325
Views
4
CrossRef citations to date
0
Altmetric
Original Research

Thromboembolic Events in Patients with HER2-Negative, Hormone Receptor-Positive, Metastatic Breast Cancer Treated with Ribociclib Combined with Letrozole or Fulvestrant: A Real-World Data

ORCID Icon, ORCID Icon, , , , , , ORCID Icon, & show all
Pages 1033-1041 | Published online: 08 Mar 2022

References

  • Abdol Razak NB, Jones G, Bhandari M, Berndt MC, Metharom P. Cancer-associated thrombosis: an overview of mechanisms, risk factors, and treatment. Cancers. 2018;10(10):380. doi:10.3390/cancers10100380
  • Prandoni P, Falanga A, Piccioli A. Cancer and venous thromboembolism. Lancet Oncol. 2005;6(6):401–410. doi:10.1016/S1470-2045(05)70207-2
  • Mulder FI, Horváth-Puhó E, van Es N, et al. Venous thromboembolism in cancer patients: a population-based cohort study. Blood. 2021;137(14):1959–1969. doi:10.1182/blood.2020007338
  • Moik F, Chan WE, Wiedemann S, et al. Incidence, risk factors, and outcomes of venous and arterial thromboembolism in immune checkpoint inhibitor therapy. Blood. 2021;137(12):1669–1678. doi:10.1182/blood.2020007878
  • Fuentes HE, Tafur AJ, Caprini JA. Cancer-associated thrombosis. Dis Mon. 2016;62(5):121–158. doi:10.1016/j.disamonth.2016.03.003
  • Khorana AA, Francis CW, Culakova E, Lyman GH. Risk factors for chemotherapy-associated venous thromboembolism in a prospective observational study. Cancer. 2005;104(12):2822–2829. doi:10.1002/cncr.21496
  • Khorana AA, Dalal M, Lin J, Connolly GC. Incidence and predictors of venous thromboembolism (VTE) among ambulatory high-risk cancer patients undergoing chemotherapy in the United States. Cancer. 2013;119(3):648–655. doi:10.1002/cncr.27772
  • Abdel-Razeq H, Mansour A, Abdulelah H, et al. Thromboembolic events in cancer patients on active treatment with cisplatin-based chemotherapy: another look! Thromb J. 2018;16(2). doi:10.1186/s12959-018-0161-9
  • Sung H, Ferlay J, Siegel RL, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71(3):209–249. doi:10.3322/caac.21660
  • Ferlay J, Colombet M, Soerjomataram I, et al. Cancer statistics for the year 2020: an overview. Int J Cancer. 2021;149(4):778–789. doi:10.1002/ijc.33588
  • Lei S, Zheng R, Zhang S, et al. Global patterns of breast cancer incidence and mortality: a population-based cancer registry data analysis from 2000 to 2020. Cancer Commun. 2021;41(11):1183–1194. doi:10.1002/cac2.12207
  • Howlader N, Altekruse SF, Li CI, et al. US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status. J Natl Cancer Inst. 2014;106(5):dju055. doi:10.1093/jnci/dju055
  • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001):1341–1352. doi:10.1016/S0140-6736(15)61074-1
  • US Food & Drug Administration. Resources for Information; Approved Drugs: Palbociclib (IBRANCE); 2017. Available from: https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance. Accessed February 28, 2022.
  • Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, Phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17 (4): e136][published correction appears in Lancet Oncol. 2016;17 (7): e270]. Lancet Oncol. 2016;17(4):425–439. doi:10.1016/S1470-2045(15)00613-0
  • Dickler MN, Tolaney SM, Rugo HS, et al. MONARCH 1, A Phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2− metastatic breast cancer [published correction appears in Clin Cancer Res. 2018; 24(21):5485]. Clin Cancer Res. 2017;23(17):5218–5224. doi:10.1158/1078-0432.CCR-17-0754
  • Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–524. doi:10.1056/NEJMoa1911149
  • Sledge GW Jr, Toi M, Neven P, 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(25):2875–2884. doi:10.1200/JCO.2017.73.7585
  • Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719–729. doi:10.1007/s10549-018-05125-4
  • Hortobagyi GN, Stemmer SM, Burris HA, 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 [published correction appears in Ann Oncol. 2019; 30(11):1842]. Ann Oncol. 2018;29(7):1541–1547. doi:10.1093/annonc/mdy155
  • Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925–1936. doi:10.1056/NEJMoa1607303
  • Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638–3646. doi:10.1200/JCO.2017.75.6155
  • Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med. 2018;379(20):1926–1936. doi:10.1056/NEJMoa1810527
  • Llombart-Cussac A, Pérez-García JM, Bellet M, et al. Fulvestrant-palbociclib vs letrozole-palbociclib as initial therapy for endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer: a randomized clinical trial. JAMA Oncol. 2021:e214301. doi:10.1001/jamaoncol.2021.4301
  • Neven P, Rugo HS, Tolaney SM, et al. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021;23(1):87. doi:10.1186/s13058-021-01463-2
  • Tripathy D, Im SA, Colleoni M, 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(7):904–915. doi:10.1016/S1470-2045(18)30292-4
  • Yang L, Xue J, Yang Z, et al. Side effects of CDK4/6 inhibitors in the treatment of HR+/HER2- advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials. Ann Palliat Med. 2021;10(5):5590–5599. doi:10.21037/apm-21-1096
  • NCCN Clinical practice guidelines in oncology. Breast cancer, version 8; 2021. Available from: https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Accessed November 01, 2021.
  • Hu W, Sung T, Jessen BA, et al. Mechanistic investigation of bone marrow suppression associated with palbociclib and its differentiation from cytotoxic chemotherapies. Clin Cancer Res. 2016;22(8):2000–2008. doi:10.1158/1078-0432.CCR-15-1421
  • Chandrasekhar S, Fradley MG. QT interval prolongation associated with cytotoxic and targeted cancer therapeutics. Curr Treat Options Oncol. 2019;20(7):55. doi:10.1007/s11864-019-0657-y
  • Thein KZ, Htut TW, Ball S, Swarup S, Sultan A, Oo TH. Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2020;183(2):479–487. doi:10.1007/s10549-020-05783-3
  • Raschi E, Fusaroli M, Ardizzoni A, Poluzzi E, De Ponti F. Thromboembolic events with cyclin-dependent kinase 4/6 inhibitors in the FDA adverse event reporting system. Cancers. 2021;13(8):1758. doi:10.3390/cancers13081758
  • Rugo HS, Huober J, García-Sáenz JA, et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3 [published correction appears in Oncologist. 2021; 26(3):e522]. Oncologist. 2021;26(1):e53–e65. doi:10.1002/onco.13531
  • Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987–3998. doi:10.1200/JCO.20.02514
  • Yan MM, Wu SS, Qi YP, et al. Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. Expert Opin Drug Saf. 2021:1–7. doi:10.1080/14740338.2021.1981856
  • Weimar C, Masuhr F, Hajjar K. Diagnosis and treatment of cerebral venous thrombosis. Expert Rev Cardiovasc Ther. 2012;10(12):1545–1553. doi:10.1586/erc.12.126
  • Cole B, Criddle LM. A case of postpartum cerebral venous thrombosis. J Neurosci Nurs. 2006;38(5):350–353. doi:10.1097/01376517-200610000-00005
  • Nagumo K, Fukushima T, Takahashi H, Sakakibara Y, Kojima S, Akikusa B. [Thyroid crisis and protein C deficiency in a case of superior sagittal sinus thrombosis]. Brain Nerve. 2007;59(3):271–276. Japanese.
  • Zhang Z, Long J, Li W. Cerebral venous sinus thrombosis: a clinical study of 23 cases. Chin Med J. 2000;113(11):1043–1045. PMID: 11776122.
  • Aguiar de Sousa D, Mestre T, Ferro JM. Cerebral venous thrombosis in Behçet’s disease: a systematic review. J Neurol. 2011;258(5):719–727. doi:10.1007/s00415-010-5885-9
  • Katsanos AH, Katsanos KH, Kosmidou M, Giannopoulos S, Kyritsis AP, Tsianos EV. Cerebral sinus venous thrombosis in inflammatory bowel diseases. QJM. 2013;106(5):401–413. doi:10.1093/qjmed/hcs229