Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the phase 3b CompLEEment-1 trial
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Ferlay J, Colombet M, Soerjomataram I, Mathers C, Parkin DM, Pineros M, et al. Estimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methods. Int J Cancer 2019; 144: 1941-53. doi: 10.1002/ijc.31937FerlayJColombetMSoerjomataramIMathersCParkinDMPinerosMet alEstimating the global cancer incidence and mortality in 2018: GLOBOCAN sources and methodsInt J Cancer201914419415310.1002/ijc.3193730350310Open DOISearch in Google Scholar
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin 2018; 68: 394-424. doi: 10.3322/caac.21492BrayFFerlayJSoerjomataramISiegelRLTorreLAJemalAGlobal cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countriesCA Cancer J Clin20186839442410.3322/caac.2149230207593Open DOISearch in Google Scholar
Yousef AJA. Male breast cancer: epidemiology and risk factors. Semin Oncol 2017; 44:. 267-72. doi: 10.1053/j.seminoncol.2017.11.002YousefAJAMale breast cancer: epidemiology and risk factorsSemin Oncol2017442677210.1053/j.seminoncol.2017.11.00229526255Open DOISearch in Google Scholar
Turashvili G, Brogi E. Tumor heterogeneity in breast cancer. Front Med 2017; 4: 227. doi: 10.3389/fmed.2017.00227TurashviliGBrogiETumor heterogeneity in breast cancerFront Med2017422710.3389/fmed.2017.00227572704929276709Open DOISearch in Google Scholar
Howlader N, Cronin KA, Kurian AW, Andridge R. Differences in breast cancer survival by molecular subtypes in the United States. Cancer Epidemiol Biomarkers Prev 2018; 27: 619-26. doi: 10.1158/1055-9965.EPI-17-0627HowladerNCroninKAKurianAWAndridgeRDifferences in breast cancer survival by molecular subtypes in the United StatesCancer Epidemiol Biomarkers Prev2018276192610.1158/1055-9965.EPI-17-062729593010Open DOISearch in Google Scholar
National Institute for Health and Care Excellence (NICE). Advanced breast cancer: diagnosis and treatment CG81. Updated 2017. [Internet]. [cited 2022 Jan 15]. Available at: https://www.nice.org.uk/guidance/cg81National Institute for Health and Care Excellence (NICE)Advanced breast cancer: diagnosis and treatment CG81Updated2017[Internet]. [cited 2022 Jan 15]. Available athttps://www.nice.org.uk/guidance/cg81Search in Google Scholar
Cardoso F, Paluch-Shimon S, Senkus E, Curigliano G, Aapro MS, Andre F, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol 2020; 31: 1623-49. doi: 10.1016/j.annonc.2020.09.010CardosoFPaluch-ShimonSSenkusECuriglianoGAaproMSAndreFet al5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)Ann Oncol20203116234910.1016/j.annonc.2020.09.010751044932979513Open DOISearch in Google Scholar
Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A, et al. Breast cancer, version 4.2017, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw 2018; 16: 310-20. doi: 10.6004/jnccn.2018.0012GradisharWJAndersonBOBalassanianRBlairSLBursteinHJCyrAet alBreast cancer, version 4.2017, NCCN Clinical Practice Guidelines in OncologyJ Natl Compr Canc Netw2018163102010.6004/jnccn.2018.001229523670Open DOISearch in Google Scholar
Telli ML, Gradishar WJ, Ward JH. NCCN Guidelines updates: breast cancer. J Natl Compr Canc Netw 2019; 17: 552-5. doi: 10.6004/jnccn.2019.5006TelliMLGradisharWJWardJHNCCN Guidelines updates: breast cancerJ Natl Compr Canc Netw201917552510.6004/jnccn.2019.500631117035Open DOISearch in Google Scholar
Robertson JFR, Bondarenko IM, Trishkina E, Dvorkin M, Panasci L, Manikhas A et al. Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial. Lancet 2016; 388: 2997-3005. doi: 10.1016/S0140-6736(16)32389-3RobertsonJFRBondarenkoIMTrishkinaEDvorkinMPanasciLManikhasAet alFulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trialLancet20163882997300510.1016/S0140-6736(16)32389-327908454Open DOISearch in Google Scholar
Yamamoto-Ibusuki M, Arnedos M, Andre F. Targeted therapies for ER+/ HER2- metastatic breast cancer. BMC Med 2015; 13: 137. doi: 10.1186/s12916-015-0369-5Yamamoto-IbusukiMArnedosMAndreFTargeted therapies for ER+/ HER2- metastatic breast cancerBMC Med20151313710.1186/s12916-015-0369-5446218426059247Open DOISearch in Google Scholar
Araki K, Miyoshi Y. Mechanism of resistance to endocrine therapy in breast cancer: the important role of PI3K/Akt/mTOR in estrogen receptor-positive, HER2-negative breast cancer. Breast Cancer 2018; 25: 392-401. doi: 10.1007/s12282-017-0812-xArakiKMiyoshiYMechanism of resistance to endocrine therapy in breast cancer: the important role of PI3K/Akt/mTOR in estrogen receptor-positive, HER2-negative breast cancerBreast Cancer20182539240110.1007/s12282-017-0812-x29086897Open DOISearch in Google Scholar
AlFakeeh A, Brezden-Masley C. Overcoming endocrine resistance in hormone receptor-positive breast cancer. Curr Oncol 2018; 25(Suppl 1): S18-27. doi: 10.3747/co.25.3752AlFakeehABrezden-MasleyCOvercoming endocrine resistance in hormone receptor-positive breast cancerCurr Oncol201825Suppl 1S182710.3747/co.25.3752600175629910644Open DOISearch in Google Scholar
Hamilton E, Infante JR. Targeting CDK4/6 in patients with cancer. Cancer Treat Rev 2016; 45: 129-38. doi: 10.1016/j.ctrv.2016.03.002HamiltonEInfanteJRTargeting CDK4/6 in patients with cancerCancer Treat Rev2016451293810.1016/j.ctrv.2016.03.00227017286Open DOISearch in Google Scholar
Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med 2016; 375: 1925-36. doi: 10.1056/NEJMoa1607303FinnRSMartinMRugoHSJonesSImSAGelmonKet alPalbociclib and letrozole in advanced breast cancerN Engl J Med201637519253610.1056/NEJMoa160730327959613Open DOISearch in Google Scholar
Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, 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 2017; 35: 2875-84. doi: 10.1200/JCO.2017.73.7585SledgeGW JrToiMNevenPSohnJInoueKPivotXet alMONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2-advanced breast cancer who had progressed while receiving endocrine therapyJ Clin Oncol20173528758410.1200/JCO.2017.73.758528580882Open DOISearch in Google Scholar
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. doi: 10.1056/NEJMoa1609709HortobagyiGNStemmerSMBurrisHAYapYSSonkeGSPaluch-ShimonSet alRibociclib as first-line therapy for HR-positive, advanced breast cancerN Engl J Med201637517384810.1056/NEJMoa160970927717303Open DOISearch in Google Scholar
Tripathy D, Bardia A, Sellers WR. Ribociclib (LEE011): mechanism of action and clinical impact of this selective cyclin-dependent kinase 4/6 inhibitor in various solid tumors. Clin Cancer Res 2017; 23: 3251-62. doi:10.1158/1078-0432.Ccr-16-3157TripathyDBardiaASellersWRRibociclib (LEE011): mechanism of action and clinical impact of this selective cyclin-dependent kinase 4/6 inhibitor in various solid tumorsClin Cancer Res20172332516210.1158/1078-0432.Ccr-16-3157Open DOISearch in Google Scholar
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 15417. doi: 10.1093/annonc/mdy155HortobagyiGNStemmerSMBurrisHAYapYSSonkeGSPaluch-ShimonSet alUpdated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancerAnn Oncol2018291541710.1093/annonc/mdy15529718092Open DOISearch in Google Scholar
Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, 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 2018; 36: 2465-72. doi: 10.1200/JCO.2018.78.9909SlamonDJNevenPChiaSFaschingPADe LaurentiisMImSAet alPhase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3J Clin Oncol20183624657210.1200/JCO.2018.78.990929860922Open DOISearch in Google Scholar
Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N 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 2018; 19: 904-15. doi: 10.1016/S1470-2045(18)30292-4TripathyDImSAColleoniMFrankeFBardiaAHarbeckNet alRibociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trialLancet Oncol2018199041510.1016/S1470-2045(18)30292-429804902Open DOISearch in Google Scholar
Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Hart L, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med 2022; 386: 942-50. doi: 10.1056/NEJMoa2114663HortobagyiGNStemmerSMBurrisHAYapYSSonkeGSHartLet alOverall survival with ribociclib plus letrozole in advanced breast cancerN Engl J Med20223869425010.1056/NEJMoa211466335263519Open DOISearch in Google Scholar
Tripathy D, Im S, Colleoni M, Franke F, Bardia A, Harbeck N, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. [Abstract PD2-04]. San Antonio Breast Cancer Virtual Symposium, San Antonio, Texas, USA, December 8-12, 2020. doi: 10.1158/1538-7445.SABCS20-PD2-04TripathyDImSColleoniMFrankeFBardiaAHarbeckNet alUpdated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with hormone receptor positive epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. [Abstract PD2-04]. San Antonio Breast Cancer Virtual SymposiumSan Antonio, Texas, USADecember 8-12202010.1158/1538-7445.SABCS20-PD2-04Open DOISearch in Google Scholar
Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. doi: 10.1056/NEJMoa1911149SlamonDJNevenPChiaSFaschingPADe LaurentiisMImSAet alOverall survival with ribociclib plus fulvestrant in advanced breast cancerN Engl J Med20203825142410.1056/NEJMoa191114931826360Open DOISearch in Google Scholar
DeLaurentiis M, Neven P, Jerusalem GHM, Bachelot TD, Jacot W, Dent SF, et al. Ribociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) with no prior endocrine therapy (ET) for ABC: Preliminary results from the phase 3b CompLEEment-1 trial. [Abstract 1056P]. J Clin Oncol 2018; 36: 1056. doi: 10.1200/JCO.2018.36.15_suppl.1056DeLaurentiisMNevenPJerusalemGHMBachelotTDJacotWDentSFet alRibociclib (RIBO) + letrozole (LET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced breast cancer (ABC) with no prior endocrine therapy (ET) for ABC: Preliminary results from the phase 3b CompLEEment-1 trial[Abstract 1056P]. J Clin Oncol201836105610.1200/JCO.2018.36.15_suppl.1056Open DOISearch in Google Scholar
De Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, et al. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat 2021; 189: 68999. doi: 10.1007/s10549-021-06334-0De LaurentiisMBorstnarSCamponeMWarnerEBofillJSJacotWet alFull population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded populationBreast Cancer Res Treat20211896899910.1007/s10549-021-06334-0850529134414532Open DOISearch in Google Scholar
Bilgin B, Sendur MAN, Sener Dede D, Akinci MB, Yalcin B. A current and comprehensive review of cyclin-dependent kinase inhibitors for the treatment of metastatic breast cancer. Curr Med Res Opin 2017; 33: 1559-69. doi: 10.1080/03007995.2017.1348344BilginBSendurMANSenerDede DAkinciMBYalcinBA current and comprehensive review of cyclin-dependent kinase inhibitors for the treatment of metastatic breast cancerCurr Med Res Opin20173315596910.1080/03007995.2017.134834428657360Open DOISearch in Google Scholar
Finn RS, Aleshin A, Slamon DJ. Targeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancers. Breast Cancer Res 2016; 18: 17. doi: 10.1186/s13058-015-0661-5FinnRSAleshinASlamonDJTargeting the cyclin-dependent kinases (CDK) 4/6 in estrogen receptor-positive breast cancersBreast Cancer Res2016181710.1186/s13058-015-0661-5474689326857361Open DOISearch in Google Scholar
Verma S, O’Shaughnessy J, Burris HA, Campone M, Alba E, Chandiwana D, et al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res Treat 2018; 170: 535-45. doi:10.1007/s10549-018-4769-zVermaSO’ShaughnessyJBurrisHACamponeMAlbaEChandiwanaDet alHealth-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2Breast Cancer Res Treat20181705354510.1007/s10549-018-4769-z602253129654415Open DOISearch in Google Scholar