluationProgram.
https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcv20_4-30-992.pdf
|
|
45
|
Ng HS, Vitry A, Koczwara B, Roder D and
McBride ML: Patterns of comorbidities in women with breast cancer:
A Canadian population-based study. Cancer Causes Control.
30:931–941. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
46
|
Khan NF, Mant D, Carpenter L, Forman D and
Rose PW: Long-term health outcomes in a British cohort of breast,
colorectal and prostate cancer survivors: A database study. Br J
Cancer 105 Suppl. 1 (Suppl 1):S29–S37. 2011. View Article : Google Scholar : PubMed/NCBI
|
|
47
|
Cardoso F, Paluch-Shimon S, Senkus E,
Curigliano G, Aapro MS, André F, Barrios CH, Bergh J, Bhattacharyya
GS, Biganzoli L, et al: 5th ESO-ESMO international consensus
guidelines for advanced breast cancer (ABC 5). Ann Oncol.
31:1623–1649. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
48
|
Varghese F and Wong J: Breast cancer in
the elderly. Surg Clin North Am. 98:819–833. 2018. View Article : Google Scholar : PubMed/NCBI
|
|
49
|
Spring LM, Zangardi ML, Moy B and Bardia
A: Clinical management of potential toxicities and drug
interactions related to cyclin-dependent kinase 4/6 inhibitors in
breast cancer: Practical considerations and recommendations.
Oncologist. 22:1039–1048. 2017. View Article : Google Scholar : PubMed/NCBI
|
|
50
|
Ettl J: Management of adverse events due
to cyclin-dependent kinase 4/6 inhibitors. Breast Care (Basel).
14:86–92. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
51
|
Vallet-Regí M, Manzano M, Rodriguez-Mañas
L, López MC, Aapro M and Balducci L: Management of cancer in the
older age person: An approach to complex medical decisions.
Oncologist. 22:335–342. 2017. View Article : Google Scholar : PubMed/NCBI
|
|
52
|
Hart LL, Bardia A, Beck JT, Chan A, Neven
P, Hamilton EP, Sohn J, Sonke GS, Bachelot T, Spring L, et al:
Impact of ribociclib (RIB) dose modifications (mod) on overall
survival (OS) in patients (pts) with HR+/HER2- advanced breast
cancer (ABC) in MONALEESA(ML)-2. J Clin Oncol. 40 (16_suppl):S1017.
2022. View Article : Google Scholar
|
|
53
|
Murphy CG: The role of CDK4/6 inhibitors
in breast cancer. Curr Treat Options Oncol. 20:522019. View Article : Google Scholar : PubMed/NCBI
|
|
54
|
Cazzaniga ME, Danesi R, Girmenia C,
Invernizzi P, Elvevi A and Uguccioni M: NetworkER+: Management of
toxicities associated with targeted therapies for HR-positive
metastatic breast cancer: A multidisciplinary approach is the key
to success. Breast Cancer Res Treat. 176:483–494. 2019. View Article : Google Scholar : PubMed/NCBI
|
|
55
|
Sammons SL, Topping DL and Blackwell KL:
HR+, HER2- advanced breast cancer and CDK4/6 inhibitors: Mode of
action, clinical activity, and safety profiles. Curr Cancer Drug
Targets. 17:637–649. 2017. View Article : Google Scholar : PubMed/NCBI
|
|
56
|
Thill M and Schmidt M: Management of
adverse events during cyclin-dependent kinase 4/6 (CDK4/6)
inhibitor-based treatment in breast cancer. Ther Adv Med Oncol.
10:17588359187933262018. View Article : Google Scholar : PubMed/NCBI
|
|
57
|
Spring LM, Wander SA, Andre F, Moy B,
Turner NC and Bardia A: Cyclin-dependent kinase 4 and 6 inhibitors
for hormone receptor-positive breast cancer: Past, present, and
future. Lancet. 395:817–827. 2020. View Article : Google Scholar : PubMed/NCBI
|
|
58
|
Raschi E, Fusaroli M, Ardizzoni A, Poluzzi
E and De Ponti F: Cyclin-dependent kinase 4/6 inhibitors and
interstitial lung disease in the FDA adverse event reporting
system: A pharmacovigilance assessment. Breast Cancer Res Treat.
186:219–227. 2021. View Article : Google Scholar : PubMed/NCBI
|
|
59
|
Caillet P, Pulido M, Brain E, Falandry C,
Desmoulins S, Ghebriou D, Soubeyran P, Paillaud E, Rifi N, Vauthier
JM, et al: PALOMAGE, a French real-world cohort of elderly women
beyond age 70 with advanced breast cancer receiving palbociclib:
Baseline characteristics and safety evaluation. J Clin Oncol. 39
(15_suppl):1012. 2021. View Article : Google Scholar
|
|
60
|
Fountzilas E, Koliou GA, Vozikis A, Rapti
V, Nikolakopoulos A, Boutis A, Christopoulou A, Kontogiorgos I,
Karageorgopoulou S, Lalla E, et al: Real-world clinical outcome and
toxicity data and economic aspects in patients with advanced breast
cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors
combined with endocrine therapy: The experience of the Hellenic
cooperative oncology group. ESMO Open. 5:e0007742020. View Article : Google Scholar : PubMed/NCBI
|
